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Hana Biosciences to Report Third Quarter 2008 Results and Business Update On November 13, 2008
Thursday November 6, 7:30 am ET


SOUTH SAN FRANCISCO, Calif., Nov. 6, 2008 (GLOBE NEWSWIRE) -- Hana Biosciences (NasdaqCM:HNAB - News), a biopharmaceutical company focused on strengthening the foundation of cancer care, will announce its third quarter 2008 results on Thursday, November 13, 2008, after the close of the financial markets. Following the announcement, Hana Biosciences' management team will host a conference call to include a discussion of results and highlights of the third quarter 2008 and a business update at 5:00pm ET, 2:00pm PT.

in die richtige Richtung.
Schlusskurs in Amiland 0,24$ (+4,35%).

Am Donnerstag kommt der Quartalsbericht + Update.  
Hoffe auf gute Nachrichten.
Gestern gab es ein kleines Plus von 4,17%, Kurs 0,25$.

0,26 (+4%).
Morgen dann noch gute Nachrichten und die kleine Party kann beginnen.

  submitted to the Independent Data Monitoring Committee (IDMC),
  which will examine the interim safety results of the trial.  During
  the third quarter, Marqibo received orphan drug designation from
  the European Medicines Evaluation Agency in adult ALL.  Hana
  previously received orphan drug and fast track designations for
  Marqibo for adult ALL from the U.S. Food and Drug Administration.
  The Company expects the IDMC interim analysis of the rALLy trial,
  as well as efficacy and safety updates from the trial during the
  first quarter of 2009.

* Menadione Topical Lotion for EGFRI-associated skin rash: Data
  presented at the European Society for Medical Oncology Conference
  demonstrated that topical menadione did not affect the anti-tumor
  effect of erlotinib (Tarceva(r)), an approved epidermal growth
  factor receptor inhibitor (EGFRI), in preclinical models.  Other
  preclinical data presented at the meeting showed menadione's
  ability to restore kinase activity in the presence of specific
  kinase inhibitors.  These data indicate that treatment with
  menadione may result in restoration of normal cell turnover rates
  and prevent skin toxicities that result from inhibition of protein
  kinases associated with tumor growth signaling pathways, such as
  the tyrosine kinases MEK, CDK and RAF.  Hana is currently
  evaluating menadione in a Phase 1 clinical trial for the treatment
  and/or prevention of EGFRI associated skin toxicities, and expects
  top-line data during the fourth quarter of 2008.  Currently, there
  are no FDA-approved products or therapies available to treat these
  skin toxicities.

* Alocrest(tm) for solid tumor cancers and lymphomas:  At the
  European Society for Medical Oncology Conference, Hana presented
  Phase 1 data for Alocrest, the Company's OPTISOME(tm) encapsulated
  formulation of vinorelbine tartrate.  Overall, this study achieved
  a disease control rate of 47 percent, including three of four
  elderly non-small cell lung cancer (NSCLC) subjects who achieved
  stable disease.  Of 27 subjects with refractory solid tumors and 3
  subjects with NHL evaluable for efficacy, one patient achieved a
  Partial Response (unconfirmed) and 13 patients achieved Stable
  Disease.  Alocrest was generally well-tolerated with reversible
  neutropenia as the most common dose limiting toxicity, and a
  maximum tolerated dose comparable to unencapsulated vinorelbine in
  heavily pre-treated patients.

Subsequent Events



* In November 2008, Hana initiated a Phase 1 trial with Brakiva(tm)
  (topotecan liposomes injection, OPTISOME(tm)) in advanced solid
  tumors in patients with small cell lung and ovarian cancers.  The
  primary objective is to evaluate the safety, tolerability, and to
  determine the maximum tolerated dose of Brakiva when administered
  to subjects with tumors that have relapsed, are refractory to
  standard treatment, or for whom there is no standard therapy
  available.  Secondarily, the study will assess the pharmacokinetic
  (PK) profile of Brakiva and examine the PK/pharmacodynamic
  relationship between measures of exposure and effect.  Data is
  expected at the end of 2009.

ADVERTISEMENT


Third Quarter 2008 Financial Results

The Company reported a net loss of $5.2 million, or $0.16 per share, for the three months ended September 30, 2008 compared to $5.1 million, or $0.16 per share, for the same period in 2007.

Research and development expense for the quarter ended September 30, 2008 was $4.3 million, compared to $5.7 million for three months ended September 30, 2007. The decrease in research and development costs was primarily due to decreased spending on earlier-stage pipeline programs partially offset by increased spending for clinical development of Marqibo and menadione.

General and administrative expenses totaled $1.0 million for the quarter ended September 30, 2008 compared with $0.5 million for the three months ended September 30, 2007. The increase was primarily due to an increase in employee related stock option expenses.

Cash used in operations was $5.5 million for the quarter ended September 30, 2008. As of September 30, 2008, the Company had cash and cash equivalents and available-for-sale securities of $3.8 million. In October 2007, the Company entered into a $30 million financing commitment with Deerfield Management, a leading healthcare investment fund, to finance ongoing working capital requirements of the development of the Company's pipeline of product candidates. On October 14, 2008, the Company borrowed $12.5 million under the agreement and on November 5, 2008 requested an additional $2.5 million.

``Our current cash balance along with the funds available through the Deerfield agreement will enable us to deliver valuable Phase 2 clinical data for Marqibo, and to further advance our lead pipeline programs,'' said John Iparraguirre, Vice President and Chief Financial Officer.

Conference Call

Hana Biosciences' management will host a conference call discussion today, November 13, 2008, at 5:00pm ET, 2:00pm PT.



