Immunotherapien.

Damit möchte ich einen Überblick gewinnen und schaffen über die derzeitige Entwicklung auf  dem Gebiet der Antikörpertherapien + Immunotherapien, natürlich vorwiegend soweit börsennotierte  Unternehmen involviert sind. Da es sich um einen neueren Threapieansatz handelt - derzeit sind laut 'Nature' 18 Medikamente zugelassen, die auf
Antikörpern basieren, wird die weitere kommerzielle Nutzung des Therapieansatzes und damit auch die Börsenkurse der betroffenen Unternehmen von weiteren Zulassungserfolgen abhängen.
Dieser Trend  soll hier beobachtet und ggf. kommentiert werden. Ergänzungen willkommen.

 

The study in question, an international, multicentre, randomised, 3-arm trial is being conducted by the Breast International Group (BIG) in collaboration with the pharmaceutical company Roche AG, manufacturers of Herceptin. In total, 5,090 early breast cancer patients have been enrolled into this trial by the 478 participating institutions from Europe, Canada, South Africa, Israel, the Asia Pacific Region, Japan and Latin America. All women accrued had HER-2 positive breast cancer (either node negative or positive) and had completed at least four cycles of an acceptable (neo) adjuvant chemotherapy regimen. For women with hormone receptor positive disease, adjuvant endocrine therapy (most commonly tamoxifen) followed chemotherapy. The average age of study participants is 49 years.

The aim of this trial is to compare the effect of 1 year of Herceptin infusions, given every 3 weeks, with one year of simple observation, on survival – primarily DFS but also overall survival (OS), relapse-free survival (RFS) and distant disease free survival (DDFS), as well as comparable assessment of overall and cardiac safety. The study also consists of a 2-year arm – where 2 years of 3-weekly Herceptin is being compared with observation.

Results from the 1-year arm of the study, showcased at ECCO 13, show that Herceptin is associated with a significant improvement in DFS in this group of patients. The difference in Herceptin treated women was 85.8% compared to 77.4% of women on observation alone. Patients receiving Herceptin therapy for 1 year also showed significant improvements in other survival measures – including RFS and DDFS. OS was also better in the Herceptin group versus observation, although the difference was not significant. In terms of safety, Herceptin-treated women experienced a higher incidence of cardiac side effects, which occurred in 0.5% of patients. In contrast, no observational patient experienced an adverse cardiac event.

These positive results are further supported by preliminary survival data from the 2-year Herceptin arm which also demonstrate a highly significant improvement in DFS compared with observation (p<0.0001). This important trial is continuing, gathering further data to assess and compare 2 years versus 1 year of Herceptin treatment, as well as carefully monitoring potential late-stage effects.

Professor Michael Untch, the study's Principle Investigator, from the Frauenklinik der LMU München Klinikum Grosshadern, Germany remarked: "These notable early findings show that Herceptin can provide significant improvements in survival for women with early HER-2 positive breast cancer who have completed initial chemotherapy cycles. By reducing the incidence of recurrences and metastasis by 50 % it means that patients have a significant gain in their chance to survive and a tremendous increase of their life quality. "

Another new monoclonal antibody, bevacizumab has recently completed Phase III clinical trials for the treatment of locally advanced or metastatic breast cancer. Bevacizumab is a monoclonal antibody to vascular endothelial growth factor (VEGF) and acts to inhibit tumour angiogenesis (process of diverting nutrients to the tumour).

The randomised Phase III trial was coordinated by the Eastern Cooperative Oncology Group to compare the efficacy and safety of paclitaxel with or without bevacizumab as first line therapy in patients with locally advanced or metastatic breast cancer. 722 patients were recruited between December 2001 and May 2004 and were divided into two groups receiving either paclitaxel alone or the combination of paclitaxel and bevacizumab. The primary endpoint was progression-free survival (PFS).

The results were positive and indicated that the combination of paclitaxel and bevacizumab improved overall survival of patients than receiving paclitaxel alone (no final data available yet). Importantly the progression-free survival was improved with combination therapy, 10.97 months vs 6.11 months for paclitaxel alone. In addition, the investigators noted that combination therapy did not cause significant toxicity effects.

Speaking at ECCO 13, Dr Kathy Miller from the Indiana University Cancer Centre, USA, commented, "This is the first study to confirm the benefit of anti-angiogenic therapy in patients with breast cancer. Importantly, the improvements in response rate and progression-free survival were obtained with minimal increase in side effects. Given the benefit of bevacizumab in patients with metastatic disease, we look forward to initiating trials in the adjuvant setting."

###

About Breast cancer
Breast cancer is a malignant tumour that usually begins in the milk ducts (ductal carcinoma) or lobules or milk producing tissue (lobular carcinoma) of the breast. Either type if diagnosed early enough, may be called 'in situ' which means the cancer has not spread or invasive if it has. Rarer breast cancers affect other types of breast tissue.

Breast cancer is the most commonly diagnosed cancer in women, nearly 1 in 3 of all cancers in women occur in the breast.1 80% of breast cancers appear in post-menopausal women. Although rarer, some men can suffer from breast cancer.

Associated risks of breast cancer can be attributed to genetics, early onset of menstruation, no pregnancies or first pregnancy after the age of thirty, previous breast disorders, alcohol, smoking and diet.2

Treatment depends on the staging of the disease, classified from I to IV (higher the number, the more advanced the cancer). Surgery and radiotherapy is usually first line treatment, however hormone or chemotherapy treatment can be given first to shrink the tumours. The majority of breast cancers are hormone responsive and can be treated with oestrogen blockers such as tamoxifen or the newer aromatose inhibitors which are normally administered after surgery to prevent the cancer returning.

In non-hormone responsive breast cancers, which includes those with a genetic predisposition to breast cancer and who are carrying the HER2 gene, the new drug Herceptin offers hope. It is successful in blocking the growth-promoting protein found on the surface of most breast cancers thereby preventing the spread of the cancer.3 Recently other types of biological therapies similar to Herceptin are starting to show promise in the treatment of advanced breast cancers.

For further information please contact:
Tonic Life Communications:
Stéphanie Makin: + 44 7769 673 973 or e-mail stephanie.makin@toniclc.com or
Kirsten Mason: + 44 7796 955 353 or e-mail kirsten.mason@toniclc.com

Press room:
Telephone: + 33 (0)1 40 68 27 45/ + 33 (0)1 40 68 27 46
Telefax: + 33 (01) 40 68 27 49/ + 33 (01) 40 68 27 52

For any enquiries after Thursday 3rd November 2005, please contact:
Stéphanie Makin: + 44 (0)20 7798 9905 or e-mail stephanie.makin@toniclc.com or
Kirsten Mason: + 44 (0)20 7798 9911 or e-mail kirsten.mason@toniclc.com

1 www.breastcancercare.org.uk
2 Information from breastcancercare.org.uk and Canadian Cancer Society
3 www.cancer.org

ischämischen Schlaganfall zulässt, die Registrierung zur Studie
wiederaufzunehmen", sagte Dr. Jerome A. Boscia, Senior Vice President für
Klinische F&E bei Centocor, Inc. "Es ist jedoch wichtig anzumerken, dass
REOPRO für seine genehmigten Einsatzbereiche bei Patienten, die sich
Eingriffen am Herzen, wie einer Angioplastie oder Stent-Implantation,
unterziehen, über ein etabliertes positives Nutzen-Risiko-Profil verfügt."

REOPRO gilt gegenwärtig als Mittel zur Unterstützung einer perkutanen
Koronarintervention (PCI) zur Verhinderung von ischämischen
Herzkomplikationen bei Patienten, die sich einer PCI unterziehen, sowie bei
Patienten mit instabiler Angina, die auf herkömmliche medikamentöse Therapie
nicht ansprechen, wenn die perkutane Koronarintervention innerhalb von 24
Stunden geplant ist. Die Unternehmen unterstreichen noch einmal eindeutig,
dass sie keinerlei neue Daten kennen, die das positive Produktprofil für
REOPRO unter genehmigten Indikationen ändern, also unter Indikationen, die
durch über 14 randomisierte klinische Studien und durch ein ganzes Jahrzehnt
klinischer Erfahrungen unterstützt werden. Die gegenwärtige Studie AbESTT-II
bewertet die Sicherheit und Wirksamkeit von REOPRO bei Patienten mit akutem
ischämischen Schlaganfall.

 

Über AbESTT-II

AbESTT-II ist eine multinationale, multizentrische, randomisierte,
doppeltblinde, placebokontrollierte Studie der Phase 3, die die
Sicherheit und Wirksamkeit von REOPRO zur Verbesserung der neurologischen
Funktion und zur Minimierung der Behinderung bei Patienten bewertet, die
einen akuten ischämischen Schlaganfall erlitten haben. Vorläufige Ergebnisse
aus anderen Studien legen nahe, dass sich REOPRO für die
Schlaganfallbehandlung über das Zeitfenster von drei Stunden hinaus als
nützlich erweisen könnte, innerhalb dessen die einzige, zur Zeit genehmigte
Therapie eingesetzt wird, um bei Patienten mit ischämischen Schlaganfall
Blutgerinnsel aufzulösen. Die meisten Schlaganfallpatienten kommen erst
später als drei Stunden nach Einsetzen der Symptome in der Notaufnahme an.
Die Studie bewertet zwei Populationen: innerhalb von 4,5 Stunden
randomisierte Patienten mit einer geplanten Behandlung innerhalb von fünf
Stunden nach Beginn des Schlaganfalls (primäre Analysepopulation, n=1200) und
eine begleitende Population von Patienten, die 4,5 bis 5,5 Stunden nach dem
beginnenden Schlaganfall randomisiert werden und bei denen die geplante
Behandlung innerhalb von sechs Stunden begonnen wird oder die mit
Schlaganfallsymptomen aufwachen und innerhalb von 2,5 Stunden nach dem
Erwachen randomisiert werden (n=600). Im Mai 2005 wurde die Behandlung jenes
kleinen Segmentes an Patienten, die nach einem erlittenen Schlaganfall
aufgewacht sind, aufgrund eines erhöhten intrakraniellen Blutungsrisikos in
dieser Population eingestellt. Zu diesem Zeitpunkt empfahl der SEMC die
Fortführung der Registrierung, wobei die verbleibenden Gruppen in der Studie
bewertet werden sollten.

An dieser weltweiten klinischen Studie 'AbESTT-II', die 2003 begann,
nehmen ca. 150 Institutionen teilen. Ziel waren 1800 registrierte Teilnehmer.

 

Über den akuten ischämischen Schlaganfall

Ein akuter ischämischer Schlaganfall tritt ein, wenn im Gehirn ein
Blutgefäss blockiert wird. Diese Blockade verhindert, dass Sauerstoff und
Nährstoffe im Blut zu einem bestimmten Gehirnteil gelangen, wodurch dieses
abstirbt. Ungefähr 85 % aller Schlaganfälle gelten als ischämisch, werden
also durch ein Blutgerinnsel oder eine Ablagerung verursacht, das bzw. die im
Gehirn ein Blutgefäss blockiert. In den Vereinigten Staaten sind
Schlaganfälle die dritthäufigste Todesursache und führen jährlich zu über
150.000 Todesfällen.

 

Wichtige Sicherheitsinformationen

REOPRO kann potenziell - besonders bei anwesenden Antikoagulationsmitteln
, wie Heparin, oder anderer Gerinnungshemmer oder Thrombolytika - das Risiko
von Blutungen erhöhen. Das Risiko einer grösseren Blutung infolge einer
REOPRO-Therapie ist bei Patienten erhöht, die Thrombolytika einnehmen, und
sollte gegen die erwarteten Nutzeffekte abgewogen werden.

Zu den Richtlinien zur Verringerung von Blutungen zählen u. a.: der
Einsatz eines gering dosierten, an das Gewicht angepassten Heparinkur, die
Einstellung der Heparin-Einnahme bei Abschluss der Prozedur mit Entfernung
der Arterienscheide innerhalb von sechs Stunden, sorgfältige Beobachtung und
Behandlung der Gefässzugangsstelle und des Patienten insgesamt,
einschliesslich der nötigen Aufmerksamkeit für andere potenzielle
Blutungsstellen, Einsatz eines an das Gewicht angepassten Bolus und eine
kontinuierliche Infusionsdosis von REOPRO.

In klinischen Studien war die Wahrscheinlichkeit abnehmender
Thrombozytenmengen, einschliesslich schwerer Thrombozytopathien (siehe auch
unten: Erneute Verabreichung) bei Patienten, die mit REOPRO behandelt worden
waren, grösser als bei Patienten, die ein Placebo erhalten hatten.

Die Verabreichung von REOPRO kann zur Bildung humaner, antichimärer
Antikörper (HACA) führen, die potenziell allergische Reaktionen oder
Überempfindlichkeit, (einschliesslich Anaphylaxie), Thrombozytopenien oder
eine verringerte Wirkung bei erneuter Verabreichung hervorrufen kann. In
einer Registrierstudie zur erneuten Verabreichung von REOPRO (1342
Behandlungen bei 1286 Patienten) gab es keine Berichte über schwerwiegende
allergische Reaktionen oder Anaphylaxie. Fälle von Thrombozytopenien traten
in der Studie zur erneuten Verabreichung häufiger auf als in den Studien der
Phase 3 zur erstmaligen Verabreichung. Dies legt nahe, dass die erneute
Verabreichung u. U. mit einer gestiegenen Häufigkeit und Schwere von
Thrombozytopenien verbunden ist. Dieses erhöhte Risiko ging einher mit
Thrombozytopenien in der Vergangenheit bei vergangenen REOPRO-Zuführungen,
einer positiven HACA-Probe an der Basislinie und einer erneuten Verabreichung
innerhalb von 30 Tagen.

In Berichten über unerwünschte Wirkungen nach dem Vertrieb wurden seltene
Fälle von Anaphylaxie bei mit REOPRO behandelten Patienten gemeldet. Wenn
eine Überempfindlichkeit auftritt, ist die Verabreichung von REOPRO sofort
einzustellen, und es sind geeignete Wiederbelebungsmassnahmen einzuleiten.

Da REOPRO das Blutungsrisiko vergrössern kann, darf es in folgenden
klinischen Situationen nicht angewandt werden: aktive innere Blutungen,
kürzliche (innerhalb von sechs Wochen) Magen-Darm-Blutungen oder urogenitale
Blutungen von klinischer Bedeutung, Apoplexie in der Krankengeschichte
innerhalb der letzten zwei Jahre von oder Apoplexie mit einem bedeutenden
neurologischen Restdefizit, Blutungsdiathese, Verabreichung oraler
Gerinnungshemmer innerhalb von sieben Tagen, sofern die Prothrombinzeit
weniger oder gleich dem 1,2-fachen des Kontrollwertes liegt,
Thrombozytopenien (< 100.000 Zellen/pro Mikroliter), vor kurzem (innerhalb
der letzten sechs Wochen) erfolgte schwere Operationen oder Traumen,
intrakranielles Neoplasma, arteriovenöse Fehlfunktion oder Aneurysma, schwere
unkontrollierte Hypertonie, angenommene oder dokumentierte Vorgeschichte von
Vasculitis, Verwendung von intravenösem Dextran vor einem perkutanen
Herzeingriff oder bei geplanter Verwendung während des Eingriffs, bekannte
Überempfindlichkeit gegenüber einem Bestandteil dieses Produktes oder
gegenüber Mäuseproteinen.

REOPRO wurde von Centocor in Malvern, Pa., USA, entwickelt und von
Centocor, B.V. im niederländischen Leiden hergestellt. Eli Lilly and
Company vermarktet und vertreibt das Produkt weltweit, mit Ausnahme von
Japan.

 

Über Centocor

Centocor ist ein führendes biopharmazeutisches Unternehmen, das
kosteneffektive Therapien mit langfristigen Vorteilen für Patienten und
Gesundheitswesen entwickelt, akquiriert und vermarktet. Die Firma engagiert
sich in der Forschung und Entwicklung zur Behandlung einer breiten Palette an
Krankheiten, wie Krebs, Infektions-, Herz-Kreislauf- und Stoffwechsel- sowie
immunvermittelte Entzündungskrankheiten (I.M.I.D.), wie beispielsweise
Arthritis und Entzündungskrankheiten der Haut. Mit Centocors Produkten, die
vor allem durch monoklonale Antikörpertechnologie entwickelt werden, können
Ärzte innovative Behandlungsmöglichkeiten besser realisieren, um die
menschliche Gesundheit zu verbessern und die Lebensqualität der Patienten
wiederherzustellen. Centocor ist ein hundertprozentiges Tochterunternehmen
von Johnson & Johnson, dem weltweiten Hersteller von Gesundheitsprodukten.

 

Über Eli Lilly and Company

Lilly, ein führendes innovationsorientiertes Unternehmen, entwickelt ein
wachsendes Portfolio an pharmazeutischen 'First-In-Class'- und
'Best-In-Class'-Produkten, indem es die neuesten Forschungsergebnisse aus
firmeneigenen internationalen Laboratorien einsetzt und mit herausragenden
wissenschaftlichen Organisationen zusammenarbeitet. Das Unternehmen hat
seinen Hauptsitz in Indianapolis, Indiana, und bietet durch seine Medikamente
und Informationen Lösungen für einige der weltweit dringlichsten
medizinischen Probleme. Zusätzliche Informationen zu Lilly finden Sie unter
http://www.lilly.com.

 

Website: http://www.lilly.com

Centocor, Inc.; Eli Lilly and
 

yahoo.reuters.com/...2548_2005-10-31_19-31-51_n31680796_newsml

UPDATE 1-Abbott's Humira promising for Crohn's Disease
Mon Oct 31, 2005 02:31 PM ET (Adds details, background, stock price)
NEW YORK, Oct 31 (Reuters) - Abbott Laboratories Inc. (ABT.N: Quote, Profile, Research) on Monday said its rheumatoid arthritis drug Humira showed positive results in a late-stage trial in treating the chronic intestinal condition Crohn's Disease.
The suburban Chicago company said 83 percent of patients who received the drug every week stayed disease-free for one year, while the rates of remission were 74 percent for those taking it every other week and 44 percent for those taking a placebo.
Abbott is presenting the results from its Phase 3 extension study, involving 55 patients whose moderate to severe disease went into remission after receiving Humira for four weeks, at a gastroenterology meeting this week.
William Sandborn of the Mayo Clinic's inflammatory bowel disease clinic called the results promising.
"There is no cure for Crohn's disease ... the next critical step is maintaining clinical remission, thereby preventing disease flares that may disrupt patients' lives," he said.
Crohn's Disease is a chronic inflammation of the intestinal wall that causes frequent diarrhea, cramping and abdominal pain.
Humira, which was recently approved to treat psoriatic arthritis, is Abbott's biggest product with global sales of $356 million during the third quarter.
Abbott shares were up 29 cents at $43.05 in afternoon trading on the New York Stock Exchange.

Crohn's disease is a chronic inflammatory bowel disorder that affects approximately one million people in the US and Europe alone.(1,2) Because there is no cure, treatment is focused on suppressing the inflammatory response that is at the root of its cause. Cimzia(TM) is a biologic agent that has been designed to inhibit the production of tumor necrosis factor alpha (TNF-alpha), a protein involved in the inflammation process.
   Study Highlights    -- 64 percent of the 668 patients enrolled in the trial responded to      induction therapy by week 6. Those who responded were randomized to      receive maintenance treatment with either Cimzia(TM) (n=216) or placebo      (n=212).    -- 62.8 percent of patients receiving Cimzia(TM) maintenance therapy      sustained an overall clinical response throughout the 26-week study      period, compared to 36.2 percent with placebo.    -- The primary endpoints of PRECiSE 2 trial were met with statistical      significance, irrespective of C-reactive protein (CRP, a marker of      inflammation) status or prior exposure to anti-TNF therapy.    -- 47.9 percent of patients receiving Cimzia(TM) maintenance therapy were      in clinical remission at week 26, compared to 28.8 percent with      placebo.    -- Adverse events were mostly mild to moderate with the most common being      headache (maintenance: certolizumab 6.9 percent; placebo 6.6 percent).      Serious non-CD-related infections were observed in both the Cimzia(TM)      (certolizumab pegol, CDP 870) (3 events) and placebo (2 events)      treatment groups.  



The PRECiSE clinical trial program is composed of four studies (PRECiSE 1, 2, 3 and 4). In addition to PRECiSE 2, the detailed results of which were presented at ACG, PRECiSE 1 is a 26-week double-blind, placebo-controlled trial, and represents the first long-term fully placebo-controlled clinical trial of a biologic in Crohn's disease. PRECiSE 1 successfully met its primary endpoints with statistical significance. As expected from a study with such a challenging trial design, top-line results were of lower magnitude than observed in the PRECiSE 2 trial. The detailed analysis of the PRECiSE 1 data is still ongoing, with results planned for presentation at a forthcoming gastroenterology congress. PRECiSE 3 and 4 are both 24-month, open-label trials for patients who participated in either PRECiSE 1 or 2, assessing the longer-term safety and tolerability of Cimzia(TM), and are currently ongoing.
Methods
The 26-week PRECiSE 2 study was designed to assess the safety and efficacy of Cimzia 400 mg for the maintenance of clinical response after open-label induction therapy in patients with mild to moderate Crohn's disease. Those who responded by week six were randomized to receive either a once-monthly maintenance dose of certolizumab 400 mg or placebo. Clinical response was defined as a 100 point drop in the Crohn's Disease Activity Index (CDAI), which measures the disease severity by taking into account a number of factors such as intensity of symptoms, medication and general well-being. The primary endpoint was the percentage of patients at week 26 with a C-reactive protein (CRP, a marker of inflammation) level greater than or equal to 10 mg who maintained a clinical response after successful induction. Major secondary endpoints included remission (CDAI less than or equal to 150) in those with a CRP level greater than or equal to 10mg, and response and remission in the overall treatment population.
About Crohn's Disease
Crohn's disease is a chronic disorder that causes inflammation of the gastrointestinal tract, most commonly at the end of the small intestine (the ileum) and beginning of the large intestine (the colon). Common symptoms include diarrhea, fever, abdominal pain and weight loss. Although it can occur at any age, it primarily impacts young adults between the ages of 15 and 35. Because it is a chronic illness, patients experience an ongoing cycle of symptom "flare-ups" and periods of remission, when symptoms disappear or are controlled.(1) This cycle can impact all aspects of a patient's life, including their pursuit of higher education and relationships with employers, friends and family members.(3)
About Cimzia(TM)
Cimzia(TM) is unique anti-TNF therapy in that it is a humanized antibody Fab' fragment chemically attached to polyethylene glycol (PEG, i.e. PEGylated). PEGylation increases the plasma half-life of certolizumab to approximately two weeks.
About UCB
UCB (http://www.ucb-group.com/) is a global biopharmaceutical leader dedicated to the research, development and commercialization of innovative products in the fields of central nervous system disorders, allergy and respiratory diseases, immune and inflammatory disorders and oncology. UCB employs over 8,500 people operating in over 40 countries, and achieved revenues of 2.1 billion euros (including net turnover, royalties, and fees) in 2004. UCB is listed on the Euronext Brussels with a market capitalization of approximately 5.5 billion euros. Worldwide headquarters are located in Brussels, Belgium.
UCB Pharma, Inc. is the North American subsidiary of UCB, with U.S. headquarters located in Smyrna, Georgia. UCB's key products in the U.S. are Keppra(R) (levetiracetam), Zyrtec(R)+ (cetirizine HCl), Tussionex(R) CIII
(hydrocodone polistirex/chlorpheniramine polistirex), and Metadate CD(TM) CII (methylphenidate HCl, USP).
   + Zyrtec is licensed to and co-promoted with Pfizer, Inc. in the United     States.    (1)  Crohn's and Colitis Foundation of America. Disease Information page:        http://www.ccfa.org/info/about/crohns. Accessed October 3, 2005.   (2)  European Federation of Crohn's & Ulcerative Colitis Associations.        Newsletter, pg. 30, May 2005 (http://www.efcca.org/efcca_nl22.pdf).   (3)  Crohn's and Colitis Foundation of America and the Digestive Disease        National Coalition. Voices of Crohn's Survey:        http://www.crohnsresource.com/voices/key_findings.html. Accessed        September 22, 2005.  
UCB Pharmaceuticals Inc.
CONTACT: Lisa B. Garman, Head, U.S. Communications & Public Relations,Mobile, +1-404-291-4772, or Susan Thiele, Ketchum Public Relations,+1-646-935-4133, susan.thiele@ketchum.com; or Investor Relations -Jean-Christophe Donck, Vice President, Corporate Communication & InvestorRelations, +32-2-559-9588, Fax +32-2-559-9571, JC.Donck@UCB-Group.com
Web Site: http://www.ucb-group.com/http://www.ccfa.org/info/...ey_findings.html
Source: PRNewswire

About Head and Neck Cancer

According to the American Cancer Society, approximately 40,000 Americans will be diagnosed with head and neck cancer this year, including cancers of the tongue, mouth, pharynx, and larynx. In addition, it is estimated that more than 11,000 will die from the disease in 2005 in the U.S.

About ERBITUX(R) (Cetuximab)

On February 12, 2004, the FDA approved ERBITUX for use in the United States in combination with irinotecan in the treatment of patients with EGFR-expressing, metastatic colorectal cancer who are refractory to irinotecan-based chemotherapy and for use as a single agent in the treatment of patients with EGFR-expressing, metastatic colorectal cancer who are intolerant to irinotecan-based chemotherapy. The effectiveness of ERBITUX for the treatment of colorectal cancer is based on objective response rates. Currently, no data are available that demonstrate an improvement in disease-related symptoms or increased survival with ERBITUX in metastatic colorectal cancer patients.

ERBITUX binds specifically to the epidermal growth factor receptor (EGFR, HER1, c-ErbB-1) on both normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha. The EGFR is constitutively expressed in many normal epithelial tissues, including the skin and hair follicle. Over-expression of EGFR is also detected in many human cancers including those of the colon and rectum.

Important Safety Information

Severe infusion reactions, rarely fatal and characterized by rapid onset of airway obstruction (bronchospasm, stridor, hoarseness), urticaria, and hypotension, have occurred in approximately 3% (20/774) of patients with the administration of ERBITUX. Most reactions (90%) were associated with the first infusion of ERBITUX despite the use of prophylactic antihistamines. Severe infusion reactions require immediate and permanent discontinuation of ERBITUX therapy. Caution must be exercised with every ERBITUX infusion as there were patients who experienced their first severe infusion reaction during later infusions. A 1-hour observation period is recommended following the ERBITUX infusion. Longer observation periods may be required in patients who experience infusion reactions.

Severe cases of interstitial lung disease (ILD), which was fatal in one case, occurred in less than 0.5% of 774 patients receiving ERBITUX.

Dermatologic toxicities, including acneform rash (11% of 774 patients, grade 3/4), skin drying and fissuring, inflammatory or infectious sequelae (e.g., blepharitis, cheilitis, cellulitis, cyst) and paronychial inflammation (0.4% of 774 patients, grade 3) were reported. Sun exposure may exacerbate any skin reactions.

Hypomagnesemia has been reported with ERBITUX when administered as a single agent and in combination with multiple different chemotherapeutic regimens. The incidence of hypomagnesemia (both overall and severe (NCI CTC grades 3 & 4)) was increased in patients receiving ERBITUX alone or in combination with chemotherapy as compared to those receiving best supportive care or chemotherapy alone based on ongoing, controlled clinical trials in 244 patients. Approximately one-half of these patients receiving ERBITUX experienced hypomagnesemia and 10-15% experienced severe hypomagnesemia. Electrolyte repletion was necessary in some patients, and in severe cases, intravenous replacement was required. Patients receiving ERBITUX therapy should be periodically monitored for hypomagnesemia, and accompanying hypocalcemia and hypokalemia during, and up to 8 weeks following the completion of, ERBITUX therapy.

Other serious adverse events associated with ERBITUX in clinical trials (n=774) were fever (5%), sepsis (3%), kidney failure (2%), pulmonary embolus (1%), dehydration (5% in patients receiving ERBITUX plus irinotecan, 2% receiving ERBITUX as a single agent) and diarrhea (6% in patients receiving ERBITUX plus irinotecan, 0.2% with ERBITUX as a single agent).

Additional common adverse events seen in patients receiving ERBITUX plus irinotecan (n=354) or ERBITUX as a single agent (n=420) were acneform rash (88%/90%), asthenia/malaise (73%/48%), diarrhea (72%/25%), nausea (55%/29%), abdominal pain (45%/26%), vomiting (41%/25%), fever (34%/27%), constipation (30%/26%) and headache (14%/26%).

Full prescribing information, including boxed WARNING regarding infusion reactions, is available upon request or by visiting www.Erbitux.com.

About ImClone Systems

ImClone Systems Incorporated is committed to advancing oncology care by developing a portfolio of targeted biologic treatments, designed to address the medical needs of patients with a variety of cancers. The Company's research and development programs include growth factor blockers and angiogenesis inhibitors. ImClone Systems' strategy is to become a fully integrated biopharmaceutical company, taking its development programs from the research stage to the market. ImClone Systems' headquarters and research operations are located in New York City, with additional administration and manufacturing facilities in Branchburg, New Jersey.

Certain matters discussed in this news release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Although the company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions it can give no assurance that its expectations will be achieved. Forward-looking information is subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected. Many of these factors are beyond the company's ability to control or predict. Important factors that may cause actual results to differ materially and could impact the company and the statements contained in this news release can be found in the company's filings with the Securities and Exchange Commission including quarterly reports on Form 10-Q, current reports on Form 8-K and annual reports on Form 10-K. For forward-looking statements in this news release, the company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The company assumes no obligation to update or supplement any forward-looking statements whether as a result of new information, future events or otherwise.

About Bristol-Myers Squibb

Bristol-Myers Squibb is dedicated to the discovery, development and exhaustive exploration of innovative cancer fighting therapies that extend and enhance the lives of patients living with cancer. More than 40 years ago, Bristol-Myers Squibb built a unified vision for the future of cancer treatment. With expertise, dedication and resolve, that vision led to the development of a diverse global portfolio of anti-cancer therapies that are an important cornerstone of care today. Hundreds of scientists at Bristol-Myers Squibb's Pharmaceutical Research Institute are studying ways to improve current cancer treatments and identify better, more effective medicines for the future.

Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that ERBITUX will receive regulatory approval for the treatment of SCCHN, or, if approved, will be commercially successful. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2004 and in our Quarterly Reports on Form 10-Q. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.



Source: Business Wire

biz.yahoo.com/bizj/051014/1178039.html?.v=2

bizjournals.com
MedImmune files to test lupus drug in humans
Friday October 14, 3:07 pm ET


MedImmune and its New Jersey partner have filed with federal regulators to begin human testing on a drug for treating lupus and potentially other autoimmune disorders.
In November 2004, Gaithersburg-based MedImmune (NASDAQ: MEDI - News) and Princeton-based Medarex (NASDAQ: MEDX - News) formed a collaboration to develop antibody drugs targeting interferon-alpha.

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Preclinical data indicate that levels of interferon-alpha are elevated in many patients with lupus or other autoimmune disorders. The drug, called MEDI-545, binds to interferon-alpha and has been shown to neutralize its activity in preclinical studies.

To begin Phase I human tests on the lupus drug, MedImmune and Medarex filed an investigational new drug application with the Food and Drug Administration. Once that application is approved, the biotechnology companies begin the long, and costly, process of taking a product candidate through the development cycle.

Under the terms of their agreement, MedImmune currently has full responsibility for all ongoing development activities on the lupus drug.

The filing, says MedImmune Senior Director of Research of Anthony Coyle, "reflects MedImmune's commitment to the development of new treatments targeting inflammatory and autoimmune diseases and marks another milestone in our efforts to advance our pipeline of product candidates."

The Lupus Foundation of America estimates about 1.5 million people in the United States suffer from some form of lupus, which is a chronic inflammatory disease that causes the body to attack its own tissue and organs, including the skin, joints, blood and kidneys.

MedImmune has local competition in the race to bring new lupus drugs to market.

Rockville-based Human Genome Sciences (NASDAQ: HGSI - News) on Oct. 5 reported that a midstage clinical trial found its lupus drug to be safe and well tolerated, but the drug did not meet its primary efficacy goals. That news caused stock in Human Genome Sciences to fall about 30 percent.

Published October 14, 2005 by the Washington Business Journal

de.biz.yahoo.com/051031/217/4qtx5.html

PR Newswire
Neue europäische Studie zum Einsatz von Cetuximab als adjuvante Therapie bei kolorektalem Karzinom
Montag 31. Oktober 2005, 09:04 Uhr



PARIS, Frankreich, October 31 /PRNewswire/ --


- 13. Annual European Conference on Clinical Oncology


In einer grossen europaweiten Zusammenarbeit wird ab heute untersucht,
ob Cetuximab in Kombination mit Oxaliplatin-haltiger Chemotherapie (FOLFOX-
4) bei völliger Resektion im Erkrankungsstadium III nach der Operation die
Anzahl der Krankheitsrückfälle reduziert und die Überlebenszeit verlängert.
Wissenschaftler der Fédération Francophone de Cancérologie Digestive (FFCD)
leiten diese Intergroup-Studie in Zusammenarbeit mit der European
Organisation for Research and Treatment ANZEIGE
 
of Cancer (EORTC) sowie mit den
nationalen Gruppen, die an den europaweiten Studien zur Krebsstruktur im
Verdauungskanal (PETACC) beteiligt sind. Diese von der FFCD finanzierte
Studie wird 2.000 Patienten rekrutieren und soll vor Ende dieses Jahres
beginnen.


Circa 25 Prozent der 370.000 Patienten in Europa, die jedes Jahr mit
kolorektalem Karzinom diagnostiziert werden, befinden sich im
Erkrankungsstadium III.(1,2) In diesem Stadium hat der Tumor bereits
begonnen, sich durch die Darmwand und in die angrenzenden Lymphknoten
auszuweiten. Eine Operation mit nachfolgender Chemotherapie hat die
Überlebenszeit zwar signifikant verbessert, jedoch werden etwa ein Drittel
der Patienten aller Wahrscheinlichkeit nach innerhalb der nächsten drei
Jahre einen Krankheitsrückfall erleiden. (3) Daher ist es wichtig, dass
neue Therapien untersucht werden, welche die Rückfallrate mindern und die
Überlebenszeit verbessern.


In der PETACC-8-Studie werden Patienten mit völlig resektiertem
kolorektalen Karzinom im Erkrankungsstadium III randomisiert ausgewählt und
erhalten entweder Cetuximab in Kombination mit FOLFOX-4 oder FOLFOX-4
alleine. Die Therapien werden für die Dauer von 6 Monaten durchgeführt.


Etwa 340 führende Zentren in ganz Europa, einschliesslich Frankreich,
Deutschland, Belgien, Spanien, Grossbritannien, Österreich, Italien,
Dänemark, Portugal, Schweden und andere Länder, werden Patienten
rekrutieren. Weitere Informationen erhalten Sie von
Martina Schneider, PETACC-8-Projektmanager (+33-3-80-39-34-83,
Martina.Schneider@u-bourgogne.fr).


"Mehr und mehr Menschen entwickeln kolorektales Karzinom und mindestens
30 Prozent der Patienten mit völliger Resektion im Erkrankungsstadium III
werden rückfällig. Daher müssen wir die Chancen der Patienten durch die
Aufnahme neuer gezielter Therapien in unsere Behandlungsstrategien
verbessern", sagte der leitende Prüfarzt der Studie, Dr. Julien Taïeb vom
Groupe Hospitalier Pitié Salpêtrière, Paris. "Wir hoffen sehr, dass die
Kombination Cetuximab und FOLFOX, die sich bereits bei Patienten im
fortgeschrittenen Erkrankungsstadium als wirksam erwies, auch die
krankheitsfreie Überlebenszeit nach der Operation signifikant verbessern
wird."


Cetuximab zielt speziell auf den epidermalen Wachstumsfaktorrezeptor
(EGFR) ab, der oft in Krebszellen vorhanden ist. Durch Blockieren des EGFR
wird verhindert, dass der Tumor weiter wächst und die Krebszellen sich auf
andere Organe im Körper ausweiten. Cetuximab hat auch eine verbesserte
Wirkung von Strahlen- und Chemotherapie gezeigt.


Die am häufigsten verschriebene adjuvante Chemotherapie (nach der
Operation) ist seit geraumer Zeit 5-Fluorouracil/Leucovorin (5-FU/LV).
Oxaliplatin ist eine neue Generation von Chemotherapie, die in Kombination
mit 5-FU/LV die dreijährige krankheitsfreie Überlebensrate im
Erkrankungsstadium III von 65,3 Prozent (5-FU/LV allein) auf 72,2 Prozent
(Oxaliplatin und 5-FU/LV; FOLFOX) erhöhen konnte.(3) Cetuximab zeigte
konsistent hohe Responseraten und längere progressionsfreie
Überlebenszeiten, wenn es in den späteren Stadien von kolorektalem Karzinom
verwendet wurde,(4) und es wird erwartet, das Oxaliplatin das Wachstum und
die Ausbreitung von Krebszellen in den früheren Erkrankungsstadien, in
denen die Chance für eine Heilung noch grösser ist, wirksam verhindert.
Daher erwarten die Prüfärzte, dass die zusätzliche Verabreichung von
Cetuximab einen Meilenstein bei der Heilung von noch mehr Patienten
darstellen wird, ohne deren Sicherheit zu kompromittieren.


Hinweise an die Redakteure:


Über PETACC (Pan-European Trials in Alimentary Tract Cancer)


Umfangreiche klinische Studien sind erforderlich, um die signifikanten
Vorteile einer neuen adjuvanten Chemotherapie für die Behandlung von
Darmkrebs aufzuzeigen. In Anbetracht der grossen Anzahl an Patienten, die
rekrutiert werden sollen, haben sich mehrere Kooperationsgruppen unter dem
Namen PETACC zusammengeschlossen. Dieses Konsortium besteht aus über einem
Dutzend europäischer nationaler und internationer Kooperationsgruppen. Jede
Gruppe kann Projekte vorschlagen, die dann von der PETACC-
Generalversammlung diskutiert und genehmigt werden. Der betriebliche Teil
der PETACC-Studien ist aus Gründen der Einheitlichkeit zentralisiert
(Verfahren, Qualitätssicherung usw.), aber jede Gruppe behält ihre
Individualität innerhalb des allgemeinen Rahmens bei.


Über die FFCD


Die Fédération Francophone de Cancérologie Digestive (FFCD) ist ein
französischer Akademikerverband, der 1991 von Fachpersonal für
Krebserkrankungen im Verdauungstrakt (Gastroenterologen, Onkologen,
Radiologen, Chirurgen, Pathologen usw.) gegründet wurde.
Zu den Forschungstätigkeiten zählen hauptsächlich das Design neuer
klinischer Studien durch das wissenschaftliche Kommitee der FFCD, die
Durchführung von klinischen Phase-II- und Phase-III-Studien sowie die
Errichtung eines biologischen Forschungszentrums für Translational Research
(Umsetzung von Erkenntnissen aus dem Labor zum Krankenbett).


Die FFCD ist der rechtliche Sponsor der PETACC-8-Studie.


Über kolorektales Karzinom


Das kolorektale Karzinom ist die dritthäufigste bösartige
Krebserkrankung weltweit.(5) Allein in Europa erkrankten im Jahr 2002 mehr
als 370.000 Menschen an diesem Leiden, was für 12 Prozent aller
Krebskranken und ca. 200.000 Tote verantwortlich war.(1)


Quellenhinweise:


1. Ferlay J et al. GLOBOCAN 2002: Cancer Incidence, Mortality and
Prevalence Worldwide IARC Cancer Base No. 5. Version 2.0, IARC Press, Lyon,
2004


2. Effective Health Care, NHS Center for Reviews and Dissemination,
University of York 1997; 3: ISSN: 0965-0288.


3. Andre T et al. Oxaliplatin, fluorouracil, and leucovorin as adjuvant
treatment for colon cancer. N Engl J Med 2004 Jun 3; 350 (23):2343-51.


4. Cunningham D et al. Cetuximab monotherapy and cetuximab plus
irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J
Med 2004; 22; 351(4): 337-45.


5. Parkin DM et al. Estimating the world cancer burden. GLOBOCAN 2000.
Int J Cancer 2001; 94(2): 153-156.


Federation Francophone de Cancerologie Digestive (FFCD)
 

Prostatacarcinom

www.rednova.com/news/health/289680/...dex.html?source=r_health

Dendreon's Second Randomized Phase 3 D9902A Trial of PROVENGE Extends Survival in Patients With Advanced Prostate Cancer
PARIS, Oct. 31 /PRNewswire-FirstCall/ -- Dendreon Corporation today announced that final results of its second Phase 3 study (D9902A) of PROVENGE(R) (sipuleucel-T), the Company's investigational active cellular immunotherapy for the treatment of prostate cancer, were presented here today during a late-breaking clinical trials session at ECCO 13-the European Cancer Conference. Researchers concluded that these results are consistent with the results from the Company's first Phase 3 study (D9901). The Company recently announced plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) to market PROVENGE based on discussions of these data with the FDA.

"The combined data from the trials of PROVENGE versus placebo demonstrate that active immunotherapy favorably impacts survival in men with asymptomatic, metastatic, androgen-independent prostate cancer," reported Celestia S. Higano, M.D., director and associate professor of the Genitourinary Oncology Clinical Research Group at the University of Washington, Seattle, who presented the data. "Given the favorable side effect profile, PROVENGE may provide a useful alternative for men prior to initiating chemotherapy."


  Summary of PROVENGE Studies                                     Study 1    Study 2   Studies 1 and 2                                     (D9901)    (D9902A)    Integrated                                     N = 127     N = 98       N = 225   Median Survival in months:                          PROVENGE    25.9        19.0         23.2                           Placebo    21.4        15.7         18.9   Median Survival Benefit: %   (months)                         21% (4.5)   21% (3.3)    23% (4.3)   Hazard Ratio                        1.7         1.3          1.5   p-value (log rank)                p=0.010     p=0.331      p=0.011   Hazard Ratio                        2.1         1.9          1.8   p-value (Cox regression, adj.)    p=0.002     p=0.023      p=0.0006   36-Month Survival: % (patients)                          PROVENGE   34% (28)    32% (21)     33% (49)                           Placebo   11%  (5)    21%  (7)     15% (12)     Study Results  
In the D9902A study, the three-year final survival analysis in the intent- to-treat population of the double-blind, placebo-controlled study of PROVENGE in 98 men with asymptomatic, metastatic, androgen-independent (hormone- refractory) prostate cancer showed those patients who received PROVENGE had a 19.0 month median survival time compared with only 15.7 months for the patients who were randomized to receive a placebo. This represents a 3.3 month or 21 percent improvement in median survival for patients who were randomized to receive PROVENGE compared to placebo (p-value = 0.331, log-rank; HR = 1.3). This hazard ratio implies that patients receiving placebo have a relative risk of dying that is 30 percent higher than those patients receiving PROVENGE. A Cox multivariate regression analysis of overall survival, which adjusts for imbalances in prognostic factors known to influence survival, met the criteria for statistical significance (p-value = 0.023; adjusted HR = 1.9). The hazard ratio observed in this analysis was consistent with that seen in the Company's first Phase 3 study, D9901. In addition, at the three- year final follow up, 32 percent of the men in the PROVENGE group were alive compared to only 21 percent of the men in the placebo group, a 52 percent improvement in the survival rate.

As in previous studies, PROVENGE was well tolerated with the most common adverse events reported being fever and chills lasting for one to two days.

As reported earlier this year, the final three-year follow up of the D9901 study of PROVENGE in 127 men with asymptomatic, metastatic, androgen- independent prostate cancer showed a median survival benefit of 21 percent or 4.5 months and a three-fold improvement in survival at 36 months (p-value = 0.010; HR = 1.7). In addition, a Cox multivariate regression analysis was used to test the validity of the survival benefit seen in this study. The results showed that patients receiving placebo had a relative risk of dying that is more than twice as high as those patients receiving PROVENGE (p-value = 0.002; adjusted HR = 2.1).

