Adolor nach Pfizer Deal weiter auf dem Vormarsch?!

The terms of the agreement provide for Pfizer and Adolor to share revenues and expenses 60/40 percent in the United States. Outside the U.S., Pfizer will fund development activities and, on commercialization, Adolor will receive royalties on Pfizer net sales. Adolor will receive an upfront, non-refundable payment of $30 million, plus $1.9 million reimbursement for prior Phase 2 development costs. Adolor may also receive payments of up to $232.5 million upon the achievement of development and regulatory milestones for its Delta compounds. More than 50 percent of these milestones may be earned prior to regulatory approval of the compounds, with the first milestone payment available to be earned on commencement of Phase 2b clinical studies.

“We are pleased to be partnering with Pfizer in this very exciting program,” said Michael R. Dougherty, president and chief executive officer of Adolor Corporation. “Our vision for the Delta agonists has been to develop a new class of opioids, delivering analgesia without some of the complicating side effects of traditional mu agonists. Pfizer brings extensive pain management development and commercial expertise to this collaboration and we look forward to working with Pfizer in the pursuit of this vision.”

ADL5859 is in a Phase 2 development program exploring its analgesic efficacy in inflammatory pain associated with rheumatoid arthritis and acute post-dental surgery pain. Additional programs are planned to evaluate ADL5859 in patients with diabetic peripheral neuropathy and osteoarthritis. All future development work is subject to a Joint Development Committee. Adolor expects to begin Phase 1 clinical testing of ADL5747 in the first quarter of 2008.

“This collaboration demonstrates our commitment to executing against the R&D plan we outlined, including expanding our Phase 2 portfolio with a strong focus in our key therapeutic areas,” said Dr. Martin Mackay, president of Pfizer Global Research and Development. “Pfizer has a strong history in bringing to market novel pain solutions including Lyrica, Neurontin and Celebrex. However, there still remains a significant unmet medical need for patients suffering from a variety of debilitating pain conditions.”

One of three opioid receptors, the Delta receptor has potential utility in a variety of indications, including the modulation of pain. Through a proprietary research platform based on cloned, human opioid receptors, Adolor has identified a series of novel, orally active Delta agonists - compounds that selectively stimulate the Delta opioid receptor. Delta compounds may have a number of potential advantages, including an improved side effect profile, as compared to mu opioid receptor agonists. On the basis of preclinical evaluation in animal models of human conditions, a Delta agonist may show effect in inflammatory pain, among other pain conditions. In addition, Delta agonists are thought to modulate other biological processes that may manifest themselves in disease states or conditions such as cardio-protection, overactive bladder, and depression. There are currently no selective Delta agonists approved by the FDA.

For more information on Pfizer Inc or Adolor Corporation, please visit www.pfizer.com or www.adolor.com.


www.adolor.com

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Adolor and GlaxoSmithKline Announce FDA Advisory Committee to Review Entereg(R) (alvimopan) for the Management of Postoperative Ileus (POI)
Wednesday November 28, 11:08 am ET


EXTON, Pa. & PHILADELPHIA--(BUSINESS WIRE)--Adolor Corporation (Nasdaq:ADLR - News) and GlaxoSmithKline (NYSE:GSK - News) announced today that the Gastrointestinal Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) will review Adolor’s New Drug Application (NDA) for Entereg® (alvimopan) for the proposed indication of acceleration of time to upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis on January 23, 2008 from 8:00 AM to 5:00 PM. The meeting will take place at the Hilton Washington DC/Silver Spring, Maryland Ballroom in Silver Spring, Maryland.
About Adolor Corporation

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Adolor Corporation (Nasdaq:ADLR - News) is a biopharmaceutical company specializing in the discovery, development and commercialization of novel prescription pain management products. Entereg® (alvimopan) is Adolor's lead product candidate under development for the management of the gastrointestinal side effects associated with opioid use. Adolor also has a number of discovery and clinical research programs focused on the identification of novel compounds for the treatment of pain. By applying its knowledge and expertise in pain management, along with ingenuity, Adolor is seeking to make a positive difference for patients, caregivers and the medical community. For more information, visit www.adolor.com.