Dr. Higano also presented an integrated analysis of the data from studies D9901 and D9902A, which showed a statistically significant survival benefit in the overall intent-to-treat population of 225 patients. In this analysis, patients receiving PROVENGE had a median survival of 23.2 months compared to 18.9 months for patients in the placebo group, a 4.3 month or 23 percent improvement in median survival. This analysis was statistically significant by both log rank (p-value = 0.011; HR = 1.5) and Cox multivariate regression analysis of overall survival (p-value = 0.0006; adjusted HR = 1.8). In addition, at the three-year final follow up, 33 percent of the men who received PROVENGE were alive compared to only 15 percent of the men who received placebo, a greater than 100 percent improvement.

"We were pleased to see a statistically consistent and meaningful survival benefit across the three analyses," said Robert M. Hershberg, M.D., Ph.D., Dendreon's chief medical officer. "We will be working closely with the FDA to complete our BLA and to bring PROVENGE to market for men with advanced stage prostate cancer who currently have few appealing treatment options available to them."

Conference Call Details

LIVE Access on October 31, 2005, 17:30 Paris time; 11:30 a.m. ET; 8:30 a.m. PT:


  -- Phone 877-502-9274 (domestic) or +1-913-981-5584 (international)   -- Webcast connection through the Dendreon website at www.dendreon.com/ in      the Investors/Webcast section.    REPLAY Access:   -- Phone replay available at 2:00 p.m. ET for 3 days by calling      888-203-1112 (domestic) or +1-719-457-0820 (international);      Passcode: 6720485   -- Webcast replay will be available for 90 days from the Dendreon website      at www.dendreon.com/ in the Investors/Webcast section.    About Prostate Cancer  
More than one million men in the United States have prostate cancer, with an estimated 220,000 new cases of prostate cancer diagnosed each year. More than 30,000 men die each year from the disease. Prostate cancer is the most commonly diagnosed non-skin cancer in the United States and the third most common cancer worldwide.

About PROVENGE (sipuleucel-T)

The generic name "sipuleucel-T" has been approved by the United States Adopted Names (USAN) Council for Dendreon's investigational active cellular immunotherapy (ACI) for prostate cancer, previously known as APC8015. If approved, sipuleucel-T will be marketed as PROVENGE.

PROVENGE (sipuleucel-T) is an investigational product that may represent the first in a new class of active cellular immunotherapies (ACIs) that are uniquely designed to stimulate a patient's own immune system. ACIs hold promise because they may provide patients with a meaningful survival benefit with low toxicities. PROVENGE targets the prostate cancer antigen, prostatic acid phosphatase (PAP), which is found in approximately 95% of prostate cancers. PROVENGE is in late-stage clinical development for the treatment of patients with early-stage and advanced prostate cancer. In clinical studies, patients typically received three infusions over a one-month period as a complete course of therapy.

About Dendreon

Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the development of innovative cancer treatments. In addition to its immunotherapies in clinical and preclinical development for a variety of cancers, Dendreon's product pipeline also includes monoclonal antibody and small molecule product candidates. Dendreon has research and development alliances with Genentech, Inc., Abgenix, Inc. and Dyax Corp. For more information about the company and its programs, visit www.dendreon.com/.

Except for historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties surrounding the efficacy of PROVENGE to treat men suffering from prostate cancer, risks and uncertainties surrounding the presentation of data to the FDA and approval of product applications by the FDA and risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Factors that may cause such differences include risks related to our limited operating history, risks associated with completing our clinical trials, the risk that the safety and/or efficacy results of a clinical trial for PROVENGE will not support an application for a biologics license, the risk that the FDA may interpret data differently than we do or require more data or a more rigorous analysis of data than expected, the risk that the FDA will not approve a product for which a biologics license has been applied, the risk that the results of a clinical trial for PROVENGE or other product may not be indicative of results obtained in a later clinical trial, risks that we may lack the financial resources and access to capital to fund required clinical trials or commercialization of PROVENGE, our dependence on the efforts of third parties, including collaborators, and our dependence on intellectual property. Further information on the factors and risks that could affect Dendreon's business, financial condition and results of operations are contained in Dendreon's public disclosure filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov/.

Dendreon Corporation

CONTACT: Monique M. Greer, Sr. Director, Corporate Communications ofDendreon Corporation, 206-829-1500

Web site: www.dendreon.com/



Source: PRNewswire-FirstCall

www.medicalnewstoday.com/medicalnews.php?newsid=32835


Phase III MabThera maintenance trial in lymphoma shows positive results earlier than expected
Category: Lymphoma/Leukemia News
Article Date: 31 Oct 2005





Roche has been informed by the European Organisation for Research and Treatment of Cancer (EORTC) that a phase III study[1] in relapsed indolent non-Hodgkin's lymphoma (NHL) evaluating the use of MabThera (rituximab) as maintenance treatment has shown positive results earlier than expected. MabThera maintenance therapy is administered over two years and aims to prevent disease recurrence.

“Our study confirms that MabThera maintenance therapy is beneficial for patients that have already received MabThera as part of their initial therapy” said lead investigator, Professor Marinus van Oers M.D., from the Academic Medical Center of the University of Amsterdam. “The full results of the trial will be presented as an oral presentation at this year's annual conference of the American Society of Hematology (ASH) in Atlanta.”

Non-Hodgkin's lymphoma affects 1.5 million people worldwide. Indolent NHL, representing about 45% of NHL patients, is a slow developing but serious cancer of the lymphatic system.

“We look forward to the presentation of the full trial results in December“, said Eduard Holdener, Head of Pharma Development at Roche. “Based on this new information MabThera maintenance therapy could well become the new standard treatment in this disease.”

Roche is currently preparing an application to the European Authorities to request a label extension for maintenance therapy, expected to be submitted in the fourth quarter 2005, making this treatment option available to all patients.

About the study

The international cooperative group phase III trial was conducted in 18 countries and recruited 465 patients with relapsed indolent NHL. Patients were randomized to receive either six cycles of MabThera in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy, or CHOP chemotherapy alone. Patients who responded to initial treatment were then randomised to MabThera maintenance therapy (one infusion every three months for two years) or no further treatment.

A pre-planned analysis in early 2004 showed that induction treatment with MabThera plus CHOP was significantly superior to CHOP alone and that two years of MabThera maintenance therapy substantially improved progression-free survival compared to observation. Therefore, the trial was suspended as it had reached both primary endpoints. At that time the results were not mature enough to determine if MabThera maintenance therapy also prolongs progression-free survival for the subgroup of patients who already had received MabThera plus CHOP as initial treatment. The EORTC therefore originally decided to amend the study to evaluate this outstanding question.

An updated analysis of the study data with additional follow-up of approximately 18 months has now demonstrated a significant benefit of MabThera maintenance therapy for patients who initially received MabThera plus CHOP. Consequently, the EORTC, following the recommendation by the Independent Data Monitoring Committee, has stopped the study and decided to report the results at the ASH meeting in December.

About MabThera

MabThera is a therapeutic antibody that binds to a particular protein - the CD20 antigen - on the surface of normal and malignant B-cells. It then recruits the body's natural defences to attack and kill the marked B-cells. Stem cells (B-cell progenitors) in bone marrow lack the CD20 antigen, allowing healthy B-cells to regenerate after treatment and return to normal levels within several months.

MabThera was initially indicated as a single-agent treatment for relapsed or refractory indolent NHL, and received European approval in March 2002 for the treatment of aggressive NHL in combination with CHOP chemotherapy. In August of 2004 MabThera received European approval for first line treatment of Indolent NHL in combination with CVP chemotherapy. MabThera is known as Rituxan in the United States, Japan and Canada. More than 700,000 patients have been treated with MabThera worldwide to date.

Genentech and Biogen Idec co-market MabThera in the United States, and Roche markets MabThera in the rest of the world, except Japan, where MabThera is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (www.roche.com).

All trademarks used or mentioned in this release are legally protected.

Further Information:
- About Roche in Oncology
- About Genentech
- About BiogenIdec
- About cancer
- About Lymphoma

[1] European Organization for Research and Treatment of Cancer (EORTC) Study 20981

basel.mediaoffice@roche.com
 

www.medicalnewstoday.com/medicalnews.php?newsid=32690

Multi-million dollar deal to benefit medical research
Category: Biology/Biochemistry News
Article Date: 29 Oct 2005





The drug, HUMIRA®, is so far used to treat rheumatoid arthritis but has other applications in the pipeline. The Scripps Research Institute and the American company, Stratagene will share US$64m as part of the agreement.

The technology, developed by the MRC Laboratory of Molecular Biology, was the basis for the setting up of Cambridge Antibody Technology Ltd in 1990 as a business.

The American pharmaceutical company, Abbott has agreed to pay (via Cambridge Antibody Technology) US$255 million in place of the future royalties the MRC, Scripps Research and Stratagene would have received on sales of HUMIRA®. In addition, Cambridge Antibody Technology will pay the MRC a further US$7.5m over five years from 2006, providing that HUMIRA® remains on the market.

The MRC patents cover a series of inventions made by Sir Gregory Winter and his colleagues at the MRC Laboratory of Molecular Biology during the late 1980s and early 1990s for making 'human monoclonal antibodies'.

Sir Gregory commented "Our inventions originated from pure curiosity-driven and long-term basic research funded at the Laboratory of Molecular Biology by the MRC. Provided such research is intelligently and quickly exploited, it can pay handsome dividends for medicine, UK industry and human health. It can also generate considerable royalty income, which ploughed back into science will help generate the medicines and industries of the future."

Professor Colin Blakemore, the MRC Chief Executive added "This deal is great news for British science. It shows the wonderful achievements that can be won for human health when the Medical Research Council works with industry. It also gives the UK an opportunity to reap the rewards from our past discoveries to make the fullest possible investment in future science. The agreement will help us give our scientists new research facilities and the best laboratories. We also want to invest in initiatives which will help us to translate cutting-edge scientific research into healthcare for all".

The related Scripps Research patents cover inventions which hailed from the laboratory of Dr. Richard A. Lerner, president of the Institute. Dr. Lerner said, "It is wonderful to see the work from our two laboratories come together to benefit so many patients suffering from a variety of serious conditions."

Although the scientists from MRC and Scripps Research were scientific competitors in earlier years, they pooled their inventions in Cambridge Antibody Technology to facilitate exploitation of the technology for creation of new medicines.

Monoclonal Antibodies. These are often referred to as 'magic bullets'. They are custom-made protein molecules that have been designed to home in on specific targets. Dr César Milstein and Dr George Köhler discovered how to make monoclonal antibodies at the MRC Laboratory of Molecular Biology in Cambridge. Their work earned them the Nobel prize in Physiology or Medicine in 1984. It has led to therapeutic products for breast cancer, leukaemia, asthma and transplant rejection; many more are in late stage clinical trials.

HUMIRA® is the first fully human monoclonal antibody to be approved by the American Food and Drug Administration and was developed using combinatorial antibody libraries, on which the founding of Cambridge Antibody Technology was based. It is currently approved only for treatment of rheumatoid arthritis, but it is also in clinical trials for use in other indications including Phase III trials for use in juvenile rheumatoid arthritis, Crohn's disease, psoriatic arthritis and ankylosing spondylitis.

The Medical Research Council (MRC) is a national organization funded by the UK tax-payer. Its business is medical research aimed at improving human health; everyone stands to benefit from the outputs. The research it supports and the scientists it trains meet the needs of the health services, the pharmaceutical and other health-related industries and the academic world. MRC has funded work which has led to some of the most significant discoveries and achievements in medicine in the UK. About half of the MRC's expenditure of approximately £500 million is invested in its 40 Institutes, Units and Centres. The remaining half goes in the form of grant support and training awards to individuals and teams in universities and medical schools. Web site at: www.mrc.ac.uk

Keith McKeown
kmckeown@scripps.edu
Scripps Research Institute
www.scripps.edu

Zum Hintergrund : Zwischen CAT (Entwickler des Antikörpers) und Abbott (vetreiben das darauf beruhende Medikament gegen Rheumat. Arthritis)   tobte ein jahrelanger Rechtssttreit um die Höhe der Royalties (Zahlungen mit denen der Entwickler am Umsatz beteiligt ist). Die Einigung zeigt, welche Summen dabei zur Debatte standen.  

Rektumkarzinom . Panitumumab  ist eine gemeinsame Entwicklung von Amgen (AMGN) und Abgenix (ABGX). Steht in Konkurrenz zum bereits zugelassenen AK-Therapie gegen dieselbe Indikation Erbitux von Imclone (IMCL)  und Bristol-Myers Squibb (BMY) die ihrerseit gegen andere Indikationen getestet wird. (Posting 6)

Presseschau dazu  
biz.yahoo.com/ap/051103/amgen_colon_cancer.html?.v=3

AP
Amgen: Cancer Therapy Slows Tumor Growth
Thursday November 3, 2:50 pm ET
By Heidi Vogt, AP Business Writer  
Amgen Says Its Experimental Colon Cancer Therapy Slowed Tumor Growth in Late-Stage Study


NEW YORK (AP) -- Biotech drug maker Amgen Inc. said Thursday that its experimental colon cancer therapy, a potential rival to ImClone Inc.'s Erbitux, significantly slowed tumor growth in a late-stage study.
ADVERTISEMENT


Amgen shares rose $3.33, or 4.5 percent, to $77.23 in afternoon trading on the Nasdaq while shares of Abgenix Inc., its partner in the drug, jumped $3.73, or 40 percent to $13.10. Shares of New York-based ImClone dove $7.39, or 20 percent, to $28.72.

Amgen said tumors grew 46 percent more slowly in patients taking its Panitumumab drug than in those who received palliative care -- a standard that can include a number of treatments but did not include chemotherapy drugs in this study. The 463-patient trial consisted of patients with colon cancer that had spread and who had failed standard chemotherapy.

The results exceeded the company's target for a 33 percent decrease in tumor growth.

Thousand Oaks, Calif.-based Amgen said the study results mean its drug is the first of its class to improve the likelihood that patients will live without their disease getting worse. ImClone's Erbitux approval is based on a different measure -- tumor shrinkage. Amgen said its drug also decreased tumor size, a measure it had set as a secondary endpoint, and that those results were comparable with mid-stage trials.

Panitumumab and Erbitux work in generally the same way, by binding to a protein that is associated with tumor growth. However, Panitumumab is derived solely from human antibodies, while Erbitux is partly made up of mouse antibodies.

"The benefit with a fully human antibody is that a human's body is less likely to reject it," said Citigroup analyst Elise Wong. "With Panitumumab you have very low infusion reactions and very low rates hypersensitivity."

Though she cautioned that the broad top-line data make firm conclusions difficult, Wong said the results appear "very robust," adding that "it should prove to be a very competitive product to Erbitux" if just based on the safety advantage and its less-frequent dosing regimen (every other week versus once a week).

Wong also noted that Amgen's study group consisted of patients that had more advanced cancer than those that Erbitux used to gain its approval last February.

Merrill Lynch analyst Eric Ende had said that ImClone shares would be worth between $28 and $31 if the Amgen trial met its endpoint, arguing that a positive study result could lead to Panitumumab dominating the colon cancer market despite Erbitux's head start.

Amgen said it plans to start the process of applying for approval from the Food and Drug Administration by the end of the year with the aim of completing its submission in the first quarter of 2006.

Abgenix of Fremont, Calif., helped develop panitumumab with its animal research technology -- a method of genetically engineering mice for use in creating antibody therapies. The company stands to get a share of the drug's profits if it is approved.

Panitumumab is also in clinical trials for lung and kidney cancer, while ImClone is investigating Erbitux for head and neck cancer.


--------------------------------------------------

www.marketwatch.com/news/yhoo/...456A%2DA3AD%2DC4D0ED803767%7D


Abgenix, Amgen rally on drug news
Therapy seen as potential rival to ImClone's Erbitux
By Val Brickates Kennedy, MarketWatch
Last Update: 5:02 PM ET Nov. 3, 2005  
Disable MW live quotes | E-mail it | Print | Alert | Reprint |  

BOSTON (MarketWatch) -- Shares of Abgenix Inc. jumped Thursday, while Amgen Inc. scored more modest gains, as they said that a drug they've been developing has been shown to be highly effective in slowing the progression of advanced colorectal cancer.

ABGXABGX, , ) rocketed 38% to close at $12.90, while Amgen shot up 5% to $77.51.

Amgen and Abgenix announced that patients in a Phase III clinical trial who took the drug panitumumab, an antibody-based therapy, had a 46% decrease in the progression of their cancerous tumors as opposed to those who didn't receive the therapy.

The companies tested the drug in 463 patients with advanced colorectal cancer who had already failed standard chemotherapy treatment.

Amgen and Abgenix said they hope to finish filing for regulatory approval of panitumumab during the first quarter of 2006.

Shares of rival ImClone Systems (IMCL:
sank on the news, dropping as much as 19%. Imclone and partner Bristol-Myers Squibb (BMY: BMY
market Erbitux as an antibody-based colorectal cancer drug.

ImClone shares had been on a roll in recent days after it announced it had filed to have Erbitux approved for the treatment of head and neck cancers. Erbitux is currently ImClone's only drug on the market.

Wenn du hier was reinstellst zu einem AK, dann schreib doch einfach unten in dein posting noch den Namen der betroffenen AG mit dazu. Wenn man dann nach Threads zur AG sucht, wird u.a. immer auch dieser Thread gefunden.

Dieses posting hänge ich beispielhaft an Abgenix....

Grüße
ecki  

 
Darmkrebs 1

Darmkrebs 2

Warum Antikörper?

Technologie Hintergrund der Morphosys Technik: Antikörper ohne Tiere (sog. humane AK's)  
Diashow

Homepages einiger  Firmen, die therapeutische Antikörper herstellen und  Ak-Medikamenten in der Pipeline haben.

Die Firmenseiten enthalten zum Teil auch Basisinfos über Antikörper und Beschreibungen spezieller Technologien zur Herstellung.
Europa: Homepages
Morphosys
Micromet

Genmab
Cambridge Antibody (CAT)  
Cytos
Biotest
Allgemeines zu Antikörpern v. der Biotest HP :  
Autoimmunerkrankungen
Antikörper  
Aktivitäten zu therapeutischen - Aks (Pipeline inbes. AK zu Rheum. Arthritis )  von Biotest sind in PDF-Files (Rede zur HV, Herbstkonferenz) hier dargestellt:
hier



USA
Medarex Homepage (MEDX)  
Finanzporträt   + News    MEDX


Abgenix HP (ABGX)  
Finanzporträt ABGX

HP Protein Design Labs (PDLI)
Finanzporträt + News PDLI
Finanzporträt + News PDLI  

Web Site: HP Human Genome Sciences  (HGSI)
Finanzporträt + News HGSI  
Lupus Medikament Studienziel nicht erreicht

Abbott HP (ABT News zu Humira)    

Eli Lilly (LLY, Reopro)



Roche Pipeline zu Alzheimer  


(Diskussionen zu den Werten im finance-yahoo message board)

 

Firmen (teilweise nur in den Links erwähnt)
Roche Novartis Schering Pfizer Eli Lilly Abgenix Protein Design Medarex Genmab Morphosys Micromet Biotest
Cambridge Antibody  Genmab

de.biz.yahoo.com/040805/36/45g1e.html

dpa-afx
Hugin-News: GPC Biotech AG
Mittwoch 9. November 2005, 09:31 Uhr


Deutsche Zulassungsbehörde erteilt GPC Biotech (Xetra: 585150 - Nachrichten) die Genehmigung den monoklonalen Krebs-Antikörper 1D09C3 in zusätzlicher klinischer Phase-1-Studie zu testen
Corporate news- Mitteilung verarbeitet und übermittelt durch Hugin. Für den Inhalt der Mitteilung ist der Emittent verantwortlich.

--------------------------------------------------

--------------

Martinsried/München und U.S.-Forschungs- und Entwicklungsstandorte in Waltham/Boston, Mass., und Princeton, N.J., 9. November ANZEIGE
 
2005 - Die GPC Biotech AG (Frankfurt: GPC; TecDAX 30; NASDAQ (NASDAQ: Nachrichten) : GPCB) gab heute bekannt, dass das Paul-Ehrlich-Institut (PEI) die Genehmigung erteilt hat, in Deutschland die klinischen Studien im Menschen mit dem monoklonalen Krebsantikörper 1D09C3 zu beginnen. Das PEI ist die deutsche Zulassungsbehörde für biologische und hämatologische Arzneimittel. Die offene Phase-1-Studie untersucht 1D09C3 bei Patienten, die an einem resistenten B-Zell-Tumor leiden oder nach einer zuvor durchgeführten Standardtherapie einen Rückfall erlitten haben. Sie untersucht ein anderes Verabreichungsschema als die bereits in der Schweiz und Italien laufende Phase-1-Studie. Ziel der klinischen Studie ist es, die Sicherheit und Verträglichkeit des Antikörpers bei Patienten zu ermitteln und eine Empfehlung für die Dosierung sowie für das Verabreichungsschema für weiterführende Phase-2-Studien zu geben. Diese zweite Phase-1-Studie wird an der Universitätsklinik Köln durchgeführt und von Prof. Dr. Michael Hallek, Direktor der Abteilung für Innere Medizin, geleitet. Dr. Marcel Rozencweig, Senior Vice President, Drug Development von GPC Biotech, sagte: "Ich freue mich, dass wir die Genehmigung des Paul-Ehrlich-Instituts erhalten haben, mit dieser Studie beginnen zu können. Dies ermöglicht es uns, das Phase-1-Studienprogramm für unseren monoklonalen Krebsantikörper auszuweiten. Wir freuen uns sehr darüber mit Professor Hallek zusammen arbeiten zu können. Er ist ein weltweit anerkannter Experte in der Behandlung von Leukämien und Lymphomen und arbeitet bereits seit mehreren Jahren mit GPC Biotech an der Entwicklung von 1D09C3." Dr. Rozencweig sagte weiter: "Trotz der Fortschritte in der Behandlung von Lymphomen gibt es noch immer einen großen medizinischen Bedarf an Therapien für Patienten, die einen Rückfall erlitten haben oder bereits resistent gegen andere Behandlungen geworden sind. 1D09C3 scheint einen anderen Wirkmechanismus zu haben als die Medikamente, die derzeit gegen Blutkrebs eingesetzt werden. Deshalb hat 1D09C3 das Potenzial zu einer wichtigen neuen Behandlungsmöglichkeit zu werden." Über 1D09C3: 1D09C3 ist ein Anti-MHC (Major Histocompatibility Complex) Klasse II monoklonaler Antikörper. Er bindet an spezifische Zelloberflächenrezeptoren und führt so zum gezielten Absterben aktivierter, sich vermehrender MHC-Klasse-II-positiver Tumorzellen, darunter B-Zell- und T-Zell-Lymphome sowie weitere Blutkrebsarten. Im Jahr 2004 erkrankten schätzungsweise über 54.000 Menschen in den USA und ungefähr 64.000 Menschen in der EU am Non-Hodgkin-Lymphom, der häufigsten Lymphomart. Daten belegen, dass 1D09C3 den programmierten Zelltod auslöst, ohne hierfür ein voll funktionsfähiges Immunsystem zu benötigen. 1D09C3 befindet sich derzeit in einem klinischen Phase-1-Studienprogramm, in welchem der Antikörper in wichtigen europäischen Krebszentren bei Patienten getestet wird, die an einem resistenten B-Zell-Lymphom leiden oder nach einer zuvor durchgeführten Standardtherapie einen Rückfall erlitten haben. Zu den B-Zell-Lymphomen zählen auch die Hodgkin- und Non-Hodgkin Lymphome. GPC Biotech wurde von der europäischen Zulassungsbehörde EMEA für 1D09C3 zur Behandlung von Hodgkin-Lymphom der Orphan-Drug-Status zugesprochen. Weiterführende Informationen zu 1D09C3 sind in der Rubrik "Anti-Krebs-Programme" auf der Webseite des Unternehmens unter www.gpc-biotech.com abrufbar.

Die GPC Biotech AG ist ein biopharmazeutisches Unternehmen, das in der Entdeckung und Entwicklung neuartiger Krebsmedikamente tätig ist. Nach der Durchführung eines "Special Protocol Assessment" bei der U.S.-Zulassungsbehörde FDA und dem Erhalt eines "Scientific Advice" der europäischen Zulassungsbehörde EMEA, befindet sich der am weitesten in der Entwicklung fortgeschrittene Produktkandidat Satraplatin in einer Phase-3-Zulassungsstudie als Zweitlinien-Chemotherapie zur Behandlung von Patienten mit hormonresistentem Prostatakrebs. Die FDA hat Satraplatin für diese Indikation zudem den "Fast-Track-Status" erteilt. GPC Biotech entwickelt außerdem einen monoklonalen Antikörper mit neuartigem Wirkmechanismus gegen verschiedene Blutkrebsarten, der sich derzeit in der klinischen Phase 1 befindet, und betreibt mehrere Medikamentenentdeckungs- und -entwicklungsprogramme im Bereich der Kinase-Hemmer. GPC Biotech hat eine mehrjährige Allianz mit der ALTANA Pharma AG in deren Rahmen GPC Biotech mit dem ALTANA Research Institute in den USA zusammenarbeitet. Diese Allianz bildet für GPC Biotech eine Umsatzbasis bis Mitte 2007. Sitz der GPC Biotech AG ist Martinsried/Planegg. Die U.S.-Tochtergesellschaft, GPC Biotech Inc., hat Forschungs- und Entwicklungseinrichtungen in Waltham/Boston (Massachusetts) und Princeton (New Jersey). Weitere Informationen sind unter www.gpc-biotech.com verfügbar.

Diese Pressemitteilung kann Prognosen, Schätzungen und Annahmen über unternehmerische Pläne und Zielsetzungen, Produkte oder Dienstleistungen, zukünftige Ergebnisse oder diesen zugrunde liegende oder darauf bezogene Annahmen enthalten. Jede dieser in die Zukunft gerichteten Angaben unterliegt Risiken und Ungewissheiten, die nicht vorhersehbar sind und außerhalb des Kontrollbereichs der GPC Biotech AG liegen. Viele Faktoren können dazu führen, dass die tatsächlichen Ergebnisse wesentlich von denen abweichen, die in diesen zukunftsgerichteten Angaben enthalten sind. Hierzu zählen insbesondere: der Zeitpunkt und die Auswirkung der Maßnahmen von Behörden, die Ergebnisse klinischer Prüfungen, der relative Erfolg der GPC Biotech AG im Hinblick auf die Entwicklung sowie die Marktakzeptanz jedweder neuer Produkte und die Wirksamkeit des Patentschutzes. Es kann weder gewährleistet werden, dass die SPARC-Studie mit Satraplatin oder die Studie mit 1D09C3 abgeschlossen wird, noch dass diese Medikamente in absehbarer Zeit - wenn überhaupt - die Marktzulassung erhalten. Die Gesellschaft übernimmt keine Verpflichtung dafür, diese in die Zukunft gerichteten Aussagen oder die Faktoren, die sich auf die zukünftigen Ergebnisse, Leistungen oder Erfolge der Gesellschaft auswirken könnten, fortzuschreiben oder an zukünftige Ereignisse anzupassen, selbst wenn in der Zukunft neue Informationen verfügbar werden.

Kontakte: GPC Biotech AG Fraunhoferstr. 20 82152 Martinsried / München Tel./Fax: +49 (0)89 8565-2600/-2610 Martin Brändle (Durchwahl -2693) Associate Director, Investor Relations & Corporate Communications ir@gpc-biotech.com In den USA: Laurie Doyle Associate Director, Investor Relations & Corporate Communications Tel.: +1 781 890 9007 (Durchwahl -267) Fax: +1 781 890 9005 usinvestors@gpc-biotech.com Zusätzlicher Medienkontakt für Europa: Maitland Noonan Russo In London: Brian Hudspith Phone: +44 (0)20 7379 5151 bhudspith@maitland.co.uk --- Ende der Mitteilung --- WKN: 585150; ISIN: DE0005851505; Index: CDAX, MIDCAP, Prime All Share, TecDAX (Xetra: Nachrichten) , HDAX, TECH All Share; Notiert: Prime Standard in Frankfurter Wertpapierbörse, Freiverkehr in Börse Berlin Bremen, Freiverkehr in Bayerische Börse München, Freiverkehr in Börse Düsseldorf, Freiverkehr in Börse Stuttgart, Freiverkehr in Hanseatische Wertpapierbörse zu Hamburg, Freiverkehr in Niedersächsische Börse zu Hannover, Geregelter Markt in Frankfurter Wertpapierbörse;

www.gpc-biotech.com/

Copyright © Hugin ASA 2005. All rights reserved.

Genmab brachte heute seinen 9 Monatsbericht raus. Ich stelle ihn ein, nicht wegen der Zahlen, sondern wegen der Kurzbeschreibung der Koopaerationsaktivitäten die darin enthalten sind. "Höhepunkte" etc.

de.biz.yahoo.com/051109/36/4r9f3.html

dpa-afx
ots news: Genmab A/S / Genmab gibt Ergebnisse für die ersten neun Monate ...
Mittwoch 9. November 2005, 07:51 Uhr


Kopenhagen, Dänemark, November 9 (ots/PRNewswire) - Genmab A/S (CSE: GEN) gab heute die Ergebnisse für den Neumonatszeitraum bis einschliesslich 30. September 2005 bekannt. Für diesen Zeitraum meldete Genmab (Kopenhagen: GEN.CO - Nachrichten) die folgenden Ergebnisse:

- Die Nettoverluste in Höhe von 293 Millionen DKK (ungefähr 47 Millionen USD) entsprachen den Nettoverlusten von 293 Millionen DKK (ungefähr 47 Millionen USD) im selben Zeitraum im Jahr 2004. In den ersten neun Monaten des Jahres 2005 betrug der Nettoverlust pro Aktie ANZEIGE
 
damit 9,57 DKK (ungefähr 1,54 USD) im Vergleich zu 11,57 DKK (ungefähr 1,87 USD) im entsprechenden Vorjahreszeitraum. - Der Betriebsverlust belief sich auf 323 Millionen DKK (ungefähr 52 Millionen USD). Der Betriebsverlust für den gleichen Zeitraum im Jahr 2004 betrug dagegen 318 Millionen DKK (ungefähr 51 Millionen USD). - Das Nettofinanzeinkommen erreichte eine Gesamthöhe von 30 Millionen DKK (ungefähr 5 Millionen USD) gegenüber einem Nettofinanzeinkommen in Höhe von 25 Millionen DKK (ungefähr 4 Millionen USD) in den ersten neun Monaten im Jahr 2004. - Genmab schloss den Neunmonatszeitraum mit einem Kassenstand von 1,394 Milliarden DKK (ungefähr 225 Millionen USD) ab. Dies entspricht einer Nettosteigerung von 236 Millionen DKK (ungefähr 38 Millionen USD) in den ersten neun Monaten des Jahres 2005. - Die Erlöse in den ersten neun Monaten dieses Jahres beliefen sich auf insgesamt 45 Millionen DKK (ungefähr 7 Millionen USD). Im Vergleichszeitraum des Jahres 2004 wurden dagegen keine Erlöse erwirtschaftet.


Höhepunkte

Im dritten Quartal konnten die folgenden geschäftlichen und wissenschaftlichen Leistungen erzielt werden:


- Einleitung einer zweiten Phase in der Untersuchung von HuMax-CD20 für die Behandlung von Patienten mit chronischem Gelenkrheumatismus (rheumatoide Arthritis/RA), bei denen die Behandlung mit einer oder mehreren DMARD-Mitteln (Disease Modifying Anti-Rheumatic Drugs) versagt hat. - Genmab gewährte Serono (Virt-X: SEO.VX - Nachrichten) im August die exklusiven weltweiten Rechte zur Entwicklung und Kommerzialisierung von HuMax-CD4. Genmab erhielt Lizenzgebühren in Höhe von 20 Millionen USD, und Serono investierte 50 Millionen USD in Stammaktien von Genmab mit 18 % Agio. Die Zahlungen an Genmab einschliesslich aller Meilensteine können sich auf insgesamt 215 Millionen USD belaufen, und Genmab stehen Tantiemen für den weltweiten Verkauf von HuMax-CD4 zu. - Im September wurden positive Zwischenergebnisse für die erste und zweite Phase der HuMax-CD20-Untersuchung bezüglich des Einsatzes bei Patienten mit chronischer Lymphozytenleukämie (CLL) vorgelegt. Bei Patienten, die mit der höchsten Dosis behandelt wurden, konnte eine Reaktionsrate von 52 % beobachtet werden. - Bo Kruse wurde mit Wirkung vom Oktober 2005 zum Vice President, Chief Financial Officer von Genmab ernannt.


Finanzprognose

Genmab überarbeitet derzeit seine Finanzprognose für das Jahr 2005. Aufgrund der verbesserten Betriebseffizienz und günstiger Entwicklungen in den Devisenkursen haben wir unsere Vorhersage für den Kassenstand zum Jahresende 2005 auf ungefähr 1,225 Milliarden DKK revidiert, was einer Steigerung von ungefähr 67 Millionen DKK gegenüber dem Kassenstand zum Jahresende 2004 entspricht.

Zusätzlich haben wir unsere Prognosen für Betriebs- und Nettoverluste angepasst und gehen jetzt davon aus, dass diese Werte ungefähr 440 Millionen DKK bzw. 410 Millionen DKK betragen werden. Wir haben zwar von Serono die gesamten Lizenzgebühren für HuMax-CD4 in Höhe von 20 Millionen USD im dritten Quartal erhalten, haben uns jedoch zu einer konservativen Verbuchung unserer Erlöse entschlossen, die höchsten Buchhaltungsnormen gerecht wird. Aus diesem Grund haben wir die Anrechnung eines Teils dieser Lizenzgebühren verschoben und werden diesen Anteil bis zum Jahresende 2007 linear abschreiben.

Änderungen der Prognosen können vor allem aufgrund der Terminierung und der Vielfältigkeit klinischer Aktivitäten, damit zusammenhängender Kosten und der Schwankungen in den Devisenkursen notwendig werden. Bei den Prognosen wird ausserdem davon ausgegangen, dass im verbleibenden Zeitraum des Jahres 2005 keine weiteren Vereinbarungen getroffen werden, die die Ergebnisse wesentlich beeinflussen könnten.

Konferenzschaltung

Genmab wird morgen, am Mittwoch, den 9. November 2005, eine Telefonkonferenz abhalten, bei der die Ergebnisse des dritten Quartals besprochen werden. Die Konferenzschaltung findet zu folgenden Ortszeiten statt:

15:30 MEZ (mitteleuropäische Zeit) 14:30 WEZ (britische Zeit) 09:30 EST (amerikanische Ostküstenzeit) Die Telefonkonferenz wird auf Englisch abgehalten. Folgende Einwahlnummern stehen zur Verfügung: +1-800-946-0786 (in den USA) +1-719-457-0786 (von ausserhalb der USA) -- verlangen Sie die Genmab-Konferenzschaltung

Wichtige Präsentationsfolien für die Konferenz stehen bereits vorab unter www.genmab.com zur Verfügung.

Informationen zu Genmab A/S

Genmab A/S ist ein Biotech-Unternehmen, das sich mit der Herstellung und Entwicklung menschlicher Antikörper zur Behandlung lebensbedrohlicher und beeinträchtigender Krankheiten befasst. Genmab entwickelt derzeit zahlreiche Mittel zur Behandlung von Krebs, Infektionskrankheiten, chronischem Gelenkrheumatismus und anderen Entzündungskrankheiten und hat sich zum Ziel gesetzt, sein breites Portfolio neuer therapeutischer Produkte kontinuierlich zu erweitern. Genmab unterhält derzeit eine Reihe von Partnerschaften (u.a. mit Roche (Virt-X: ROG.VX - Nachrichten) , Amgen (NASDAQ: AMGN - Nachrichten) und Serono), um Zugang zu krankheitsrelevanten Targets zu erhalten und neue menschliche Antikörper zu entwickeln. Durch eine breitgefächerte Allianz hat Genmab Zugang zu den Technologien von Medarex Inc., u.a. zur UltiMAb(R )-Plattform für die schnelle Entwicklung und Herstellung menschlicher Antikörper für praktisch jedes krankheitsrelevante Target (NYSE: TGT - Nachrichten) . Genmab verfügt über Niederlassungen in Kopenhagen (Dänemark), Utrecht (Niederlande) und Princeton (New Jersey/US). Weitere Informationen zu Genmab erhalten Sie unter www.genmab.com.

Diese Pressemitteilung enthält zukunftsgerichtete Aussagen. Zukunftsgerichtete Aussagen können an Begriffen wie "glauben", "erwarten", "vorhersehen", "beabsichtigen" und "planen" oder ähnlichen Ausdrücken erkannt werden. Tatsächliche Ergebnisse bzw. Leistungen können wesentlich von den durch diese Erklärungen ausgedrückten oder implizierten zukünftigen Ergebnissen bzw. Leistungen abweichen. Die Hauptfaktoren, die zu wesentlichen Abweichungen der tatsächlichen Ergebnisse oder Leistungen führen können, umfassen unter anderem Risiken im Zusammenhang mit der Entdeckung und Entwicklung von Medikamenten, Ungewissheiten in Verbindung mit dem Ergebnis und der Durchführung klinischer Studien, darunter unvorhergesehene Sicherheitsrisiken, Ungewissheiten bezüglich der Herstellung eines Mittels, mangelnde Marktakzeptanz unserer Produkte, Schwierigkeiten beim Management des Wachstums sowie des Konkurrenzumfelds in unserem Geschäftsbereich und auf unseren Märkten, unsere eingeschränkte Fähigkeit, qualifiziertes Personal anzuwerben und dauerhaft zu halten, die Nichtdurchsetzbarkeit oder mangelnder Schutz unserer Patente und Urheberrechte, unsere geschäftlichen Beziehungen mit angeschlossenen Unternehmen, technologische Veränderungen und Entwicklungen, die unsere Produkte überholen können, sowie weitere Faktoren. Genmab ist nicht dazu verpflichtet, diese Prognosen nach Veröffentlichung dieser Pressemitteilung zu aktualisieren bzw. in Bezug auf die tatsächlich eingetretenen Ergebnisse zu bestätigen, es sei denn, es gibt eine gesetzliche Verpflichtung hierfür.

UltiMAb(R) ist eine Marke von Medarex (NASDAQ: MEDX - Nachrichten) , Inc.

Genmab(R), HuMax(R), HuMax-CD4(TM) und das Y-förmige Genmab-Logo sind Marken von Genmab A/S.

Website: www.genmab.com

Originaltext: Genmab A/S Digitale Pressemappe: presseportal.de/story.htx?firmaid=17265 Pressemappe via RSS : feed://presseportal.de/rss/pm_17265.rss2 ISIN: DE0005651327

Pressekontakt: Helle Husted, Director, Anlegerbetreuung, Genmab A/S, +45-33-44-77-30 oder mobil unter +45-25-27-47-13, hth@genmab.com

 
yahoo.reuters.com/...78197_2005-11-16_06-44-04_l1688240_newsml

Roche's MabThera helps arthritis patients
Wed Nov 16, 2005 01:44 AM ET
ZURICH, Nov 16 (Reuters) - Cancer drug MabThera improves the symptoms of patients with rheumatoid arthritis who had failed to benefit from other forms of treatment, Roche Holding AG (ROG.VX: Quote, Profile, Research) said on Wednesday.
In data released at a medical meeting in San Diego, Roche said that its MabThera drug significantly improved all measures of efficacy for rheumatoid arthritis patients for six months following a single course of two infusions of the drug.

The patients tested had previously failed to benefit from so-called anti-TNF therapies which are designed to block an inflammation-causing protein.

The drug is already indicated as a treatment for non-Hodgkin's lymphoma, or lymph cancer. It was developed by Genentech Inc. (DNA.N: Quote, Profile, Research) , majority-owned by Roche, and Biogen Idec (BIIB.O: Quote, Profile, Research) and is marketed in the U.S. as Rituxan.

yahoo.reuters.com/...9194_2005-11-16_21-02-53_n16387786_newsml

CORRECTED - UPDATE 1-J&J, Schering-Plough RA drug shows promise in trial
Wed Nov 16, 2005 04:02 PM ET
(In story headlined "Update 1-J&J, Schering-Plough RA drug shows promise in trial," please read in paragraph 9, "An FDA advisory panel backed Bristol-Myers Squibb Co.'s treatment, Orencia, for rheumatoid arthritis ..." instead of "Bristol-Myers Squibb Co. won approval for its rheumatoid arthritis drug Orencia ..." (Correcting to show drug has not yet received FDA approval.)
BOSTON, Nov. 16 (Reuters) - Johnson & Johnson (JNJ.N: Quote, Profile, Research) and Schering-Plough Corp. (SGP.N: Quote, Profile, Research) said on Wednesday that their experimental rheumatoid arthritis drug showed promise in a mid-stage trial.

The companies said that more than 60 percent of patients taking the drug, golimumab, combined with the common treatment methotrexate, saw an improvement in their symptoms of at least 20 percent after 16 weeks.

Results of the phase II trial, presented this week at the annual meeting of the American College of Rheumatology, showed that a quarter of patients receiving the combination treatment achieved remission of their symptoms.

Schering-Plough's shares rose about 1 percent to $19.31 in early trading on the New York Stock Exchange. Johnson & Johnson's shares rose a similar amount to $63.44.

Golimumab is designed to work by blocking an inflammation-causing protein known as tumor necrosis factor. Johnson & Johnson already has a drug on the market -- Remicade -- that blocks the same protein. Amgen Inc.'s (AMGN.O: Quote, Profile, Research) Enbrel and Abbott Laboratories Inc.'s (ABT.N: Quote, Profile, Research) Humira attack the same target.

TNF-inhibitors have been among the most successful of all biotechnology drugs and rheumatoid arthritis, which affects more than 2 million people in the United States, is one of the most hotly-contested disease areas.

Genentech Inc. (DNA.N: Quote, Profile, Research) and Biogen Idec Inc. (BIIB.O: Quote, Profile, Research) recently filed for marketing approval to sell their cancer drug Rituxan as a treatment for rheumatoid arthritis in patients who have failed to respond to TNF blockers.

Roche Holding AG (ROG.VX: Quote, Profile, Research) , which is developing a drug called MRA together with Chugai Pharmaceutical Co Ltd (4519.T: Quote, Profile, Research) sees rheumatoid arthritis as a major area for potential future growth.

An FDA advisory panel backed Bristol-Myers Squibb Co.'s (BMY.N: Quote, Profile, Research) treatment Orencia for rheumatoid arthritis earlier this year to treat patients who fail to respond to one or more other therapies. The FDA is still considering the panel's recommendation that the agency approve the drug.

Orencia is the first of a new class of drugs know as T-cell co-stimulation modulators. The drug works by inhibiting activation of T-cells, components of the immune system involved in inflammation.

Golimumab is being co-developed by Schering-Plough and J&J's Centocor unit.

Cheshire, Conn.-based Alexion (ALXN:
ALXN
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FinancialsMore ALXNALXN, , ) said a Phase III clinical trial of pexelizumab found that while the drug appeared to reduce the incidence of heart attack or death in some patients who had just undergone coronary bypass surgery, those results were statistically insignificant.

The company plans to present the clinical data at an upcoming scientific meeting. The drug trial, which consisted of about 4,250 heart patients, was cosponsored by the pharmaceuticals division of Procter & Gamble.(PG:
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Alexion also said it will assess what impact the results might have on a second Phase III clinical trial currently testing pexelizumab in patients who had just undergone angioplasty.

"We are clearly disappointed that pexelizumab did not meet its primary endpoint," said Leonard Bell, Alexion's chief executive officer, in a release. "We look forward to completing an analysis of the data and obtaining a more in-depth understanding of these results."

In related news, Alexion also said it was expecting initial results from a Phase III clinical trial for its drug eculizumab for the treatment of a rare blood disorder during the first quarter 2006.

The timing of Alexion's announcement made a research note from Banc of America Securities seem a bit prescient, although the firm's initiation of the stock with a neutral rating may be in jeopardy following the Wednesday's results.

Banc of America asserted that Wall Street didn't fully appreciate the challenges facing Alexion, commercially and clinically. The analysts said they believed the pexelizumab trial for bypass surgery had only about a 50% chance of being successful. They added they believed the on-going Phase III trial for eculizumab had about a 70% chance of success.

Prior to the news, the firm projected pexelizumab would have peak sales of $500 million, if approved. It estimated peak sales of eculizumab would be around $150 million.

--------------------------------------------------
Alexion : HP http://www.alexionpharm.com

Alexion Pharmaceuticals, Inc., together with its subsidiaries, engages in the discovery and development of biologic therapeutic products for the treatment of severe diseases. It develops therapeutic products for the treatment of hematologic and cardiovascular disorders, autoimmune diseases, and cancer; and additional antibody therapeutics for other medical needs. The company primarily develops two lead product candidates, eculizumab and pexelizumab, which address specific diseases that arise when the human immune system produces inflammation in the human body. Eculizumab is in phase III clinical development for treatment of Paroxysmal Nocturnal Hemoglobinuria, a chronic hematologic disease. Pexelizumab is in clinical development for the reduction of the incidence of death, myocardial infarction or heart attack, and other complications associated with coronary artery bypass graft surgery; and for acute myocardial infarction. Alexion Pharmaceuticals has a strategic alliance with Procter and Gamble Pharmaceuticals for the development of pexelizumab. The company was co-founded by Leonard Bell, Stephen P. Squinto, Scott A. Rollins, and Joseph A. Madri in 1992. Alexion Pharmaceuticals is headquartered in Cheshire, Connecticut.

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 GROWING GLOBAL CONCERN about a possible pandemic stemming from avian flu have put the spotlight on several drug companies that may have treatments, notably Switzerland's Roche, maker of the highly sought-after anti-viral, Tamiflu.
AVI BioPharma (AVII), a little-known U.S. biotechnology firm, also could be a beneficiary of flu fears because its novel "antisense" drugs may be effective in combating the flu virus, as well as hepatitis C and a range of bio-terror threats, including the dreaded Ebola virus.

Antisense drugs potentially offer an elegant antidote to viral diseases because they're designed to enter cells and eliminate viruses by preventing their replication. The drugs, which act by blocking critical viral genetic sequences, may be more potent than anti-virals such as protease inhibitors, which seek to inhibit a protein needed for viral replication. AVI's specialty is single-strand RNA viruses, which include Ebola, hepatitis C and the flu.
 
Based in Portland, Ore., AVI has developed a drug, now in early clinical trials, to treat hepatitis C. Its drug to prevent restenosis, or the reclogging of arteries that can occur after angioplasty, is undergoing a clinical trial in Europe. The results from the hepatitis C trial are expected late this year or early in 2006, and the restenosis-trial data are likely next year.

The hepatitis trial, combining the first and second phases of the three trials typically required by the Food and Drug Administration, admittedly is small, involving about 40 sick patients. But, if that trial proves a success, AVI would stand a good chance of forming a potentially lucrative partnership with a major drug maker. Such a pact could help lift the company from obscurity and power its stock, which now languishes around $3 a share.

While AVI has little support on Wall Street, its fans believe it could be a big winner. "AVI has created and patented a core technology that has multiple applications that span everything from infectious disease to restenosis to muscular dystrophy and cancer," says Richard Macary, a managing partner at Corporate Insights, an independent research firm in New York. Macary owns AVI shares.

AVI clearly is a speculative stock. It has no drugs on the market, and minimal revenues other than government grants. As such, it has had to rely on dilutive equity financings, including a $24 million deal earlier this year, to fund itself. AVI has a modest market value of about $140 million, based on 44 million shares outstanding. It has $31 million of cash, enough to last more than a year, given its current annual cash-burn rate of about $22 million.

Unlike most other biotech companies with depressed shares, AVI hasn't had any failures in clinical trials. The company arguably has too much on its plate, and its management has been faulted for not telling its story well to investors and for not moving quickly enough with clinical trials in order to commercialize its products.

yahoo.smartmoney.com/barrons/images/20051114b2.gif" style="max-width:560px" >

E = Estimate
Sources: Company Reports; Legg Mason  


What attracts Macary is AVI's technology and the broad range of diseases its drugs presumably could treat, including avian flu. Once AVI's technology is "proven in one area," he says, Wall Street and the drug industry will take notice. That could come with the Phase I/II trial involving AVI's hepatitis C drug. AVI is taking on a difficult disease — a leading cause of liver failure — that may affect 200 million to 300 million people worldwide, including as many as four million in the U.S.

Hepatitis C represents a multibillion-dollar opportunity for any company that can come up with a better treatment than the current standard, a long, toxic and costly regimen involving Interferon and ribavirin that is ineffective in about half of patients. Many drug companies are working on hepatitis C drugs, including Vertex Pharmaceuticals (VRTX

Page 2 of 2)

AVI has developed treatments for a range of bio-terror threats, including the Ebola and Marburg viruses, anthrax and ricin, as well as West Nile virus and dengue fever. A U.S. Senate committee has approved an appropriation of $22 million to the company to pursue these drugs.
If the funds materialize in 2006, it will help AVI move forward with the testing necessary to seek FDA approval. The company has a strong relationship with the U.S. Defense Department and its top lab, the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), at Fort Detrick, Md. AVI's Ebola and Marburg treatments have been effective in animals, including primates, but haven't yet been tested in humans.

AVI also has had success in preclinical experiments with a drug to combat the flu. The company now wants to expand its research to animals, and later to humans.

Wall Street analysts generally are cool to AVI, partly because the history of antisense drugs hasn't been a happy one for investors. The FDA failed to approve antisense cancer drugs from Genta (GNTA) and Isis Pharmaceuticals (ISIS) in the past two years, casting a pall over any biotech company pursuing such therapies.

One of AVI's biggest critics on the Street is Legg Mason biotech analyst Edward Nash, who has a Sell rating on the stock. "So we ask ourselves, why would investors invest in AVI with no near-term hope of profitability when they could invest in other biotech companies that have near-term, late-stage clinical, and/or commercialization milestones," Nash wrote in a recent note, titled "AVII: AVI (an) is for the birds."

AVI's situation could change dramatically if its hepatitis C drug trial meets the company's goal of substantially reducing the viral count in diseased patients. Major drug companies are desperate for products, and hepatitis C is considered one of the largest opportunities. Biotech firms with promising drugs, even those not yet in Phase III trials, are reaching lucrative deals with Big Pharma. AVI's chief executive, Denis Burger, says the company is likely to partner with one of several big drug makers if the hepatitis C trial goes well.

AVI was formed in 1980, and its drug platform is supported by more than 100 patents. The company's top executives and directors have significant experience in the drug and biotech industries. Burger, who has been AVI's CEO since the company went public in 1997, acknowledges it's a show-me story. "With the high-profile antisense failures, the Street is leery of the word antisense. Pharmaceutical companies and investors are leery," he says.

Burger says AVI's third-generation Neugene technology differs fundamentally from antisense drugs developed by rivals. AVI drugs use a patented, synthetic chemical backbone to deliver their gene-blocking payload. This structure is designed to prevent the human body's tendency to break them down before they reach target cells.

Antisense drugs also have to overcome other biochemical hurdles, including the ability to cross cellular barriers and then block specific genetic targets. The drugs need to work without causing severe side effects, as safety has been a problem with rivals' drugs. "We've completed 11 human clinical trials involving 250 patients, and we've not had a single drug-related adverse event," Burger says.

AVI can develop a drug quickly once it knows the genetic code of the target virus. With the flu, it strives to target a critical section of the virus that is common to multiple strains. Because the flu virus mutates, a new vaccine must be developed yearly.

Small Firm, Big Targets
AVI Biopharma is developing drugs based on its patented anti-viral technology to combat hepatitis C, which lacks strong existing treatments, and a variety of bioterrorist threats, including Ebola.  
 
Sources: Company Reports  
yahoo.smartmoney.com/barrons/images/20051114b3.gif" style="max-width:560px" >

If its technology works, AVI could develop drugs for a host of ailments that have a genetic cause. GlaxoSmithKline (GSK), for instance, is using AVI's technology to develop a treatment for muscular dystrophy. Other applications could include diabetes and multiple sclerosis.

In 2004, a worker at the USAMRIID lab was stuck by a needle while working with Ebola, prompting fears the worker might contract the deadly disease. AVI formulated a drug within days that got special FDA approval, though the worker proved to be unharmed. AVI was then able to test the drug in primates who were given a fatal dose of Ebola, and 75% survived.

The U.S. government is eager for drugs to combat a range of bio-terror threats because few treatments now exist. Ebola, which causes a hemorrhagic fever that is usually fatal, largely has been confined to central Africa. It is transmitted through direct contact with the blood or bodily secretions of those afflicted. The fear is that terrorists could produce an airborne form of Ebola and then seek to infect a city.

If AVI's Ebola and other bio-terror treatments are deemed sufficiently promising, the government could commission the company to produce a significant amount of the drugs for stockpiling. The government already has an $877 million contract with VaxGen (VXGN), a California biotech, to make 75 million doses of an anthrax vaccine. The advantage of AVI's treatment over a vaccine is that it can be used immediately when an outbreak of the disease occurs. Vaccines typically aren't effective for those who already have contracted a disease, and they can take weeks to provide immunity to healthy people. The chief of immunology at USAMRIID, Sina Bavari, said recently that favorable animal tests involving AVI drugs "represent important progress for the potential treatments of these deadly bio-threats," according to an AVI press release.

The Bottom Line
AVI BioPharma's shares trade for $3, but could soar if the company's flu, hepatitis and restenosis drugs move toward FDA approval. That could also lead to a deal with Big Pharma.  
 

One of the knocks against AVI is that it lacks a major drug partner. In 2001, AVI traded up to $12 share after it partnered with Medtronic (MDT), which planned to use AVI's restenosis drug for a new stent. That partnership lapsed in 2004 without producing a drug-coated stent, and its failure has been interpreted as a sign that the AVI drug isn't effective. Drug-coated stents from Boston Scientific (BSX) and Johnson & Johnson (JNJ) now dominate the market. Stents are used as scaffolding to hold open arteries after they've been cleared of blockages. Drug-coated stents have reduced the incidence of restenosis, or the reclogging of arteries, compared with bare-metal stents.

In Europe, AVI is testing its drug in conjunction with bare-metal stents, commonly used on the continent, to see if the combination can achieve similar success at much lower cost. The AVI drug is injected.

A U.S. Phase II trial in 2003 found that AVI's Resten drug, when delivered via catheter, was effective in preventing restenosis. "It's a very good drug," says Dr. Nicholas Kipshidze, a physician and researcher at Lenox Hill Hospital in New York, which conducted the 2003 trial. "We got very good results with inferior delivery. It's less toxic than any other drug we are using. I still believe that Resten will play a role in the stent" market. Kipshidze consults for AVI, but doesn't own stock.

The Street has written off AVI's restenosis drug, just as it has downplayed the potential of its other products. The biotech industry is full of hype, hope and frequent disappointment. Like most biotechs, AVI amounts to a lottery ticket. But, in this case, the payoff just might be huge.

de.biz.yahoo.com/12122005/217/...darabin-refraktaerer-cll.html

www.campath.com/

PR Newswire
Behandlung mit subkutanem (SC) MabCampath(R) (Alemtuzumab) bei Patienten mit fludarabin-refraktärer CLL effektiv und unbedenklich
Montag 12. Dezember 2005, 09:09 Uhr



Atlanta, December 12 /PRNewswire/ --


- Laut Zwischenanalyse ist SC MabCampath so effektiv und gut verträglich
wie IV-Therapie



Gemäss den Zwischenergebnissen der Phase-II-UKCLL02-Studie ist
MabCampath(R) (Alemtuzumab) in subkutaner (SC) Form sowohl effektiv wie auch
gut verträglich im Vergleich zu historischen Patientengruppen, die sich
intravenösen (IV) Behandlungen für fludarabin-refraktäre, chronisch
lymphatische Leukämie (CLL) unterzogen. Die Ergebnisse, die bei der 47.
Jahrestagung der American Society of Hematology (ASH) vorgestellt wurden,
bewiesen, dass fast Anzeige
 

die Hälfte aller mit SC MabCampath behandelten Patienten
entweder mit partiellem oder vollständigen Ansprechen reagierten, wobei
manche Patienten die MRD-Negativität erreichten (MRD = minimale
Resterkrankung).


"Obwohl MabCampath IV erfolgreiche Ansprechraten zwischen 33 und 50
Prozent erzielt hat, können die Infusionsreaktionen und zweistündigen
Behandlungen, die dreimal pro Woche während eines Zeitraums von 12 Wochen
stattfinden, sowohl in Hinblick auf Nebenwirkungen wie auch den Zeitaufwand
für die Patienten problematisch werden", so Peter Hillmen, M.B, Ch.B,
Facharzt für Hämatologie am Allgemeinkrankenhaus Leeds in Leeds,
Grossbritannien. "Diese Ergebnisse sind für Patienten und Ärzte
gleichermassen sehr ermutigend, da sie zu der Annahme führen, dass SC
MabCampath so effektiv wie die herkömmliche IV-Behandlung sein könnte. Bei
diesen Patienten, deren Behandlung sich als überaus schwierig erwiesen hat,
wird die SC-Behandlung besser vertragen, wobei die einfachere
Verabreichungsmethode ein zusätzlicher Bonus ist."



Ergebnisse der Studie


Von den bis dato 44 ersten untersuchten Patienten haben 36 die Therapie
vollständig abgeschlossen. Die Gesamtansprechrate für MabCampath und die
Fludarabin-Therapie lag bei 44 Prozent (39 Prozent bei ausschliesslich
Campath), wobei drei Patienten in der MabCampath-Monotherapiephase ein
vollständiges Ansprechen (zwei MRD-negativ und eines MRD-positiv) und 11
Patienten ein partielles Ansprechen (einschliesslich einem MRD-negativen
Patienten, der zytopenisch blieb) erreichten. Zwei Nicht-Responder erzielten
partielles Anspechen, als sie mit einer Kombinationstherapie von MabCampath
und oral verabreichtem Fludarabin behandelt wurden, während ein Nicht-
Responder vollständiges Ansprechen erreichte (MRD-positiv). Darüberhinaus
sprachen 20 Patienten mit einer genetischen Disposition zu schlechtem
Ansprechen auf Chemotherapie (p53-Dysfunktion oder Deletion) gut auf die
Behandlung mit MabCampath an.


Die häufigsten Nebenwirkungen, die während der anfänglichen Verabreichung
von MabCampath beobachtet wurden, waren örtlich begrenzte, erythematöse
Hautreaktionen, Fieber und Starre, wobei alle Reaktionen innerhalb von 48
Stunden nach der Behandlung nachliessen. Thrombozytopenie Grad 3+ und
Neutropenie wurden bei je 16 und 25 Patienten beim Monotherapiearm von
MabCampath, bzw. bei einem und zwei Patienten beim kombinierten Therapiearm
beobachtet. Zu den potenziell gravierenden Infektionen, die bei der
MabCampath-Monotherapie auftraten, gehörten die CMV-Reaktivation
(Zytomegalovirus), febrile Neutropenie, invasive Pilzkrankheiten und
Lungenentzündung. Bei den Kombinationstherapie-Patienten trat lediglich
CMV-Reaktivation auf, und alle CMV-Reaktivationen konnten erfolgreich mit
antiviraler Therapie behandelt werden.


Im Vergleich hierzu wurden gewisse ungünstige Prozesse, die mit der
intravenösen Verabreichung einhergingen, insbesondere Schüttelfrost,
Hautausschläge und Übelkeit/Erbrechen, durch die subkutane Verabreichung von
MabCampath drastisch reduziert oder gar eliminiert.


Das mittlere Alter der Patienten lag bei 66 Jahren (zwischen 41 und 79),
wobei 36 Patienten dreimal pro Woche bis zu 24 Wochen (abhängig von der alle
6 Wochen erfolgenden Knochenmark-Beurteilung) eine 30mg-Dosis von SC
MabCampath erhielten. Patienten, die während der subkutanen Verabreichung
kein Ansprechen erreichten, konnten für je drei Tage alle vier Wochen 40mg/m2
orales Fludarabin in Kombination mit SC MabCampath bekommen.



Näheres über chronisch lymphatische Leukämie (CLL)


CLL ist die häufigste Form der Leukämie bei Erwachsenen und befällt
jährlich etwa 120.000 Menschen in Europa und den USA, wobei Patienten im
Alter von 50 Jahren und darüber am häufigsten betroffen sind.
Charakteristisch für CLL ist die Ansammlung funktionell nicht ausgereifter
weisser Blutkörperchen (Lymphozyten) im Knochenmark, dem Blut, Lymphgewebe
und anderen Organen. Es befinden sich zwei Arten von Lymphozyten im Blut, die
B-Zellen und die T-Zellen. Bei etwa 95 Prozent der CLL-Fälle sind krebsartige
B-Zellen im Spiel. Da diese B-Zellen eine längere Lebensdauer als normal
haben, beginnen sie, sich aufzubauen und die normalen, gesunden
Blutkörperchen zu "verdrängen". Die Anhäufung funktionell nicht ausgereifter
Zellen im Knochenmark schliesst die Bildung von gesunden Zellen aus und kann
sich tödlich auswirken. Zu den Symptomen zählen Müdigkeit, Knochenschmerzen,
Nachtschweiss sowie Appetit- und Gewichtsverlust. Wenn das Knochenmark
betroffen ist, kann dies aber auch zu einer Schwächung des Immunsystems
führen, wodurch der Patient einer höheren Infektionsgefahr ausgesetzt ist.



Informationen zu MabCampath(R) (Alemtuzumab)


MabCampath, das in den USA auch unter dem Namen Campath(R) vertrieben
wird, ist der erste und einzige für CLL zugelassene humanisierte monoklonale
Antikörper und das erste Medikament mit bewährter Wirkung bei CLL-Patienten,
die weder auf Alkylantien noch die Behandlung mit Fludara (
Fludarabinposphaten) ansprechen. Keine andere Therapie hat bei dieser
Patientengruppe ähnliche Wirkung gezeigt. Die Wirkungsweise von
MabCampath/Campath und herkömmlichen Behandlungsmethoden ist vollkommen
unterschiedlich, da sich ersteres gezielt gegen das CD52-Antigen der malignen
Lymphozyten richtet. Die hierdurch in Gang gesetzten Prozesse führen zur
Lysis, also dem Tod oder der Auflösung der bösartigen Zellen. Diese Prozesse
führen dann zur Entfernung der malignen Lymphozyten aus dem Knochenmark, dem
Blut und anderen betroffenen Organen, was dann wiederum eine gesteigerte
Lebenserwartung nach sich ziehen kann.


Die bei dieser Indikation auftretenden Nebenwirkungen von MabCampath
können gut unter Kontrolle gebracht werden, wenn das eventuelle Auftreten
opportunistischer Infektionen genau überwacht und entsprechende
prophylaktische Massnahmen dagegen getroffen werden. Diese Nebenwirkungen
sind vorhersehbar, kontrollierbar und reversibel. Darüberhinaus können
Patienten wieder ihre eigenen gesunden Blutkörperchen bilden, da MabCampath
die Stammzellen im Knochenmark nicht angreift.



Ansprechpartner:
Greg Moulds
Leiter der Medienabteilung
Leeds Teaching Hospitals
+44-0113-2066244


Leeds Teaching Hospitals

ng.

de.biz.yahoo.com/12122005/36/...biets-mabthera-beantragen.html

dpa-afx
Roche will Erweiterung des Anwendungsgebiets von MabThera beantragen
Montag 12. Dezember 2005, 19:12 Uhr


BASEL (dpa-AFX) - Roche (Virt-X: ROG.VX - Nachrichten) wird bei den europäischen Behörden ein Zulassungsgesuch zur Erweiterung des Anwendungsgebiets seines Krebsmittels MabThera einreichen. Wie der Schweizer Pharmakonzern unter Berufung auf neue klinische Daten an diesem Montag mitteilte, bewirkt eine zweijährige Erhaltungstherapie mit dem Präparat eine drastische Verbesserung der Überlebenschancen von Patienten mit indolentem Non-Hodgkin-Lymphom (NHL). Die Erhaltungstherapie soll das Wiederauftreten dieser bösartigen Erkrankung des ANZEIGE
 
Lymphsystems verhindern. Der Pharmachef von Roche, William Burns, sprach von einem "bislang ungekannten Überlebensvorteil bei dieser als unheilbar geltenden Krebskrankheit". Allein in Westeuropa werde das indolente NHL jährlich bei 20.000 Patienten neu diagnostiziert und rund 40.000 Patienten mit dieser Erkrankung werden behandelt./hi/zb  

14.12.2005 22:44

Amgen will Abgenix für 22,50 Dollar je Aktie in bar plus Schulden kaufen

Der weltgrößte Biotechnologiekonzern Amgen <AMGN.NAS> <AMG.FSE> (Nachrichten/Aktienkurs) will den Konkurrenten Abgenix <ABGX.NAS> <ANX.ETR> (Nachrichten) für 22,50 US-Dollar je Aktie in bar übernehmen. Der Kaufpreis liege damit bei 2,2 Milliarden Dollar, teilte Amgen am Mittwoch in Thousand Oaks nach Börsenschluss mit. Zudem sollen die Schulden des Biotechnologie-Spezialanbieters übernommen werden. Die Abgenix-Aktie schloss am Mittwoch mit einem Plus von 3,24 Prozent bei 14,65 Dollar. Nachbörslich legte sie 41,23 Prozent auf 20,69 Dollar zu, bevor sie vom Handel ausgesetzt wurde. Amgen-Anteile verbilligten sich unterdessen etwas. Durch die Akquisition, die im ersten Quartal des kommenden Jahres abgeschlossen sein soll, erhalte Amgen den vollen Zugang zum gemeinsam entwickelten Krebsmedikament Panitumumab. Amgen schätzt, dass der jährliche Spitzenumsatzes des Medikaments, dessen Entwicklung den Angaben zufolge weite fortgeschritten ist, bis zu zwei Milliarden Dollar betragen könnte. Das Unternehmen geht davon aus, dass die Übernahme den Gewinn je Aktie vor Sonderposten in den Jahren 2006 und 2007 zwischen fünf und zehn Cent belasten wird. Danach werde die Akquisition im Falle eines kommerziellen Erfolgs von Panitumumab den Gewinn je Aktie vor Sonderposten positiv beeinflussen. Zur Höhe der Schulden, die Amgen übernimmt, machten die Unternehmen keine Angaben. Den zuletzt veröffentlichten Zahlen zufolge hatte Abgenix per Ende September neben einer ausstehenden Wandelanleihe von knapp 450 Millionen Dollar rund 85 Millionen Dollar ausstehende Schulden./zb/hi ISIN US0311621009 US00339B1070 AXC0182 2005-12-14/22:39

War gestern zu müde.  

hier noch etwas ausführlicher.

www.marketwatch.com/news/yhoo/...403C%2D849B%2DCDA85F73D5D7%7D

News of the deal, disclosed after Wednesday's close, was warmly received Thursday, with shares of the biotechnology giant (AMGN:
) jumping 4% to $79.99, while Abgenix (ABGX: ABGX
rocketed 28% to $21.71.

Amgen and Abgenix said they have signed a definitive merger agreement that calls for Amgen to pay $2.2 billion in cash, or $22.50 share, and to assume Abgenix's debt.

Amgen, with a market capitalization of $94.8 billion, is the largest biotechnology company in the world next to Genentech (DNA:
DNA
) , which is partially owned by Roche. Genentech had a market capitalization of $99.6 billion, as of Wednesday evening.

Amgen and Abgenix have been collaborating on developing two major drug candidates, most notably the cancer therapy panitumumab. They're also working on denosumab, a treatment for osteoporosis and bone cancer.

Amgen said it was particularly interested in panitumumab, which it says could have peak sales of more than $2 billion. The drug still must be approved by the Food and Drug Administration.

Amgen noted in its statement that by acquiring Abgenix, it will eliminate the need to pay future royalties on those drugs if and when they are approved. In early November, the companies unveiled favorable Phase III clinical data for panitumumab as a therapy for the treatment of colorectal cancer in patients who had failed on standard chemotherapy regimens.

Amgen and Abgenix expect to apply for U.S. regulatory approval of panitumumab during the first quarter of 2006. They added they also plan testing the therapy for the treatment of head and neck cancers.

That news could spell trouble for rival ImClone Systems (IMCL:
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FinancialsMore IMCLIMCL, , ) , whose antibody-based drug Erbitux is also approved to treat colorectal cancer in patients who have failed chemotherapy. Likewise, ImClone and partner Bristol-Myers Squibb (BMY: BMY
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FinancialsMore BMYBMY, , ) have been running Phase III clinical trials for Erbitux for the treatment of head and neck cancers.

Abgenix is best known for its XenoMouse technology, which allows mouse antibodies to be used as therapies in humans through genetic manipulation.

Amgen said that as a result of the merger, it expects earnings to be diluted by 5 cents to 10 cents a share in 2006 and 2007. If panitumumab is successfully launched, the deal should be accretive to dilutive earnings after 2007.

The two companies don't anticipate significant layoffs as a result of the merger, they said.

biz.yahoo.com/ap/051205/imclone_mover.html?.v=1


AP
Imclone Systems Shares Down on Report
Monday December 5, 1:50 pm ET  
Imclone Systems Shares Fall After Analyst Forecasts Stiff Competition for Erbitux


NEW YORK (AP) -- Shares of Imclone Systems Inc. slipped Monday after one analyst predicted that a competing cancer treatment may usurp U.S. market share from Erbitux in the next three to four years.
Imclone shares fell 81 cents, or 2.5 percent, to $31.69 in afternoon trading on the Nasdaq, after dropping as low as 7 percent this morning.

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In a research note, SG Cowen & Co. analyst Eric Schmidt said that he expects panitumumab, a cancer drug developed by biotech companies Amgen Inc. and Abgenix Inc., to gain U.S. approval and launch by the third quarter of 2006. Combined with favorable clinical trial data and a less frequent dosing regimen, Schmidt believes that U.S. doctors will have an incentive to adopt panitumumab over Erbitux.

The analyst cited data where tumor growth was hindered by 43 percent in patients given panitumumab, comparable to Erbitux. However, Schmidt said that panitumumab is given intravenously once every two to three weeks compared with Erbitux, which must be given once a week.

With the convenience of less frequent dosing and a lower incidence of infusion toxicities, Schmidt said that a majority of his sources estimated that panitumumab will grab 60 percent to 70 percent of the colorectal cancer treatment market in about three to four years.

Imclone sells Erbitux with marketing partner Bristol-Myers Squibb Co. Both Erbitux and panitumumab are antibodies that inhibit epidermal growth factor receptor, a protein found on the surface of many cancer cells. Annual sales of Erbitux, currently the only anti-EGFR antibody on the U.S. market, are around $450 million, and the U.S. market for the drug class is expected to grow to $750 million to $1.25 billion by 2008.

Shares of Amgen fell 46 cents to $80.32 and Abgenix shares rose 30 cents, or 2.1 percent, to $14.37 on the Nasdaq. Bristol-Myers Squibb shares dipped 8 cents to $21.80 on the New York Stock Exchange.

biz.yahoo.com/rb/051217/glaxo_cervical.html?.v=1

Reuters
Cancer vaccine has strong response in young girls
Saturday December 17, 10:18 am ET
By Ransdell Pierson


NEW YORK (Reuters) - Girls aged 10 to 14 who received GlaxoSmithKline Plc's (London:GSK.L - News) vaccine to prevent infection with the virus that causes cervical cancer had immune responses twice as strong as women 15-25 years old given the vaccine, the company said on Saturday, describing results of a late-stage trial.
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Glaxo said the first published data from a Phase III trial of its Cervarix vaccine suggest it may provide the strongest and most-prolonged protection if given to girls at very young ages, long before they encounter the sexually transmitted virus.

"The concentrations of antibodies to the virus were twice as high in the bloodstreams of the young girls," said Gary Dubin, a senior research official at Glaxo who was the lead author on the study.

Antibodies are immune-system proteins that seek out and destroy bacteria and viruses. Vaccines, by introducing the body to snippets of specific bacteria or viruses, train the body to crank out tailor-made antibodies that attack them.

Dubin said the trial was not designed to confirm actual effectiveness of the vaccine because few girls in the 10 to 14 age group are yet sexually active. Instead, he said the immune response is the best "surrogate" indicator of the vaccine's potential ability to protect them from prolonged infection with the virus.

Results of the trial were presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Washington, D.C.

The Glaxo-financed trial, conducted in Europe and Russia, involved 158 healthy girls aged 10-14 and 458 women aged 15-25 who received three doses of the vaccine over a six month period.

Cervarix, which has not yet been submitted for regulatory approvals, is one of the most important experimental products being developed by the British drugmaker. It is expected to eventually compete with a similar Merck and Co. (NYSE:MRK - News) vaccine, Gardasil, that is already awaiting approval from U.S. and European regulators.

Like Gardasil, the Glaxo product blocks infection with two strains of human papillomavirus that are responsible for about 70 percent of cases of cervical cancer. It is the second most common fatal cancer in women.

biz.yahoo.com/ap/060103/wyeth_trubion.html?.v=1

Technologie Trubion www.trubion.com/products.asp
www.trubion.com/sci_tech_mech.asp
www.trubion.com/products_pipeline.asp

AP
Wyeth in Drug Partnership With Trubion
Tuesday January 3, 12:37 pm ET  
Wyeth to Pay at Least $40 Million to Trubion Pharmaceuticals As Part of Deal to Develop Drugs


NEW YORK (AP) -- Wyeth said Tuesday that will pay at least $40 million to biotech drug developer Trubion Pharmaceuticals Inc. as part of a partnership to develop therapies for immune diseases and cancer.
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Including performance-related payments, the deal could be worth up to $800 million, said Cavan Redmond, executive vice president and general manager of Wyeth's biopharmaceuticals business.

Redmond said the pact will give it access to Trubion's proprietary "SMIP" technology -- a term that stands for "small modular immuno-pharmaceuticals" and refers to the ability they give scientists to customize proteins.

Wyeth will have the exclusive rights to the specific disease targets the companies settle on, Redmond said.

Seattle-based Trubion is a small biotech company focused on developing therapies for inflammatory diseases and cancer. It was founded in 2002 by Dr. Peter Thompson, who still heads the firm.

Shares of Madison, N.J.-based Wyeth slipped 15 cents to $45.92 in midday trading on the New York Stock Exchange.

biz.yahoo.com/prnews/060103/sftu089.html?.v=39

PDL Grants Patent Licenses to Merck for Humanized Antibodies Against Two Undisclosed Antigens
Tuesday January 3, 4:00 pm ET


FREMONT, Calif., Jan. 3 /PRNewswire-FirstCall/ -- Protein Design Labs, Inc. (PDL) (Nasdaq: PDLI - News) today announced that it has entered into an agreement with Merck & Co., Inc. that provides Merck with non-exclusive licenses under PDL's humanization patents for antibodies developed by Merck against two undisclosed antigens.

In exchange for the license grant, Merck will pay PDL an upfront licensing payment, development milestones and royalties on future sales of any product developed in association with this licensing agreement. Additional financial terms were not disclosed.

"The licensing of our humanized antibody technology has been the driver for a strong foundation of royalties to PDL, enabling us to advance our pipeline and more recently, build a commercial operation focused on the acute care hospital setting," said Mark McDade, Chief Executive Officer, PDL. "We are pleased that Merck joins our extensive network of licensed partners."

PDL holds various important antibody-related patents, and has entered into agreements with numerous pharmaceutical and biotechnology companies for rights covering more than 40 humanized antibodies, more than half of which are in clinical development.

About PDL

PDL is a biopharmaceutical company focused on the research, development and commercialization of novel therapies for inflammation and autoimmune diseases, acute cardiac conditions and cancer. PDL markets several biopharmaceutical products in the United States through its hospital sales force and wholly-owned subsidiary, ESP Pharma, Inc. As a leader in the development of humanized antibodies, PDL has licensed its patents to numerous pharmaceutical and biotechnology companies, some of which are now paying royalties on net sales of licensed products. Companies currently holding patent licenses for marketed products are Genentech, Inc. (Herceptin®, Xolair®, Raptiva® and Avastin(TM)); MedImmune, Inc. (Synagis®); Roche (Zenapax®); and Wyeth (Mylotarg®). Further information on PDL is available at www.pdl.com .

Forward-Looking Statement

The information in this press release should be considered accurate only as of the date of the release. PDL has no intention of updating and specifically disclaims any duty to update the information in this press release. This press release may contain forward-looking statements involving risks and uncertainties and PDL's actual results may differ materially from those in the forward-looking statements. Factors that may cause such differences are discussed in PDL's filings with the Securities and Exchange Commission.

NOTE: Protein Design Labs and the PDL logo are registered trademarks of Protein Design Labs, Inc. Zenapax is a registered trademark of Roche. Herceptin and Raptiva are registered trademarks and Avastin is a trademark of Genentech, Inc. Xolair is a trademark of Novartis AG. Synagis is a registered U.S. trademark of MedImmune, Inc. Mylotarg is a registered U.S. trademark of Wyeth.




--------------------------------------------------
Source: Protein Design Labs, Inc.

An dem wahrscheinlichen medizinischen und wirtschaftlichen Erfolg hat die deutsche Grundlagenforschung einen entscheidenden Anteil. Die Erkenntnisse, auf denen die Impfstoffe basieren, hatten Mitte der siebziger Jahre Forscher am Deutschen Krebsforschungszentrum (DKFZ) in Heidelberg gewonnen. Dort mußte Harald zur Hausen die damals neue Annahme, der Krebs werde durch ein Virus ausgelöst, jahrelang gegen eine große Zahl von Fachkollegen vertreten. Inzwischen sind die Erkenntnisse Allgemeingut. Und nach den Worten des GSK-Vorstandsvorsitzenden Jean-Pierre Garnier ist der Erfolg des neuen Impfstoffs, der bei den Briten Cervarix heißt, programmiert: „Er ist hundertprozentig wirksam.” Die Zulassung in Europa, der 2007 die Markteinführung folgen soll, wird in den kommenden Monaten beantragt werden.

„In weniger als drei Jahren” auf dem Markt

Auch auf anderen Märkten der Welt sei damit zu rechnen, daß das Produkt „in weniger als drei Jahren” auf dem Markt sei. Garnier würde es nach eigenen Worten nicht schrecken, wenn der Wettbewerber Merck & Co. mit dem Produkt schneller auf den Markt käme als Glaxo. „Der Bedarf wird so groß, da schadet es nicht, wenn es zwei Anbieter gibt”, sagt Garnier. Tatsächlich hat Merck & Co. beziehungsweise das Gemeinschaftsunternehmen Sanofi Pasteur MSD, an dem Merck & Co. und der französische Sanofi-Aventis-Konzern zu gleichen Teilen beteiligt sind, bei der europäischen Arzneimittel-Zulassungsbehörde Emea schon im Dezember den Zulassungsantrag für seinen Impfstoff Gardasil eingereicht, der dem von Glaxo in der Wirkung grundsätzlich vergleichbar ist, auch wenn die Unternehmen gegenüber der Fachöffentlichkeit graduelle Unterschiede herausstellen.


Schneller als der Virus: Forscher zielen auf junge Mädchen
Aus deutscher Sicht ist der zu erwartende Markterfolg der ausländischen Pharmakonzerne angesichts der Saat aus der hiesigen Grundlagenforschung nicht ganz ohne bitteren Beigeschmack. "Deutschen Unternehmen haben wir das lange vergeblich angeboten", hat Otmar Wiestler, der Leiter des DKFZ, schon beklagt. Andererseits gibt es nur noch wenige große Impfstoffhersteller auf der Welt - und Sanofi Pasteur MSD hat immerhin noch Wurzeln, die sich bis zur alten Frankfurter Hoechst AG zurückverfolgen lassen.

Für Mädchen im Alter von 10 bis 15

Grundsätzlich geht es bei der Impfung um den Schutz vor dem sogenannten Humanen Papillomvirus (HPV). Da die Viren in erster Linie durch sexuelle Aktivitäten übertragen werden, gilt es als sinnvoll, Mädchen im Alter zwischen zehn und fünfzehn Jahren zu impfen. Einige Forscher regen inzwischen an, die Impfung sogar noch früher vorzunehmen, so lange nämlich, wie die Betroffenen den Arzt ohnehin noch im Rahmen ihres normalen Impfzyklus aufsuchten, um die umfassende Versorgung sicherzustellen. Sicher ist, daß der Impfstoff gegen die Erreger nichts mehr ausrichten kann, wenn sie sich nach dem ersten Geschlechtsverkehr erst einmal in den Zellen des Gebärmutterhalses eingenistet haben.

Die Impfung schützt gegen die gefährlichsten Virenstämme 16 und 18 sowie im Fall von Merck & Co. wohl auch gegen HPV 6 und HPV 11, die vor allem Genitalwarzen verursachen. 70 Prozent aller sexuell aktiven Menschen werden einmal in ihrem Leben mit HPV infiziert, bei einem Teil von ihnen kommt es zu einer chronischen Infektion. Bei Frauen kann das zu Gebärmutterhalskrebs führen. Die meisten der rund zweihundert Virustypen sind für Menschen völlig harmlos. Das gilt allerdings nicht für die Typen 6, 11, 16 und 18. „Man weiß heute, daß mehr als 99 Prozent aller Gebärmutterhalskarzinome von HP-Viren verursacht werden”, sagt Torsten Strohmeyer, Leiter der Abteilung Forschung und Medizin bei Glaxo Smith Kline. In 70 bis 80 Prozent der Fälle seien es die Typen 16 oder 18 - und genau gegen diese Typen sei der von GSK entwickelte Impfstoff vollständig wirksam. Noch ist unklar, wie lange der für jeweils rund 800 Millionen Euro entwickelte Impfschutz anhält. Da die frühesten Patientenstudien erst vor gut sechs Jahren angelaufen sind, wird es noch einige Zeit dauern, bis man hierüber Klarheit erhält.


 

(im Tiermodell)

www.sciencedaily.com/releases/2005/10/051018224620.htm

Source:   University of California - Los Angeles

Date:   2005-10-19
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UCLA Researchers Identify How Antibody Blocks Prostate Cancer Growth In Animal Models
Researchers at UCLA's Jonsson Cancer Center have uncovered the mechanism by which an antibody blocks the growth of prostate cancer in animal models, a discovery that could pave the way for development of a new molecularly targeted therapy.

Related News Stories  
Drug Combo Effective For Advanced Breast Cancer (May 19, 2004) -- A pair of studies at UCLA's Jonsson Cancer Center that takes laboratory science to the patients' bedside found that combining the molecularly targeted therapy Herceptin with a specific ... > full story

UCLA Research Shows Immunotherapy May Prove A Potent New Weapon Against Prostate Cancer (May 23, 2001) -- Researchers at UCLA's Jonsson Cancer Center have shown for the first time that immunotherapy delivered via gene therapy may prove to be a potent weapon in the fight against locally advanced ... > full story

UCLA Cancer Researchers Shake Loose Hidden Biomarker (May 11, 2005) -- Using a common chemotherapy agent, researchers at UCLA's Jonsson Cancer Center and the Department of Pathology and Laboratory Medicine found a way to move an important biomarker expressed in ... > full story

PSA Level Predicts Future Prostate Growth (February 15, 2000) -- The higher a man's prostate specific antigen (PSA) level is, the more likely his prostate will continue to grow abnormally, researchers at UT Southwestern Medical Center at Dallas report. ... > full story

> more related stories


--------------------------------------------------
Related section: Health & Medicine





The antibody, called 1G8 and discovered by UCLA scientists, signals the prostate cancer cells to stop growing and die, said Dr. Robert E. Reiter, a Jonsson Cancer Center researcher and professor of urology. The antibody proved effective in several different animal models of prostate cancer, Reiter said, indicating that is could be a potent cancer fighter.

The research appears in the Oct. 15 issue of Cancer Research, a peer-reviewed journal published by the American Association for Cancer Research.

The 1G8 antibody binds to prostate stem cell antigen or PSCA, a cell surface protein discovered by Reiter that is found in about 95 percent of early stage prostate cancers and about 87 percent of prostate cancers that have spread to the bones. PSCA also is found in bladder and pancreatic cancers, Reiter and his team previously discovered, so a new targeted therapy developed from the antibody may also prove effective in battling those cancers.

"The big question with antibodies has been, how do they work?" said Reiter, senior author of the study. "Do antibodies recruit the immune system to kill the cancer or do they send a signal that tells the cancer cells to stop growing? This study shows how the antibody works, so we'll know how to apply it in the clinical setting."

The 1G8 antibody has two parts, one that binds with PSCA and one that binds with macrophages, the immune system's killer cells. Reiter and his team fragmented the antibody, separating the part that binds to PSCA and testing it alone in the animal models to see how it affected the prostate cancer cells. Even without engaging an immune response, the antibody blocked the growth of the prostate cancer cells.

"The fragments we created were unable to bind to the immune system, but they retained the same activity the whole antibody showed, so we proved that 1G8 must work by signaling the cancer cells to stop growing and die," Reiter said. "That's important because it provides a lot more information about what PSCA does and how antibodies work. It also suggests that PSCA is a very good target for therapy and that our antibody, in particular, is extremely active and binds to a region on the cell surface protein that may be an optimal target for a new treatment."

Molecularly targeted therapies are the new wave of cancer therapy, homing in on what is broken or mutated in the cancer cells and leaving the healthy cells alone. Because they only target the cancer cells, these therapies typically cause few side effects, if any, and are much easier for patients to tolerate.

The next step, Reiter said, is to test the 1G8 antibody in human clinical trials, probably in about a year.

This study is the result of years of laboratory research and is part of the Jonsson Cancer Center's Specialized Program of Research Excellence in prostate cancer, a National Cancer Institute-funded program to discover new and better ways to prevent, detect and treat prostate cancer.

"This work from start to finish is a UCLA discovery, true translational research that will go from the lab bench to the patient bedside," Reiter said.

Prostate cancer will strike more than 232,000 men in the United States this year alone, killing more than 30,350. Prostate cancer is the second leading cause of cancer death in men, according to the American Cancer Society.

###
UCLA's Jonsson Comprehensive Cancer Center comprises more than 240 researchers and clinicians engaged in cancer research, prevention, detection, control, treatment and education. One of the nation's largest comprehensive cancer centers, the Jonsson Cancer Center is dedicated to promoting research and translating the results into leading-edge clinical studies. In July 2005, the Jonsson Cancer Center was named the best cancer center in the western United States by U.S. News & World Report, a ranking it has held for six consecutive years.

Recently the company has squabbled with marketing partner Roche over the rights for Tamiflu, but it remains at the forefront of any discussion about how best to prepare and protect against the bird flu.

There's little doubt that Gilead has a leading position in this fight, but rather quietly, lesser-known and often very small companies like Biocryst Pharmaceuticals (BCRX:Nasdaq - commentary - research - Cramer's Take) and AVI BioPharma (AVII:Nasdaq - commentary - research - Cramer's Take) are stepping up their own attempts at easing spreading fears of a pandemic.

The avian flu, primarily the H5N1 strain transferred from bird to bird, has been detected in more than 100 humans since the first reported bird-to-human case in Hong Kong in 1997. What's been garnering the most attention lately are worries that a mutant human-to-human version could be on the horizon.

Now that the disease has leaked westward, with cases showing up in Romania and Turkey, biotech companies are scrambling to develop their own vaccines and treatments for the disease.

Treatment Rush
Unlike vaccines, which are given as a preventative measure, antiviral drugs are meant for people already exposed to the virus. The goal with this type of treatment is to kill the invading bug before it spreads.

Besides Tamiflu, only one currently approved antiviral flu drug has been shown to work against the avian flu, Relenza from Australia's Biota. Relenza is marketed by drug giant GlaxoSmithKline (GSK:NYSE - commentary - research - Cramer's Take).