Adolor, kooperation mit Glaxo, Pfizer und Girindus. Vor allem letztere ist der Star...

;-)

auch gleich wech!

unwichtig.
Handeln sollte man solche in Deutschland marktengen Werte lieber nur in den USA

Kleine Mengen sind aber auch gut in FRA zu ergattern. Die 400 von heute sind z.B. meine und waren sogar marginal unter pari zu bekommen. Aber wo se herkommen ist wurscht, hauptsache sie steigt.;-)

bigcharts.marketwatch.com/charts/...6973&mocktick=1&rand=6636" style="max-width:560px" >

war das Teil so abgesackt?

In einer Langzeitstudie von Glaxo Smith Kline zum Anwendungsbereich OBD, sind cardiovaskuläre Auffälligkeiten entdeckt worden.

In diesem Anwendungsbereich werden chronische Schmerzen im Magen-Darmbereich behandelt, die durch Nebenwirkungen bei der dauerhaften Einnahme von opiatbasierenden Schmerzmittel auftreten.(opiate inducted bowl dysfunction OBD)

Bei der kurtfristigen Einnahme (post operativer Dramverschluss-post operative Ileus POI), sind diese Nebenwirkungen aufgrund der kurzzeitigen Behandlung nicht aufgetreten. Und über die Zulassung wird am 23.1.2008 entschieden. Da hat der WS Alvimopan sichere und effiziente Studienergebnisse gezeigt.

Anmerken sollte man auch, dass im Bereich OBD diese Auffälligkeiten nicht stat. signif. waren. Es wurde auch da breits an mehren tausen Patienten erfolgreich getestet. Nur bei einer handvoll Leuten sind die aufgetreten.

Adolor hat die Vermarktungsrechte von Alvimopan für POI
Glaxo Smith Kline die weltweiten Vermarktungsrechte von Alvimopan für OBD
Hergestellt wird der Wirkstoff in Künsebeck bei Girindus.
-----
Und Pfizer die anderen beiden Wirkstoffkandidaten.ff

ADL5859 is in a Phase 2 development program exploring its analgesic efficacy in inflammatory pain associated with rheumatoid arthritis and acute post-dental surgery pain. Additional programs are planned to evaluate ADL5859 in patients with diabetic peripheral neuropathy and osteoarthritis. All future development work is subject to a Joint Development Committee. Adolor expects to begin Phase 1 clinical testing of ADL5747 in the first quarter of 2008.

Adolor Initiates Phase 2a Study of Delta Agonist ADL5859 in Neuropathic Pain
Friday December 14, 8:30 am ET


EXTON, Pa.--(BUSINESS WIRE)--Adolor Corporation (Nasdaq: ADLR - News) announced today the initiation of a third Phase 2a study of ADL5859, a novel Delta opioid agonist in development for the treatment of pain. Study 33CL231 will explore the analgesic efficacy of ADL5859 in treating pain associated with diabetic peripheral neuropathy. Recently, Adolor and Pfizer Inc (NYSE: PFE - News) entered into a collaboration to develop and commercialize two Delta opioid agonist compounds, including ADL5859, for the treatment of a wide range of inflammatory, neuropathic and acute pain conditions.
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“We are pleased to be advancing the clinical development of ADL5859,” said Michael R. Dougherty, president and chief executive officer of Adolor Corporation. “This is our third Phase 2a ADL5859 Study and the first one announced since our collaboration with Pfizer earlier this month.”

Study 33CL231 is a double-blind trial expected to enroll approximately 210 patients experiencing pain associated with diabetic peripheral neuropathy. Following a 7-day baseline period, patients will be randomized to receive a 4-week treatment of either placebo, ADL5859, or the active control, duloxetine. The primary measure of efficacy for the study will be the change in mean pain intensity score.