On Friday, Biota said it would support the French government's plan to build its Relenza stockpile to 9 million doses in the next two years, but there are concerns about just how much of the drug can be produced. After all, the proposed stockpile equals three times the drug's total sales since its launch in 1999, and Biota is suing GlaxoSmithKline, alleging that the company hasn't adequately supported Relenza.

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Flu Frenzy Frames Biotechs' Futures
Page 2  


Among proposed new antivirals, Biocryst Pharmaceuticals' Peramivir is on its way to clinical trials with support from the National Institutes of Health.

Peramivir, originally co-developed with Johnson & Johnson (JNJ:NYSE - commentary - research - Cramer's Take), was shown to stop the replication of the avian flu in lab mice in 2001. However, late-stage studies fell short of their goals and the partnership dissolved, with J&J saying it needed to focus its resources on higher-priority drugs.





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Biocryst has said safety wasn't a factor in the pact falling apart, and investor hopes are running high that Peramivir might have a future after all. Biocryst shares have tripled in recent months to $11.30 from a 52-week low of $3.68.

Another antiviral drug developer, AVI BioPharma, is targeting several strains of the avian flu, as well as the common flu. AVI says its drug kills viruses by targeting a specific chunk of genetic code common in several types of influenza and that are critical to virus survival. The drugs were effective in early studies, and could enter animal studies as early as the end of the year, AVI Chief Executive Denis Burger said in an interview.

AVI, though small with a market cap around $160 million, has seen its shares run up 66% from the beginning of September, closing Monday at $3.69.

Protective Approach
Elsewhere, Novavax (NVAX:Nasdaq - commentary - research - Cramer's Take), which has a $130 million market cap, said it's focusing its resources to develop its own bird flu vaccine. Earlier this month, the company contended that it has a "compelling solution" to a pandemic and can produce large quantities of vaccine in a short period of time.

The company says a planned secondary stock offering will help fund the production, and New Jersey-based firm Wave Biotech will manufacture it.

Another tiny firm, Generex Biotechnology (GNBT:Nasdaq - commentary - research - Cramer's Take) (market cap $44 million) is looking to co-develop its avian influenza vaccine in China, and has proposed partnerships with the Harbin Veterinary Research Institute, Sinovac Biotech and Shanghai Institutes for Biological Sciences.

Go to NEXT PAGE
Flu Frenzy Frames Biotechs' Futures
Page 3  


Of course, Gilead's Tamiflu has easily received the most attention. Tamiflu has been proven effective in treating the avian flu in humans, and it's already approved by the Food and Drug Administration to treat common strains of influenza. But Gilead says Roche has failed to adequately market Tamiflu, and the companies are involved in arbitration to decide the rights to the drug.

Roche has the sole marketing rights to the drug Gilead developed. Where it could get worrisome for these two companies, from an investment standpoint at least, is the fact that Taiwanese researchers and Indian generic drug company Cipla claim to have copied the drug. Cipla has said it plans to manufacture it, despite a possible court showdown with Roche.





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Initially, Roche had refused to allow another company to manufacture Tamiflu, but that's changed amid growing worry and pressure from various regulators. Roche now says it's in discussions with eight companies, including large generic-drug makers, along with the governments of Taiwan and Vietnam.

Roche estimates it will have the capacity to produce 300 million doses of Tamiflu a year by 2006, or 10 times its 2004 capacity. The company expects to select potential partners for more detailed production discussions by the end of this month.

content.nejm.org/cgi/content/full/353/25/2667
und ausserdem ist Tamiflu längst weidlich diskutiert worden unter Roche!

yahoo.businessweek.com/magazine/content/06_03/b3967104.htm

SPECIAL REPORT

Crossing The Gene Barrier
On the frontiers of biotech, two scientists are mingling the genetic materials of man and beast in new ways. The hoped-for outcome: Radical treatments for some of mankind's most intractable ailments


Slide Show >>Goats throughout history have been symbols of vitality and cunning, and treasured for their silky fur and nutrient-rich milk. But Sweetheart, a brown-striped goat with soulful eyes, has a secret that could elevate her far above this illustrious legacy. Named for her laid-back disposition, she has a single human gene in the twined strands of her DNA that enables her to produce a life-saving drug in her milk. It's a protein that's normally found in human blood.

In ancient times, the Greeks revered the god Pan -- part-man, part-goat -- who defended Athens against the Persians. Today, the dash of humanity imbedded in Sweetheart and 59 other goats at a central Massachusetts farm could provide a different but equally vital line of defense. Some people don't make enough of the protein in their livers, explains Harry M. Meade, the chief scientist at the company that created her. That raises the risk they'll suffer fatal blood clots during surgery. Others, such as burn victims and heart surgery patients, need a bit more of the protein to speed their recovery. If regulators in Europe approve Sweetheart's elixir in February, as expected, it's likely to be the first drug on the market derived from the milk of a part-human "chimera" -- a creature that bears the cells of two or more species.

A Tale of Two Scientists
Three thousand miles away, scientist Nils Lonberg reaches into a cage and scoops up a different sort of chimera. It looks like a subway-variety mouse, but its tiny body cradles a partial replica of one of the most intricate systems known to biology: a human immune system. This whiskered fur ball has the extraordinary ability to produce disease-fighting antibodies in its cells that can be harvested and turned into drugs. As the creature sniffs the hand of the scientist that invented her, the 49-year-old Lonberg responds as if he is encountering the animal for the first time. "I find this amazing," he says. The challenge of engineering this rodent is comparable to building a towering skyscraper, he says: "It's amazing that people can create something of this complexity."

This is the story of two scientists, Meade and Lonberg, who are toiling on the fringes of biotechnology. Their paths crossed 20 years ago, setting them on a quest to alter the age-old partnership between man and beast by mixing genes to concoct new medicines. Since then the two have pursued their goal on separate but parallel tracks. Meade, 59, is now chief scientific officer of Framingham (Mass.)-based GTC Biotherapeutics (GTCB ), which created Sweetheart. Lonberg is scientific director at Medarex Inc. (MEDX ), which is taking a lead in commercializing transgenic mice.

In the business of biotech, chimeras are about as close to science fiction as you can get. People have been crossing critters for centuries -- yielding everything from mules to labradoodles. But jumping the gene barrier by giving animals copies of human genes is more sensational. These creatures look, act, and smell like animals, yet their cellular machinery conceals unique biochemical capabilities. Already, 50 biotech and pharmaceutical companies are using mice from Medarex to develop treatments for terrible diseases -- from malignant melanoma to lymphoma to lupus. And GTC's goats may become factories for drugs that are too complex to produce any other way.

Yet as promising as these developments are, Meade and Lonberg strive to hold their optimism in check. Both spent years confronting the skepticism of other scientists, and even derision. Today, GTC and Medarex are burning through cash and investors are getting impatient. Other transgenics companies have shriveled and died. As drug regulators start issuing their rulings in coming months, the two men will learn whether their life's work will enrich mankind's supply of drugs or if their companies will sink into oblivion like so many other promising biotechs.

The saga of the goat and the mouse began in 1984, in a lab at Biogen Inc. in Cambridge, Mass. Meade and Lonberg were brainstorming how to manufacture a human protein that looked promising as a treatment for blood clots. They pulled an all-nighter devising a scheme for slipping human genes into the DNA of animals and then milking them to harvest the drug. The pair thought it was a brilliant idea, but few of their colleagues agreed. When Lonberg described it the next day to then-CEO Walter Gilbert and his management team, they nearly laughed the young scientist out of the room. "Gilbert looked at me and said, 'how about making it in goose eggs? You could have the goose who laid the golden egg,"' recalls Lonberg.

In fact, Meade points out, companies are now trying to do exactly that -- extract drugs from transgenic chicken eggs. "It sounds incredibly simple," Meade says, "but everything's in the details."

When Meade and Lonberg first began to tackle those details, they found themselves cast in the role of mad scientists. Having left Biogen in 1985, Lonberg was studying transgenics at Memorial Sloan-Kettering Cancer Center in New York. With the help of Meade, who often visited the lab, he succeeded in rejiggering the DNA of mice so they could produce human proteins in their milk. The scientists then rented a woman's breast pump from a pharmacy in New York and rigged it up to fit their tiny research subjects. "I remember them using this pipetting apparatus and applying it to the mouse nipples," laughs Elizabeth Lacy, Lonberg's former adviser at the cancer center. When Meade tried to return the borrowed breast pump a year later, the pharmacist was so shocked to hear what it had been used for that he refused to take it back.

Meade and Lonberg seemed like biotech's version of the Odd Couple. Meade, a jock who sometimes bikes 26 miles to work, once attracted a crowd at Biogen by demonstrating the moves he had learned in a break-dancing class. He wore his bike helmet to protect his head as he spun on the floor. The display startled Lonberg, who once ditched a required physical education credit at Reed College. It cost him his bachelor's degree, but it was a satisfying "act of defiance," Lonberg says. Having already been admitted to Harvard's PhD program in molecular biology, Lonberg called the head of the department to make sure the missing degree wouldn't matter.

Differences aside, Meade and Lonberg played off each other's strengths. Meade, the elder, passed on his knowledge of biochemistry and genetics to the young student. And as Lonberg focused his postgraduate studies on the then-embryonic field of transgenics, he taught Meade the intricacies of stitching human genes into animals. Together they co-authored the first issued patent on extracting drugs from milk in 1989.

Contemplating the gallons of milk necessary to make a drug, Meade planned to apply the technology to cows. Having grown up on a dairy farm outside Pittsburgh, he knew his research subject intimately. When the young Meade didn't have his nose buried in a science textbook, he was milking the family's herd and hanging out with the 4-H Club and the Future Farmers of America. "I was probably the only person who figured out butterfat content using a slide rule," Meade jokes.

At Biogen, Meade wasn't always confident that his bosses supported his plan to marry biotech with bovines. During analyst meetings, he recalls, "I had this feeling they were trotting me out for comic relief." He didn't feel truly in his element until he was managing research at GTC, a company devoted mostly to goat/human chimeras.

The Dolly Difference
In principal, giving Sweetheart and the rest of her herd the machinery to make human proteins is basic college biology. It's a matter of inserting a copy of a single human gene into her DNA and programming it to turn on in her mammary gland. But in the early days, GTC's method for tweaking the goat's DNA was so clumsy that only 5% of the kids were born carrying the human gene. Over the years, a string of scientific breakthroughs enhanced the process. Topping the list was the sheep called Dolly. After the Roslin Institute in Scotland cloned the now-famous sheep, GTC adapted the technology to its newest breeds of drugmaking goats -- boosting the success rate to nearly 100%.

Investors at first went wild over GTC's goats. In the late 1990s demand for biotech drugs was skyrocketing, and drugmakers faced a dire manufacturing crunch. GTC promised virtually unlimited capacity at a fraction of the $500 million it costs to build the typical biotech factory. It made perfect sense: You need more drugs? Breed more goats. Even some majors like Bristol-Myers Squibb (BMY ) and Johnson & Johnson (JNJ ) began talking with GTC. Investors piled in, pumping GTC's stock up to $50, which gave the unprofitable biotech a market value of more than $1 billion.

This wasn't sustainable. Drugmakers gradually improved the traditional way of making biotech proteins -- in cells housed in giant steel vats. Fears of a biotech manufacturing shortage subsided, and one by one, GTC's deep-pocketed partners pulled out. Investors bailed, too, driving GTC's stock down to single-digit territory. "You don't get many swings at the bat in this business," Meade says. "People lost faith."

But Meade himself remained steadfast. He was certain that his goats could correct a major shortcoming of steel vats -- the latter are terrible at churning out complex proteins. Sweetheart's protein, called antithrombin, is one such molecule. And to this day it can only be harvested from donated human blood, which is often in short supply. So, armed with $75.7 million from a stock offering GTC pulled off during the 2000 market boom, the company charged ahead on its own. Executives at GTC's former parent Genzyme Corp. (GENZ ) were impressed that Meade and his team never seemed to get discouraged. "There were enormous challenges. Some people thought they were crazy," says James A. Geraghty, senior vice-president at Genzyme, which still owns 9.6% of GTC's stock. "But crazy is not that different from passionate."

For Meade's old partner, Lonberg, passion has always come in a small package: mice. As a boy, in Arlington, Va., he took two gerbils his grandmother gave him and bred them into a colony of 56. And Lonberg met his scientist wife in a lab at Sloan-Kettering. "We literally met in a mouse house," he says. He remembers the two of them attending a transgenics conference in 1989, where a scientist announced a new technique for knocking out certain genes in mice in order to make them more like people. "Everyone got up and applauded," he says.

That same year, Lonberg joined a company with an ambitious plan to make mice more like men. Scientists in the early 1980s had already figured out how to produce human proteins in mice. But there was one snag: Resulting products would have bits of mouse protein in them, which would make people sick with side effects.

Ensconced at his new company, called GenPharm, he created and then bred two different varieties of gene-modified mice. One had a disabled immune system -- it couldn't produce any of its own antibodies. The other bore the genes that are responsible for making human antibodies. Immunologically speaking, the offspring of these two rodents is more human than rodent. Provoked by a disease-causing agent -- bits of a human tumor, for example -- "their cells produce antibodies in exactly the right form to go into humans," Lonberg says. The antibodies can then be mass-produced as drugs.

Triumph to Turmoil
What should have been a triumph led instead to a period of turmoil. After Lonberg trumpeted his mice at a 1993 conference, rival Cell Genesys (CEGE ) filed suit against GenPharm, claiming theft of trade secrets. GenPharm answered with claims of patent infringement. As the battle dragged on, chewing up the company's scarce capital, GenPharm was forced to pare down from 110 employees to seven. Still, amid general despair, Lonberg was determined to keep the technology alive. "We were so sad to see our good team falling apart," says former co-worker Frank Pieper. "One day Nils took us aside and spent a great deal of time explaining why GenPharm was right and how he was going to make sure we came out as winners." Three years later the parties settled. Cell Genesys (now called Abgenix (ABGX )) dropped the theft charge and paid GenPharm $40 million to cross-license its patents.

Once the legal hurdles were cleared, other biotechs started approaching Lonberg. One company that was particularly interested was Medarex, which like hundreds of other biotechs was pursuing antibodies, but without a distinctive technology that could quickly identify and generate the most promising molecules. "We needed a tool," recalls Donald L. Drakeman, CEO of Medarex. "Nils's transgenic mice gave us that." Medarex bought GenPharm in 1997 for $62.2 million in stock. Around this time, the stock market once again began to smile on biotech after a long slump. In March, 2000, Medarex made a smart move, just as GTC had done. It raised $388 million in a stock offering. "This changed Medarex," Lonberg says, by allowing it to build a research facility.

As if to remind Lonberg of his ongoing battle to conquer transgenics, a giant framed photo of a mouse stares down at the scientist in his Milpitas (Calif.) lab. Down the hall, more than 6,000 mice live in pathogen-proof rooms, hidden behind double doors. The scientists who wish to enter must first take showers and don cloth gowns from head to toe, to avoid passing along their germs to the valuable and pampered rodents.

But what if the protected mice were the ones that posed the threat? In Greek mythology, the chimera was a hybrid beast that breathed fire and foreshadowed natural disasters. Some experts take that as a metaphor. They worry that transplanted human genes -- particularly in farm animals -- could "leak" into the food supply, say, if a genetically modified critter were to run off and mate with a non-GM cousin. One of the last things you'd want is a bit of human protein -- one that could make healthy people sick -- turning up in the goat cheese that's sprinkled on top of your salad. Some people call this the "ick" factor. "Even when you have an ethical rationale for doing this work, people find it troubling," says Michigan State University philosophy professor Paul B. Thompson.

It would help if the regulations meant to prevent nightmarish accidents were actually enforced. Critics blast the Food & Drug Administration and U.S. Agriculture Dept. for failing to tighten regulations that will keep transgenic animals used in health care out of the food supply. Lobbying groups such as the Union of Concerned Scientists (UCS) were dismayed in 2002 when the University of Illinois at Urbana-Champaign sent 386 pigs used in transgenic experiments to slaughter. Only one animal had transgenes, but none of the pigs had been approved by the FDA for commercial use. (None ended up in the food supply.)

To avoid mistakes, GTC has rigorous security protocols. And the farm is hidden on a back road with no signs, to foil animal-rights vigilantes who might want to "liberate" the goats. GTC also designed nibble-proof pens, recognizing that goats have an uncanny ability to open latched doors with their teeth.

Even with such careful measures, there are questions that can't be corralled in electronic fences. As researchers amble further out on biology's frontier, they are forcing society to confront what it means to be human, and to consider whether scientists are changing that very definition by so freely mixing the genes of humans and beasts.

The pioneers of transgenics regard such metaphysical debates as random noise. They argue that a human being isn't defined by individual genes -- most of which are common to all animals. "DNA does not contain the soul or consciousness of a person," Meade declares.

For now, he and Lonberg are focusing on a more urgent matter: persuading regulators that their drugs are safe and effective. Their latest clinical-trial data are compelling, the scientists say, but now they are stuck in a waiting game. In September, European regulators said they needed more time to decide whether to approve goat-made antithrombin -- disappointing investors who had hoped for an October ruling. CEO Geoffrey F. Cox takes the delays in stride. "Making transgenic animals is very clever, but it's not a business," he says. "We've got work to do." If GTC succeeds, he says antithrombin could someday bring in more than $500 million in annual sales.

On a crisp October morning, the normally casual Meade arrives for work dressed in a suit. It's his turn to talk strategy with the board of directors. These days, the discussion is no longer confined to antithrombin. GTC has developed herds to produce other drugs, such as a malaria vaccine and a treatment to shrink solid tumors. Even though Meade is approaching the age when others might prefer golf courses to goat farms, he's too energized by the potential of transgenics to leave it behind. One day, he says, he'd like to make goats that can churn out treatments for infectious diseases such as HIV. "The first 20 years of my life I worked on a farm milking cows," Meade says. "The last 20 years I've spent trying to make [transgenics] work. It all kind of ties in."

As GTC inches toward approval of its first goat-made drug, other companies are showing interest in the technology. In July, Boston-based Merrimack Pharmaceuticals expanded a partnership with GTC, which has developed goats that produce Merrimack's experimental rheumatoid arthritis treatment. "We tried standard production technologies, but they didn't allow us to make it in a commercially viable way," says Robert Mulroy, CEO of Merrimack, who estimates that the drug will address a $4 billion market.

Medarex can also point to some progress. Of the 40 or so experimental drugs that have been derived from humanized mice, 27 come from Medarex' animals and the rest from rival Abgenix. In November, Abgenix announced that a cancer treatment developed with giant Amgen (AMGN ) shrank colon tumors 46% in a late-stage trial. A month later, Amgen scooped up Abgenix for $2.2 billion.

These developments also vindicate Medarex's work in humanized mice -- and it's own close partnership with Amgen. The biotech giant is developing three drugs using Medarex's mice. "It's a highly productive relationship and we anticipate doing further business with Medarex," says Scott Foraker, vice-president of licensing for Amgen. Will Amgen swallow Medarex, too? "We are continually evaluating acquisition and licensing opportunities," he says.

Last September, Pfizer Inc. (PFE ) took a stake in Medarex and paid $80 million up front for rights to as many as 50 antibodies over the next decade. The deal could ultimately bring Medarex $400 million. And Medarex and Bristol are co-developing a drug to treat metastatic melanoma. To remind himself how far he and his mice have come, Lonberg often pulls up before-and-after X-rays of a patient who received the drug. "He had 31 lung tumors. They're all gone," Lonberg says. The proof won't come until a pivotal, late-stage trial is completed next year, but Bristol is thinking about using the mice on more drugs.

Lonberg and Meade often catch up on the phone and at conferences. The two share a dream of making a drug together -- first generating a life-saving molecule in Lonberg's mice, then mass-producing it in Meade's goats. "Harry and I agree it would be a wonderful collaboration," Lonberg says. And a fitting epilogue to a 20-year history of transgenic beasts and human health care.

biz.yahoo.com/iw/060109/0105586.html

Press Release Source: CancerVax


CancerVax and Micromet Announce Merger Agreement
Monday January 9, 3:01 am ET


Conference Call Scheduled for January 9, 2006, at 9:00 AM Eastern / 03:00 PM Central European Time


CARLSBAD, CA and MUNICH, GERMANY--(MARKET WIRE)--Jan 9, 2006 -- CancerVax Corporation (NasdaqNM:CNVX - News), a biotechnology company focused on the research, development and commercialization of novel biological products for the treatment of cancer, and Micromet AG, one of the leading privately held European biopharmaceutical companies focused on the development of antibody-based drugs, announced today the signing of a definitive merger agreement. The merger is expected to create a transatlantic, NASDAQ-listed company with a highly differentiated drug development pipeline focused on oncology, autoimmune and inflammatory diseases, and a strong, proprietary technology base for the development of antibody-based product candidates.

"We believe that the proposed merger of CancerVax and Micromet is consistent with our objective of maximizing value for our stockholders, and will result in an organization with a robust pipeline of drug candidates as well as significant experience in drug discovery and development," said David F. Hale, President and CEO of CancerVax Corporation.

"This transaction will allow Micromet to access U.S. capital markets, which is essential in our efforts to accelerate the development of our novel, antibody-based drug compounds based on our proprietary BiTE(TM), or bi-specific T cell engager, and single-chain antibody drug development platforms," said Christian Itin, Ph.D., CEO of Micromet. "It also strengthens our management team and financial position, allows us to leverage CancerVax's existing U.S. public company infrastructure, and adds to our product development portfolio."

The merged company will have a substantial product pipeline, with two compounds in clinical development in three major cancer indications and several preclinical and research-stage product candidates.

Product Candidate    Indication         Development Stage   Collaboration

MT201                Metastatic Breast  Phase 2             Serono
Adecatumumab         Cancer
(human antibody)     Prostate Cancer

MT103                Non-Hodgkin's      Phase 1             MedImmune, Inc.
(BiTE™)              Lymphoma (NHL)

MT110                Solid Tumors       Pre-clinical        ---
(BiTE™)

MT203                Inflammatory       Pre-clinical        ---
(human antibody)     Diseases

D93                  Solid Tumors       Pre-clinical        ---
(humanized antibody)
Details of the Proposed Transaction

Under the terms of the merger agreement, CancerVax will issue, and Micromet stockholders will receive, shares of CancerVax stock such that Micromet stockholders will own approximately 67.5 percent of the combined company, on a pro forma basis, and CancerVax stockholders will own approximately 32.5 percent. It is anticipated that, on a pro forma basis, cash, cash equivalents and securities available-for-sale for the combined Companies as of December 31, 2005 will be between $57 million and $60 million. The merger is intended to qualify for federal income tax purposes as a tax-free reorganization under the provisions of Section 368(a) of the U.S. Internal Revenue Code of 1986, as amended. The merger agreement has been approved by both Boards of Directors and will need to be approved by each company's stockholders.

CancerVax expects to file a Form S-4 and related proxy statement/prospectus with the U.S. Securities and Exchange Commission and any other necessary government filings in the coming weeks. Depending on the review process of the agencies, the Companies would expect their respective stockholder votes to occur in the second quarter of 2006. Upon closing of the transaction, the Company's shares are expected to continue to trade on the NASDAQ National Market. CancerVax will be renamed as Micromet, Inc., and application will be made to NASDAQ to change the ticker symbol to "MITI." Piper Jaffray & Co. served as financial advisor and Latham and Watkins LLP as legal advisor to CancerVax. Cooley Godward LLP served as legal advisor to Micromet.

Management and Organization

Following the closing, the merged Company's U.S. headquarters will be in Carlsbad, CA, while the Company's German headquarters will remain in Munich, Germany. Research and development activities will be consolidated in Munich.

David F. Hale, currently President and Chief Executive Officer of CancerVax, will become Chairman of the Board of Directors of the merged company. Micromet's Chief Executive Officer, Christian Itin, will become President and CEO and serve on the Board of Directors. Patrick Baeuerle, currently Chief Scientific Officer of Micromet, will become CSO of the combined entity. CancerVax's Chief Financial Officer, William R. LaRue, will serve as CFO of the merged company. Gregor Mirow, Micromet's Chief Financial and Chief Operating Officer, will be COO, and Hazel M. Aker, CancerVax's General Counsel, will continue to serve as General Counsel. The combined company's Board of Directors will consist of five current Micromet directors, including one director who is also currently a director of CancerVax, three other CancerVax directors and a ninth director to be named by Micromet prior to the merger.

Outlook for 2006

Following the merger, the Company plans to focus its resources on accelerating the development of its clinical-stage product development programs and leveraging its strong R&D base and pipeline-generating capabilities related to human antibodies, BiTE(TM) molecules and single-chain antibodies. The Company also plans to continue to build on Micromet's track record of successfully establishing drug development collaborations with major pharmaceutical companies, while retaining substantial commercial rights.

Anticipated milestones for the merged Company in 2006 include:

--  Closing the merger transaction in the second quarter;
--  Phase 2 clinical trial results for MT201 in patients with metastatic
   breast cancer and in patients with prostate cancer;
--  Phase 1 results for MT103 in the treatment of patients with NHL;
--  Filing of an investigational new drug application in the first quarter
   to initiate clinical trials with D93; and
--  Continuing to pursue partnering opportunities.
MT201 - Adecatumumab

Micromet's lead product candidate, MT201, is a recombinant human monoclonal antibody of the IgG1 subclass with a binding specificity to epithelial cell adhesion molecule (Ep-CAM). Ep-CAM is over-expressed with high frequency on most solid tumor types, including prostate, breast, colon, gastric, ovarian and lung cancer. MT201 is in Phase 2 clinical trials in patients with prostate cancer and metastatic breast cancer. In addition, MT201 is being evaluated as a combination therapy with Taxotere® (docetaxel) in a Phase I clinical trial in patients with metastatic breast cancer. The FDA has approved an investigational new drug application for MT201 for the treatment of patients with metastatic breast cancer.

In December 2004, Micromet announced an exclusive worldwide collaboration and license agreement with Serono, a Swiss corporation, for the development and commercialization of MT201. Micromet received an initial license fee of US$10 million and may receive additional milestone payments of up to US$138 million if the product is successfully developed and registered worldwide in three or more indications. In addition, Micromet may receive undisclosed royalties based on net sales of the product. Under certain terms and conditions, Micromet may elect to share in the development and commercialization of the product in the U.S. and E.U. in exchange for a share of profits.

MT103

Micromet's other leading product candidate, MT103, is being studied in a European Phase 1 clinical trial. MT103 represents a new class of therapeutics that may be capable of instructing the patients' own T cells (a very potent type of killer cell) to repeatedly eliminate tumor cells. This technology is called BiTE(TM) (bi-specific T cell engager). MT103 binds to CD19 on B cells, a cell surface antigen.

In June 2003, Micromet announced an agreement to jointly develop MT103 with MedImmune, Inc. Under the terms of the agreement, Micromet would receive milestone payments based on the successful development, filing, registration and marketing of MT103, as well as royalties on MedImmune's North American sales of the product. Micromet retained all rights to the product candidate outside of North America.

D93

CancerVax's D93 is a humanized, monoclonal antibody being studied for the treatment of solid tumors, which has been shown to selectively bind to denatured or remodeled protein in diseased or damaged tissues, but not to native collagen in the extra-cellular matrix of healthy tissue. D93 has demonstrated the ability to selectively bind to denatured collagen targets in colon, melanoma, lung, and breast cancer tumors grown in xenogeneic mouse models. The Company expects to submit an investigational new drug application for D93 to the FDA in the first quarter of 2006, and plans to initiate the first clinical trial for D93 later in 2006.

Micromet's BiTE(TM) Technology

Micromet's BiTE(TM) technology represents a novel therapeutic modality with the potential to develop antibody-based products to improve the treatment of diseases that currently lack satisfactory treatment options and that are resistant or refractory to standard therapies. BiTE(TM) molecules constitute a novel class of bi-specific antibodies that appear to be unique in their ability to activate the body's killer T cells against target cells. The proposed mechanism of action of Micromet's BiTE(TM) technology involves the activation of the available T cells in a patient's body, regardless of their specificity. This approach may have advantages, since in cancer therapy, patient-derived cancer tissue has to be recognized as "foreign" and eliminated by the patient's T cells. In many cases, tumors evade the recognition mechanisms used by T cells, in particular, and thus cannot be controlled by the patient's immune system. In summary, BiTE(TM) molecules are designed to provide each T cell with the ability to circumvent a number of tumor cell defense mechanisms.

Single-Chain Antibodies

Single-chain antibodies, which are used in the construction of BiTE(TM) product candidates, have demonstrated potential as therapeutics, diagnostics and as research tools. Single-chain antibodies comprise the antigen-binding site of antibodies engineered as a single protein. Under an agreement with Enzon Pharmaceuticals, Inc. Micromet is the exclusive licensor of the two companies' combined intellectual property estate in the field of single-chain antibody technology. Current licensees include Alexion Pharmaceuticals, Alligator Bioscience, Amersham Pharmacia, Arizeke Pharmaceuticals, Baxter Healthcare Corporation, BioInvent International AB, Bristol-Myers Squibb Company, Cambridge Antibody Technology, UCB Pharma, Crucell, EvoGenix, ESBATech, Invitrogen, MorphoSys, Merck & Co., Neoprobe Corporation and Xoma Corporation.

Conference Call Monday, January 9, at 9:00 AM Eastern Time / 03:00 PM Central European Time

CancerVax and Micromet will host a joint conference call on Monday, January 9, to discuss the planned merger and its business overview at 9:00 a.m. Eastern Time. A live audio webcast of management's presentation will be available at ir.cancervax.com. Alternatively, callers may participate in the conference call by dialing (866) 700-7173 (domestic) or (617) 213-8838 (international). The passcode for the call is 36272047. Following the call, the webcast will be archived on the investor relations section of the CancerVax website.

About CancerVax Corporation (www.cancervax.com)

CancerVax Corporation is a biotechnology company focused on the research, development and commercialization of novel biological products for the treatment and control of cancer. The Company's leading product candidate is D93, an anti-angiogenic, humanized, monoclonal antibody. CancerVax plans to file an investigational new drug application for clinical trials of D93 in the first quarter of 2006. Upon the consummation of the merger, the Company intends to focus on the development of antibody-based product candidates for the treatment of cancer and inflammatory and autoimmune diseases. As a result, CancerVax is actively seeking to sublicense its rights to its three licensed product candidates that target the epidermal growth factor receptor signalling pathway.

About Micromet (www.micromet.de)

Micromet AG is a private Munich, Germany-based biotechnology company with a focus on the development of novel, proprietary antibody-based products for cancer and inflammatory and autoimmune diseases. Two product candidates are currently in clinical trials. MT201, a recombinant human monoclonal antibody is being evaluated in Phase 2 clinical trials for the treatment of certain solid tumors. MT103 is being studied in a Phase 1 clinical trial. The Company has established a powerful drug development platform based on its BiTE(TM) technology, a unique drug format that leverages the cytotoxic potential of T cells, the most powerful 'killer cells' of the human immune system. Micromet has integrated infrastructure and expertise in all disciplines of drug design and development. The Company has attracted both top-tier life science investors and collaborators, such as MedImmune, Inc. and Serono.

Forward-Looking Statements

This release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding the proposed transaction, the efficacy, safety, and intended utilization of the companies' respective product candidates, the conduct and results of future clinical trials, and plans regarding regulatory filings, future research and clinical trials and plans regarding partnering activities. Factors that may cause actual results to differ materially include the risk that CancerVax and Micromet may not be able to complete the proposed transaction, the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials, the risk that CancerVax and Micromet will not obtain approval to market their respective products, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on collaborative partners for further clinical trials, development and commercialization of product candidates. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. The transaction is subject to customary closing conditions, including approval of CancerVax's and Micromet's stockholders. These factors and others are more fully discussed in CancerVax's periodic reports and other filings with the SEC.

Any forward-looking statements are made pursuant to Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and, as such, speak only as of the date made. CancerVax undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.

Additional Information about the Merger and Where to Find It

In connection with the proposed transaction described herein, CancerVax will file a registration statement that contains a proxy statement/prospectus with the SEC. Investors and security holders of CancerVax and Micromet are urged to read the proxy statement/prospectus (including any amendments or supplements to the proxy statement/prospectus) regarding the proposed transaction when it becomes available because it will contain important information about CancerVax, Micromet and the proposed transaction. CancerVax's stockholders will be able to obtain a copy of the proxy statement/prospectus, as well as other filings containing information about CancerVax and Micromet, without charge, at the SEC's Internet site (www.sec.gov). Copies of the proxy statement/prospectus and the filings with the SEC that will be incorporated by reference in the proxy statement/prospectus can also be obtained, without charge, by directing a request to CancerVax Corporation, 2110 Rutherford Road, Carlsbad, CA 92008, Attention: Investor Relations, Telephone: (760) 494-4200.

Participants in the Solicitation

CancerVax and its directors and executive officers and Micromet and its directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of CancerVax in connection with the proposed transaction. Information regarding the special interests of these directors and executive officers in the merger transaction will be included in the proxy statement/prospectus referred to above. Additional information regarding the directors and executive officers of CancerVax is also included in CancerVax's proxy statement for its 2005 Annual Meeting of Stockholders, which was filed with the SEC on April 28, 2005. This document is available free of charge at the SEC's web site (www.sec.gov) and from Investor Relations at CancerVax at the address described above.



Contact:
         Contact for CancerVax Corporation
    William R. La Rue
    SVP & Chief Financial Officer
    +1 760-494-4200
    Email Contact
    www.cancervax.com
     
    Contacts for Micromet
    Evelyn Wolf (media)
    +49 89 895277-220
    Email Contact
     
    Ines-Regina Buth (investors)
    +49 89 895277-221
    Email Contact
    www.micromet.de
     

www.nature.com/news/2006/060109/full/060109-14.html


Bird flu mutation sparks concern
Genetic tweak makes virus favour human nose and throat.
Declan Butler



© WHO

Researchers have sequenced the bird flu viruses that killed two people in Turkey in early January, and say that one of them contains a worrying mutation.

This genetic tweak can make the H5N1 virus more adapted to humans than to birds, and more adapted to the nose and throat than to the lungs. This latter effect could help to increase the chances of bird flu being transmitted between people, researchers say.

They add that many more mutations would probably be necessary before the virus is capable of sparking a full-blown pandemic, in which disease spreads like wild fire from person to person.

The samples of H5N1 virus, taken from the first two victims who died of bird flu in Turkey, were sequenced at a World Health Organisation (WHO) collaborating centre at the National Institute for Medical Research in London, UK. The results were announced on Thursday 12 January, along with confirmation of two new cases: bird flu has now also struck Sanliurfa Province, near Turkey's southern border with Syria, and Siirt Province, in the eastern part of Turkey.

The total number of reported human cases has now reached 18 in less than two weeks, three of which have been fatal.

In a bind

The WHO has released details of only one of the mutations found in the viruses. This genetic change results in a substitution of the amino acid serine by another amino acid, asparagine, at a specific position in one of the virus's proteins; a protein that helps the flu virus to bind to receptors on host cells.

This mutation has been observed twice before: in a father and son in Hong Kong in February 2003, and in one fatal case in Vietnam last year. It is known to increase the affinity of the virus for human receptors over poultry ones.

Until samples from the remaining cases are sequenced over the coming week, it is unknown how many of these came from viruses with the same mutation. If many prove to have the same tweak, this may help to account for the relatively large size of Turkey's rapid outbreak. The WHO's current explanation for the spate of cases is simply that people are bringing chickens into their homes during the harsh Turkish winter.

Nose and throat

The mutation also has a secondary effect, which may be more worrying.

There are two subtypes of receptors in the human respiratory tract: alpha 2.3, which occurs mainly in the lower respiratory tract; and alpha 2.6, which occurs mainly in the nose and throat. Human flu viruses typically show a preference for the 2.6 receptors, whereas H5N1 strains typically prefer 2.3.

This is good news for those worried about bird flu, since human-to-human transmission is thought to be more likely via droplets coughed from the nose and throat than from infections lower down. But the mutation found in the Turkey viruses is also known to be able to increase the affinity for H5N1 to the 2.6 receptors, points out Sylvie van der Werf, head of the Laboratory of Molecular Genetics of Respiratory Viruses at the Pasteur Institute in Paris, France.

Van der Werf adds that this affinity will, however, be affected by other genetic changes in the virus, which at present are an unknown factor.

Multiple mutations

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Thankfully, one mutation alone is unlikely to lead to efficient human-to-human transmission. The genetic changes that would allow this to happen are poorly understood, but are thought to require an exact combination of changes in multiple genes.

"Adaptation to humans is a polygenic trait. It requires mutations in each of the eight segments of the virus's genome. Every one has to be correctly optimized to ensure human-to-human transmission," explains Edward Holmes, who is studying virus evolution at Pennsylvania State University in Philadelphia. "You are talking multiple mutations across the entire genome."

That's an improbable, but not impossible event.

Researchers continue to examine the genome of bird flu viruses, and are taking measures to stop the spread of disease among birds and people in Turkey.

A mutated strain of bird flu has genetic make up that increases its chance of transferring to people.

von Novartis

de.biz.yahoo.com/060119/38/4u7e4.html

Xolair (Omalizumab) ist einer der ersten monoklonalen Antikörper seiner Art zur Behandlung von schwerem persistierendem allergischem Asthma. Das Medikament wurde im Oktober 2005 in der EU zugelassen. Die Einführung von Xolair in den wichtigsten europäischen Ländern ist in Vorbereitung. Das Medikament gilt unter vielen Experten in der Asthma-Behandlung als einer der bedeutendsten Fortschritte der vergangenen 15 Jahre. Xolair wurde erstmals im Juni 2003 in den USA zugelassen, wo es seither schätzungsweise 55 000 Patienten verschrieben wurde. Xolair wurde im Rahmen einer Kooperationsvereinbarung zwischen der Novartis Pharma AG, Genentech und Tanox entwickelt.


Lucentis (Ranibizumab) besitzt das Potenzial, neuer Therapiestandard für "feuchte" altersbedingte Makuladegeneration (AMD) zu werden. Der EU-Zulassungsantrag soll im ersten Quartal 2006 eingereicht werden. Im Rahmen der Phase-III-Studie ANCHOR erreichte Lucentis nach einjähriger Behandlung den primären Wirksamkeitsendpunkt, der die Aufrechterhaltung oder Verbesserung der Sehfähigkeit betraf. Der Zulassungsantrag für Lucentis in den USA wurde im Dezember durch Genentech eingereicht. Genentech behält in den USA die Entwicklungs- und Vermarktungsrechte des Produkts.

AVII (vgl. Posting 21/22 /Ende November und 34) hat heute einen Erfolg gegen das H5N1-Virus vermelden können. In 34 schrieb ich noch, dass dieses Anwendungsgebiet bei AVII bislang eine Nebenrolle spielte, da die Hep C weiter fortgeschritten sind.  Das dürfte ab heute anders sein. Die Aktie gewinnt über 30% auf diese Nachricht hin. Seit dem 1. Posting zu dem Unternehmen in diesem Thread immerhin über 100% Kursplus.

biz.yahoo.com/bw/060120/20060120005147.html?.v=1

Press Release Source: AVI BioPharma, Inc.


AVI BioPharma Reports Confirmation of Efficacy against Influenza Strains
Friday January 20, 9:00 am ET  
NEUGENE Antisense Efficacy against Influenza Strains, Including Avian Influenza, to Lead to IND Filing with the FDA


PORTLAND, Ore.--(BUSINESS WIRE)--Jan. 20, 2006--AVI BioPharma, Inc. (Nasdaq:AVII - News) today announced confirmation from three independent laboratories of NEUGENE® antisense efficacy in preclinical experiments against multiple strains of influenza, including avian influenza strain H5N1.
Dr. P. Puthavathana at Mahidol University in Bangkok, Thailand, confirmed NEUGENE antisense efficacy against an H5N1 viral isolate in her assay system.
Dr. Darwyn Kobasa at the Public Health Agency of Canada in Winnipeg, Manitoba, completed an initial dose-response study in cell culture demonstrating NEUGENE efficacy against both the H1N1 and H3N2 strains.
Dr. Manoj Pastey at Oregon State University in Corvallis, Ore., confirmed efficacy using the same NEUGENE antisense agents against the H7N7 and H3N8 strains.
Taken together, these data confirm efficacy observed with the H1N1 strain previously reported from Drs. Jianzhu and Chen Qin Ge at Massachusetts Institute of Technology in Boston and now represent positive reports from four laboratories using different endpoints and methodologies.

"These confirmations validate our approach to blocking replication of influenza viruses. We now believe that a single NEUGENE drug could be effective against most influenza subtypes, including the H5N1 avian strain," said Patrick L. Iversen, Ph.D., senior vice president of research and development at AVI. "By targeting regions of the viral genetic code that are common to all influenza A subtypes, we expect that our NEUGENE drugs will be effective against avian flu and the far more common influenza A viruses, which kill an average of 35,000 Americans every year."

AVI is also conducting collaborative animal studies evaluating NEUGENE efficacy against influenza strains at Tulane University in New Orleans and at the U.S. Army Medical Research Institute of Infectious Disease (USAMRIID) in Frederick, Maryland.

"Based on these recent findings and other results from additional studies, AVI now plans to file an Investigative New Drug (IND) application with the FDA for the treatment of influenza A virus with NEUGENE antisense drugs," said Denis R Burger, Ph.D., chief executive officer of AVI. "We feel confident in the safety, efficacy and potency of our NEUGENE drugs targeting influenza and plan to move forward into the clinical trial process later this year."

AVI's NEUGENE antisense drug development program against the influenza A virus specifically targets genetic regions of the virus that are highly conserved between six viral subtypes that cause human disease. These include three subtypes that caused pandemics in the 20th century -- the 1918 Spanish flu (H1N1), the 1957 Asian flu (H2N2) and the 1968 Hong Kong flu (H3N2) -- and three subtypes of avian flu that have been reported to cause disease in humans (H5N1, H7N7 and H9N2).

AVI's Antiviral Program

AVI's proprietary NEUGENE antisense drug candidates have demonstrated efficacy in preclinical studies against SARS coronavirus, West Nile virus (WNV), hepatitis C virus (HCV), dengue virus, Ebola virus, and Marburg virus. AVI has filed IND applications with the U.S. Food and Drug Administration and has ongoing clinical trials in WNV and HCV.

Showing how versatile NEUGENE drugs can be across viral subtypes, AVI demonstrated in its collaboration with the Centers for Disease Control and Prevention that NEUGENE agents are efficacious against all four immunologically distinct subtypes of the dengue virus. This outcome was achieved by targeting a highly conserved region of the dengue viral genetic code. In collaborative work with the USAMRIID targeting the Ebola virus, NEUGENE drugs protected three animal species from lethal challenges with this virus (see PloS Pathog 2(1): e1). Additional clinical development efforts targeting dengue virus and Ebola virus are planned for 2006.

The speed with which effective NEUGENE drugs can be designed and manufactured exceeds any other modern drug development timeframe. For example, NEUGENE compounds targeting SARS, WNV and Ebola were developed within days to weeks of obtaining the appropriate genetic sequences for the viruses.

AVI's Clinical Experience

AVI's NEUGENE antisense drugs have a well-defined safety record in human clinical trials. Approximately 300 patients have been dosed with NEUGENE drug candidates targeting host and viral gene targets in 12 clinical studies under multiple INDs. Five routes of administration have been employed in AVI's clinical studies, and doses up to 450 mg have been administered without a single drug-related, serious adverse event. The combination of AVI's NEUGENE chemistry with conserved viral targets that are not expressed in the human genome makes a strong case for the potential for success in the development of candidates to address influenza, including the possible emergence of a transmittable avian flu.

About Influenza A Viruses

Influenza, or flu, is a contagious respiratory illness caused by influenza viruses. On average 5 percent to 20 percent of the U.S. population is infected with the flu each year. Influenza A virus is an enveloped negative-strand RNA virus, with eight genome segments that code for 10 proteins. Influenza strains are subtyped according to the antigenic and genetic nature of their surface glycoproteins: hemagglutinin (HA or H) and neuraminidase (NA or N). Fifteen H and nine N subtypes have been identified, with three associated with widespread human disease (H1N1, H2N2 and H3N2). In addition, several subtypes of avian influenza virus -- H5N1, H7N7 and H9N2 -- can infect and cause disease in humans.