With the initiation of 33CL231, ADL5859 is now being evaluated in Phase 2a studies involving acute pain following dental surgery, inflammatory pain associated with rheumatoid arthritis, and pain associated with diabetic peripheral neuropathy.



Erst wurde die Kooperation mit Pfizer vermeldet und schon gehts in die Vollen.

With regard to the specific questions posed by the FDA to the committee, members voted 13-0, with two abstentions, that the efficacy results from the submitted studies in postoperative ileus (POI) were clinically meaningful. Although the panel voted (8 to 6 with one abstention) that a potential cardiovascular risk signal seen in one long-term OBD study (Study 014) remained a concern for short-term use in managing POI, a majority (9-6) agreed that the overall benefits of treatment with alvimopan outweighed the potential risks for short-term in-hospital use in the proposed bowel resection patient population. The panel voted 14 to 0 with one abstention that the preliminary risk management plan proposed by Adolor was not adequate to address potential risks.

“This is an important milestone for ENTEREG and we are pleased with the favorable outcome of the Committee meeting,” said Michael R. Dougherty, president and chief executive officer of Adolor Corporation. “This is further validation of our confidence in ENTEREG and our belief in the clinical benefit offered by ENTEREG in this indication. I would like to commend the significant effort of the combined Adolor and GSK development team. We look forward to working with the FDA, including the further development of a risk management plan, as they complete the review of the NDA for ENTEREG.”

The Committee’s recommendation, although not binding, will be considered by the FDA as it completes its review of the NDA for ENTEREG. The Prescription Drugs User Fee Act (PDUFA) action date for the NDA is February 10, 2008.

“A majority of the Committee agreed that ENTEREG produced clinically meaningful acceleration in GI recovery in bowel resection patients,” said Yvonne Greenstreet, senior vice president of the medicine development centre at GlaxoSmithKline. “Postoperative ileus can be uncomfortable for the patient, hinder post surgical recovery and delay hospital discharge in bowel resection patients. If approved, ENTEREG would be the first medication to address this common and burdensome complication.”

biz.yahoo.com/bw/080123/20080123006382.html?.v=1


Grösster Profiteur ist Girindus (588040) als Hersteller von Alvimopan für Adolor und Glaxo.

Opioid pain relievers have a role in inhibiting bowel function and motility. POI is associated with abdominal distension and bloating, persistent abdominal pain, nausea and vomiting, delayed passage of or an inability to pass flatus (gas) or stool, and an inability to tolerate oral intake or progress to a solid diet.(2)

Opioid analgesics, such as morphine, are widely used for the treatment of postoperative pain. Entereg works by binding to mu-opioid receptors in the gut, selectively inhibiting the negative effects of opioid medications on GI function and motility without reversing central analgesic effects of the opioids.

Entereg is for short-term hospital use only. The recommended adult dose of Entereg is a single 12 mg capsule administered orally 30 minutes to five hours prior to surgery followed by a 12 mg capsule twice daily beginning the day after surgery for a maximum of seven days or until discharge, not to exceed 15 doses.

Enrollment in the E.A.S.E.(TM) Program

Entereg is available only to hospitals that perform bowel resections and are enrolled in the E.A.S.E. Program. This program is designed to maintain the benefits associated with short-term use in the bowel resection population and prevent long-term, outpatient use. Hospitals that have reviewed the E.A.S.E. educational materials and have systems in place to limit the use of Entereg to no more than 15 doses per patient, can enroll at www.entereg.com. Upon enrollment, Entereg can be ordered directly from the wholesalers and shipped to the hospital pharmacy.


phx.corporate-ir.net/...=irol-newsArticle&t=Regular&id=1163663

Nun hat Adolor und Glaxo Smith Kline die Zulassung von Entereg für Post Operative Illeus (POI) bekommen, aber im Kurs von ADLR nur leichte Bewegung nordwärts. Da steckt noch viel neg. Stimmung in die Knochen, die sich ADLR nach den Studien OBD eingefagen hat. Glaxo hat aber in der Zulassung gesagt, dass "A causal relationship with alvimopan has not been established."

Im Kontext.