The current influenza pandemic in birds throughout Asia, Eastern Europe and Turkey is caused by the H5N1 subtype. It is thought that co-infection of humans or certain animals (such as pigs) with both H1N1 and H5N1 can lead to a reassortment or recombination of viral particles, resulting in the emergence of a virus with dangerous public health properties, namely one to which the human population has no natural immunity and which has the ability to spread easily from person to person. It is believed that emergence of avian flu by this general mechanism may have led to the worldwide pandemics of 1918, 1957 and 1968.

About AVI BioPharma

AVI BioPharma develops therapeutic products for the treatment of life-threatening diseases using third-generation NEUGENE antisense drugs. AVI's lead NEUGENE antisense compound is designed to target cell proliferation disorders, including cardiovascular restenosis, cancer and polycystic kidney disease. In addition to targeting specific genes in the body, AVI's antiviral program uses NEUGENE antisense compounds to combat disease by targeting single-stranded RNA viruses, including West Nile virus, hepatitis C virus, dengue virus and Ebola virus. AVI has introduced a NEUGENE-based exon-skipping technology called ESPRIT therapy. More information about AVI is available on the company's Web site at www.avibio.com.

"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including, but not limited to, the results of research and development efforts, the results of preclinical and clinical testing, the effect of regulation by the FDA and other agencies, the impact of competitive products, product development, commercialization and technological difficulties, and other risks detailed in the company's Securities and Exchange Commission filings.



Contact:
AVI BioPharma, Inc.
Michael Hubbard, 503-227-0554
hubbard@avibio.com
or
Lippert/Heilshorn & Associates Inc.
Bruce Voss, 310-691-7100 (Investors)
bvoss@lhai.com
Jody Cain, 310-691-7100 (Investors)
jcain@lhai.com
or
Waggener Edstrom Worldwide
Bioscience and Healthcare Practice
Jenny Moede, 503-443-7000 (Press)
jmoede@waggeneredstrom.com

--------------------------------------------------
Source: AVI BioPharma, Inc.

Lange darsuf gewartet, nun ist es soweit:
(zur Diskussion dazu siehe wallstreet online thread von eck)

 de.biz.yahoo.com/25012006/36/hugin-news-morphosys-ag.html

dpa-afx
Hugin-News: MorphoSys AG
Mittwoch 25. Januar 2006, 07:31 Uhr


Roche (Virt-X: ROG.VX - Nachrichten) plant Start der klinischen Entwicklung mit einem von MorphoSys (Xetra: 663200 - Nachrichten) generierten Alzheimer-Antikörper
Corporate news- Mitteilung verarbeitet und übermittelt durch Hugin. Für den Inhalt der Mitteilung ist der Emittent verantwortlich.

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Die MorphoSys AG (Frankfurt: MOR; Prime Standard Segment; TecDAX) Anzeige
 
gab heute bekannt, dass ihr Partner Roche alle notwendigen Anträge für den Start einer europäischen Phase-1-Studie mit einem HuCAL®-basierten Antikörper zur Behandlung von Alzheimer eingereicht hat. Der HuCAL® Antikörper soll anormale, für Alzheimer-Patienten typische Ansammlungen des Proteins Amyloid-beta im Gehirngewebe, so genannte Plaques, angreifen und diese auflösen helfen. Der Antrag für den Beginn klinischer Studien löst eine Meilensteinzahlung von Roche an MorphoSys aus. Weitere finanzielle Einzelheiten wurden nicht bekannt gegeben. In präklinischen Studien hat der vollständig menschliche Antikörper eine hoch-affine Bindung an die Amyloid-beta-Plaques gezeigt und konnte diese spezifisch in menschlichen Gewebeproben von Alzheimer-Patienten erkennen. Darüber hinaus konnte in einem in-vitro-Test durch Bindung des Antikörpers an Amyloid-beta-Moleküle eine Ansammlung der Proteine aufgelöst werden. Der HuCAL® Antikörper wurde darüber hinaus in einem Tiermodell für die Untersuchung von Alzheimer eingesetzt. In die Blutbahn verabreicht konnte der Antikörper hier zeigen, dass er die Blut-Hirn-Schranke passieren und an Amyloid-beta-Plaques im Gehirn binden kann. Die internationale Alzheimer-Forschung sieht im Aufbrechen der Amyloid-beta-Ansammlungen einen viel versprechenden Ansatzpunkt für eine Therapie der Krankheit. Ein Entfernen der Plaques konnte mit einer Verbesserung der kognitiven Funktionen in Verbindung gebracht werden. "Wir sind sehr stolz, einen vollständig menschlichen Antikörper aus der HuCAL® Technologie von MorphoSys in die klinische Entwicklung bringen zu können. Dies ist ein wichtiger Schritt hin zu einer modernen Therapie von Alzheimer mit einer neuen Substanzklasse", sagte Andrew Sleight, Leiter der Forschungsabteilung Zentralnervensystem (ZNS) bei Roche. "Alzheimer ist sowohl eine verheerende Krankheit für die Betroffenen, als auch eine enorme finanzielle Belastung für die Gesundheitssysteme weltweit", erklärt Dr. Marlies Sproll, Forschungsvorstand der MorphoSys AG. "Der Antikörper aus unserer Kooperation mit Roche hat sich als sehr aussichtsreicher Kandidat in präklinischen Studien erwiesen und wir erwarten den Ausgang der Studien in menschlichen Patienten mit großem Interesse."

hugin.info/130295/R/1031187/165553.pdf

MorphoSys in Kürze: MorphoSys beschäftigt sich mit der Entwicklung und Anwendung von Technologien zur Herstellung synthetischer Antikörper, die die Entdeckung neuer Medikamente bzw. krankheitsassoziierter Zielmoleküle beschleunigen. Das Unternehmen wurde 1992 gegründet und verfügt über eine Reihe innovativer Technologien, allen voran HuCAL®, die Humane Kombinatorische Antikörper-Bibliothek, die weltweit von Wissenschaftlern zur Herstellung von menschlichen Antikörpern genutzt wird. Das Unternehmen hat Partnerschaften mit internationalen pharmazeutischen Unternehmen wie Bayer (Berkeley, Kalifornien/USA), Boehringer Ingelheim (Ingelheim, Deutschland), Bristol-Myers Squibb (Wilmington (London: WIL.L - Nachrichten) , Delaware/USA), Centocor Inc. (Malvern, Pennsylvania/USA), GPC Biotech AG (Xetra: 585150 - Nachrichten) (Martinsried/Deutschland), Hoffmann-La Roche AG (Basel/Schweiz), ImmunoGen Inc (NASDAQ: IMGN - Nachrichten) . (Cambridge, Massachusetts/USA), Novartis AG (Basel, Schweiz), Merck & Co., Inc. (New Jersey/USA), Novoplant GmbH (Gatersleben, Deutschland), Pfizer Inc. (Delaware/USA), ProChon Biotech Ltd. (Rehovot/Israel), Schering AG (Xetra: 717200 - Nachrichten) (Berlin/Deutschland), Shionogi & Co (München: 855648 - Nachrichten) ., Ltd. (Osaka/Japan), Xoma Ltd (NASDAQ: XOMA - Nachrichten) . (Berkeley, Kalifornien/USA) und andere. MorphoSys ist im Markt der Forschungsantikörper durch seine Geschäftseinheit Antibodies by Design tätig. Antibodies by Design wurde im Jahr 2003 gegründet, um den nicht-therapeutischen Markt für MorphoSys zu erschließen. Die Aktivitäten in diesem Bereich wurden durch die Akquisition der Biogenesis-Gruppe in Großbritannien und in den USA im Januar 2005 sowie durch die Akquisition der Serotec-Gruppe in 2006 nachhaltig gestärkt. Weitere Informationen finden Sie unter www.morphosys.com/. Für weitere Informationen kontaktieren Sie bitte: Dr. Claudia Gutjahr-Löser, Director Corporate Communications, Tel: +49 (0) 89 / 899 27-122, gutjahr-loeser@morphosys.com oder Mario Brkulj, Manager Public Relations, Tel: +49 (0) 89 / 899 27-454, brkulj@morphosys.com --- Ende der Mitteilung --- WKN: 663200; ISIN: DE0006632003; Index: CDAX, HDAX, Prime All Share, TECH All Share, TecDAX (Xetra: Nachrichten) , MIDCAP; Notiert: Prime Standard in Frankfurter Wertpapierbörse, Geregelter Markt in Frankfurter Wertpapierbörse, Freiverkehr in Börse Berlin Bremen, Freiverkehr in Börse Düsseldorf, Freiverkehr in Hanseatische Wertpapierbörse zu Hamburg, Freiverkehr in Niedersächsische Börse zu Hannover, Freiverkehr in Bayerische Börse München, Freiverkehr in Börse Stuttgart;

www.morphosys.com

Copyright © Hugin ASA 2006. All rights reserved.

biz.yahoo.com/ap/060125/...ntibody_technology_humira.html?.v=1

AP
Cambridge Antibody Drug Now Blockbuster
Wednesday January 25, 12:42 pm ET  
Cambridge Antibody Technology Group Says Arthritis Drug It Developed Achieves Blockbuster Status


NEW YORK (AP) -- Cambridge Antibody Technology Group PLC acknowledged Wednesday that the arthritis drug it developed has finally achieved blockbuster status in excess of previous estimates.
The Cambridge, England-based biotech company noted that Abbott Laboratories reported worldwide Humira sales of $1.4 billion, above the estimated $1.3 billion in sales. A blockbuster drug is one that has annual sales in excess of $1 billion. Humira is Cambridge's first marketed product. The company receives royalties of about 2.7 percent of Abbott's worldwide Humira sales. Abbott reported today that its 2005 revenue rose 14 percent to $22.34 billion from a year ago.

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Cambridge Antibody also recognized that Abbott forecasts worldwide Humira sales of $1.9 billion in 2006.

The two companies reached a settlement in October over Humira royalty rates. Abbott agreed to pay Cambridge more than $300 million, but reduced the royalty rate to the present one from 5.1 percent.

Cambridge American depositary shares rose 37 cents, or 3.2 percent, to $11.98 in midday trading on the Nasdaq. Abbott shares added $2.58, or 6.4 percent, to $42.64 on the New York Stock Exchange.

1D09C3 ist ein Anti-MHC (Major Histocompatibility Complex) Klasse II monoklonaler Antikörper. Er bindet an spezifische Zelloberflächenrezeptoren und führt so zum gezielten Absterben aktivierter, sich vermehrender MHC-Klasse-II-positiver Tumorzellen, darunter B-Zell- und T-Zell-Lymphome sowie weitere Blutkrebsarten. In präklinischen Studien konnte gezeigt werden, dass 1D09C3 den programmierten Zelltod auslöst, ohne hierfür ein voll funktionsfähiges Immunsystem zu benötigen.

Der Krebsantikörper befindet sich derzeit in einem klinischen Phase-1-Studienprogramm, in welchem er bei Patienten getestet wird, die an einem resistenten B-Zell-Lymphom leiden oder nach einer zuvor durchgeführten Standardtherapie einen Rückfall erlitten haben. 1D09C3 wurde bereits für die Behandlung von Hodgkin-Lymphom der Orphan-Drug-Status zugesprochen.

Bisher stiegen die Aktien um 4,11 Prozent und schlossen bei 11,66 Euro.

"Through its scientific co-founder Gert Riethmuller of Munich University, Micromet has a long-standing expertise and interest in Ep-CAM as a target for antibody-based therapeutics. Our data strongly support the notion that Ep-CAM is a prime target for immunotherapy", comments Patrick Baeuerle, Micromet's Chief Scientific Officer. "Together with data published earlier on breast cancer, our study suggests that a large percentage of patients with colon, lung, prostate, gastric and breast cancer may qualify for treatment with Ep-CAM-directed antibody therapies, such as adecatumumab. Therefore, we expect that at least five of the most frequent human malignancies can potentially be addressed by our product candidate."

Recently published studies support that over expression of Ep-CAM plays a pivotal role in tumorigenesis. In human breast cancer, over expression of Ep-CAM is a negative and independent prognostic marker for overall survival (2), and Ep-CAM is expressed significantly higher on metastatic than on primary breast tumors (3). Proliferation, migration and invasiveness of tumor cells is inhibited when Ep-CAM expression in breast cancer cell lines is reduced by a specific small inhibitory RNA (4). When over expressed in quiescent cells, Ep-CAM behaves like a classical oncogene, enabling growth of cells in soft agar and independence on serum growth factors (5). Lastly, highly tumorigenic human breast cancer stem cells are characterized by expression of Ep-CAM (ESA) (6).

In January 2006, Micromet announced a definitive agreement to merge with CancerVax Corporation (NASDAQ: CNVX) to create a transatlantic, NASDAQ-listed company with a highly differentiated drug development pipeline focused on oncology, autoimmune and inflammatory diseases, and a proprietary technology base for the development of antibody-based product candidates. The merger is subject to a number of conditions and expected to close in the second quarter of 2006. Upon closing of the transaction, the Company's shares are expected to continue to trade on the NASDAQ National Market.  CancerVax will be renamed as Micromet, Inc., and application will be made to NASDAQ to change the ticker symbol to "MITI". CancerVax expects to file a Form S-4 and related proxy statement/prospectus with the U.S. Securities and Exchange Commission and any other necessary government filings in the coming weeks. ###

Contact
Media: Evelyn Wolf
Phone: +49 89 895277-220, Email: evelyn.wolf@micromet.de

Investors: Ines-Regina Buth
Phone: +49 89 895277-221, Email: ines-regina.buth@micromet.de

References
(1) Went P, Vasei M, Bubendorf L, Terracciano L, Tornillo L, Riede U, Kononen J, Simon R, Sauter G, Baeuerle PA (2006). Frequent high-level expression of the immunotherapeutic target Ep-CAM in colon, stomach, prostate and lung cancers, Brit J Cancer 94: 128-35.

(2) Spizzo G, Went P, Dirnhofer S, Obrist P, Simon R, Spichtin H, Maurer R, Metzger U, von Castelberg B, Bart R, Stopatschinskaya S, Kochli OR, Haas P, Mross F, Zuber M, Dietrich H, Bischoff S, Mirlacher M, Sauter G, Gastl G (2004). High Ep-CAM expression is associated with poor prognosis in node-positive breast cancer. Breast Cancer Res Treat  86: 207-13.

(3) Rao CG, Chianese D, Doyle GV, Miller MC, Russell T, Sanders Jr RA, Terstappen LWMM (2005). Expression of epithelial cell adhesion molecule in carcinoma cells in blood and primary and metastatic tumors. Intl J Oncol  27: 49-57.

(4) Osta WA, Chen Y, Mikhitarian K, Mitas M, Salem M, Hannun YA, Cole DJ, Gillanders WE (2004). Ep-CAM is overexpressed in breast cancer and is a potential target for breast cancer gene therapy. Cancer Res 64: 5818-24.

(5) Munz M, Kieu C, Mack B, Schmitt B, Zeidler R, Gires O (2004). The carcinoma-associated antigen Ep-CAM upregulates c-myc and induces cell proliferation. Oncogene 23: 5748-58.

(6) Al-Hajj W, Micha M, Benito-Hernandez A, Morrison SJ, Clarke MF (2003). Prospective identification of tumorigenic breast cancer cells. Proc Natl Acad Sci USA 100: 3983-8.

About Micromet
Micromet AG is a private Munich, Germany-based biotechnology company with a focus on the development of novel, proprietary antibody-based products for cancer and inflammatory and autoimmune diseases. Two product candidates are currently in clinical trials. MT201, a recombinant human monoclonal antibody is being evaluated in Phase 2 clinical trials for the treatment of certain solid tumors.  MT103 is being studied in a Phase 1 clinical trial. The Company has established a powerful drug development platform based on its BiTE™ technology, a unique drug format that leverages the cytotoxic potential of T cells, the most powerful 'killer cells' of the human immune system. Micromet has integrated infrastructure and expertise in all disciplines of drug design and development. The Company has attracted both top-tier life science investors and collaborators, such as MedImmune, Inc. and Serono.  

In January 2006, Micromet announced an agreement to merge with CancerVax Corporation (NASDAQ: CNVX) to create a transatlantic, NASDAQ-listed company with a highly differentiated drug development pipeline focused on oncology, autoimmune and inflammatory diseases, and a proprietary technology base for the development of antibody-based product candidates. The merger is subject to a number of conditions and expected to close in the second quarter of 2006.
For further information, please visit the Company's website at www.micromet.de.

Der schweizerischen Cytos AG sind klinische Wirksamkeitsnachweise für Impfstoffe zur Behandlung von Allergien und Nikotinsucht gelungen. 4 neue klinische Studien u.A. zu Hausstaubmilbenallergien , teilweise mit Novartis wurden begonnen.  

THOUSAND OAKS, Kalif. 3. April 2006 Amgen (Nasdaq:AMGN), das größte Biotechnologie-Unternehemen weltweit, gab heute Ergebnisse der Phase-3-Pivotalstudie bekannt, die zeigen, dass Panitumumab das progressfreie Überleben der Krankheit und die Krankheitskontrolle (Ansprechrate und Stillstand der Krankheit) wesentlich verbessert verglichen mit Patienten, die mit besten verfügbaren Therapien (Best Supportive Care, BSC) bei fortgeschrittenem Kolorektalkrebs behandelt wurden und bei denen die konventionelle Chemotherapie nicht angeschlagen hatte. Die Ergebnisse wurden bei einer klinischen Plenarsitzung bei der 97. Jahresversammlung der ANZEIGE

American Association for Cancer Research (Abstract #CP-1) präsentiert.
"Panitumumab reduzierte das Fortschreiten der Krankheit um etwa die Hälfte verglichen mit den mit den besten verfügbaren Therapien behandelten Patienten", sagte Marc Peeters, M.D., Ph.D., Koordinator der Digestive Oncology Unit im Universitätsklinikum Gent und einer der Versuchsleiter der Studie. "Darüber hinaus ergaben die Unterschiede bei der objektiven Ansprechrate und dem Verhältnis der Patienten mit einer Stabilisierung der Krankheit zwischen Panitumumab und der besten verfügbaren Therapie die signifikante Wirksamkeit dieses Wirkstoffs."

Bei dieser multinationalen, offenen Phase-3-Studie wurden 463 Patienten mit fortgeschrittenem Kolorektalkrebs, bei denen die konventionelle Chemotherapie einschließlich Oxaliplatin und Irinotecan nicht angeschlagen hatte, randomisiert und erhielten 6 mg/kg Panitumumab plus BSC (n=231) alle zwei Wochen oder nur BSC (n=232). Ein unabhängiger zentraler Radiologie-Prüfungsausschuss beurteilte den Krankheitsverlauf und das Schrumpfen der Tumoren.

Patienten, die alle zwei Wochen Panitumumab erhielten, wiesen eine 46%ige Verringerung des Tumorfortschritts gegenüber denen auf, die nur BSC erhielten (p weniger als 0.000 000 001). Eine verhältnismäßig höhere Anzahl von Patienten zeigte mit Panitumumab an allen planmäßigen Untersuchungszeitpunkten bis Woche 32 kein weiteres Fortschreiten der Krankheit bzw. überlebten bis Woche 32. Zum Beispiel lebten nach sechs Monaten (Woche 24) ungefähr viermal mehr Patienten, die mit Panitumumab behandelt wurden, ohne weiteres Fortschreiten der Krankheit (18 Prozent gegenüber fünf Prozent, die nur BSC erhielten).

Doppelt so viele Patienten, die mit Panitumumab behandelt wurden, lebten in der Woche 32 ohne weiteres Fortschreiten der Krankheit (10 Prozent gegenüber vier Prozent, die nur BSC erhielten).

Versuchsleiter berichteten auch, dass Panitumumab gegenüber BSC allein die Krankheitskontrolle wesentlich verbesserte (36 Prozent gegenüber 10 Prozent), wie anhand der Ansprechrate und des Stillstandes der Krankheit bemessen wurde. Die objektiv und unabhängig bewertete Ansprechrate betrug mit Panitumumab acht Prozent gegenüber null mit BSC allein und die durchschnittliche Dauer der Response betrug 17 Wochen. Die Rate bezüglich des Stillstandes der Krankheit betrug mit Panitumumab 28 Prozent gegenüber 10 Prozent mit BSC allein.

Rund 75 Prozent der Patienten, die mit den besten verfügbaren Therapien behandelt wurden, wurden in einen Cross-Over-Arm aufgenommen, wo sie Panitumumab nach Fortschreiten ihrer Krankheit erhielten (n = 174). Die Behandlung mit Panitumumab erwies sich auch bei Patienten, die von dem BSC-Arm wechselten, als klinisch vorteilhaft, trotz des Progresses der Krankheit. In diesen Patienten bewirkte die Behandlung mit Panitumumab eine partielle Response von 10% und eine Stabilisierung der Krankheit und komplette Response bei 32 Prozent.

Eine Zwischenanalyse des Gesamtüberlebens in den beiden Gruppen erbrachte ähnliche Ergebnisse. Die Rate (75 Prozent) und der Zeitpunkt (durchschnittlich nach 7 Wochen) des Crossover aus dem Arm, der nur BSC erhielt, zu einer Behandlung mit Panitumumab sowie die Antitumoraktivität, die nach dem Crossover festgestellt wurde, beeinträchtigte die Möglichkeit, einen Behandlungseffekt auf das Gesamtüberleben zu zeigen (Risikoverhältnis = 0,93).

Panitumumab verbesserte das progressfreie Überleben und die Responserate unabhängig von dem gemessenen Grad bzw. der Intensität der EGFr-Färbung. Die Verbesserungen des progressfreien Überlebens und der Krankheitskontrolle waren unabhängig vom Alter, Geschlecht, dem Ort des primären Tumors (Kolon oder Rektum) oder dem Performance-Status.

Prüfplangemäß erforderte die Gabe von Panitumumab keine Vormedikation oder Aufsättigungsdosis und die Inzidenz von Infusionsreaktionen (jeden Schweregrades) war niedrig (ein Prozent). Es gab keine Infusionsreaktionen 3. oder 4. Grades. Im Panitumumab-Arm gaben mehr Patienten toxische Hautreaktionen, Erschöpfung, Bauchschmerzen, Übelkeit und Durchfall an. Bei 38 Prozent der mit Panitumumab behandelten Patienten wurde eine Hypomagnesiämie beobachtet (drei Prozent 3./4. Grades). Es bildeten sich weder Human-Anti-Human-Antikörpern (HAHA) noch Antikörper gegen Panitumumab de novo. Bei Patienten mit Anti-Panitumumab -Antikörpern wurde kein Einfluss auf die Wirksamkeit, Sicherheit und Pharmakokinetik festgestellt.

Patienten und Ärzte erhalten unter www.amgentrials.com mehr Informationen über laufende klinische Studien mit Panitumumab.

Webcast-Information

Amgen veranstaltet heute um 12.30 EDT ein Webcast mit der Investmentgemeinschaft, um die Daten der Phase-3-Studie zu erörtern. Das Webcast ist offen für Mitglieder der Nachrichtenmedien, Investoren und die allgemeine Öffentlichkeit über die Website von Amgen unter www.amgen.com unter der Rubrik "Investoren". Das Webcast wird außerdem archiviert und steht mindestens 72 Stunden lang nach Ende der Veranstaltung für eine Wiederholungsabspielung zur Verfügung.

Über Panitumumab

Bei Panitumumab handelt es sich um einen experimentellen vollständig humanen monoklonalen Antikörper, der gegen den Rezeptor des epidermalen Wachstumsfaktor (EGFr) gerichtet ist, ein Protein, das bei der Signalübertragung von Krebszellen eine wichtige Rolle spielt. Panitumumab, ein monoklonaler IgG2-Antikörper, bindet mit hoher Affinität an EGFr. Panitumumab wurde anhand der XenoMouse®-Technologie hergestellt, welche einen vollständig humanen monoklonalen Antikörper erzeugt, der kein Mausprotein enthält. Das Immunsystem des Körpers kann das in chimären und humanisierten Antikörpern vorhandene Mausprotein als fremd erkennen und eine Immunantwort in Form von Infusionsreaktionen, allergischen Reaktionen oder Anaphylaxien auslösen. Das Ziel der Entwicklung vollständig humaner monoklonaler Antikörper ist es, eine wirksame und hoch affine Therapie anzubieten, die das Risiko dieser Art von Immunantwort minimiert.

Panitumumab erhielt im Juli 2003 von der US-amerikanischen Food and Drug Administration (FDA) die Einstufung "Fast Track" als Indikation bei Patienten mit metastasierendem Kolorektalkarzinom, die auf Standardchemotherapien nicht ansprechen. In klinischen Studien wurde der Wirkstoff sowohl als Monotherapie als auch in Kombination mit anderen Wirkstoffen zur Behandlung verschiedener Krebsarten, beispielsweise Kolorektalkrebs, Lungenkrebs und Krebs im Kopf-/Halsbereich, untersucht.

Über den Rezeptor des epidermalen Wachstumsfaktors (EGFr)

EGFr ist normalerweise an der Regulierung des Wachstums vieler verschiedener Zellen im Körper beteiligt, kann aber auch das Wachstum von Krebszellen anregen. Tatsächlich brauchen viele Krebszellen Signale vom EGFr um zu überleben. Der Rezeptor sitzt auf der Oberfläche dieser Tumorzellen und wird aktiviert, wenn natürlicherweise im Körper vorkommende Proteine, beispielsweise der epidermale Wachstumsfaktor (EGF) oder der transformierende Wachstumsfaktor alpha (TGF-alpha), an ihn binden. Durch diese Bindung verändert sich die Form des EGFr, wodurch wiederum interne zelluläre Signale in Gang gesetzt werden, die das Wachstum der Tumorzelle anregen. Panitumumab bindet an den EGFr, wodurch die Bindung natürlicher Liganden wie EGF und TGF-alpha an den Rezeptor verhindert wird und die Signale, die andernfalls das Wachstum der Krebszelle stimulieren und ihr Überleben ermöglichen würden, blockiert werden.

Über Kolorektalkarzinom

Kolorektalkrebs ist die dritthäufigste Krebsart, die in den USA bei Männern und Frauen diagnostiziert wird. Die American Cancer Society schätzt, dass 2006 rund 106.680 neue Fälle von Kolonkrebs und 41.930 neue Fälle von Rektalkrebs diagnostiziert werden.

Über Amgen

Amgen entdeckt, entwickelt und liefert innovative humane Medikamente. Amgen ist seit 1980 ein Pionier in der Biotechnologie und war eines der ersten Unternehmen, welches das neue Versprechen der Wissenschaft, sichere und wirksame Medikamente aus dem Labor zur Produktionsanlage zum Patienten zu bringen, umsetzte. Die Medikamente von Amgen haben die Anwendung von Medizin verändert und halfen Millionen von Menschen in der ganzen Welt bei dem Kampf gegen Krebs, Nierenerkrankungen, rheumatoide Arthritis und andere ernste Erkrankungen.

Mit einer langen Reihe potenzieller neuer Medikamente verpflichtet sich Amgen weiterhin, die Wissenschaft so voranzutreiben, dass die Lebensqualität der Menschen erheblich verbessert wird. Um mehr über unsere bahnbrechende Wissenschaft und unsere lebenswichtigen Medikamente zu erfahren, besuchen Sie bitte unsere Webseite unter www.amgen.com.

Amgen zukunftsbezogene Aussagen

Diese neue Pressemitteilung enthält zukunftsbezogene Aussagen, die signifikante Risiken und Unsicherheiten, einschließlich der nachfolgend erklärten und anderen, betreffen, die in unserem Formular 10-K für das am 31. Dezember 2005 beendete Jahr und in unseren regelmäßigen Berichten im Formular 10-Q und Formular 8-K eingesehen werden können. Amgen stellt diese Informationen zum Zeitpunkt dieser neuen Mitteilung bereit und verpflichtet sich nicht, zukunftsbezogene Aussagen, die in diesem Dokument enthalten sind, aufgrund neuer Informationen, künftiger Ereignisse oder sonstigem, zu aktualisieren.

Zukunftsbezogene Aussagen erfolgen ohne Gewähr und aktuelle Ergebnisse können sich wesentlich von den uns vorhergesehenen unterscheiden. Die Entdeckung oder Erkennung neuer Bewerberprodukte oder die Entwicklung neuer Indikationen für bestehende Produkte können nicht garantiert werden und der Weg von der Planung bis zum Produkt ist unsicher; folglich kann nicht garantiert werden, dass ein spezielles Bewerberprodukt oder die Entwicklung einer neuen Indikation für ein bestehendes Produkt erfolgreich sein wird und es ein Handelsprodukt wird. Darüber hinaus garantieren vorklinische Ergebnisse nicht die Sicherheit und Wirksamkeit von Produktkandidaten beim Menschen. Die Komplexität des menschlichen Körpers lässt sich nicht perfekt, und bisweilen nicht einmal annähernd, im Computer oder Zellkultursystemen oder Tiermodellen simulieren. Die Zeit, die Amgen zur Vollendung klinischer Versuche und zur Erlangung behördlicher Genehmigung für den Vertrieb des Produktes benötigt, war in der Vergangenheit unterschiedlich lang und Amgen rechnet auch künftig mit ähnlichen Unterschieden. Amgen entwickelt Produktkandidaten intern und durch Lizenznahmevereinbarungen, Partnerschaften und Joint Ventures. Produktkandidaten, die im Rahmen solcher Geschäftsbeziehungen entstehen, sind ggf. Gegenstand von Auseinandersetzungen zwischen den Parteien oder können sich als nicht so wirksam oder so sicher erweisen, wie Amgen zum Zeitpunkt der Aufnahme solcher Geschäftsbeziehungen angenommen hat. Amgen oder andere könnten Nebenwirkungen oder Produktionsprobleme bei Amgens Produkten feststellen, nachdem sie auf dem Markt sind.

Zudem werden die Umsätze von Amgens Produkten beeinflusst durch Rückerstattungsverträge, die durch Versicherungen Dritter erhoben werden, einschließlich Regierungen, private Krankenkassen und Pflegedienstleister und können auch beeinflusst werden durch inländische und internationale Trends in Bezug auf Pflege- und Gesundheitskostendämpfung als auch durch eventuelle US-amerikanische Gesetze, welche Einfluss haben auf die Preisgestaltung in der Pharmazie und auf Rückerstattungen. Regierungsgesetze und Rückerstattungsverträge können die Entwicklung, die Anwendung und die Preisgestaltung unserer Produkte beeinflussen. Außerdem steht Amgen hinsichtlich einiger von Amgen vertriebener Produkte und auch der Entdeckung und Entwicklung neuer Produkte im Wettbewerb mit anderen Unternehmen. Amgen ist der Meinung, dass einige der neueren Produkte, Produktkandidaten oder neuen Indikationen für bestehende Produkte bei und im Falle einer Zulassung und Vermarktung einer Wettbewerbssituation ausgesetzt sein werden. Produkte von Amgen stehen unter Umständen mit Produkten im Wettbewerb, die billiger sind, für die bereits Rückerstattungsverträge vorliegen, die überlegene Leistung haben, einfacher zu verabreichen sind oder in anderer Weise mit unseren Produkten konkurrieren.

Während wir routinemäßig Patente für unsere Produkte und Technologie erlangen, kann zudem der Schutz, den unsere Patente und Patentbewerbungen bieten, von unseren Mitbewerbern angefochten, für ungültig erklärt oder umgangen werden, und es kann nicht garantiert werden, dass Amgen in der Lage sein wird, Patentschutz für Produkte oder Produktkandidaten von Amgen zu erhalten oder aufrecht zu erhalten. Amgen kann ferner nicht garantieren, dass es in der Lage sein wird, kommerziell erfolgreiche Produkte zu produzieren oder den wirtschaftlichen Erfolg der bestehenden Produkte von Amgen aufrecht zu erhalten. Der Kurs der Aktie von Amgen kann von tatsächlichen oder prognostizierten Marktchancen, der Wettbewerbsposition und dem Erfolg bzw. Misserfolg von Produkten oder Produktkandidaten von Amgen beeinflusst werden. Darüber hinaus könnte die Entdeckung signifikanter Probleme in Verbindung mit einem Produkt, das einem Produkt von Amgen ähnlich ist, Auswirkungen auf eine ganze Produktklasse haben und deshalb den Verkauf der betroffenen Produkte und das Geschäft Amgens und das Betriebsergebnis in erheblichem Maße ungünstig beeinflussen.

Die in dieser Pressemeldung beschriebenen wissenschaftlichen Informationen in Bezug auf unsere Produktkandidaten sind vorläufig und experimenteller Natur. Solche Produktkandidaten sind von der US-amerikanischen Food and Drug Administration (FDA) nicht zugelassen und es können und sollten keine Schlussfolgerungen über die Sicherheit oder Wirksamkeit der Produktkandidaten gezogen werden. Nur die FDA kann festlegen, ob die Produktkandidaten in Bezug auf den untersuchten Verwendungszweck sicher und effektiv sind. Darüber hinaus sind die wissenschaftlichen Daten in dieser Pressemeldung, die sich auf neue Indikationen für unsere Produkte beziehen, vorläufig und experimenteller Natur und gehören nicht zu der Kennzeichnung, die von der FDA für diese Produkte gestattet wurde. Die Produkte sind für den experimentellen Gebrauch, der hierin beschrieben ist, nicht zugelassen, und es können und sollten keine Schlussfolgerungen über die Sicherheit oder Wirksamkeit der Produktkandidaten für diesen Gebrauch gezogen werden. Nur die FDA kann festlegen, ob die Produkte in Bezug auf den untersuchten Verwendungszweck sicher und effektiv sind. Medizinisches Fachpersonal sollte sich auf die von der FDA genehmigte Kennzeichnung der Produkte beziehen und verlassen und nicht auf die in dieser Pressemeldung beschriebenen Informationen.

ANMERKUNG DER REDAKTION: Zugang zu einer elektronischen Version dieser Pressemitteilung erhalten Sie auf der Webseite unter www.amgen.com. Um alle Pressemitteilungen zum Zeitpunkt der Herausgabe elektronisch zu erhalten, können sich Journalisten und Medienbeauftragte anmelden, indem sie ein kurzes Formular unter der Medienrubrik der Webseite ausfüllen.

Kontakt

Amgen, Thousand Oaks
Trish Hawkins/Kristen Davis, +1 805-447-4587 (Medien)
Arvind Sood, +1 805-447-1060 (Investoren)

Antikörper aus der Brauerei ist natürlich nicht ganz ernst gemeint, es handelt sich um eine Koop zwischen Kirins Pharmatochter und Intercell. Schöner Upfront von 4 Mio.

de.biz.yahoo.com/06042006/341/...rin-tochter-antikoerpern.html

Dow Jones
Intercell kooperiert mit Kirin-Tochter bei Antikörpern
Donnerstag 6. April 2006, 08:19 Uhr




WIEN (Dow Jones)--Die Intercell AG, Wien, hat mit der Pharma-Tochter der Kirin Brewery Co Ltd, Tokio, eine Kooperation vereinbart. Die Unternehmen wollen bei der Entwicklung monoklonaler Antikörper gegen schwere Infektionen, die durch Pneumokokken hervorgerufen werden, zusammenarbeiten, wie es in einer Mitteilung vom Donnerstag hieß. Die medizinische Bedeutung von Pneumokokkenerkrankungen, insbesondere bei älteren Menschen, werde immer größer.

Im Zuge der Vereinbarung erhalte Kirin die weltweiten Rechte zur Entwicklung und Vermarktung von Antikörpern, die gegen Antigene gerichtet seien, welche mit Intercells eigenem Antigen-Identifikations-Programm ANZEIGE
 
(AIP) entdeckt worden seien. Diese Technologie identifiziert Antigene, die in Impfstoffen schützend wirken, aber auch passende Ziele sind, um die Ansteckungsfähigkeit von Pathogenen zu blockieren.

Die Partner werden in der prä-klinischen Entwicklung des Produkts zusammenarbeiten; Kirin ist für die klinische Entwicklung, Registrierung und Vermarktung des Produkts verantwortlich, wie Intercell erklärte. Während der Vertragsdauer habe Intercell Anspruch auf Meilenstein-Zahlungen von insgesamt 40 Mio EUR, inklusive einer Vorauszahlung von 4 Mio EUR. Zudem erhalte das Unternehmen Lizenzgebühren aus zukünftigen Produktverkäufen. Zusätzlich würden Intercell alle Entwicklungsaufwendungen erstattet.

DJG/nas/jhe

www.nytimes.com/2006/04/08/world/europe/...l?pagewanted=1&_r=2

British Rethinking Rules After Ill-Fated Drug Trial
Sign In to E-Mail This Print Single Page Save  By ELISABETH ROSENTHAL,
International Herald Tribune
Published: April 8, 2006
In February, when Rob O. saw the text message from Parexel International pop up on his cellphone in London — "healthy males needed for a drug trial" for £2,000, about $3,500 — it seemed like a harmless opportunity to make some much-needed cash. Parexel, based in Waltham, Mass., contracts with drug makers to test new medicines.

Just weeks later, the previously healthy 31-year-old was in intensive care at London's Northwick Park Hospital — wires running directly into his heart and arteries, on dialysis, his immune system, liver, kidneys and lungs all failing — the victim of a drug trial gone disastrously bad.

One of six healthy young men to receive TGN1412, a novel type of immune stimulant that had never before been tried in humans, Rob O. took part in a study that is sending shock waves through the research world and causing regulators to rethink procedures for testing certain powerful new drugs.

Although tests of TGN1412 in monkeys showed no significant trouble, all six human subjects nearly died. One is still hospitalized and the others, though discharged, still have impaired immune systems, their future health uncertain.

On Wednesday, after releasing its interim report on the trial as well as previously confidential scientific documents that were part of the application for a trial permit, the British government announced it was convening an international panel of experts to "consider what necessary changes to clinical trials may be required" for such novel compounds.

The outcome "could potentially affect clinical trials regulation worldwide," the announcement said.

In statements this week, both Parexel and the drug's manufacturer, TeGenero, emphasized that they had complied with all regulatory requirements and conducted the trial according to the approved protocol. But they declined to answer questions e-mailed to them about the specifics of the science involved.

"The companies have worked according to strict standards applicable for such type of studies," said Kristin Kaufmann, a spokeswoman for TeGenero.

Within an hour of receiving the milky white drug in a Parexel research ward in the hospital on March 13, the volunteers were racked with chills, pain and nausea, said Rob O., who asked that his last name not be used, for fear that he might be hurt professionally. A doctor informed him he was "seriously ill."

"But no one's going to die?" Rob O. recalled saying, believing he was participating in a fairly standard trial of a painkiller for arthritis.

The chilling response: "Two of you might. Who's your next of kin?"

In fact, TGN1412 is anything but standard. The first product of TeGenero, a tiny German company with just 15 employees, TGN1412 belongs to a completely novel class of manufactured antibodies that researchers thought could revolutionize the treatment of leukemia and rheumatoid arthritis.

Now, TGN1412 seems poised to go down in medical history as a pharmaceutical lemon, its disastrous trial raising serious questions about whether patient safety is adequately protected in the lucrative race to get products to market.

The British Medicine and Healthcare Products Regulatory Agency, which approved the trial at Northwick Park, announced Wednesday that "the way the trial was run" had not contributed to patient injuries, according to its preliminary investigation. The men experienced cytokine release syndrome, which involves an outpouring of toxic molecules when the immune system's T cells are activated, the report said; it could not have been predicted from previous animal studies using the drug, the association, TeGenero and Parexel agree.

But British regulators took the highly unusual additional step of appointing an expert panel to explore whether more stringent safeguards should be required for testing new biological drugs like TGN1412 that manipulate the immune system.

Many experts say that because TGN1412's unique property is to turn on potent, immune system T cells, overriding normal regulatory mechanisms, the clinical trials were extraordinarily risky. "There was strong reason to be very cautious," said Dr. Michael Ehrenstein, of University College London, who studies the molecules that TGN1412 affects. "Many people would say this was a very high-risk strategy. I'd have to agree with that."

Michael Goodyear, a Canadian oncologist and medical ethicist, said that even if the trial was not illegal or unethical, the research protocol and conduct on the day of the trial raise "a number of big red flags."

The concerns Dr. Goodyear and lawyers for the subjects raised include these:

¶Rob O. began receiving the drug intravenously long after the first volunteer was already experiencing symptoms possibly serious enough to halt the trial. Standard practice for such trials is to use just one patient or to separate tests by many days.

¶The information submitted by TeGenero to British regulators mentioned that a cytokine burst "could occur" after TGN1412 infusion. But in their application, researchers deemed the reaction "not expected" on the basis of trials with a single animal species, and did not mention this risk to the recruits, Rob O. said.

¶On its Web site, Parexel says, "The only services that matter are the ones that speed your product through clinical development." The subjects point out that approvals for drug trials in Britain are quicker than in the United States and the liability for injuries is less.

¶Rob O. said the novelty of TGN1412 never came up in upbeat pretrial briefings, adding, "I had no idea it altered the immune system."

The first human trials are risky and ethically complicated. They are designed to determine whether a compound is safe, not to provide a benefit to the subject. Such human trials must be approved by national regulators as well as medical ethics boards, though standards vary somewhat among countries and even among different panels.

"Research is a social good — we need better treatments for leukemia and arthritis — but there are risks," said Dr. Ezekiel J. Emanuel, chief of bioethics at the United States National Institutes of Health. "Being a construction worker is very risky, and we pay people to do that. So why not this?"

Noting that the TGN1412 trial had been approved by two separate British regulatory bodies and that the medicine had been tested in animals, he said, "This is a terrible, tragic event but so far I don't see any clear ethical problems."

The trial subjects, who were to spend three days as hospital inpatients, were mostly immigrants, some of them students or unemployed.

"These were not people who were well off," said Martyn Day, of the London law firm Leigh Day & Company, which is representing four of the men. "They thought this was relatively risk free."

At the orientation meeting there was little time to read the 11-page consent form, Rob O. said, although they had a chance to take it home. Headaches and bruising were listed as potential side effects, as well as a severe allergy. But eating nuts or using new cosmetics could create similar reactions, the form said.

In fact, so-called monoclonal antibodies frequently produce severe generalized symptoms like aches and chills, though their use is justified by the enormous potential benefit. "At my hospital, we almost killed people the first few times we used Herceptin," said Dr. Goodyear, referring to the popular breast cancer drug, adding that he now pretreats patients with medicines to counter possible reactions.

Parexel applied to test TGN1412 in both England and Germany in December, receiving permission in England first, on Jan. 27. Many countries are streamlining review processes to attract biomedical research, a strategy that may have backfired here, Dr. Goodyear said.

It is not clear if independent immunologists reviewed the trial design, and neither Parexel nor TeGenero answered this question.

The trial began Monday, March 13, at 8 a.m., when the men began receiving TGN1412, each 10 minutes after the last. Within half an hour, the first patient had a headache and chills, said Ann Alexander, a London lawyer who is representing him. Nevertheless, doctors continued injecting new patients. About the time Rob O.'s infusion started, at 9:10 a.m., the first patient had passed out in an adjacent room, according to Ms. Alexander.

Before long, Rob O. said, he began to ache and shiver, feeling as if he had been "submerged in arctic ice." For the rest of the day, six previously healthy men moaned in uncontrollable pain, vomited and struggled for breath, Rob O. and other participants said. Though a dose of steroids temporarily blunted the symptoms, their vital signs steadily deteriorated, and they were transferred to the intensive care unit.

Two of them were placed on ventilators. Uniformed men wheeled in blood filtering machines, Rob O. recalled, to cleanse the blood of acid. Doctors told him that his immune cells were attacking his organs.

The patients' families were summoned to the hospital at 3 a.m.

In statements, Parexel and TeGenero called the reactions "unforeseen and unexpected," noting that doses hundreds of times more powerful had proved safe in animals.