There were more reports of myocardial infarctions in patients treated with alvimopan 0.5 mg twice daily compared with placebo-treated patients in a 12-month study of patients being treated with opioids for chronic pain. This imbalance has not been observed in studies in patients undergoing bowel resection surgery who have received alvimopan 12 mg twice daily for up to 7 days. A causal relationship with alvimopan has not been established.

Das sollte die Wahrscheinlichkeit massiv erhöhen, dass Entereg auch auf dem lukrativeren OBD Markt zuglassen wird. Eines sonnigen Tages jedenfalls.

Adolor Provides Update on Entereg(R) (alvimopan) OBD Program Thursday July 3, 7:30 am ET FDA Lifts Clinical Hold on OBD IND

EXTON, Pa.--(BUSINESS WIRE)--Adolor Corporation (Nasdaq: ADLR - News) today issued an update on the Entereg® (alvimopan) Program for chronic opioid bowel dysfunction (OBD), under development in collaboration with GlaxoSmithKline (NYSE: GSK - News). ADVERTISEMENT The U. S. Food and Drug Administration (FDA) has concluded that clinical investigations relating to alvimopan in OBD may now proceed, and has therefore lifted the clinical hold on the OBD Investigational New Drug Application. “After a productive meeting and dialogue with FDA, we are very pleased to see the clinical hold lifted,” said Michael R. Dougherty, president and chief executive officer of Adolor. “There remains a large, unmet need for treatment options for the many patients suffering from this debilitating condition.” Adolor understands that GSK is evaluating all options relating to the OBD Program, including whether to proceed with its involvement with the Program. The April 2002 Collaboration Agreement between Adolor and GSK provides that GSK may terminate the Agreement with respect to the OBD product, returning rights to the OBD product to Adolor, while retaining its rights to the postoperative ileus (POI) product. Michael R. Dougherty said, “Should GSK determine to discontinue their involvement with the OBD Program, Adolor would expect to submit for review by FDA a protocol for an additional study in this indication.” GSK and Adolor are actively engaged in the commercialization of the recently approved Entereg for POI for bowel resection surgeries.

 

 

Gaaaaaaaaaaaaaaaaaaaaaaaaannnnnz wichtig!

Vor etwas mehr als einem Jahr schien das Schicksal von ADLR in Stein gemeißelt zu sein. Nach erhöhten Herz-Auffälligkeiten in der GSK Langzeitstudie gg. der Placebo Gruppe wurden die Studien von der FDA gestoppt. Es drohte der langsame Tod, ein nicht unüblich Phänomen für Biotechs. Doch was hat sich die Szenerie gewandelt? Es gab nie Zweifel an der Wirksamkeit von Entereg, dass sogar wesentlich breiter anwendbar ist, als der Konkurrenzwirkstoff Relistor von Progenics und Wyeth.

Seit nunmehr wenigen Wochen wird das Medikament zusammen mit GSK für POI vermarktet und seit Donnerstag besteht wieder die berechtigte Hoffnung, dass es auch eines Tages für den lukrativeren OBD Markt zugelassen wird. Als genau diese Phantasie bei ADLR gespielt wurde, und da gab es noch kein Pfizer, keine Zulassung, stand der Kurs bei 25$. Das muss das Ziel sein.

Studienresultate der Explorationsstudien des Deltrezeptordings mit Pfizer erwarte ich ende des Jahres. Erste Umsatzzahlen von Entereg in den nächsten Berichten.

Im 3 Jahres Chart sieht man 3 wesentliche, bis zu 50% Abschläge, die wie ne Treppe in den Keller aussehen. Es gab auch Gründe dafür.

2 von den Gründen für die herben Abschläge sind heute nichtig; besser gesagt von der FDA revidiert. 1. kein approvable letter sondern Entereg ist zugelassen und keine clinical hold mehr, welches seit Donnerstag aufgehoben ist. Der 3. Abschlag ist die Fantasie, die unweigerlich zurückkehren wird.



Im Prinzip verdammt zu steigen. Im Prinzip........