The experimental application filed with British authorities — released this week in response to a Freedom of Information Act request — showed that the companies at least realized the possibility of a devastating immune-system reaction, and that animal studies showed some signs of immune overdrive.

Those worries were set aside when monkeys infused with TGN1412 had no problems. Although Parexel technicians continued to draw blood in the intensive care unit, the companies have not been willing to share the medical data or even meet with the participants and their lawyers, Mr. Day, the lawyer, said.

With his immune system now essentially disabled, Rob O. says he cannot work, or even take the subway, for fear of infection. His liver and kidney tests are still abnormal. Britain's National Health Service covers his doctor's bills, but he has to pay the $87 cab fare.

Under British law, Rob O. may be eligible only for $50,000 to $70,000 in compensation, said Mr. Day, unless he can demonstrate permanent harm. Anyway, tiny TeGenero took out only a $3.5 million insurance policy to cover the trial.

Lawyers for the subjects are hoping to arrange for financial compensation and full disclosure of medical information on the drug without having to go to court.

"I can't believe that nobody will pay and nobody will be punished," Rob O. said. "If I've lost 20 years of life because my liver packs in at 60 rather than 80, who will cover that?"

biz.yahoo.com/prnews/060510/phw003.html?.v=54


Press Release Source: Medarex, Inc.


Oxford Genome Sciences and Medarex Sign Therapeutic Antibody Collaboration Agreement in Cancer
Wednesday May 10, 5:00 am ET


OXFORD, England and PRINCETON, N.J., May 10 /PRNewswire-FirstCall/ -- Oxford Genome Sciences (UK) Ltd "OGeS" and Medarex, Inc. (Nasdaq: MEDX - News) announced today that they have entered into a strategic collaboration to discover and develop new human antibody therapeutics for the treatment of cancers, including colorectal cancer.
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The collaboration combines OGeS' ability to discover novel targets for oncology with Medarex's expertise in the development of fully human antibody therapeutics. The collaboration provides for OGeS and Medarex to discover, develop and commercialize therapeutic antibodies on a 50:50 basis. Other financial terms of the agreement were not disclosed.

During the initial phase of the collaboration, OGeS intends to provide novel colorectal cancer targets, against which Medarex expects to generate fully human monoclonal antibodies using its proprietary UltiMAb Human Antibody Development System®. OGeS plans to utilize its unique Oxford Genome Anatomy Project (OGAP®) database, one of the world's largest human protein databases that integrates genomic, proteomic and clinical information derived from blood and tissue studies for a large number of diseases from 50 different human tissues and representing 60 diseases.

"I am extremely excited about our partnership with Medarex, a leader in the development of human antibody therapeutics. Their expertise in combination with the unique targets from our OGAP database give me great confidence that we can develop new and improved treatment options for patients with colorectal cancer," said Dr. Christian Rohlff, CEO of OGeS.

"We are very happy to have signed this agreement with OGeS and believe that access to the unique high-quality targets from the OGAP database will allow us to quickly identify novel antibody-based targets for cancer. We are impressed with the capabilities of OGeS' technology for identifying disease targets and look forward to applying our human antibody and clinical development expertise for the development of new cancer treatments," said Donald L. Drakeman, President and CEO of Medarex, Inc.

About Oxford Genome Sciences

Oxford Genome Sciences (OGeS) is focused on the development of personalized medicines, mainly for oncology indications. The company has developed a unique integrated platform that combines genomic, proteomic and clinical information to accelerate the discovery and validation of drug targets and biomarkers in human beings. OGeS believes the benefits are improved biomarkers for patient selection, drug response and efficacy monitoring, and the integration of diagnostics into drug development and product launch, thereby facilitating more accurate drug development and providing cost and time savings.

OGeS's strategy is to enter into flexible strategic alliances to capture maximum value from its unique and integrated platform for the development of new therapeutics and diagnostics in the field of cancer. In parallel, OGeS provides target and biomarker discovery and screening services to pharmaceutical and biotechnology companies providing OGeS with short-term revenues.

OGeS, a privately held company, was formed in 2004 and is based near Oxford, UK.

About OGAP

Oxford Genome Anatomy Project (OGAP) holds one of the world's largest proprietary collection of proteins represented by the database, which contains over one million peptide sequences from 50 tissues and 60 disease states, mapped to approximately 15,000 genes and over eight million SNPs and haplotypes. The database can be customized for individual partners to support and enhance their preclinical and clinical drug development activities.

For further information, please see www.oxfordgenomesciences.com.

About Medarex

Medarex is a biopharmaceutical company focused on the discovery, development and potential commercialization of fully human antibody-based therapeutics to treat life-threatening and debilitating diseases, including cancer, inflammation, autoimmune disorders and infectious diseases. Medarex applies its UltiMAb® technology and product development and clinical manufacturing experience to generate, support and potentially commercialize a broad range of fully human antibody product candidates for itself and its partners. Thirty-one of these therapeutic product candidates derived from Medarex technology are in human clinical testing or have had INDs submitted for such trials, with four of the most advanced product candidates currently in Phase III clinical trials. Medarex is committed to building value by developing a diverse pipeline of antibody products to address the world's unmet healthcare needs. For more information about Medarex, visit its website at www.medarex.com.

Medarex Statement on Cautionary Factors

Except for the historical information presented herein, matters discussed herein may constitute forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Statements that are not historical facts, including statements preceded by, followed by, or that include the words "potential"; "believe"; "anticipate"; "intend"; "plan"; "expect"; "estimate"; "could"; "may"; or similar statements are forward-looking statements. Medarex disclaims, however, any intent or obligation to update these forward-looking statements. Risks and uncertainties include risks associated with product discovery and development, uncertainties related to the outcome of clinical trials, slower than expected rates of patient recruitment, unforeseen safety issues resulting from the administration of antibody products in patients, uncertainties related to product manufacturing as well as risks detailed from time to time in Medarex's public disclosure filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the fiscal year ended December 31, 2005 and subsequent Quarterly Reports on Form 10-Q. There can be no assurance that such development efforts will succeed or that other developed products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. Copies of Medarex's public disclosure filings are available from its investor relations department.


   OGAP® is a registered trademark of Oxford Genome Sciences (UK) Ltd.
Medarex®, the Medarex logo and UltiMAb® are registered trademarks of Medarex, Inc. All rights are reserved.




--------------------------------------------------
Source: Medarex, Inc.

de.biz.yahoo.com/24052006/217/...-fruehstadium-zugelassen.html


PR Newswire
Herceptin in Europa bei HER2-positivem Brustkrebs im Frühstadium zugelassen
Mittwoch 24. Mai 2006, 07:35 Uhr

          §
LONDON, May 24 /PRNewswire/ --
- Lebensverlängerndes Medikament lässt Frauen mit aggressiver Form von
Brustkrebs in ganz Europa wieder hoffen

Roche gab heute bekannt, dass die Europäische Kommission Herceptin
(Trastuzumab) für Patientinnen mit HER2-positivem Brustkrebs im Frühstadium
im Anschluss an eine Operation und Standard-Chemotherapie zugelassen hat.
HER2-positiver Brustkrebs, der etwa 20 bis 30 Prozent [i] aller Frauen mit
Brustkrebs befällt, erfordert besondere und unmittelbare Aufmerksamkeit, da
die Tumoren schnell wachsen und eine gesteigerte Rezidivwahrscheinlichkeit besteht.

Die Zulassung basiert auf eindrucksvollen Ergebnissen aus der
internationalen HERA-Studie

(HERceptin Adjuvant), derzufolge die Verabreichung von Herceptin im
Anschluss an die Standard-Chemotherapie im Vergleich zur ausschliesslichen
Chemotherapie das Rückfallrisiko des Krebses um 46% reduziert. [ii]
Gleichermassen bemerkenswerte Vorteile wurden auch bei drei anderen grossen
globalen und US-amerikanischen Studien beobachtet. [iii]

"Es ist lobenswert, dass die Zulassung von Herceptin für Brustkrebs im
Frühstadium in Europa so erstaunlich rasch abgewickelt wurde", so der
Kommentar von William M. Burns, CEO der Pharmazeutischen Abteilung von Roche.
"Herceptin hat eindeutig bewiesen, dass es die besten langfristigen
Überlebenschancen bietet, wenn es möglichst zu Beginn des Krankheitsverlaufs
angewendet wird. Diese Entscheidung bedeutet wirklich gute Nachrichten für
Patienten und die medizinische Gemeinde. Wir werden jetzt mit den nationalen
Behörden zusammenarbeiten, damit den Ärzten und Patienten in ganz Europa
diese Behandlungsmethode garantiert zugänglich ist."

Herceptin war zuvor in der EU zur Behandlung von metastasiertem
(fortgeschrittenem) HER2-positiven Brustkrebs zugelassen worden. Diese neue
Genehmigung gestattet es nun Frauen in jedem Stadium dieser aggressiven
Krankheit, einschliesslich Brustkrebs im Frühstadium, diese
lebensverlängernde Behandlungsoption zu nutzen.

Die Beständigkeit der Ergebnisse aus vier grossen Versuchen mit über
12.000 Patientinnen hat medizinische und behördliche Organisationen auf der
ganzen Welt bewogen, schnelle Massnahmen zu ergreifen, damit Herceptin
Patientinnen mit HER2-positivem Brustkrebs im Frühstadium zur Verfügung
steht. Herceptin erhielt vor kurzem den Zulassungsstatus in Neuseeland und
Australien, und mehrere Länder haben im Lauf des letzten Jahres vor Erteilung
der Lizenz klinische Richtlinien entwickelt und Mittel bereitgestellt, um in
Frage kommenden Patienten einen schnelleren Zugang zu gewähren.

In den USA hat Genentech am 15. Februar 2006 bei der Food and Drug
Administration (FDA) einen zusätzlichen Antrag auf biologische Zulassung
(Biologic License Application = sBLA) zur Anwendung von Herceptin bei
HER2-positivem Brustkrebs im Frühstadium gestellt. Dieser Antrag basiert auf
Daten aus der kombinierten Zwischenanalyse von zwei grossen US-Versuchen
[iv], und Genentech hat einen vorrangigen Prüfungsstatus erreicht.

Informationen zur HERA-Studie

HERA, von Roche und der Breast International Group (BIG) durchgeführt
[v], ist eine der umfangreichsten adjuvanten Studien an
Brustkrebspatientinnen überhaupt; die Registrierung begann im Dezember 2001,
und es wurden beinahe 5.100 HER2-positive Patientinnen in 480
Untersuchungsstandorten in 39 Ländern weltweit aufgenommen. HERA ist ein
randomisierter Versuch im Anschluss an die herkömmliche systemische
Begleitchemotherapie und (gegebenenfalls) Strahlenbehandlung, bei dem
Beobachtung (also keine weitere Behandlung) versus Herceptin alle drei Wochen
für einen Zeitraum von 12 Monaten oder 24 Monaten bei Frauen mit
HER2-positivem Brustkrebs im Frühstadium bewertet wird. Die HERA-Studie liess
die Anwendung einer breiten Palette an chemotherapeutischen Verfahren zu, und
sowohl lymphknotenpositive wie auch lymphknotennegative Patientinnen wurden
zu dem Versuch zugelassen.

Gemäss den Ergebnissen der Zwischenauswertung wurde der primäre Endpunkt
der Wirksamkeit erreicht. Es wurde nachgewiesen, dass Patienten, die
Herceptin erhalten hatten, im 12-monatigen Arm der Studie eine statistisch
signifikante Verbesserung des krankheitsfreien Überlebens erfuhren (darunter
versteht man die Zeitspanne nach der Behandlung, während der keine
Krankheitsanzeichen auftreten). Bei einer medianen Nachbeobachtung von einem
Jahr hatte der sekundäre Endpunkt des Gesamtüberlebens noch keine
statistische Signifikanz erreicht. Es war allerdings eine eindeutige Tendenz
zur Verbesserung des Gesamtüberlebens zu beobachten, was durch längerfristige
Daten noch zu bestätigen sein wird.

Die Zwischenanalyse verglich Herceptin mit reiner Beobachtung und schloss
keine Gegenüberstellung der 12-monatigen mit der 24-monatigen
Behandlungsdauer ein. Der Versuch wird diesen Vergleich weiterhin bewerten,
die entsprechenden Daten werden im Verlauf der Studie zum gegebenen Zeitpunkt
verfügbar sein.

Die HERA-Studie untersteht einem externen Datenkontrollausschuss
(Independent Data Monitoring Committee = IDMC), der regelmässig die
Unbedenklichkeitsfaktoren der Studie überprüft. Bisher hat das IDMC bezüglich
der Sicherheit keine Bedenken geäussert, und das Auftreten von kongestiver
Herzinsuffizienz war geringfügig (0,5% beim Herceptin-Arm versus 0% beim
Beobachtungs-Arm). Die Patientinnen dieser Studie werden weiterhin auf
eventuelle Nebenwirkungen hin überwacht.

Informationen zu Brustkrebs und Herceptin

Acht bis neun Prozent aller Frauen erkranken im Lauf ihres Lebens an
Brustkrebs, was diesen zu einer der häufigsten Formen des Krebses bei Frauen
macht. [vi] Alljährlich werden weltweit über eine Million neuer Fälle von
Brustkrebs diagnostiziert, wobei die Sterberate bei fast 400.000 pro Jahr
liegt.

Beim HER2-positiven Brustkrebs befinden sich erhöhte Mengen des
HER2-Proteins an der Oberfläche der Krebszellen, was als 'HER2-positiv'
bezeichnet wird. Hohe Konzentrationen von HER2 sind bei einer besonders
aggressiven Form der Krankheit vorhanden, die nur schlecht auf Chemotherapie
anspricht. Untersuchungen haben ergeben, dass etwa 20 - 30 Prozent aller
Frauen mit Brustkrebs HER2-positiv sind.

Herceptin ist ein humanisierter Antikörper, der gezielt die Funktion von
HER2 blockieren soll. HER2 ist ein Protein, das von einem bestimmten Gen mit
krebsverursachendem Potenzial produziert wird. Abgesehen von der Wirksamkeit
bei Brustkrebs im Frühstadium hat Herceptin auch verbessertes Überleben im
fortgeschrittenen (metastasierten) Stadium unter Beweis gestellt, wo die
Kombination mit Chemotherapie im Vergleich zur Chemotherapie allein den
Patientinnen eine bis zu einem Drittel längere Überlebenszeit gewährt. [vii]

Herceptin wurde im Jahr 2000 in der Europäischen Union zur Anwendung bei
Patientinnen mit metastasiertem Brustkrebs zugelassen, deren Tumore einen
Überschuss des HER2-Proteins aufwiesen. Neben der Anwendung in Kombination
mit Docetaxel als Erstlinientherapie für HER2-positive Patienten, die keine
Chemotherapie für ihre metastasierte (fortgeschrittene) Krankheit erhalten
hatten, ist Herceptin auch als Erstlinientherapie in Kombination mit
Paclitaxel angezeigt, wenn Anthrazykline ungeeignet sind, sowie als
Monotherapeutikum bei der Drittlinientherapie. Herceptin wird in den
Vereinigten Staaten von Genentech, in Japan von Chugai und in den übrigen
Ländern von Roche vertrieben. Herceptin wurde seit 1998 zur Behandlung von
über 230.000 HER2-positiven Brustkrebspatientinnen weltweit eingesetzt.

Unternehmensprofil Roche

Das Unternehmen Roche mit Hauptsitz im schweizerischen Basel ist einer
der weltweit führenden, forschungsorientierten Gesundheitskonzerne im
Arzneimittel- und Diagnostikbereich. Mit innovativen Produkten und
Dienstleistungen, die der Früherkennung, Prävention, Diagnose und Behandlung
von Krankheiten dienen, trägt der Konzern auf breiter Basis zur Verbesserung
der Gesundheit und Lebensqualität der Menschen bei. Roche steht weltweit an
der Spitze auf dem Gebiet der Diagnostik, ist der führende Anbieter von
Krebs- und Transplantationsmedikamenten und ist marktführend auf dem Gebiet
der Virologie. Im Jahr 2005 erzielte die Pharmaabteilung einen Gesamtumsatz
von 27,3 Mrd. Schweizer Franken, die Diagnostik-Abteilung verzeichnete
Umsätze in Höhe von 8,2 Mrd. Schweizer Franken. Roche beschäftigt rund 70.000
Mitarbeiter in 150 Ländern und unterhält Forschungs- und Entwicklungsabkommen
sowie strategische Allianzen mit zahlreichen Partnern. Das Unternehmen
verfügt unter anderem über Mehrheitsbeteiligungen an Genentech und Chugai.
Weitere Informationen über den Roche Konzern finden Sie im Internet
(www.roche.com).

Alle in dieser Pressemitteilung verwendeten bzw. erwähnten Markennamen
sind gesetzlich geschützt.

Zusätzliche Informationen:

- Über Genentech: www.gene.com

- Roche in Oncology:

www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf

- Roche Health Kiosk über Krebs: www.health-kiosk.ch/start_krebs

- Videoclips (kostenlose Standardübertragung): www.thenewsmarket.com

Quellenangaben:

[i] Harries M, Smith I. The development and clinical use of trastuzumab
(Herceptin). Endocr Relat Cancer 9: 75-85, 2002.

[ii] Piccart-Gebhart M, Procter M, Leyland-Jones B, et al. A Randomized
Trial of Trastuzumab Following Adjuvant Chemotherapy in Women with HER2
Positive Breast Cancer. New England Journal of Medicine 353:16 2005.

[iii] NCCTG N9831 (US), NSABP B-31 (US), BCIRG 006 (international)

[iv] Romond, E., Perez, E. et al. Trastuzumab plus Adjuvant Chemotherapy
for Operable HER2 Positive Breast Cancer. New England Journal of Medicine
353:16 2005.

[v] Collaborative partners for the HERA study include: Roche, BIG and its
affiliated collaborative groups, plus non-affiliated collaborative groups,
and independent sites.

[vi] World Health Organization, 2000.

[vii] Extra JM, Cognetti F, Maraninchi D et al. Long-term survival
demonstrated with trastuzumab plus docetaxel: 24-month data from a randomised
trial (M77001) in HER2-positive metastatic breast cancer. Abstract #555,
American Society for Clinical Oncology (ASCO) Annual Meeting 2005.
Roche

Oder geht es hier nur um konkrete Medikamente in Indikationen?
Will ja keinen Fehler hier machen in deinem schönen Sammelthread.

@eck, kannst hier posten was du  willst, primär sicher Antikörpermedikamente und
Entwicklungsrichtung und Strategien, aber  Hauptsache irgendwie Bezug zu Ak's,
also Cat-Übernahme  hätte sicher reingehört,  da es einen unabhängigen Player weniger bedeutet, noch dazu einen, der ohne Mouse-Technology arbeitet, genau  wie  Morphosys.  

also : Cat (Cambridge Antibody Technology) wurde übernommen von
Astra-Zeneca
de.biz.yahoo.com/15052006/36/...nen-pfund-bar-uebernehmen.html

dpa-afx
AstraZeneca will CAT für 702 Millionen Pfund in bar übernehmen
Montag 15. Mai 2006, 08:30 Uhr


LONDON (dpa-AFX) - Der britisch-schwedische Pharmakonzern AstraZeneca will das Biotech-Unternehmen Cambridge Antibody Technology (CAT) für 702 Millionen britische Pfund (1,03 Mrd Euro) in bar übernehmen. Die Führungsgremien beider Firmen hätten sich auf die Bedingungen geeinigt, teilte AstraZeneca (London: AZN.L - Nachrichten) am Montag in London mit. Der Kauf werde keine Auswirkungen haben auf die Prognose für den Gewinn je Aktie oder das Aktienrückkaufprogramm bei Astrazeneca in diesem Jahr./ari/sk  

de.biz.yahoo.com/03062006/217/...lassung-europa-empfohlen.html

BASEL, Schweiz, June 3 /PRNewswire/ --


- Erstes selektiv auf die B-Zellen wirkendes Medikament bietet Patienten
eine wahre Alternative bei der Behandlung dieser beeinträchtigenden Krankheit



Roche gab heute bekannt, dass der Ausschuss für Humanarzneimittel (CHMP)
eine Zulassungsempfehlung für MabThera (Rituximab) zur Behandlung von
rheumatoider Arthritis (RA) in Europa erliess. Dies bringt MabThera, die
erste und einzige selektiv auf B-Zellen wirkende Therapie, einen Schritt
näher für RA-Patienten, die auf die gegenwärtigen Behandlungsoptionen
(einschliesslich TNF-Inhibitoren) ANZEIGE
 
mit einer unzureichenden Ansprechrate oder
Unverträglichkeit reagierten. Die B-Zellen spielen in der Entzündungskaskade,
welche letztlich zu den für rheumatoide Arthritis typischen Knochen- und
Knorpelschäden in den Gelenken führt, eine wichtige Rolle.



Professor Paul Emery, University of Leeds, GB, einer der leitenden
Prüfärzte in der REFLEX(1) Studie kommentierte: "Dies ist ein wichtiger
Moment - MabThera wird für die RA-Patienten in Europa, die durch die derzeit
verfügbaren Therapien keine ausreichende Linderung erfahren oder diese
Therapien nicht vertragen, erhebliche Vorteile bringen. Dieser neue Ansatz
verspricht mit jedem kurzen Behandlungszyklus alle 6 bis 12 Monate
nachhaltigen klinischen Nutzen."



"Die positive Stellungnahme des CHMP ist ein grosser Meilenstein für
MabThera - das erste Medikament für rheumatoide Arthritis in unserem
Produkteportfolio im Bereich der Autoimmunkrankheiten. Wir freuen uns, dass
MabThera bald vielen an dieser beeinträchtigenden Krankheit leidenden
Menschen als neue Behandlungsalternative zur Verfügung stehen wird," sagte
Eduard Holdener, Leiter von Pharma Development bei Roche.



Die positive Stellungnahme des CHMP gilt für MabThera in Kombination mit
Methotrexat zur Behandlung von erwachsenen Patienten mit schwerer aktiver
rheumatoider Arthritis (RA), die zuvor nicht ausreichend auf andere
krankheitsmodifizierenden Antirheumatika (einschliesslich eines oder mehrerer
Tumornekrosefaktor(TNF)-Inhibitoren) angesprochen oder diese Medikamente
nicht vertragen hatten. Bis zu 40 % der RA-Patienten, die mit derzeit
verfügbaren Biotherapeutika behandelt werden, sprechen nur ungenügend auf die
Behandlung an und haben wenig andere Behandlungsalternativen. Daher besteht
ein dringender Bedarf an neuen wirksamen Behandlungsoptionen für Patienten,
deren tägliches Leben durch diese schwerwiegende Krankheit beeinträchtigt
wird.



Die Bekanntmachung des CHMP kam nach den positiven Ergebnissen der
Phase-III-REFLEX-Studie, die zeigten, dass MabThera ein hochwirksames
Präparat zur Symptomlinderung bei RA-Patienten ist und eine nachhaltige
Verbesserung nach nur zwei Infusionen pro Behandlungszyklus bringt. Die
Studie zeigte insbesondere, dass MabThera beeindruckende Ergebnisse bei der
Reduzierung von Schwellungen und Schmerzen der Gelenke erzielte und somit die
Abgeschlagenheit und Lebensqualität der Patienten verbesserte. Eine
detaillierte Analyse der REFLEX-Studie einschliesslich der röntgenologischen
Daten über einen Zeitraum von einem Jahr sowie der Wirkung von wiederholten
Behandlungszyklen wird im Juni 2006 auf dem EULAR-Kongress (European League
Against Rheumatism) präsentiert.



MabThera wird in den USA von Genentech unter dem Namen Rituxan vertrieben
und erhielt vor kurzem nach einem beschleunigten Verfahren die Zulassung der
amerikanischen Gesundheitsbehörde FDA für die Behandlung von mittelschwerer
bis schwerer RA.



Die rheumatoide Arthritis stellt eine der häufigsten Autoimmunkrankheiten
dar und betrifft mit bis zu 2 Millionen Erkrankten allein in Europa mehr als
21 Millionen Menschen weltweit.



MabThera wird bereits als bewährte Behandlung von Non-Hodgkin-Lymphom
(NHL), einer Form von Lymphdrüsenkrebs, eingesetzt. Über 730.000 Patienten
wurden in den letzten 7 Jahren mit MabThera behandelt, ohne grösseren Anlass
zu Bedenken bezüglich der Sicherheit zu geben.



Über die REFLEX-Studie



Die REFLEX-Studie (Randomised Evaluation oF Long-term Efficacy of
Rituximab in RA) ist eine randomisierte, doppelblinde, placebokontrollierte
Phase-III-Studie an mehreren Zentren. Bei Patienten, die im Rahmen dieser
Studie einen einzigen Behandlungszyklus von nur zwei Infusionen MabThera in
Kombination mit einer gleich bleibenden Dosis Methotrexat (MTX) erhielten,
wurde nach 24 Wochen eine statistisch signifikante Besserung der Symptome im
Vergleich zur Patientengruppe mit Placebo plus MTX gemessen. Bei den meisten
Patienten, die weitere Behandlungszyklen erhielten, erfolgten diese jeweils
24 Wochen nach dem vorhergehenden Behandlungszyklus. Eine vorläufige Analyse
der REFLEX-Daten lieferten keine unerwarteten Erkenntnisse hinsichtlich der
Medikamentensicherheit. Die Unternehmen kontrollieren weiterhin die
langfristige Sicherheit von MabThera in allen klinischen Studien.



Signifikante Verbesserungen aller Symptomparameter



Die Ergebnisse der 6-Monatsanalyse zeigten, dass MabThera in Kombination
mit Methotrexat (MTX), einer Standardbehandlung von RA, hoch wirksam war und
verglichen mit MTX plus Placebo statistisch signifikant höhere Ansprechraten
erzielte: 51 % der Patienten verzeichneten eine 20-prozentige Verbesserung
der Anzeichen und Symptome (ACR20(2)), verglichen mit 18 % bei MTX allein.
Der Unterschied zwischen den beiden Gruppen war nach 8 Wochen ersichtlich und
wurde für die gesamte Dauer der Studie nach nur einem Behandlungszyklus von 2
Infusionen von MabThera im Abstand von 2 Wochen aufrechterhalten. Im Verlauf
der sechs Monate erzielten mehr als fünfmal so viel Patienten in der
MabThera-Gruppe eine 50-prozentige Verbesserung der Anzeichen und Symptome
verglichen mit MTX allein (ACR50: 27 % vs. 5 %), und zwölfmal so viele
MabThera-Patienten erzielten eine 70-prozentige Verbesserung (ACR70: 12 % vs.
1 %). Bei den meisten Patienten, die weitere Behandlungszyklen erhielten,
erfolgten diese 6 Wochen nach dem vorhergehenden Behandlungszyklus.



Über MabThera und rheumatoide Arthritis



MabThera zielt selektiv auf eine Untergruppe der B-Zellen ab, die CD20
exprimieren. Die Stamm-, Pro-B- und Plasmazellen bleiben dabei unangetastet.
Dieser Untergruppe der B-Zellen kommt im Autoimmunprozess bei rheumatoider
Arthritis eine zentrale Rolle zu; MabThera wirkt auf eine Unterbrechung
dieser Abfolge von Reaktionen hin, die zur Entzündung der Gelenkinnenhaut und
schliesslich zu dem für diese Krankheit typischen Knorpelschwund und
Knochenabbau führen. Mehr als 1000 Patienten mit RA wurden bisher in
klinischen Studien mit MabThera behandelt. Ein umfangreiches klinisches
Phase-III-Entwicklungsprogramm prüft derzeit den potenziellen klinischen
Nutzen von MabThera in früheren Stadien der rheumatoiden Arthritis näher.



Über rheumatoide Arthritis



Bei der rheumatoiden Arthritis handelt es sich um eine progressive
systemische Autoimmunkrankheit, bei der sich die Gelenkinnenhaut entzündet.
Diese Entzündung verursacht einen Verlust der Form und Funktion des Gelenks,
was zu Schmerzen, Steifigkeit und Schwellungen und schliesslich zu einer
irreversiblen Zerstörung des Gelenks und zu Behinderung führt. Zu den
typischen Symptomen der rheumatoiden Arthritis zählen Schwellungen, Schmerzen
und eingeschränkte Beweglichkeit der Gelenke an Händen, Füssen, Ellenbogen,
Knien und im Nacken. Rheumatoide Arthritis kann, wenn sie wichtige
Organsysteme beeinträchtigt, die Lebenserwartung verkürzen. Nach 10 Jahren
sind weniger als 50 % der Patienten noch in der Lage, einer Arbeit oder ihren
gewohnten Alltagsaktivitäten nachzugehen.



Über Roche



Roche mit Hauptsitz in Basel, Schweiz, ist ein global führendes, auf
Forschung fokussiertes Healthcare-Unternehmen in den Bereichen Pharma und
Diagnostics. Mit innovativen Produkten und Dienstleistungen, die der
frühzeitigen Entdeckung, Prävention, Diagnose und Behandlung von Krankheiten
dienen, trägt das Unternehmen auf breiter Basis zur Verbesserung der
Gesundheit und Lebensqualität von Menschen bei. Roche ist ein global
führendes Unternehmen auf dem Diagnostikmarkt sowie der führende Anbieter von
Krebs- und Transplantationsmedikamenten und nimmt in der Virologie eine
Spitzenposition ein. 2005 erzielte die Division Pharma einen Umsatz von 27,3
Milliarden Franken und die Division Diagnostics Verkäufe von 8,2 Milliarden
Franken. Roche beschäftigt rund 70.000 Mitarbeitende in 150 Ländern und führt
strategische Allianzen sowie Forschungs- und Entwicklungskooperationen mit
zahlreichen Partnern. Hierzu gehören auch die Mehrheitsbeteiligungen an
Genentech und Chugai. Weitere Informationen zur Roche-Gruppe finden sich im
Internet (www.roche.com).



Alle in dieser Pressemitteilung erwähnten Markennamen sind gesetzlich
geschützt.



Literaturhinweise:



1. Die REFLEX-Studie (Randomised Evaluation oF Long-term Efficacy of
Rituximab in RA) ist eine randomisierte, doppelblinde, placebokontrollierte
Phase-III-Studie an mehreren Zentren.



2. Die ACR-Response ist ein vom American College of Rheumatology (ACR)
entwickelter Massstab zur Beurteilung des Therapieerfolgs bei rheumatoider
Arthritis. Dabei müssen sich bei einem Patienten die Anzahl Symptome und die
Krankheitswerte um einen bestimmten prozentualen Anteil reduzieren. Eine
Verminderung um 20 %, 50 % oder 70 % (prozentuale Verbesserung der
RA-Symptome) wird beispielsweise als ACR20, ACR50 oder ACR70 ausgewiesen.
Eine ACR70-Response wird von den bestehenden Therapien nur in Ausnahmefällen
erreicht und bedeutet eine signifikante Verbesserung des Gesundheitszustandes
eines Patienten.


Roche


 
 


Über Thema diskutieren   Per  

Hier geht es nicht um Antikörper sondern um einen neuen Ansatz des Pharmariesen Novartis. Artikel enthält auch einige interessante Aussagen zur Zukunftstrategie des Pharma-Konzerns.  


de.biz.yahoo.com/03062006/345/...zwingt-konzerne-umdenken.html

Samstag 3. Juni 2006, 21:15 Uhr


Die Zukunft von Novartis (Virt-X: NOVN.VX - Nachrichten) schwimmt zu Tausenden in kleinen Aquarien. Während man sonst in der Pharmaforschung auf die typischen Labormäuse zählt, sind in das neue Forschungszentrum des Schweizer Pharmakonzerns in Boston Zebrafische eingezogen.

Die durchsichtigen Organismen stehen seit zehn Jahren Modell für Grundlagenforscher, die verstehen wollen, wie sich komplexe Organe wie das Herz entwickeln. Novartis will mit ihnen in seinem Institute of Biomedical Research (NIBR) Wissen und Inspirationen Anzeige
 
für die Medikamenten-Entwicklung sammeln.

Ein großer, 1 Mrd. $ teurer Schritt in Richtung Grundlagenforschung - Terrain, auf das sich bisher meist nur Biotech (Brüssel: BIOT.BR - Nachrichten) -Unternehmen wagten.

"Die pure Ausrichtung auf angewandte Forschung, die man sich in den 80er und 90er Jahren leisten konnte, weil es genügend Therapieansätze gab, kann man sich heute nicht mehr leisten", sagt Jörg Reinhardt, einst Entwicklungschef von Novartis, heute Chef der von Novartis übernommenen Impfstofffirma Chiron. Während in den 90er Jahren jährlich Dutzende neuartige Medikamente auf den Markt kamen, waren es 2002 nur noch 17.

Immer häufiger genügen Neuentwicklungen den strengen Zulassungsstandards nicht. Ein "Produktivitätsloch", sagt Reinhardt. Gleichzeitig stiegen aber die Kosten von Entwicklung und Vermarktung auf bis zu 1,7 Mrd. $ pro Medikament. Und es sanken die Einnahmen: Die Verkaufsschlager der 90er verlieren den Patentschutz, bis zu 80 Prozent des Umsatzes gehen an Nachahmerpräparate verloren.Von Mäusen, Fischen und Fliegen"Die Pharmaforschung kann so nicht weitermachen", sagt Marc Fishman. Der Mediziner, der dem Zebrafisch zum Durchbruch verhalf, leitet die weltweite Forschung von Novartis in seinem Büro im NIBR. "Es gibt so viele Patienten, die wir noch immer nicht behandeln können. Die Medikamenten-Entwicklung ist einfach zu langsam."

Fishmans Vision für eine neue Pharmaforschung beruht auf Mäusen, Fischen, Fliegen und Hefezellen. Denn diese Arbeitstiere der biomedizinischen Forschung sind die Werkzeuge, das das Zusammenspiel der Gene in normalen und kranken Zellen verstehen und eventuell beeinflussen hilft.

So wissen Forscher inzwischen, dass grundlegende entwicklungsbiologische Mechanismen sich bei verschiedenen Organismen kaum unterscheiden. Die Evolution hat nicht nur einzelne Gene, sondern auch die Interaktionen zwischen ihnen, die so genannten Signalketten, jahrmillionenlang beibehalten.

Ein klassisches Beispiel ist die fast identische Signalkette, die sowohl beim Säugetier als auch bei der Fruchtfliege Drosophila die Augenentwicklung anstößt. Die Gene sind derart identisch, dass mit dem Gen der Maus der Ausfall des Fliegen-Pendants ersetzt werden kann. Und das Herz des Menschen wird von den gleichen Genen gebaut, die auch beim Zebrafisch aktiv sind.In der Zebrafisch-Arbeitsgruppe von Fabrizio Serluca am NIBR untersuchen die Forscher beispielsweise, welche Gene die Darmbewegungen der Fische kontrollieren. Diverse menschliche Erkrankungen hängen damit zusammen.

"Bei Mäusen lässt sich das schlecht untersuchen, aber der Zebrafisch ist durchsichtig, man kann direkt in den Darm sehen." Bestimmte Mutationen an Genen des Signalwegs lassen den Transport stocken. Diese neuralgischen Punkte will Novartis nutzen, um in die Regulation einzugreifen.

Dennoch sind die Zebrafische ungewöhnlich für Pharmafirmen, die so anwendungsferne Forschung in meist über Kooperationen mit Biotech-Unternehmen oder Universitäten regeln. Das ließ die Biotechbranche zunächst nervös werden, aus Angst, Kooperationen mit Novartis könnten wegbrechen.Den Signalweg erkennenAus den Novartis-Aktivitäten lasse sich kein allgemeiner Trend ableiten, meint Ralf Kindervater, Geschäftsführer des baden-württembergischen Biopro-Netzwerks: "Eine Trendwende zum kooperationsaversen Verhalten der Pharma-Unternehmen sehen wir nicht." Allerdings sind Firmen wie Novartis und auch GlaxoSmithKline (London: GSK.L - Nachrichten) mit ihren Forschungseinheiten auf die Grundlagenforscher zugegangen.

Die Biotech-Unternehmen müssen nun der Pharmabranche entgegenkommen. "Für Unternehmen, die mit ihren Entwicklungen den ,Proof of Concept‘ geliefert haben, stehen die Chancen gut", sagt Kindervater. "Wirkstoffe, für die eine Phase-IIb-Studie erfolgreich abgeschlossen wurde, sind interessant für Pharma."

Dass das Konzept "Mehr Forschung wagen" aufgehen kann, zeigt Novartis' Krebsmedikament Gleevec. Zwar taugt es nicht zum Kassenschlager, da es nur für etwa 30.000 Patienten im Jahr in Frage kommt. Doch Fishman zuckt nur mit den Schultern: "Wir werden Blockbuster-Signalketten haben, wodurch wir verschiedene Krankheiten ähnlich behandeln können."

Und auch Entwicklungschef Jörg Reinhardt ist sich sicher: "Das ist nur die erste Designermedizin, die wir durch unsere neue Forschungsstrategie, das Ziel und den Signalweg zu kennen, zu entdecken hoffen." Schon heute hat Novartis die Zahl neuer Wirkstoffe in der Pipeline mit 80 im Vergleich zu 1997 verdreifacht.

 
de.biz.yahoo.com/05062006/85/...isse-leukaemie-medikament.html

finanzen.net
Schering legt positive Forschungsergebnisse für Leukämie-Medikament vor
Montag 5. Juni 2006, 09:59 Uhr


Westerburg, 5. Juni 2006 (aktiencheck.de AG) - Der Pharmahersteller Schering AG (ISIN DE0007172009/ WKN 717200) und die amerikanische Genzyme Corp (NASDAQ: GENZ - Nachrichten) . (ISIN US3729171047/ WKN 871137) haben positive Forschungsergebnisse einer Phase III-Studie für das Medikament MabCampath vorgelegt.
Wie der Konzern am Samstag bekannt gab, hat die vorläufige Analyse des sekundären Studienendpunktes dieser Studie gezeigt, dass Patienten mit chronischer lymphatischer B-Zell-Leukämie (B-CLL), die den monoklonalen Antikörper MabCampath Anzeige
 
erhielten, signifikant höhere Ansprechraten (Gesamtansprechraten - ORR - und Raten der vollständigen Rückbildung der Krankheitssymptome - CRR) aufwiesen als Patienten, die mit Chlorambucil behandelt wurden. Im Rahmen der klinische Phase-III-Studie wurde MabCampath (Alemtuzumab) mit Chlorambucil verglichen.

In der offenen, randomisierten Studie mit 297 Patienten wurden Wirksamkeit und Sicherheit von MabCampath und Chlorambucil verglichen. Chlorambucil wird im Hinblick auf die Sicherheit für nicht vorbehandelte Patienten als weitestgehend gut verträgliche Therapie betrachtet. Als primären Endpunkt untersuchte die Studie das progressionsfreie Überleben. Die sekundären Endpunkte der Studie beinhalten Sicherheit, Ansprechrate und Gesamtüberleben.

MabCampath erhielt 2001 die beschleunigte Zulassung für die Behandlung von B-CLL bei Patienten, die bereits mit alkylierenden Substanzen behandelt worden waren und bei denen eine Fludarabinphosphat-Therapie nicht angeschlagen hatte. Schering besitzt die exklusiven weltweiten Marketing- und Vertriebsrechte für das Produkt, das in den USA von Berlex Oncology, einem Unternehmen der US-Tochter von Schering, Berlex Laboratories, unter der Bezeichnung Campath vertrieben wird. Schering und Genzyme arbeiten gemeinsam an der Entwicklung von MabCampath für onkologische und andere Indikationen.

Die Aktie von Schering notiert aktuell mit einem Minus von 0,01 Prozent bei 85,39 Euro.
 

de.biz.yahoo.com/06062006/341/...ng-ms-medikament-tysabri.html

Dow Jones
FDA genehmigt Wiederzulassung von MS-Medikament Tysabri
Dienstag 6. Juni 2006, 07:09 Uhr

Aktienkurse  
Biogen Idec Inc
BIIB
45.39
+0.00%





(korrigierte Fassung)

WASHINGTON (Dow Jones)--Die US-Gesundheitsbehörde FDA hat die Wiederzulassung des Multiple-Sklerose-Medikaments "Tysabri" genehmigt. Tysabri wurde gemeinsam von der Biogen Idec Inc und Elan Corp entwickelt und vermarktet. Die Unternehmen mussten das Medikament im Februar 2005 vom Markt nehmen, nachdem zwei Patienten im Zusammenhang mit der Einnahme des Medikaments an der seltenen Krankheit PML gestorben waren.

Bereits Anfang März hatte ein Beratergremium der FDA eine Wiederzulassung von Tsyabri einstimmig empfohlen. Die US-Gesundheitsbehörde kündigte jedoch Mitte März an, ihre Untersuchung des Medikaments Anzeige
 
um bis zu 90 Tage verlängern. Nach Unternehmensangaben soll das Medikament nun im Juli wieder erhältlich sein. Laut Analystenaussagen vom März hängt die Zukunft des schuldenbeladenen irischen Pharmakonzerns Elan von der Entscheidung der FDA ab.

Die Verwendung wurde jedoch beschränkt. Nach Angaben der FDA soll Tysabri künftig nur bei Multiple-Sklerose-Patienten angewendet werden, bei denen andere Therapien fehlgeschlagen sind. Zudem sollte Tysabri nicht in Kombination mit anderen Medikamenten genommen werden, die das Immunsystem beeinflussen.

-Von Jennifer Corbett Dooren, Dow Jones Newswires, +49 (0)69 - 29725 111, unternehmen.de@dowjones.com DJG/DJN/abe/nas/jhe

de.biz.yahoo.com/06062006/217/...lt-weiterhin-versprechen.html

PR Newswire
Merck KGaA: Erbitux(R) (cetuximab) hält weiterhin sein Versprechen
Dienstag 6. Juni 2006, 08:43 Uhr



ATLANTA, Georgia, June 6 /PRNewswire/ --


- Kurzreferate: 3085, 3509, 3535, 3549, 3555, 3556, 5537, 7109



- Veranstaltungsort: 42. Jahrestagung der American Society of Clinical
Oncology (ASCO) 2006, Atlanta, Georgia



- Merck KGaA veröffentlicht eine Vielzahl neuer Daten über Erbitux(R)
(cetuximab) anlässlich der ASCO Jahrestagung



Die anlässlich der 42. Jahrestagung der American Society of Clinical
Oncology (ASCO) vorgestellten Daten aus klinischen Versuchen mit 1.147
Patienten, die zuvor nicht mehr auf die auf der Basis von Irinotecan
ANZEIGE
 
durchgeführte Behandlung ihres metastasierenden kolorektalen Karzinoms (mCRC)
angesprochen hatten, lieferten den Beweis einer mittleren Überlebensdauer von
9,2 Monaten durch eine gezielte Krebstherapie mit Erbitux(R) (cetuximab) und
Irinotecan.(1) Diese Ergebnisse der Versuche mit mehr als 1.000 Patienten
bestätigen die Wirksamkeit und Sicherheit von Erbitux plus Irinotecan an
vorbehandelten Patienten und liefern den weiteren Beweis, dass Erbitux sein
Versprechen hält.



"Die hier vorgetragenen Ergebnisse ermutigen uns sehr," sagte Professor
Hansjochen Wilke von den Kliniken Essen Mitte, Essen, Deutschland, der
Versuchsleiter der Studie. "Die Behandlung von Patienten, die auf
Standard-Chemotherapien nicht mehr ansprechen, ist für Ärzte eine
Herausforderung. Die Therapie mit Erbitux plus Irinotecan erweist sich als
hochwirksame Behandlung für diese Patienten und ist zum Behandlungsstandard
von Patienten geworden, deren Behandlung mit einer zuvor durchgeführten auf
Irinotecan basierenden Therapie gescheitert war."



Die Studie unter dem Namen MABEL[a] wurde in 197 Zentren in acht
europäischen Ländern durchgeführt und wertete progressionsfreie
Überlebensraten von Patienten mit mCRC aus, deren Erkrankung auf die zuvor
durchgeführte Therapie mit Irinotecan nicht ansprach. Die Patienten wurden
mit Erbitux in Verbindung mit Irinotecan behandelt. Die progressionsfreie
Überlebensrate betrug 61% bei 12 Wochen und 34% bei 24 Wochen und bestätigte
damit deutlich die bereits in zuvor durchgeführten Studien beobachtete
Wirksamkeit dieser Behandlungsmöglichkeit.(1)



Ferner wurden vorläufige Befunde aus einem klinischen Versuch mit Erbitux
plus Chemotherapie bei zuvor unbehandelten Patienten mit mCRC von Prof. Dr.
med. Alan Venook von der University of California, San Francisco im Namen der
CALGB[b] (Chronic & Acute Leukemia Group) gemeldet. Patienten mit
unbehandeltem mCRC wurden in die Studie aufgenommen und zur Behandlung
entweder durch Chemotherapie (ausgewählt zwischen Irinotecan/5FU/LV [FOLFIRI]
oder Oxaliplatin/ 5FU/LV [FOLFOX]) oder Chemotherapie plus Erbitux
randomisiert. Die Studie, CALGB 80203, wurde im Jahr 2004 initiiert und
sollte ursprünglich ca. 2.200 Patienten aufnehmen. Die Registrierung wurde
nach der Aufnahme von 238 Patienten aufgrund eines sich entwickelnden
Standards bei der Erstbehandlung von mCRC beendet. Der primäre Endpunkt der
Studie war das allgemeine Überleben; die sekundären Endpunkte enthielten
Reaktionsrate, progressionsfreies Überleben und Toxizität. Da die Studie
vorzeitig beendet wurde, kann sie nicht zur statistischen Auswertung des
progressionsfreien und allgemeinen Überlebens verwendet werden und
Folgerungen können daraus unmöglich gezogen werden. Jedoch war die
Reaktionsrate bei Patienten, die durch die Verbindung von Erbitux und
Chemotherapie behandelt wurden, signifikant höher als die bei Patienten,
die nur eine Chemotherapie erhielten (52% respektive 38%, p=0.029).(2)



Untersuchung eines alternativen Dosierungsplans für Erbitux



Weitere auf der ASCO Jahrestagung vorgestellte Daten zeigen, dass die
Verabreichung von Erbitux jede zweite Woche (anstelle der dem gegenwärtigen
Standard entsprechenden wöchentlichen Dosierung) ein alternativer
Dosierungsplan für Patienten sein könnte.(3) Es könnte nachgewiesen werden,
dass die Verabreichung von Erbitux in Dosen von 500 mg/msquared jede zweite
Woche ähnliche pharmakokinetische Ergebnisse liefert, verglichen mit der
aktuellen wöchentlichen Standarddosierung von 250 mg/msquared. Dieses
Ergebnis ist von grosser Wichtigkeit, da es Patienten und Onkologen einen
flexibleren Dosierungsvorteil bietet.



Erbitux Phase-III-Studien werden wie geplant fortgesetzt



Auf der Tagung wurden auch frühe Ergebnisse mehrerer internationaler
klinischer Phase-III-Versuche mit mehr als 4.000 Patienten präsentiert,
die deutlich machten, dass die unabhängigen Data Safety Monitoring Boards
(DSMB) die Fortsetzung der Versuche mit Erbitux empfehlen.(4-7) Diese
klinischen Phase-III-Versuche werden mit schwierigen Krebsarten
durchgeführt, zu denen mCRC, Plattenepithelkarzinom des Kopfes und Halses
(SCCHN) und nicht kleinzelliges Bronchialkarzinom (NSCLC) zählen.(4-7)



Zwei umfangreiche Phase-III-Studien werden zu mCRC durchgeführt:
EPIC[c],(4) (Untersuchung der Anwendung von Erbitux in Verbindung mit
Irinotecan nach Versagen einer auf Oxaliplatin basierenden Chemotherapie an
1.301 Patienten) und CRYSTAL[d],(5) (Untersuchung von Erbitux mit Irinotecan
an 1.221 Patienten als Erstbehandlung). Diese Ergebnisse erlauben die
Fortsetzung der Phase-III-Studien zur weiteren Forschung, aufbauend auf den
bereits aussergewöhnlichen Phase-II-Studien, die beständig hohe
Reaktionsraten von bis zu 81% bei der Erstbehandlung von mCRC zeigten.
Hierdurch konnten die bereits auf die Leber übergegriffenen, zuvor
inoperablen Metastasen bei nahezu einem von vier Patienten chirurgisch
entfernt werden.(8,9,10) Bislang ist bei mCRC der einzige Ansatz mit einer
Hoffnung auf Heilung die Resektion von vorwiegend in der Leber gefundenen
Metastasen.(11,12)



Die Phase-III-Studie mit dem Namen EXTREME [e](6) untersucht die
Erstbehandlung mit Erbitux in Verbindung mit einer Chemotherapie (Cisplatin
plus 5-FU oder Carboplatin plus 5-FU) an 442 Patienten mit rekurrenten
und/oder metastatischen SCCHN.



Die Phase-III-Studie FLEX[f] (7) untersucht die Überlebenschancen einer
Erstbehandlung mit Erbitux plus Chemotherapie (Cisplatin und Vinorelbin) im
Vergleich zu einer ausschliesslich durchgeführten Chemotherapie an 1.125
Patienten mit fortgeschrittenem NSCLC.



"Die anlässlich der diesjährigen ASCO Jahrestagung vorgestellten Daten
über Erbitux bekräftigen die überragende Wirksamkeit bei der Erstbehandlung
und späteren Therapien bei Patienten mit metastatischem kolorektalem Krebs
nach zuvor fehlgeschlagener Chemotherapie," sagte Dr. Wolfgang Wein, Senior
Vice President und Leiter der Global Oncology Commercialization' bei der
Merck KGaA. "Die neuen Daten, die beweisen, dass Erbitux jede zweite Woche
verabreicht werden kann, sind für uns auch sehr ermutigend."



Hinweise für Redakteure



Informationen zu ERBITUX



ERBITUX(R) ist ein erstklassiger und sehr aktiver, auf den epidermalen
Wachstumsfaktor-Rezeptor (EGFR) gerichteter IgG1 monoklonaler Antikörper. Als
monoklonaler Antikörper unterscheidet sich die Wirkungsweise von Erbitux
von standardmässigen, nicht selektiven Chemotherapien dadurch, dass er
spezifisch auf den EGFR gerichtet ist und an den EGFR bindet. Diese Bindung
hemmt die Aktivierung des Rezeptors und des nachfolgenden
Signalübertragungspfads und führt somit zu einer Reduktion der Invasion des
gesunden Gewebes durch Tumorzellen und die Distribution von Tumoren an neuen
Stellen. Man geht auch davon aus, dass das Mittel die Fähigkeit von
Tumorzellen hemmt, den durch Chemotherapie und Radiotherapie verursachten
Schaden zu reparieren und die Bildung von neuen Blutgefässen innerhalb von
Tumoren zu hemmen, was zu einer allgemeinen Unterdrückung des Tumorwachstums
zu führen scheint. Die am häufigsten gemeldete Nebenwirkung von Erbitux ist
ein akneähnlicher Hautauschlag, der mit dem guten Ansprechen auf die Therapie
zusammenzuhängen scheint. Bei etwa fünf Prozent der Patienten kann während
der Behandlung mit Erbitux eine Überempfindlichkeit festgestellt werden; rund
die Hälfte davon ist schwerwiegend.



Erbitux ist in 53 Ländern bereits zur Behandlung von Patienten mit
EGFR-positivem metastasierendem kolorektalem Karzinom, das auf
Irinotecan-Therapien nicht mehr anspricht, zur Anwendung in Kombination mit
Irinotecan zugelassen: der Schweiz, den USA, Mexiko, Argentinien, Chile,
Island, Norwegen, der Europäischen Union, Peru, Australien, Kroatien, Israel,
Bulgarien, Panama, Guatemala, Kolumbien, Singapur, Hongkong, Südkorea,
Kanada, Ecuador, Malaysia, den Philippinen, Taiwan, China, Indien, Libanon,
Venezuela und Nicaragua. In den USA, Argentinien, Chile, Mexiko, Peru,
Singapur, Australien, Panama, Kolumbien, Guatemala, Hongkong, Kanada,
Ecuador, den Philippinen, Libanon, Venezuela und Nicaragua ist Erbitux auch
als Monowirkstoff zugelassen.



Ferner ist Erbitux in Kombination mit einer Radiotherapie zur Behandlung
lokal fortgeschrittener Plattenepithelkarzinome des Kopfes und Halses (SCCHN)
in der Schweiz, Argentinien, Kolumbien, den USA, der Europäischen Union,
Norwegen, Island und den Philippinen zugelassen. In Argentinien, den USA und
den Philippinen ist Erbitux auch als Monotherapie bei Patienten mit
rekurrenten und/oder metastatischen SCCHN zugelassen, die auf frühere
Chemotherapien nicht mehr angesprochen haben.



Informationen zur Merck KGaA



Die Merck KGaA, Darmstadt, hat die Lizenz zur Vermarktung von Erbitux
ausserhalb der USA und Kanada im Jahre 1998 von ImClone Systems Incorporated
of New York erworben. In Japan teilt sich die Merck KGaA das exklusive
Marketing-Recht mit ImClone Systems.



Die Merck KGaA ist dem stetigen Fortschritt der Behandlungsmethoden in
der Onkologie verpflichtet. Derzeit untersucht das Unternehmen neuartige
Therapien in zielgerichteten Bereichen, wie z. B. dem Einsatz von Erbitux
beim kolorektalen Karzinom, Plattenepithelkarzinom im Kopf- und Nackenbereich
und nicht kleinzelligen Bronchialkarzinom. Die Merck KGaA hat auch die Rechte
zur Behandlung von Krebs mit UFT(R) (Tegafur-Uracil) erworben - einer oralen
Chemotherapie, die mit Folinsäure (FA) zur Erstbehandlung von metastatischem
kolorektalem Krebs verabreicht wird.



Die Merck KGaA untersucht zurzeit unter anderen Krebstherapien auch den
Einsatz von Stimuvax(R) (zuvor als BLP25 Liposom-Impfstoff bezeichnet) bei
der Behandlung von nicht kleinzelligem Bronchialkarzinom. Der Impfstoff
befindet sich seit September 2004 im beschleunigten Zulassungsverfahren der
FDA. Merck erwarb die exklusiven weltweiten Lizenzen von Biomira Inc. in
Edmonton, Alberta, Kanada mit Ausnahme von Kanada, wo die Unternehmen sich
die Rechte teilen.



Quellenangaben:



1. Wilke H et al. Poster-Präsentation auf der ASCO Jahrestagung, Atlanta,
Georgia, 2006; ID-Nummer 3549



2. Venook A et al. Präsentation auf der ASCO Jahrestagung, Atlanta,
Georgia, 2006; ID-Nummer 3509



3. Tabernero J et al. Poster-Präsentation auf der ASCO Jahrestagung,
Atlanta, Georgia, 2006; ID-Nummer 3085



4. Abubakr Y et al. Poster-Präsentation auf der ASCO Jahrestagung,
Atlanta, Georgia, 2006: ID-Nummer 3556



5. Láng I et al. Poster-Präsentation auf der ASCO Jahrestagung, Atlanta,
Georgia, 2006: ID-Nummer 3555



6. Vermorken J et al. Poster-Präsentation auf der ASCO Jahrestagung,
Atlanta, Georgia, 2006; ID-Nummer 5537



7. Von Pawel J et al. Poster-Präsentation auf der ASCO Jahrestagung,
Atlanta, Georgia, 2006; ID-Nummer 7109



8. Diaz Rubio E et al. Vortrag auf der ASCO Jahrestagung, Orlando,
Florida, 2005: Abstr. 3535



9. Folprecht G et al. Cetuximab and irinotecan/5-fluorouracil/folinic
acid is a safe combination for the first-line treatment of patients with
epidermal growth factor receptor expressing metastatic colorectal carcinoma.
Ann Oncol 2006; 17: 450-456



10. Peeters M et al. Eur J Cancer 2005; Supplement 3: Abstract 664



11. Macdonald JS. Adjuvant Therapy of Colon Cancer. CA Cancer
J Clin 1999; 49 (4), 202-219.



12. Mineo TC et al. Long term results after resection of
simultaneous and sequential lung and liver metastases from colorectal
carcinoma. J Am Coll Surg 2003; 197: 386-391.



Sämtliche Pressemitteilungen der Merck KGaA werden zeitgleich mit der
Publikation im Internet per eMail versandt. Nutzen Sie bitte die Webadresse
www.subscribe.merck.de, um sich online zu registrieren, die getroffene
Auswahl zu ändern oder den Service wieder zu kündigen.



Merck ist ein weltweit tätiges Pharma- und Chemieunternehmen mit einem
Umsatz von EUR 5,9 Mrd. im Jahre 2005. Die Firmengeschichte begann im Jahr
1668 und die Zukunft wird von 29.133 Mitarbeitern in 54 Ländern gestaltet.
Der Erfolg von Merck wird durch Innovationen unternehmerisch denkender
Mitarbeiter geprägt. Merck bündelt die operativen Tätigkeiten unter dem Dach
der Merck KGaA, an der die Familie Merck zu 73% beteiligt ist und freie
Aktionäre den restlichen Anteil von 27% halten. Die einstige
US-Tochtergesellschaft Merck & Co. ist seit 1917 ein von der Merck-Gruppe
vollständig unabhängiges Unternehmen.



[a] Monoclonal Antibody Erbitux in a European Pre-License Study



[b] The Cancer and Leukemia Group B



[c] European Prospective Investigation of Cancer



[d] Cetuximab combined with iRinotecan in first-line therapY for
metaSTatic colorectAL cancer



[e] ErbituX in first-line Treatment of REcurrent or MEtastatic head &
neck cancer



[f] First-line in Lung cancer with ErbituX




Merck

 



GPC Biotech : ASCO-Konferenz

GPC Biotech hat auf der ASCO-Konferenz in Atlanta neue Informationen zum Krebsmedikament Satraplatin bekannt gegeben. So ist Satraplatin bei leichter und mittlerer Beeinträchtigung der Leberfunktion gut verträglich. Die häufigsten Nebenwirkungen betreffen das Blutbild. Auch bei Patienten mit fortgeschrittenen Tumoren und eingeschränkter Nierenfunktion soll das Medikament gut verträglich sein.

AktienEinblick.de

06.06.2006 12:52

Anmerkung zu Posting 58: Satraplatin von GPC ist ein Platinderivat, derzeit in Phase III Studien,
(kleines Molekül ->Chemotherapie) also  kein Antikörper.      GPC hat auch einen Antikörper von Morphosys in der Pipe, allerdings erst in Phase 1 (siehe oben).

 

biz.yahoo.com/prnews/060627/sftu075.html?.v=58


Press Release Source: Genentech, Inc.


Phase III Study of Avastin(R) in Advanced Pancreatic Cancer Does Not Meet Primary Endpoint
Tuesday June 27, 1:30 am ET  
Genentech Remains Committed to Broad Avastin Development Program in Multiple Tumor Types and Stages of Disease


SOUTH SAN FRANCISCO, Calif., June 27 /PRNewswire-FirstCall/ -- Genentech, Inc. (NYSE: DNA - News) today announced that a Phase III trial of Avastin® (bevacizumab) in combination with gemcitabine chemotherapy as first-line treatment for advanced pancreatic cancer did not meet its primary endpoint of overall survival. The trial was stopped at the recommendation of an independent data monitoring board based on an interim analysis indicating that it is very unlikely that significant differences in overall survival will be shown between treatment arms as the data mature. The study was not stopped due to safety events and no new safety concerns related to Avastin were observed in this trial. Data from the study will be presented at an upcoming medical meeting.
ADVERTISEMENT


"We are disappointed in these results and will be evaluating the data to understand potential reasons why Avastin did not add a clinical benefit in this trial," said Hal Barron, M.D., senior vice president, Development and chief medical officer for Genentech. "Chemotherapy has had a limited impact in advancing outcomes for patients with pancreatic cancer, and treatments that may improve survival are desperately needed. We will continue to explore novel biologic and targeted therapy approaches that may lead to improved clinical outcomes for patients with pancreatic cancer."

This randomized, controlled study of 602 patients was sponsored by the National Cancer Institute (NCI) and conducted by a network of researchers led by the Cancer and Leukemia Group B (CALGB). The trial was initiated based on results from a single-arm Phase II study combining Avastin with gemcitabine in pancreatic cancer. The Phase II study results were first presented in 2003 at the annual meeting of the American Society of Clinical Oncology.

Genentech is pursuing a broad development program for Avastin that currently includes 130 clinical trials across 25 different types of cancer. As part of this program, a randomized Phase III study evaluating the addition of Avastin to a standard regimen of gemcitabine and Tarceva® (erlotinib) in patients with pancreatic cancer is currently being conducted by Roche.

Avastin, in combination with intravenous 5-FU-based chemotherapy, was approved by the U.S. Food and Drug Administration (FDA) in February 2004 for first-line treatment of patients with metastatic colorectal cancer, and received approval in June 2006 for second-line treatment of colorectal cancer. The company recently submitted supplemental Biologics License Applications (sBLA) to the FDA for Avastin in advanced non-small cell lung cancer, other than predominant squamous histology (April 2006), and for locally recurrent or metastatic breast cancer (May 2006).

About the CALGB 80303 Trial

This randomized, placebo-controlled, multi-center trial, known as CALGB 80303, was sponsored by the NCI, part of the National Institutes of Health (NIH), under a Cooperative Research and Development Agreement between the NCI and Genentech, and conducted by a network of researchers led by the CALGB. In this study, 602 patients were enrolled at approximately 200 sites and were randomized to receive treatment with gemcitabine plus Avastin or gemcitabine plus placebo as a first-line therapy. Patients who had received prior chemotherapy for metastatic disease, adjuvant chemotherapy within the previous four weeks or any prior treatment with gemcitabine or Avastin in the adjuvant or metastatic setting were excluded. Patients with a prior history of bleeding events and those who had a surgical procedure, open biopsy, or significant traumatic injury 28 days prior were also excluded from the study. The statistical plan included pre-specified futility analyses that were conducted and reviewed by an independent data monitoring board.

About Avastin

Avastin is a therapeutic antibody designed to inhibit Vascular Endothelial Growth Factor (VEGF), a protein that plays an important role in tumor angiogenesis and maintenance of existing tumor vessels. By inhibiting VEGF, Avastin is designed to interfere with the blood supply to a tumor, a process that is thought to be critical to a tumor's growth and metastasis. For full prescribing information and boxed warnings on Avastin and information about angiogenesis, visit www.gene.com. For more information on Avastin, visit www.avastin.com.

Avastin, in combination with intravenous 5-FU-based chemotherapy, is indicated for first- or second-line treatment of patients with metastatic carcinoma of the colon or rectum. The FDA first approved Avastin on February 26, 2004 as a first-line treatment for metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy. Approval was based on data from two trials. The pivotal trial was a large, placebo-controlled, randomized study that demonstrated a prolongation in the median survival of patients treated with Avastin plus the IFL (5-FU/leucovorin/CPT-11) chemotherapy regimen by approximately five months, compared to patients treated with the IFL chemotherapy regimen alone (20.3 months versus 15.6 months). The addition of Avastin to IFL improved overall survival by 52 percent (based on a hazard ratio of 0.66). In addition, this study demonstrated an improvement in progression-free survival of more than four months (10.6 months in the Avastin/IFL arm compared to 6.2 months in the IFL-alone arm).

Avastin Safety Profile

Avastin has a well-established safety profile. In Genentech-sponsored studies, the most serious adverse events associated with Avastin were gastrointestinal perforation, wound healing complications, hemorrhage, arterial thromboembolic events, hypertensive crisis, nephrotic syndrome and congestive heart failure. The most common adverse events in receiving Avastin were asthenia, pain, abdominal pain, headache, hypertension, diarrhea, nausea, vomiting, anorexia, stomatitis, constipation, upper respiratory infection, epistaxis, dyspnea, exfoliative dermatitis and proteinuria.

About the Avastin Development Program

Based on data showing that VEGF may play a broad role in a range of cancers, Genentech is pursuing a broad development program for Avastin that currently includes 130 clinical trials across 25 different types of cancer. Avastin is being evaluated in Phase III clinical trials for its potential use in adjuvant and metastatic colorectal, renal cell (kidney), breast, pancreatic, non-small cell lung, prostate and ovarian cancers. Avastin is also being evaluated in earlier stage trials as a potential therapy in a variety of solid tumor cancers and hematologic malignancies. In April 2006, Genentech submitted an sBLA for Avastin plus platinum-based chemotherapy for first-line treatment of advanced non-small cell lung cancer other than predominant squamous histology. In May 2006, Genentech submitted an sBLA for Avastin in combination with taxane chemotherapy for patients who have not previously received chemotherapy for their locally recurrent or metastatic breast cancer. For further information about Avastin clinical trials, please call 888-662-6728.

About VEGF and Tumor Angiogenesis

Genentech is a leader in research and product development in the area of angiogenesis, the process by which new blood vessels are formed. The link between angiogenesis and cancer growth has been discussed by many researchers for decades. It wasn't until 1989 that a key growth factor influencing the process, VEGF, was discovered by Napoleone Ferrara, M.D., a staff scientist at Genentech. Dr. Ferrara and his team at Genentech cloned VEGF, providing some of the first evidence that a specific angiogenic growth factor existed. This research was published in the journal Science in 1989. Dr. Ferrara then created a mouse antibody to this protein.

In 1993, in a study published in Nature, Dr. Ferrara and his team demonstrated that the antibody directed against VEGF could suppress angiogenesis and tumor growth in preclinical models, providing compelling evidence that VEGF can play a critical role in tumor growth. Clinical studies with a humanized version of the antibody, Avastin, began in 1997.

About Pancreatic Cancer

The American Cancer Society estimates 33,730 Americans will be diagnosed with pancreatic cancer and 32,300 will die of the disease in 2006. Pancreatic cancer, characterized by early, distant spread, is the fourth leading cause of cancer death in the United States. For patients with advanced pancreatic cancer, the five-year survival rate across all stages is less than 1 percent, with most patients dying within one year of diagnosis.

About Genentech BioOncology

Genentech is committed to changing the way cancer is treated by establishing a broad oncology portfolio of innovative, targeted therapies with the goal of improving patients' lives. The company is the leading provider of anti-tumor therapeutics in the United States. Genentech is conducting clinical development programs for Rituxan® (Rituximab), Herceptin® (Trastuzumab), Avastin® (bevacizumab), and Tarceva® (erlotinib), and markets all four products in the United States, either alone (Avastin and Herceptin) or with Biogen Idec Inc. (Rituxan) or OSI Pharmaceuticals, Inc. (Tarceva).

The company has a robust pipeline of potential oncology therapies with a focus on four key areas: angiogenesis, apoptosis (i.e., programmed cell death), the HER pathway, and B-cell biology. An investigational antibody directed at the HER pathway is currently in Phase II trials. In early development, are a small molecule directed at the hedgehog pathway and an investigational agent targeting apoptosis.

Founded 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. A considerable number of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes multiple biotechnology products and licenses several additional products to other companies. The company has headquarters in South San Francisco, Calif., and is listed on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit www.gene.com.

For the full prescribing information for Tarceva and the full prescribing information and Boxed Warnings for Rituxan, Herceptin, and Avastin, please visit www.gene.com.


   Media Contact:        Kristina Becker    650-467-6450
   Investor Contact:     Diane Schrick      650-225-1599
   Advocacy Contact:     Kristin Reed       650-467-9831

www.marketwatch.com/News/Story/...2Fyhoo&dist=yhoo&siteid=yhoo

Genentech's eye treatment gets FDA OK

E-mail | Print |  | Disable live quotes By Carolyn Pritchard, MarketWatch
Last Update: 4:23 PM ET Jun 30, 2006


SAN FRANCISCO (MarketWatch) -- Genentech Inc. on Friday said its treament for wet age-related macular degeneration, the leading cause of blindness in the elderly, was granted approval by the Food and Drug Administration.
Shares of Genentech (DNA : genentech inc com new
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Last: 81.80+1.67+2.08%

4:42pm 06/30/2006

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DNA81.80, +1.67, +2.1%) finished higher by 2.1%, at $81.80.
The South San Francisco, Calif. biotech company's application was granted priority review by the agency at the end of December, which gave the FDA six months to decide whether or not to approve Lucentis.
The application was based on data from Phase III studies that showed the treatment not only maintained the vision of the majority of wet AMD patients, but in some cases, improved it.
"We are thrilled that after nearly a decade of rigorous study, Lucentis is approved, and we look forward to getting it to patients quickly," company spokeswoman Dawn Kalmar said. Shipments will start today.
Genentech said on a conference call that it has priced Lucentis at $1,950 a vial and is estimating the average dosage will be five to seven times a year. That would bring the average annual cost of the treatment to $9,750 to $13,650 a year.
Lucentis will enter a marketplace that includes Visudyne, an intravenously injected, light-activated treatment made by a QLT Therapeutics (QLTI : qlt inc com
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4:31pm 06/30/2006

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QLTI7.08, -0.10, -1.4%) and Novartis AG (NVS : novartis a g sponsored adr
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NVS53.92, +0.51, +1.0%) .
But it is likely to compete more closely with Macugen, made by Pfizer Inc. (PFE : Pfizer Inc
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PFE23.47, +0.23, +1.0%) and Eyetech Pharmaceuticals Inc., which was acquired last year by OSI Pharmaceuticals Inc. (OSIP : osi pharmaceuticals inc com
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OSIP32.96, -0.52, -1.6%) . Both Macugen and Lucentis are delivered directly into the eye via injection and work by binding to a protein believed to play a critical role in the formation of new blood vessels.
Wet AMD is caused by the growth of abnormal blood vessels that leak and bleed and cause blindness-inducing scar tissue. Serious vision loss by the more common, dry form of AMD is rare.
Lucentis will be also be competing against one of Genentech's own drugs, Avastin, which is approved to treat colorectal cancer but which company executives have acknowledged is increasingly being used by ophthalmologists as an "off-label" treatment for wet AMD.
The company has no plans to seek approval for Avastin to be used to treat the eye condition. "Our interpretation of Avastin use [for AMD] is it tells you how big of an unmet need there is," Genentech's president of product development, Susan Desmond-Hellman, told MarketWatch in an interview back in January. See full story.
Lucentis was developed by Genentech and Novartis AG, which maintains commercial rights to it outside of North America.  

 biz.yahoo.com/prnews/060629/sfth012.html?.v=55

Press Release Source: Dendreon Corporation


Dendreon Announces Publication of Pivotal Phase 3 Study Highlighting Survival Benefit and Safety Profile of PROVENGE in Men With Advanced Prostate Cancer
Thursday June 29, 6:00 pm ET  
First Cancer Immunotherapy to Demonstrate a Survival Benefit in a Randomized Phase 3 Study
Company Plans to Submit BLA to U.S. Food and Drug Administration Later This Year


SEATTLE, June 29 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN - News) today announced the publication of the results of its pivotal Phase 3 study (D9901) of PROVENGE® (sipuleucel-T) in the July issue of the Journal of Clinical Oncology. The article highlights the significant survival benefit and favorable safety profile of PROVENGE, the Company's investigational active cellular immunotherapy, in men with advanced androgen-independent prostate cancer. The Company plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) later this year to obtain approval to market PROVENGE.
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"This trial is an important milestone in the development of new treatments for prostate cancer patients. The survival benefit that was observed has the potential to offer important benefits to patients, and represents the first time an immunotherapy has provided a survival advantage in prostate cancer," said Eric J. Small, M.D., professor of medicine and urology at the University of California, San Francisco and lead author of the publication. "In addition to the observed survival benefit, PROVENGE has a very favorable toxicity and safety profile, with the most common side effects being low grade fevers and chills. A favorable benefit-to-risk profile will be appealing to patients with advanced stage prostate cancer who currently have few appealing treatment options available to them."

The double-blind, placebo-controlled Phase 3 Study D9901 showed that the group of men with asymptomatic, metastatic, androgen-independent prostate cancer who received PROVENGE had a median survival time 4.5 months longer than the median survival seen in the group that had been assigned to receive placebo. For the men who received PROVENGE, there was a 41 percent overall reduction in the risk of death (p-value = 0.010; HR = 1.7). In addition, 34 percent of patients receiving PROVENGE were alive 36 months after treatment compared to 11 percent of patients randomized to receive placebo. These data will form the basis of the Company's BLA to the FDA for marketing approval, which the Company plans to submit later this year.

Patients in the PROVENGE arm had a 31 percent delay in their time to disease progression compared to patients in the placebo arm (p-value = 0.052; HR = 1.45). Furthermore, patients receiving PROVENGE had an approximately 8-fold increase in their T-cell immunity after treatment compared to the placebo group (p < 0.001).

"The survival benefit demonstrated in this trial, combined with the favorable safety profile of PROVENGE, will form the basis for our BLA submission to the FDA later this year," said Mark Frohlich, M.D., vice president of clinical affairs at Dendreon. "We look forward to making this active cellular immunotherapy available for the treatment of the many men with advanced prostate cancer."

The D9901 study was conducted at 19 institutions in the United States and enrolled 127 men with asymptomatic, metastatic androgen-independent (hormone-refractory) prostate cancer. Patients were randomized in a 2:1 ratio to receive three infusions of PROVENGE (n=82) or placebo (n=45) every two weeks for a total of three infusions over a one month period.

Treatment with PROVENGE was generally well tolerated. The majority of side effects were mild, including infusion-related fever and chills that were usually of low grade and typically lasted for one to two days following infusion.

About PROVENGE (sipuleucel-T)

PROVENGE (sipuleucel-T) is an investigational product that may represent the first in a new class of active cellular immunotherapies (ACIs) that are uniquely designed to stimulate a patient's own immune system. ACIs hold promise because they may provide patients with a meaningful survival benefit with low toxicities. PROVENGE targets the prostate cancer antigen, prostatic acid phosphatase (PAP), which is found in approximately 95 percent of prostate cancers. PROVENGE is in late-stage development for the treatment of patients with advanced prostate cancer. In clinical studies, patients typically received three infusions over a one-month period as a complete course of therapy.

About Prostate Cancer

Prostate cancer is the most common non-skin cancer in the United States and the third most common cancer worldwide. More than one million men in the United States have prostate cancer, with an estimated 232,000 new cases of prostate cancer diagnosed each year. More than 30,000 men die each year of the disease.

About Dendreon

Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics that harness the immune system to fight cancer. The Company uses its experience in antigen identification, antigen engineering and antigen-presenting cell processing to produce active immunotherapy product candidates to potentially stimulate a cell-mediated immune response. PROVENGE (sipuleucel-T) is Dendreon's lead active cellular immunotherapy in Phase 3 development for prostate cancer. The Company also discovered Trp-p8, a cold receptor and transmembrane ion channel in pre-clinical development, which is over-expressed in breast, prostate, lung and colon cancers. For more information about the Company and its programs, visit www.dendreon.com.

Except for historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties surrounding the efficacy of PROVENGE to treat men suffering from prostate cancer, risks and uncertainties surrounding the presentation of data to the FDA and approval of product applications by the FDA and risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Factors that may cause such differences include risks related to our limited operating history, risks associated with completing our clinical trials, the risk that the safety and/or efficacy results of a clinical trial for PROVENGE will not support an application for a biologics license, the risk that the FDA may interpret data differently than we do or require more data or a more rigorous analysis of data than expected, the risk that the FDA will not approve a product for which a biologics license has been applied, the risk that the results of a clinical trial for PROVENGE or other product may not be indicative of results obtained in a later clinical trial, risks that we may lack the financial resources and access to capital to fund required clinical trials or commercialization of PROVENGE, our dependence on the efforts of third parties, and our dependence on intellectual property. Further information on the factors and risks that could affect Dendreon's business, financial condition and results of operations are contained in Dendreon's public disclosure filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.




--------------------------------------------------
Source: Dendreon Corporation

Da beschleicht mich das ungute Gefühl, dass die FDA sich Zeit lässt, bis die AMIS auch soweit sind und die 3. Phase abgeschlossen haben. Gefällt mir überhaupt nicht. Ist das der Grund, warum GPC im Kurs nicht vorankommen und auch PHARMION in USA auf der Stelle treten? Wer weiss Näheres ?

One potential advantage of attaching multiple nanoparticles to a single antibody is that it may be possible to load a different anticancer drug into each nanoparticle. "The idea that we can potentially carry more than one Taxol™ per buckyball is exciting, but the real advantage of fullerene immunotherapy over other targeted therapeutic agents is likely to be the buckyball's potential to carry multiple drug payloads, such as Taxol™ plus other chemotherapeutic drugs," said Wilson. "Cancer cells can become drug resistant, and we hope to cut down on the possibility of their escaping treatment by attacking them with more than one kind of drug at a time."

While it's possible to attach drug molecules directly to antibodies, researchers have not been able to attach more than a handful of drug molecules to an antibody without significantly changing its targeting ability. That happens, in large part, because the chemical bonds that are used to attach the drugs -- strong, covalent bonds -- tend to block the targeting centers on the antibody's surface. If an antibody is modified with too many covalent bonds, the chemical changes will destroy its ability to recognize the cancer it was intended to attack.

The investigators originally had planned to overcome this limitation by attaching multiple molecules of the anticancer agent paclitaxel to each buckyball, which would then be connected chemically to the antibodies. To the team members' surprise, many more buckyballs than expected attached themselves to the antibody. Moreover, the buckyballs stuck tightly to the antibodies without the need to form chemical bonds, so the increased payload did not significantly change the targeting ability of the antibody.

This work is detailed in a paper titled, "Fullerene (C60) immunoconjugates: interaction of water-soluble C60 derivatives with the murine anti-gp240 melanoma antibody." This paper was published online in advance of print publication. An abstract of this paper is available at the journal's website. View abstract.

http://nano.cancer.gov

http://www.azonano.com/news.asp?newsID=2546

Da wir grade beim thema 'der Antikörper als Transportvehikel für Tumorzellenkillersubstanzen' sind (voriges Posting) passt vielleicht auch folgendes dazu:

www.stock-world.de/news/article.m?news_id=2111562

Biotest schließt Lizenzvereinbarung für Krebsantikörper
11.07.06 14:55

Die Biotest AG hat sich über eine Kooperations- und Lizenzvereinbarung mit der ImmunoGen, Inc., Cambridge, MA (USA), die weltweiten Vermarktungsrechte für die in Entwicklung befindliche Krebstherapie (DM-Toxine) in Verbindung mit dem eigenen monoklonalen Antikörper BT-062 gesichert. Dies gab das Pharma-, Biotherapeutika- und Diagnostikunternehmen am Dienstag bekannt.Im Rahmen der Vereinbarung erhalte Biotest für ein bestimmtes Antigen die exklusiven Nutzungsrechte an der Tumor-Activated-Prodrug (TAP) Technologie von ImmunoGen. Bei dieser Technologie würden Tumorzellen mit Hilfe eines Immunkonjugats bekämpft, das sich aus dem Antikörper von Biotest sowie einem Toxin von ImmunoGen zusammensetzt. Der hochspezifische Antikörper bindet selektiv an Tumorzellen, die dann vom Zellgift zerstört werden. Diese neuartige Therapie soll in der Indikation Multiples Myelom sowie in weiteren Krebserkrankungen entwickelt werden.Im Rahmen der Vereinbarung werde Biotest an ImmunoGen eine Upfront-Zahlung in Höhe von 1 Million US-Dollar leisten (knapp 800.000 Euro). Weitere Zahlungen seien vom Erreichen definierter Meilensteine während der Entwicklung und Zulassung abhängig. Die Meilenstein-Zahlungen können eine Gesamtsumme von maximal 35,5 Millionen US-Dollar (rund 28 Millionen Euro) erreichen, teilte Biotest mit. Darüber hinaus sei ImmunoGen prozentual an den Produktumsätzen beteiligt.Für den US-amerikanischen Markt habe ImmunoGen die Option, sich gegen Zahlung einer Gebühr an Biotest unmittelbar hälftig an der Entwicklung und Vermarktung des Immunkonjugats zu beteiligen. Die Höhe dieser Gebühr betrage abhängig vom Entwicklungsstadium 5 Millionen bzw. 15 Millionen US-Dollar. Im Falle der Ausübung der Option verliert ImmunoGen den Anspruch auf Lizenzzahlungen für den US-amerikanischen Markt und alle weiteren von Biotest noch nicht entrichteten Meilensteinzahlungen. Biotest strebt auch in weiteren Ländern Entwicklungs- und Vertriebspartnerschaften an, um den Forschungs- und Entwicklungsaufwand zu begrenzen und zugleich die zügige weltweite Vermarktung des Biotherapeutikums auf Basis von BT-062 sicherzustellen.

 
   biz.yahoo.com/ap/060724/britain_drug_trials.html?.v=1

AP
Britain Seeks Tighter Drug Trial Rules
Monday July 24, 9:12 am ET

          §
British Drug Industry Proposes Stricter Clinical Trial Guidelines
LONDON (AP) -- Britain's pharmaceutical industry on Monday proposed strict new guidelines for testing some experimental drugs after a disastrous trial that left six men in comas.
In March, six healthy volunteers participated in a trial for test drug TGN1412, designed to treat leukemia, autoimmune and inflammatory diseases. Within hours of being given doses of the drug they suffered convulsions, organ failure and ultimately lapsed into comas.

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A report by the Association of the British Pharmaceutical Industry and the BioIndustry Association, the industry's two largest trade associations, proposed that drugs which stimulate the immune system should be subject to strict new safety standards when they are tested on humans for the first time.
The groups recommended that trials of drugs such as TGN1412 should be staggered, with only one person receiving the drug on the first day.
Their report also said trials should only be carried out at hospitals with intensive care facilities which are able to deal with unforeseen problems.
Martyn Day, a lawyer who represents four of the TGN1412 trial volunteers, said the report "starts the process of learning from this dreadful tragedy which has caused the six young victims to have such a terrible cloud hanging over their lives."
German drug maker TeGenero AG, which produced TGN1412, filed for bankruptcy protection earlier this month.

biz.yahoo.com/ap/060828/biogen_clinical_trial.html?.v=2
AP
Biogen, Genentech See Solid Rituxan Data
Monday August 28, 11:16 am ET  
Biogen Idec, Genentech Say Rituxan Passes Mid-Stage Trial in Multiple Sclerosis Study


NEW YORK (AP) -- Drug makers Biogen Idec Inc. and Genentech Inc. said Monday a mid-stage study of Rituxan showed it was effective in treating multiple sclerosis.
The Food and Drug Administration originally approved the drug in 1997 for the treatment of cancer. It was developed by Cambridge, Mass-based Biogen and is co-marketed with South San Francisco, Calif-based Genentech in the United States.

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The companies said the treatment reached its primary endpoint in reducing the number of gadolinium enhancing T1 lesions, or indicators of relapsing forms of MS, in a 104-patient study. The clinical trial compared Rituxan to a placebo and took place over 24 weeks.

Patients involved in the study will be followed for an additional 48 weeks as the companies monitor the long-term safety affects of the treatment.

MS, an autoimmune disease, is the leading cause of neurological disorders in young adults, the companies said, with the relapsing form of the disease accounting for 65 percent of all MS cases.

Shares of Genentech added 11 cents to $80.11 in morning trading on the New York Stock Exchange, while shares of Biogen rose 40 cents to $44.68 on the Nasdaq.


---------------------

biz.yahoo.com/prnews/060828/sfm054.html?.v=62

Press Release Source: Genentech, Inc.


Genentech and Biogen Idec Announce Positive Results From a Phase II Trial of Rituxan in Relapsing-Remitting Multiple Sclerosis
Monday August 28, 9:00 am ET


SOUTH SAN FRANCISCO, Calif. and CAMBRIDGE, Mass., Aug. 28 /PRNewswire-FirstCall/ -- Genentech, Inc. (NYSE: DNA - News) and Biogen Idec, Inc. (Nasdaq: BIIB - News) announced today that a Phase II study of Rituxan® (Rituximab) for relapsing-remitting multiple sclerosis (RRMS) met its primary endpoint. The study of 104 patients showed a statistically significant reduction in the total number of gadolinium enhancing T1 lesions observed on serial MRI scans of the brain at weeks 12, 16, 20 and 24 in the Rituxan-treated group compared to placebo. Genentech and Biogen Idec will continue to analyze the study results and will submit the data for presentation at an upcoming medical meeting.
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"These initial results exceeded our expectations," said Hal Barron, M.D., Genentech senior vice president, development and chief medical officer. "Showing a significant benefit at 24 weeks in this small Phase II trial supports our hypothesis that selective B-cell targeted therapy may play an important role in the treatment of MS."

"Biogen Idec is committed to offering multiple options for people living with MS, a devastating disease. We are very encouraged by these data and look forward to learning more about the potential of Rituxan as a therapy to treat MS," said Alfred Sandrock, M.D., Ph.D., senior vice president, neurology research and development, Biogen Idec.

Rates of overall adverse events and serious adverse events were comparable between the two treatment groups. Serious infectious adverse events occurring in Rituxan-treated patients included gastroenteritis and bronchitis. The overall rates of infection were comparable among the two treatment groups with an increase in the rates of nasopharyngitis, upper respiratory tract infections, urinary tract infections and sinusitis in the Rituxan-treated patients. There were more first infusion-related reactions with Rituxan, the majority of which were mild to moderate and were generally reversible with medical intervention. The companies continue to monitor the long-term safety of Rituxan treatment.

About the Study

This Phase II randomized, double-blind, parallel-group, placebo-controlled, multi-center study was designed to evaluate safety and efficacy of Rituxan in adults with RRMS. A total of 104 patients at 48 sites in the U.S. and Canada were randomized to receive either a single treatment course of Rituxan or placebo. Gadolinium-enhancing lesions visible by MRI scans were assessed at 12, 16, 20 and 24 weeks. Patients will continue to be followed for 48 weeks.

About MS and RRMS

MS is a chronic autoimmune disease in which the immune system is thought to attack the body's own myelin, a fatty substance that surrounds and protects the nerve fibers of the brain, optic nerves and spinal cord. There are four types of MS with a wide variety of symptoms and different courses of disease progression.

MS is the leading cause of neurological disability in young adults. Neurological disability typically accumulates over time and includes muscle weakness and spasticity, balance and coordination problems, as well as memory impairment and depression. Other symptoms include numbness, pain, slurred speech and blurred vision. Many patients experience fatigue and problems with bladder, bowel or sexual function.

RRMS is the most common form of MS and accounts for approximately 65 percent of all MS cases. RRMS is characterized by acute exacerbations with full or partial recovery between attacks. The disease does not progress between attacks.

Rituxan Safety Profile in Oncology and Autoimmune Diseases

The safety profile of Rituxan has been established in more than 960,000 patient exposures over a period of eight years.

In general, the adverse events observed in patients with RA, an autoimmune disease, were similar in type to those seen in patients with non-Hodgkin's lymphoma (NHL). The most common adverse events observed in patients treated with Rituxan for RA in clinical trials were infusion reactions and infections. No significant change in average immunoglobulin levels was observed in Rituxan-treated patients in clinical trials. There was no increase in hematologic malignancies, demyelinating events or risk of opportunistic infections (including tuberculosis) in Rituxan-treated patients over 24 weeks of treatment. Although 5 percent of Rituxan-treated patients developed human anti-chimeric antibodies (HACA), this was not associated with loss of clinical response or additional safety observations.

The majority of patients experience infusion-related symptoms with their first Rituxan infusion. These symptoms include but are not limited to: flu-like illness, fever, chills/rigors, nausea, urticaria, headache, bronchospasm, angioedema, hypotension and hypoxia. These symptoms vary in severity and generally are reversible with medical intervention.

Severe infusion reactions have been reported in patients treated with Rituxan, some with fatal outcomes in patients with NHL. These severe reactions typically occur during the first infusion. The most severe manifestations and sequelae include pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, cardiogenic shock, and anaphylactic and anaphylactoid events. Patients who develop clinically significant infusion reactions should have their Rituxan infusion discontinued and receive medical treatment. Acute renal failure requiring dialysis with instances of fatal outcome has been reported in the setting of tumor lysis syndrome following treatment with Rituxan. Severe mucocutaneous skin reactions, some with fatal outcome, have been reported in association with Rituxan treatment. Patients experiencing a severe mucocutaneous reaction should not receive any further infusions and seek prompt medical evaluation. Abdominal pain, bowel obstruction and perforation, in some cases leading to death, were observed in patients receiving Rituxan in combination with chemotherapy for diffuse large B-cell (DLBCL), CD20-positive, non-Hodgkin's lymphoma. Other serious or potentially life-threatening adverse reactions that have been reported following Rituxan therapy include Hepatitis B reactivation with fulminant hepatitis, other viral infections, hypersensitivity reactions, and cardiac arrhythmias.

About Rituxan

Rituxan is a therapeutic antibody that targets and selectively depletes CD20-positive B-cells without targeting stem cells or existing plasma cells. In addition to RRMS, Rituxan is being studied in primary progressive MS, for which there is currently no FDA-approved therapy. Rituxan is being studied in other autoimmune diseases with significant unmet medical needs, including systemic lupus erythematosus, lupus nephritis and ANCA-associated vasculitis.

Rituxan, discovered by Biogen Idec, first received FDA approval in November 1997 for the treatment of relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin's lymphoma. It was also approved in the European Union under the trade name MabThera® in June 1998. In addition, Rituxan received FDA approval in February 2006 for the treatment of diffuse large B-cell lymphoma (DLBCL) in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy regimens in previously untreated patients, as well as in combination with methotrexate to reduce signs and symptoms in adult patients with moderately-to-severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor antagonist therapies.

Genentech and Biogen Idec co-market Rituxan in the United States, and Roche markets MabThera in the rest of the world, except Japan, where Rituxan is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd. Rituxan has more than 960,000 patient exposures worldwide. For a copy of the Rituxan full prescribing information, including Boxed Warning, please call 1-800-821-8590 or visit www.gene.com .

About Genentech

Founded 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. A considerable number of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes multiple biotechnology products and licenses several additional products to other companies. The company has headquarters in South San Francisco, California and is listed on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit www.gene.com .

About Biogen Idec

Biogen Idec creates new standards of care in oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com .

This press release contains a forward-looking statement regarding the potential of Rituxan to treat MS. Such statement is a prediction and involves risks and uncertainties such that the actual results may differ materially. Among other things, the potential of Rituxan could be affected by unexpected safety, efficacy or manufacturing issues, additional time requirements for data analysis and decision-making, the need for additional clinical studies, discussions with the FDA, FDA actions, failure to receive FDA approval, competition, reimbursement, intellectual property or contract rights, pricing, the ability to supply product, or product withdrawal. Please also refer to Genentech's and Biogen Idec's periodic reports filed with the Securities and Exchange Commission. Genentech and Biogen Idec disclaim, and do not undertake, any obligation to update or revise this forward-looking statement in this press release.


    Media:     Nikki Levy         650-225-1729
    Investor:  Susan Morris       650-225-6523

    Biogen Idec Contacts:
    Media:     Amy Brockelman     617-914-6524
    Investor:  Eric Hoffman       617-679-2812

"Vectibix is the first entirely human antibody for the treatment of colorectal cancer to be approved by the FDA. It provides another option for patients with metastatic colorectal cancer that have progressed on all available chemotherapy regimens," said J. Randolph Hecht, M.D., director of the UCLA Gastrointestinal Oncology Program and clinical professor of Medicine, UCLA David Geffen School of Medicine, Los Angeles. "In a large, randomized clinical trial, Vectibix has been shown to delay progression of disease compared to best supportive care."

Epidermal growth factor receptors are proteins that play an important role in cancer cell signaling. Vectibix is an entirely human IgG2 monoclonal antibody that binds with high affinity to EGF receptors. The goal of developing entirely human monoclonal antibodies is to offer effective targeted therapies with lessened risk of immune response against these agents.

"Our goal is to fulfill the promise of biotechnology to improve the way cancer is treated," said Willard Dere, M.D., chief medical officer and senior vice president of Global Development at Amgen. "The approval of Vectibix allows us to build on our strong foundation in supportive care and move forward with our comprehensive approach to helping patients in their fight against cancer."

"One out of 18 people in this country will develop colorectal cancer in their lifetime and 20 percent of colorectal cancers are found after the disease has spread to distant organs." said Amy Kelly, director and co-founder of the Colon Cancer Alliance. "That means that a person in the U.S. is diagnosed with colorectal cancer every four minutes, heightening the need for new therapeutic options such as Vectibix."

Marketing applications were simultaneously submitted to the European Medicines Agency (EMEA) in April 2006 and Health Canada, Australia and Switzerland in May 2006. Vectibix is being evaluated in ongoing clinical trials as both a monotherapy and in combination with other agents for the treatment of various types of cancer. For more information please visit www.amgentrials.com.

Important Product Safety Information

As described below, the Vectibix Prescribing Information includes warning language as part of evolving FDA labeling for the anti-EGFr class:

Dermatologic toxicities, related to Vectibix blockade of EGF binding and subsequent inhibition of EGF receptor-mediated signaling pathways, included but were not limited to dermatitis acneiform, pruritus, erythema, rash, skin exfoliation, paronychia, dry skin, and skin fissures. Dermatologic toxicities were reported in 89 percent of patients treated with Vectibix and were severe in 12 percent of patients. Severe dermatologic toxicities were complicated by infection, including sepsis, septic death, and abscesses requiring incisions and drainage. Vectibix may need to be withheld or discontinued for severe dermatologic toxicities.

Severe infusion reactions occurred with Vectibix in approximately 1 percent of patients. Severe infusion reactions were identified as anaphylactic reactions, bronchospasm, fever, chills, and hypotension. Although fatal infusion reactions have not been reported with Vectibix, they have occurred with other monoclonal antibody products. Severe infusion reactions require stopping the infusion and possibly permanently discontinuing Vectibix, depending on the severity and/or persistence of the reaction.

Other important safety information includes:

The most common adverse reactions to Vectibix were generally mild to moderate and included skin rash with variable presentations, paronychia, fatigue, abdominal pain, nausea and diarrhea. Hypomagnesemia occurred 6 weeks or longer after the initiation of Vectibix. In some patients, hypomagnesemia was associated with hypocalcemia.

Amgen(TM) Oncology Assistance

Amgen has expanded its patient assistance programs into a comprehensive, multifaceted program with a single gateway - Amgen(TM) Oncology Assistance. Through this program, patients who are uninsured, underinsured, or unable to afford their insurance co-payments can receive financial support for Amgen's cancer medicines, including Vectibix. The Amgen Oncology Assistance program will be available for U.S. cancer patients and will launch in October. For more information, please visit www.amgen.com.

About Colorectal Cancer

Colorectal cancer is the third most common cancer diagnosed in men and in women in the United States. The American Cancer Society estimated that about 146,940 new cases of colon cancer and 41,930 new cases of rectal cancer will be diagnosed in 2006. Colorectal cancer is the second leading cause of cancer death among men and women in the United States and Canada (after lung cancer). It has been estimated that 56,370 people will die from colorectal cancer in 2006. That means that one person in the United States dies of colorectal cancer every 9.3 minutes.

About Vectibix

Although EGF receptors normally help regulate the growth of many different cells in the body, these receptors also can stimulate cancer cells to grow. In fact, some cancer cells actually require signals mediated by EGF receptors for their survival. Residing on the surfaces of these tumor cells, EGF receptors are activated when naturally occurring proteins in the body, such as epidermal growth factor (EGF) or transforming growth factor alpha (TGF-alpha), bind to them. This binding changes the shape of the EGF receptors, which, in turn, triggers internal cellular signals that stimulate tumor cell growth. Vectibix binds to EGF receptors, preventing the natural ligands such as EGF and TGF-alpha from binding to the receptors and interfering with the signals that might otherwise stimulate growth and survival of the cancer cell.

About Amgen

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com.

Forward-Looking Statement

This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and others that can be found in Amgen's Form 10-K for the year ended December 31, 2005, and in Amgen's periodic reports on Form 10-Q and Form 8-K. Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. In addition, sales of Amgen's products are affected by the availability of reimbursement and the reimbursement policies imposed by third party payors, including governments, private insurance plans and managed care providers, and may be affected by domestic and international trends toward managed care and healthcare cost containment as well as possible U.S. legislation affecting pharmaceutical pricing and reimbursement. Government regulations and reimbursement policies may affect the development, usage and pricing of Amgen's products. In addition, Amgen competes with other companies with respect to some of Amgen's marketed products as well as for the discovery and development of new products. Amgen believes that some of the newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Amgen products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while Amgen routinely obtains patents for Amgen's products and technology, the protection offered by Amgen's patents and patent applications may be challenged, invalidated or circumvented by Amgen's competitors and there can be no guarantee of Amgen's ability to obtain or maintain patent protection for Amgen's products or product candidates. Amgen cannot guarantee that it will be able to produce commercially successful products or maintain the commercial success of Amgen's existing products. Amgen or others could identify side effects or manufacturing problems with Amgen's products after they are on the market. Amgen's stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of Amgen's products or product candidates. Further, the discovery of significant problems with a product similar to one of Amgen's products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on Amgen's business and results of operations.

EDITOR'S NOTE: An electronic version of this news release may be accessed via our Web site at www.amgen.com. Journalists and media representatives may sign up to receive all news releases electronically at time of announcement by filling out a short form in the Media section of the Web site.



Contact:
Amgen
Christine Regan, 805-447-5476 (media)
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Arvind Sood, 805-447-1060 (investors)

Die (vermutlich) 13. Indikation für diesen AK : Psoriasis

  www.jnj.com/news/jnj_news/20060926_155540.htm

FDA Approves REMICADE® (Infliximab) For Treatment Of Chronic Severe Plaque Psoriasis: Marks Major Milestone For Patients With High Disease Burden
Nearly Eight Out of 10 Patients Treated With REMICADE® (Infliximab) Achieved 75 Percent Improvement in Psoriasis at Week 10
Horsham, PA (September 27, 2006) – Centocor, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved REMICADE® (infliximab) for the treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. The recommended dose is an infusion of 5 mg/kg followed by additional doses at two and six weeks after the first infusion and then every eight weeks thereafter. In the Phase 3 clinical trial EXPRESS, eight out of 10 patients receiving REMICADE® 5 mg/kg induction therapy achieved 75 percent improvement in psoriasis as measured by Psoriasis Area Severity Index (PASI 75) by week 10. Similar results were seen with EXPRESS II, the second Phase 3 study. These results were maintained by every eight-week REMICADE® 5 mg/kg maintenance infusions at six months. The majority of patients who continued on this regimen achieved PASI 75 at week 50, the last visit in both studies. More than 1,200 patients participated in the two Phase 3 clinical trials.

"The rapidity and consistency with which REMICADE® can improve clearance of patients' skin is a major step forward for a patient population where persisting unmet needs in treatment exist," said Alice B. Gottlieb, M.D., Ph.D., dermatologist-in-chief, professor of Dermatology, Tufts-New England Medical Center, and pivotal U.S. study investigator. "As a researcher involved in the clinical investigation of REMICADE® for the treatment of psoriasis, I've seen first-hand its significant results in improving psoriasis in the majority of patients treated."

Psoriasis is an inflammatory disorder characterized by raised, inflamed, red lesions, or plaques, which can cause physical pain and emotional distress. It is estimated that as many as 7.5 million people in the U.S. have psoriasis1, which can present in various forms and can range from mild to severe and disabling. Centocor will expand its educational programs to help dermatologists and their patients achieve the benefits of REMICADE® and to help manage and minimize the potential risks of biologic therapies, like REMICADE®.

Data from two multi-center, randomized, double-blind, placebo-controlled trials – EXPRESS and EXPRESS II – served as the primary basis for approval. Both EXPRESS and EXPRESS II showed that a majority of patients treated with REMICADE® achieved clinically significant levels of skin clearance with induction and every eight-week maintenance therapy. At week 10 in EXPRESS, 80 percent of patients receiving REMICADE® 5 mg/kg achieved PASI 75 versus three percent of patients receiving placebo (P < 0.001). At week 10 in EXPRESS II, 75 percent of patients receiving REMICADE® 5 mg/kg achieved PASI 75 versus two percent of patients receiving placebo (P < 0.001).

During the controlled periods in EXPRESS and EXPRESS II, adverse events (AEs) occurred at a higher incidence in the REMICADE® groups compared with the placebo groups. In the EXPRESS study, there were more serious adverse events, including one fatal infection, in the REMICADE® group compared to placebo group. In the EXPRESS II study, serious AE rates were similar in the REMICADE® 5 mg/kg and placebo groups. The only clinically significant laboratory abnormalities that occurred more frequently in the REMICADE® groups compared with the placebo groups were elevated liver enzyme tests. AEs observed in these studies were generally consistent with those described in the prescribing information, including the risk of serious infections. Please see "Important Safety Information" below.

"New biologic treatment options are needed in our struggle to more effectively manage all patients with this lifelong, chronic condition, particularly those that have severe disease," said Alan Menter, M.D., chairman, Division of Dermatology, Baylor University Medical Center, and lead U.S. study investigator. "The approval of REMICADE® offers dermatologists a treatment option that has been clinically proven to rapidly and dramatically clear the skin of patients with a high disease burden."

Psoriasis is most commonly diagnosed between the ages of 20 and 30, striking in the prime of people's lives, and the extent of skin involvement varies from mild to severe and disabling. People with severe psoriasis may have large areas of their body covered by lesions, which may crack and bleed. The pain and embarrassment associated with such skin lesions may prevent people from participating in social and work-related activities, and the physical and mental effects of psoriasis have been compared to those of other chronic illnesses such as rheumatoid arthritis, hypertension, heart disease, diabetes and depression. Skin lesions associated with psoriasis often result in feelings of sadness, despair, guilt and anger, as well as in low self-esteem. A person’s sense of self-worth can be affected, and in some cases, this emotional turmoil can lead to depression.

"The severity of psoriasis is something that can often be misunderstood. Imagine having psoriatic plaques on the soles of your feet, which makes walking painful and difficult. Or, imagine going through life with your face and arms covered in psoriasis and how that would make you feel. These are just a few examples of what some patients must contend with," said Gail Zimmerman, president and CEO, National Psoriasis Foundation. "The approval of REMICADE® is a much needed addition for patients with severe psoriasis."

REMICADE® is the first and only anti-TNF-alpha treatment to receive 13 FDA approvals across inflammatory diseases in gastroenterology, rheumatology and dermatology, and has now been used to treat more than 800,000 patients worldwide, more than all other anti-TNF agents combined. REMICADE® is an advanced biologic treatment for chronic severe plaque psoriasis, requiring as few as six treatments a year after an initial three treatments.

About EXPRESS

The European Infliximab for Psoriasis [REMICADE®] Efficacy and Safety Study (EXPRESS) was a Phase 3, multi-center, randomized, double-blind, placebo-controlled trial that evaluated the safety and efficacy of REMICADE® induction and maintenance therapy in 378 adult patients with chronic, stable plaque psoriasis involving at least 10 percent BSA, a minimum PASI score of 12 and who were candidates for phototherapy or systemic therapy. Patients received either REMICADE® 5 mg/kg or placebo administered at weeks zero, two and six, followed by maintenance treatment every eight weeks. The REMICADE® group continued on maintenance treatments every eight weeks. Beginning at week 24, patients randomized to the placebo group were crossed over to receive REMICADE® therapy through week 46.  

In EXPRESS, through week 24, AEs occurred at a higher incidence in the REMICADE® group (82 percent) compared with the placebo group (71 percent). The only clinically significant laboratory abnormalities that occurred more frequently in the REMICADE® group compared with the placebo group were elevated liver enzyme tests. There were more serious AEs (six percent), including one fatal infection, in the REMICADE® group than in the placebo group (three percent). AEs observed were generally consistent with those described in the prescribing information, including information regarding serious infections. Please see "Important Safety Information" below.

About EXPRESS II

The Evaluation of Infliximab for Psoriasis in a [REMICADE®] Efficacy and Safety Study (EXPRESS II) was a Phase 3, multi-center, randomized, double-blind, placebo-controlled trial that evaluated the safety and efficacy of REMICADE® in 835 adult patients with chronic, stable plaque psoriasis involving at least 10 percent BSA, a minimum PASI score of 12 and who were candidates for phototherapy or systemic therapy. Patients were randomized to induction doses of REMICADE® 3 mg/kg or 5 mg/kg or placebo at weeks zero, two and six. Patients in the active induction treatment groups were randomized again at week 14 to receive either scheduled or "as needed" maintenance treatment at the same dose administered during the induction phase. Patients in the placebo group were crossed over at week 16 to receive REMICADE® 5 mg/kg at weeks 16, 18 and 22, then every eight weeks through week 46.  

In EXPRESS II, through week 14 (the placebo-controlled period), AEs occurred at a higher incidence in the REMICADE® groups (63 percent and 69 percent with 3 mg/kg and 5 mg/kg, respectively), compared with the placebo group (56 percent). The only clinically significant laboratory abnormalities that occurred more frequently in the REMICADE® group compared with the placebo group were elevated liver enzyme tests. Serious AEs occurred at rates of two percent in the placebo group, three percent in the 5 mg/kg group and one percent in the 3 mg/kg group. AEs observed were generally consistent with those described in the prescribing information, including information regarding serious infections. Please see "Important Safety Information" below.

About Psoriasis

Psoriasis is a chronic, immune-mediated disease, which results when skin cells over-produce and accumulate on the surface causing red, scaly plaques that may itch and bleed. This chronic inflammation is driven in part by tumor necrosis factor alpha, or TNF-alpha, a cytokine involved in the body's normal immune response. TNF-alpha is found at increased levels in psoriatic plaques and plays a crucial part in their formation and continued existence. It is estimated that two percent of the U.S. population has psoriasis, and about 30 percent of people with psoriasis have cases that are considered moderate to severe.

About REMICADE®

REMICADE® is the global market leader among anti-tumor necrosis factor alpha (TNF-alpha) therapies and is the only anti-TNF-alpha treatment approved in three different therapeutic areas: gastroenterology, rheumatology and dermatology. REMICADE® has demonstrated broad clinical utility in Crohn's disease (CD), rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), ulcerative colitis (UC), pediatric Crohn's disease (PCD) and psoriasis (PsO). The safety and efficacy of REMICADE® have been well established in clinical trials over the past 14 years and with more than 800,000 patients treated worldwide through commercial experience.

In the U.S., REMICADE®, in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage and improving physical function in patients with moderately to severely active RA. REMICADE® is the only biologic indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult and pediatric patients with moderately-to-severely active CD who have had an inadequate response to conventional therapy. REMICADE® is also indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in patients with fistulizing CD. In December 2004, REMICADE® was approved for reducing signs and symptoms in patients with active AS. In May 2005, REMICADE® was approved for reducing signs and symptoms of active arthritis in patients with PsA. Additionally, in September 2005, REMICADE® was approved for reducing signs and symptoms, achieving clinical remission and mucosal healing and eliminating corticosteroid use in patients with moderately to severely active UC who have had an inadequate response to conventional therapy. This approval makes REMICADE® the first and only biologic approved for the treatment of moderate to severe UC. In addition, on May 19, 2006, REMICADE® was approved for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy. This approval establishes REMICADE® as the first and only biologic therapy approved for the treatment of PCD.

REMICADE® is unique among available anti-TNF biologic therapies. Unlike self-administered therapies that require patients to inject themselves frequently, REMICADE® is the only anti-TNF biologic administered directly by caregivers in the clinic or office setting. In RA (3 mg/kg), CD (5 mg/kg), PsA (5 mg/kg), UC (5 mg/kg), PCD (5 mg/kg), and PsO (5 mg/kg), REMICADE® is a two-hour infusion administered every eight weeks, following a standard induction regimen that requires treatment at weeks zero, two and six. As a result, REMICADE® patients may require as few as six treatments each year. In AS (5 mg/kg), REMICADE® is a two-hour infusion administered every six weeks, following a standard induction regimen that requires treatment at weeks zero, two and six.

Important Safety Information

There are reports of serious infections, including tuberculosis (TB), sepsis and pneumonia. Some of these infections have been fatal. Tell your doctor if you have had recent or past exposure to people with TB. Your doctor will evaluate you for TB and perform a TB test. If you have latent (inactive) TB, your doctor should begin TB treatment before you start REMICADE®. REMICADE® can lower your ability to fight infections, so if you are prone to or have a history of infections, or develop any signs of an infection such as fever, fatigue, cough, flu or warm, red or painful skin while taking REMICADE®, tell your doctor right away. Also, tell your doctor if you are scheduled to receive a vaccine or if, you have lived in a region where histoplasmosis or coccidioidomycosis is common.

Reports of a type of blood cancer called lymphoma in patients on REMICADE® or other TNF blockers are rare but occur more often than expected for people in general. People who have been treated for rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, psoriatic arthritis, or plaque psoriasis for a long time, particularly those with highly active disease, may be more prone to develop lymphoma. Cancers, other than lymphoma, have also been reported. Children and young adults who have been treated for Crohn's disease with REMICADE® have developed a rare type of lymphoma that often results in death. These patients also were receiving drugs known as azathioprine or 6-mercaptopurine. If you take REMICADE® or other TNF blockers, your risk for developing lymphoma or other cancers may increase. You should also tell your doctor if you have had or develop lymphoma or other cancers or if you have a lung disease called chronic obstructive pulmonary disease (COPD).

Many people with heart failure should not take REMICADE®; so prior to treatment you should discuss any heart condition with your doctor. Tell your doctor right away if you develop new or worsening symptoms of heart failure (such as shortness of breath, swelling of your ankles or feet or sudden weight gain).

Reactivation of hepatitis B virus has been reported in patients who are carriers of this virus and are taking TNF blockers, such as REMICADE®. Some of these cases have been fatal. Tell your doctor if you know or think you may be a carrier of hepatitis B virus or if you experience signs of hepatitis B infection, such as feeling unwell, poor appetite, tiredness, fever, skin rash and/or joint pain.

There have been rare cases of serious liver injury in people taking REMICADE®, some fatal. Tell your doctor if you have liver problems and contact your doctor immediately if you develop symptoms such as jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever or severe fatigue.  

Blood disorders have been reported, some fatal. Tell your doctor if you develop possible signs of blood disorders such as persistent fever, bruising, bleeding or paleness while taking REMICADE®. Nervous system disorders have also been reported. Tell your doctor if you have or have had a disease that affects the nervous system, or if you experience any numbness, weakness, tingling, visual disturbances or seizures while taking REMICADE®.

Allergic reactions, some severe, have been reported during or after infusions with REMICADE®. Signs of an allergic reaction include hives, difficulty breathing, chest pain, high or low blood pressure, swelling of face and hands and fever or chills. Tell you doctor if you have experienced a severe allergic reaction. The most common side effects of REMICADE® are: respiratory infections, such as sinus infections and sore throat, headache, rash, coughing and stomach pain.

Please read the Medication Guide for REMICADE® and discuss it with your doctor.

About Centocor, Inc.

Centocor, Inc., is harnessing the power of world-leading research and biomanufacturing to deliver innovative biomedicines that transform patients' lives. Centocor, Inc., has already brought innovation to the treatment of Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, pediatric Crohn's disease and psoriasis.

The world leader in monoclonal antibody production and technology, Centocor, Inc., has brought critical biologic therapies to patients suffering from debilitating immune disorders. Centocor, Inc., is a wholly-owned subsidiary of Johnson & Johnson.

1 National Institute of Arthritis and Musculoskeletal and Skin Disorders. Questions and Answers About Psoriasis. U.S. Department of Health and Human Services, National Institutes of Health; 2003. NIH Publication No. 03-5040.

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Last Updated: September 27, 2006  

"Affimed\'s custom libraries represent a powerful addition to XOMA\'s existing collection of the seven leading commercial human antibody phage display libraries. The advantage of patient-derived libraries is their potential to contain unique antibody candidates for the therapeutic area of interest," said Jack Castello, chairman of the board, president and chief executive officer of XOMA. "This collaboration extends XOMA\'s leadership in therapeutic antibodies, providing a single point of access to an even broader fully-integrated antibody discovery and development platform."

"We are delighted to enter into this broad cross-license and collaboration agreement with XOMA," said Rolf H. Gunther MD PhD, chief executive officer of Affimed. "The access to XOMA\'s state-of-the-art BCE technology represents another very important milestone for Affimed and provides new opportunities for the development of Affimed\'s promising recombinant antibody products. In addition to having the rights to use this technology in our development work, we are particularly pleased to have the benefit of XOMA\'s expertise in the development of cell lines and production systems for our TandAb therapeutic candidate."

About Affimed Therapeutics AG

Affimed is a private biopharmaceutical company based in Heidelberg, Germany and specializing in the development of recombinant antibodies -- the fastest growing segment of the pharmaceutical industry. Affimed was founded in May of 2000 by Professor Melvyn Little as a spin-off of his group "Recombinant Antibodies" at the German Cancer Research Centre in Heidelberg.

The strength of Affimed\'s discovery platform lies in three large distinct antibody libraries that are the source of antibody leads which can be produced in a variety of formats from scFv, diabodies, full length antibodies to proprietary tetravalent formats such as Affimed\'s TandAb or Flexibody.

Affimed\'s existing pipeline comprises several very novel antibody formats targeting some potentially very high value cancer targets. Two cancer products are in advanced pre-clinical development. To learn more about Affimed, please visit www.affimed.com

About XOMA and its Bacterial Cell Expression Technology

XOMA is a leader in the discovery, development and manufacture of therapeutic antibodies, with a therapeutic focus that includes cancer and immune diseases. XOMA has royalty interests in RAPTIVA(r) (efalizumab), a monoclonal antibody product marketed worldwide (by Genentech, Inc. and Serono, SA) to treat moderate-to-severe plaque psoriasis, and LUCENTIS(tm) (ranibizumab injection), a monoclonal antibody product marketed worldwide (by Genentech and Novartis AG) to treat neovascular (wet) age-related macular degeneration.

The company has built a premier antibody discovery and development platform that includes access to seven of the leading commercially available antibody phage display libraries and XOMA\'s proprietary Human Engineering(tm) and BCE technologies. BCE is an enabling technology used to discover and screen, as well as develop and manufacture, recombinant proteins and antibodies for commercial purposes. BCE is also a key technology used in multiple systems for high throughput screening of antibody domains. XOMA scientists were the first to demonstrate the secretion of antibody domains directly from the bacterial cells as fully functional, properly folded molecules. More than 45 companies have signed BCE licenses.

XOMA\'s development collaborators include Lexicon Genetics Inc., Novartis and Schering-Plough Corporation. With a fully integrated product development infrastructure, XOMA\'s product development capabilities extend from preclinical sciences to product launch. The company\'s pipeline also includes proprietary programs in preclinical and clinical development. In addition, XOMA leverages its recombinant protein and antibody production infrastructure through process development and manufacturing contracts with public and private sector organizations. For more information about XOMA\'s product pipeline and antibody product development capabilities and technologies, please visit XOMA\'s website at www.xoma.com/.

Certain statements contained herein concerning product development, customized patient-derived libraries, or that otherwise relate to future periods are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements are based on assumptions that may not prove accurate. Actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry and for companies engaged in the development of new products in a regulated market. These risks, including those related to the results of discovery research and preclinical testing; the timing or results of pending and future clinical trials (including the design and progress of clinical trials; safety and efficacy of the products being tested; action, inaction or delay by the FDA, European or other regulators or their advisory bodies; and analysis or interpretation by, or submission to, these entities or others of scientific data); uncertainties regarding the status of biotechnology patents; uncertainties as to the cost of protecting intellectual property; changes in the status of the existing collaborative and licensing relationships; the ability of collaborators, licensees and other third parties to meet their obligations; market demand for products; scale up and marketing capabilities; competition; international operations; share price volatility; XOMA\'s financing needs and opportunities and risks associated with XOMA\'s status as a Bermuda company, are described in more detail in XOMA\'s most recent annual report on Form 10-K and in other SEC filings. Consider such risks carefully in considering XOMA\'s prospects.

investors.xoma.com/releasedetail.cfm?ReleaseID=212966  

die einzige aktiengesellschaft auf der welt die monoklonale antikörper herstellt und auf wunsch der pharmaunternehmen designet heisst morphosys. alles andere ist human- oder mäusebasiert. diese methoden werden bald der vergangenheit angehören. Morphosys ist eines der interessantesten deutschen biotechunternehmen.  

Beide Unternehmen sind an der Nasdaq notiert und erproben bereits RNA-Interferenz-Medikamente an Menschen. Dabei wird die RNA per Spritze oder Pille an den Krankheitsherd gebracht. Sirna hat ein RNA-basiertes Mittel gegen eine seltene Art der Altersblindheit entwickelt: Gene, die dafür sorgen, dass die Netzhaut mit Blutgefäßen zuwächst, werden durch das Mittel ausschaltet. Alnylam testet ein Medikament gegen das Respiratory Syncytial Virus, einen häufigen und für Erwachsene harmlosen Erreger von Atemwegserkrankungen.

Das Virus nutzt RNA als Träger für die eigenen Erbinformationen, deswegen kann das aus RNA hergestellte Medikament das Erbgut des Erregers direkt blockieren. Die Hoffnung ist, den Mechanismus eines Tages auch gegen zwei sehr viel verheerendere RNA-Viren einzusetzen: den Aids-Erreger HIV und das Grippe-Virus. "Gegen Influenza gibt es sehr gute Resultate, allerdings erst im Reagenzglas und bei Tieren", sagt Chow.
Erste Tests bei Menschen erfolgreich

Alle diese Ansätze gehen allerdings davon aus, dass der Patient ständig RNA-Mittel erhält. Eleganter wäre es, wenn ein kranker oder von einem Virus befallener Kärper selbst in die Lage versetzt wird, die heilenden Erbgutschnippsel herzustellen. "Diese systemische Anwendung von RNAi ist die Hoffnung für die Zukunft", sagt Chow. Allerdings birgt diese Anwendung auch neue Risiken: Ein Versuch an Mäusen zeigte, dass sich Zellen unter Umständen selbst zugrunde richten, wenn sie durch Medikamente allzu stark zur Produktion von Blockade-RNA angeregt werden.  

Auch hier  eine weitere Indikation für einen Ak-KLassiker.

www.gene.com/gene/news/press-releases/...ethod=detail&id=10107
Mittwoch, Okt 11, 2006


FDA Approves Avastin in Combination With Chemotherapy for First-Line Treatment of Most Common Type of Lung Cancer


-- Avastin Is First Therapy to Extend Survival Beyond One Year in Patients with Advanced Non-Small Cell Lung Cancer  --


-- Genentech Expands Patient Access Programs to Include Annual Expenditure Cap for Avastin  --


South San Francisco, Calif. --  11. Oktober 2006 --  Genentech, Inc. (NYSE: DNA) announced today that the U.S. Food and Drug Administration (FDA) has approved Avastin® (bevacizumab) to be used in combination with carboplatin and paclitaxel chemotherapy for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer (NSCLC), the most common type of lung cancer. The approval is based on a Phase III study (E4599) that showed Avastin in combination with chemotherapy resulted in a 25 percent improvement in overall survival compared to chemotherapy alone (based on a hazard ratio of 0.80).
"Bevacizumab, in combination with chemotherapy, is the first therapy in 10 years to improve on standard first-line treatment for advanced lung cancer and the first FDA-approved therapy ever to extend survival for these patients beyond one year in a large, randomized clinical study," said Alan Sandler, M.D., director of Medical Thoracic Oncology at Vanderbilt-Ingram Cancer Center in Nashville, Tenn., and lead investigator on the E4599 trial. "With this survival benefit, bevacizumab represents an important therapy for many advanced lung cancer patients fighting this difficult disease."

"Lung cancer is responsible for more than one-third of all U.S. cancer deaths, killing more people than breast, prostate, colon, liver and kidney cancers combined," said Laurie Fenton, president of the Lung Cancer Alliance in Washington, D.C. "The approval of Avastin plus chemotherapy is a significant stride in the right direction, and we are pleased that Genentech continues to make lung cancer a priority."

About E4599
The FDA approval for this new indication was based on results from E4599, a randomized, controlled, multi-center trial that enrolled 878 patients with unresectable, locally advanced, recurrent or metastatic non-squamous NSCLC. Patients with mixed histology were excluded if the predominant cell type was squamous. Results showed that patients receiving Avastin plus paclitaxel and carboplatin chemotherapy had a 25 percent improvement in overall survival, the trial's primary endpoint, compared to patients who received paclitaxel and carboplatin alone (based on a hazard ratio of 0.80). One-year survival was 51 percent in the Avastin plus chemotherapy arm versus 44 percent in the chemotherapy-alone arm. Median survival of patients treated with Avastin plus chemotherapy was 12.3 months, compared to 10.3 months for patients treated with chemotherapy alone.

The E4599 trial was sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, under a Cooperative Research and Development Agreement between NCI and Genentech. The trial was conducted by a network of researchers led by the Eastern Cooperative Oncology Group (ECOG).

E4599 Safety Analysis
The most common Grade 3-5 (severe) adverse events in Study E4599 seen in Avastin-treated patients were neutropenia (low white blood cell count), fatigue, hypertension (high blood pressure), infection and hemorrhage.

In Study E4599, the rate of pulmonary hemorrhage requiring medical intervention for the paclitaxel and carboplatin plus Avastin arm was 2.3 percent (10/427), compared to 0.5 percent (2/441) for the paclitaxel and carboplatin-alone arm. There were seven deaths due to pulmonary hemorrhage reported by investigators in the paclitaxel and carboplatin-plus Avastin arm, as compared to one in the paclitaxel and carboplatin-alone arm.

In previous clinical experience with Avastin in combination with paclitaxel and carboplatin in NSCLC, patients with a specific type of NSCLC called squamous cell carcinoma had a higher risk of experiencing life-threatening or fatal pulmonary bleeding. Squamous cells are a particular kind of cell that form in the lining of the air ducts in the lung. Because of the risk of bleeding attributed to this population, patients with NSCLC classified as predominantly squamous histology were not included in the E4599 trial.

About the New Avastin Annual Expenditure Cap and Genentech's Access to Care Programs
Genentech also announced today that the company plans to initiate a first-of-its-kind program to cap the overall expense of Avastin to $55,000 per year per eligible patient for any FDA-approved indication. The program will be available for eligible patients regardless of whether they are insured. The company plans to launch the new program in January 2007. In addition, the company announced that it has doubled its contribution to independent charities that provide co-pay assistance to a total of $50 million.

"The clinical development program that led to Avastin's three FDA approvals suggested dose and duration vary depending on tumor type," said Arthur D. Levinson, Ph.D., Genentech's chairman and chief executive officer. "The new expenditure cap on Avastin is a step Genentech is taking to address this variability in current and future FDA-approved indications. This new program, along with the increased contribution to independent charities that provide co-pay assistance to patients, continues our 20-year history of commitment to patient access."

The price of Avastin was established in February 2004 upon the FDA approval of the drug for the treatment of first-line colorectal cancer in combination with 5-FU based chemotherapy. At that time, the monthly price of Avastin was set below the standard of care chemotherapy for metastatic colorectal cancer at approximately $4,400.

In advanced lung cancer, a higher dose of Avastin is indicated. This dose was based on clinical data from a randomized dose-ranging Phase II study of Avastin in combination with chemotherapy. Based on this trial, ECOG and NCI selected the higher dose for the pivotal Phase III trial in NSCLC. The typical monthly cost of Avastin at this dose is approximately $8,800 and, based on median progression-free survival as measured in the E4599 trial, the average cost per course of therapy in NSCLC is approximately $56,000.

Avastin is covered by most insurers and Medicare for its approved indications. Genentech's donation to independent co-pay charities helps provide assistance to eligible patients with higher co-pay burdens. For eligible uninsured patients, the Genentech Access to Care Foundation (GATCF) provides Avastin for free.

Genentech has provided more than $850 million in free drug to patients since 1990. In 2005 alone, GATCF supported over 18,000 patients by providing approximately $200 million of free product. To learn more about the GATCF, independent charities that provide co-pay assistance to patients and potential financial assistance options, patients can speak with an Alternative Funding Specialist from Genentech's Single Point of Contact (SPOC) group by calling 888-249-4918 or visiting www.SPOConline.com.

About Lung Cancer
According to the American Cancer Society, lung cancer is the single largest cause of cancer deaths among men and women in the U.S. and is responsible for nearly 30 percent of cancer deaths in this country. The American Cancer Society estimates that more than 170,000 Americans will be diagnosed with lung cancer this year, and 162,000 Americans will die of the disease this year. NSCLC is the most common type of lung cancer.

About Avastin
Avastin, in combination with intravenous 5-fluorouracil (FU)-based chemotherapy, is indicated for first- or second-line treatment of patients with metastatic carcinoma of the colon or rectum; and in combination with carboplatin and paclitaxel for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer (NSCLC). For full prescribing information and boxed warnings on Avastin and information about angiogenesis, visit www.gene.com. For more information on Avastin, visit www.avastin.com.

The FDA first approved Avastin on February 26, 2004, as a first-line treatment for metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy. The National Comprehensive Cancer Network recommends Avastin plus chemotherapy as a standard treatment for the first- and second-line treatment of metastatic colorectal cancer and as a first-line treatment of advanced non-squamous NSCLC.

Avastin Safety
The most serious adverse events associated with Avastin across all trials were gastrointestinal perforation, wound healing complications, hemorrhage, arterial thromboembolic events, hypertensive crisis, reversible posterior leukoencephalopathy syndrome (RPLS), neutropenia and infection, nephrotic syndrome and congestive heart failure. The most common adverse events in patients receiving Avastin were asthenia, pain, abdominal pain, headache, hypertension, diarrhea, nausea, vomiting, anorexia, stomatitis, constipation, upper respiratory infection, epistaxis, dyspnea, exfoliative dermatitis and proteinuria.

About the Avastin Development Program
Based on data showing that VEGF may play a broad role in a range of cancers, Genentech is pursuing a broad development program for Avastin that currently includes 130 clinical trials across 25 different types of cancer. Avastin is being evaluated in Phase III clinical trials for its potential use in adjuvant and metastatic colorectal, renal cell (kidney), breast, non-small cell lung, prostate and ovarian cancers. Avastin is also being evaluated in earlier stage trials as a potential therapy in a variety of solid tumor cancers and hematologic malignancies. For further information about Avastin clinical trials, please call 888-662-6728.

About VEGF and Tumor Angiogenesis
Genentech is a leader in research and product development in the area of angiogenesis, the process by which new blood vessels are formed. The link between angiogenesis and cancer growth has been discussed by many researchers for decades; however it was not until 1989 that a key growth factor influencing the process, vascular endothelial growth factor (VEGF), was discovered by Napoleone Ferrara, M.D., a staff scientist at Genentech. Ferrara and his team at Genentech cloned VEGF, providing some of the first evidence that a specific angiogenic growth factor existed. This research was published in the journal Science in 1989. Ferrara then created a mouse antibody to this protein.

In 1993, in a study published in the journal Nature, Ferrara and his team demonstrated that the antibody directed against VEGF could suppress angiogenesis and tumor growth in preclinical models, providing compelling evidence that VEGF can play an important role in tumor growth. Clinical studies with a humanized version of the antibody, Avastin, began in 1997.

About Genentech BioOncology
Genentech is committed to changing the way cancer is treated by establishing a broad oncology portfolio of innovative, targeted therapies with the goal of improving patients' lives. The company is the leading provider of anti-tumor therapeutics in the United States. Genentech is conducting clinical development programs for Rituxan® (Rituximab), Herceptin® (Trastuzumab), Avastin® (bevacizumab), and Tarceva® (erlotinib), and markets all four products in the United States, either alone (Avastin and Herceptin) or with Biogen Idec Inc. (Rituxan) or OSI Pharmaceuticals, Inc. (Tarceva).

The company has a robust pipeline of potential oncology therapies with a focus on four key areas: angiogenesis, apoptosis (i.e., programmed cell death), the HER pathway, and B-cell biology. An investigational antibody directed at the HER pathway is currently in Phase II trials. In early development are a small molecule directed at the hedgehog pathway and an investigational agent targeting apoptosis.

Founded 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. A considerable number of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes multiple biotechnology products and licenses several additional products to other companies. The company has headquarters in South San Francisco, Calif., and is listed on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit www.gene.com.

For the full prescribing information for Tarceva and the full prescribing information and Boxed Warnings for Rituxan, Herceptin, and Avastin, please visit www.gene.com.


# # #

Was ist eure Meinung bzgl. der Pipeline von Medarex?

6 Produkte in Phase III (d.h. mit verschiedenen Rechten am Markt).
Da könnte doch kräftig was laufen, wenn eine FDA Zulassung kommt.

Gruss biodani

MEDX entwickelt sich genau so, wie ich mir das vorgestellt habe. Solange jederzeit eine FDA Zulassung oder positive Testresultate ins Haus flattern können, gehts Richtung Norden.  
Spezielles Augenmerk ist bei den Produkten die mit JNJ zusammen entwickelt wurden angebracht. Solche Riesenkonzerne lassen sich Umsatzmillionen nicht gerne entgehen.
Die Barreserven und die Beteiligung an Genmab wirken sich äusserst positiv auf das Risikopotential aus.

Hier ein Überblick über die Produktepipeline von MEDX!

www.medarex.com/Development/Pipeline.htm

Die Produkte CNTO 148 und CNTO 1275 werden zusammen mit Centocor entwickelt, dies ist meines Wissens eine Tochterfirma von JNJ.
(Jüngstes Bsp. einer solchen Übernahme: Eli Lilly - ICOS)

Glaube aber nicht, dass es bei MEDX zu einer Übernahme kommt, hoffe ich zumindest. Ich sehe das Kurspotential im Alleingang am grössten.

Genmab ist heute wieder kräftig am steigen, die Story scheint im Moment einfach zu stimmen.

Gruss biodani

Die obigen Aussagen basieren auf persönlichen Recherchen und Annahmen.

de.biz.yahoo.com/21112006/389/...phan-drug-status-removab.html

Dienstag 21. November 2006, 16:02 Uhr



Der Gesundheitskonzern Fresenius hat von der Europäischen Kommission den Orphan-Drug-Status für den trifunktionalen Antikörper removab (catumaxomab) für die Behandlung von Magenkrebs erhalten. Dieser sichert dem Unternehmen unter anderem das exklusive Vermarktungsrecht innerhalb der Europäischen Union für die Dauer von bis zu zehn Jahren nach Erhalt der Zulassung.

Derzeit läuft eine Phase-II-Studie mit rund 50 Magenkrebs-Patienten, denen catumaxomab verabreicht wird. Ergebnisse hieraus erwartet das Unternehmen im zweiten Halbjahr 2007. Zuvor war bereits eine Phase-I-Studie bei fortgeschrittener Peritonealkarzinose (Ausbreitung und Ansiedlung von Tumorzellen in der Bauchhöhle) erfolgreich verlaufen, in die auch Patienten mit Magenkrebs einbezogen waren

de.biz.yahoo.com/21112006/389/...phan-drug-status-removab.html

Dienstag 21. November 2006, 16:02 Uhr



Der Gesundheitskonzern Fresenius hat von der Europäischen Kommission den Orphan-Drug-Status für den trifunktionalen Antikörper removab (catumaxomab) für die Behandlung von Magenkrebs erhalten. Dieser sichert dem Unternehmen unter anderem das exklusive Vermarktungsrecht innerhalb der Europäischen Union für die Dauer von bis zu zehn Jahren nach Erhalt der Zulassung.

Derzeit läuft eine Phase-II-Studie mit rund 50 Magenkrebs-Patienten, denen catumaxomab verabreicht wird. Ergebnisse hieraus erwartet das Unternehmen im zweiten Halbjahr 2007. Zuvor war bereits eine Phase-I-Studie bei fortgeschrittener Peritonealkarzinose (Ausbreitung und Ansiedlung von Tumorzellen in der Bauchhöhle) erfolgreich verlaufen, in die auch Patienten mit Magenkrebs einbezogen waren