Date:                        Thursday, November 13, 2008
Time:                        5:00pm ET, 2:00pm PT
Dial-in (U.S. and Canada):   (877) 407-8031
Dial-in (International):     (201) 689-8031
Webcast:                     www.hanabiosciences.com

A replay of this call will be available for one week by dialing (877) 660-6853 U.S./Canada and (201) 612-7415 for International participants. When prompted, enter Account Number #286 and Conference ID #301599. An archived version of the webcast will also be available via the company's website for 14 days following the call.

About Hana Biosciences, Inc.

Hana Biosciences, Inc. (NasdaqCM:HNAB - News) is a South San Francisco, CA-based biopharmaceutical company focused on acquiring, developing, and commercializing innovative products to strengthen the foundation of cancer care. The company is committed to creating value by building a best-in-class team, accelerating the development of lead product candidates, expanding its pipeline by being an alliance partner of choice, and nurturing a unique company culture. Further information on Hana Biosciences can be found at www.hanabiosciences.com.

The Hana Biosciences, Inc. logo is available at www.globenewswire.com/newsroom/prs/?pkgid=3290

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are often, but not always, made through the use of words or phrases such as ``anticipates,'' ``expects,'' ``plans,'' ``believes,'' ``intends,'' and similar words or phrases. These forward-looking statements include without limitation, statements regarding, the timing progress and anticipated results of the clinical development, regulatory processes, potential clinical trial initiations, potential IND and NDA filings and commercialization efforts of Hana's product candidates. Such statements involve risks and uncertainties that could cause Hana's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurances that any of Hana's development efforts relating to its other product candidates will be successful, that Hana will be able to obtain regulatory approval of any of its product candidates, and that the results of clinical trials will support Hana's claims or beliefs concerning the effectiveness of its product candidates. Additional risks that may affect such forward-looking statements include Hana's need to raise additional capital to fund its product development programs to completion, Hana's reliance on third-party researchers to develop its product candidates, and its lack of experience in developing and commercializing pharmaceutical products. Additional risks are described in the company's Annual Report on Form 10-K for the year ended December 31, 2007 filed with the Securities and Exchange Commission. Hana assumes no obligation to update these statements, except as required by law.



                      HANA BIOSCIENCES, INC.
                     CONDENSED BALANCE SHEETS
                            (Unaudited)

                                         September 30,   December 31,
                                             2008            2007
                                         -------------  -------------

ASSETS
Current assets:
Cash and cash equivalents                $   3,743,357  $  20,795,398
Available-for-sale securities                   72,000         96,000
Prepaid expenses and other current
 assets                                        738,491        489,293
                                         -------------  -------------
 Total current assets                        4,553,848     21,380,691

Property and equipment, net                    445,436        432,529
Restricted cash                                125,000        125,000
Debt issuance costs                          1,395,296      1,423,380
                                         -------------  -------------
Total assets                             $   6,519,580  $  23,361,600
                                         =============  =============

LIABILITIES AND STOCKHOLDERS' EQUITY
 (DEFICIT)
Current liabilities:
Accounts payable                         $     270,311  $   1,682,739
Accrued other expenses                         187,330        496,239
Accrued personnel related expenses             637,600        763,050
Leased equipment: short-term                    48,085         13,919
Accrued clinical development costs           2,092,441      1,156,011
                                         -------------  -------------
 Total current liabilities                   3,235,767      4,111,958
                                         -------------  -------------

Notes payable                                2,189,716      2,025,624
Warrant liabilities                          2,032,523      4,232,355
Leased equipment: long-term                     58,680         33,861
                                         -------------  -------------
Total long term liabilities                  4,280,919      6,291,840
                                         -------------  -------------
Total liabilities                            7,516,686     10,403,798
Commitments and contingencies

Stockholders' equity (deficit):
Common stock; $0.001 par value:
 100,000,000 shares authorized,
 32,386,130 and 32,169,553 shares issued
 and outstanding at September 30, 2008
 and December 31, 2007, respectively            32,386         32,170
Additional paid-in capital                 103,903,612    101,843,390
Accumulated other comprehensive loss           (20,000)      (104,000)
Accumulated deficit                       (104,913,104)   (88,813,758)
                                         -------------  -------------
Total stockholders' equity (deficit)          (997,106)    12,957,802
                                         -------------  -------------
Total liabilities and stockholders'
 equity (deficit)                        $   6,519,580  $  23,361,600
                                         =============  =============


                      HANA BIOSCIENCES, INC.
  CONDENSED STATEMENTS OF OPERATIONS AND OTHER COMPREHENSIVE LOSS
                            (Unaudited)

                    Three Months Ended         Nine Months Ended
                       September 30,             September 30,
                 ------------------------  --------------------------
                    2008          2007         2008          2007
                 -----------  -----------  ------------  ------------
License revenue  $        --  $ 1,150,000  $         --  $  1,150,000

Operating
 expenses:
General and
 administrative      973,414      481,155     4,623,889     6,553,502
Research and
 development       4,347,265    5,730,859    13,031,060    17,442,556
                 -----------  -----------  ------------  ------------
Total operating
 expenses          5,320,679    6,212,014    17,654,949    23,996,058

Loss from
 operations       (5,320,679)  (5,062,014)  (17,654,949)  (22,846,058)
                 -----------  -----------  ------------  ------------

Other income
 (expense):
Interest income       39,997      265,307       271,361       972,932
Interest expense    (254,569)      (1,138)     (756,211)       (3,807)
Other expense,
 net                 (8,516)      (42,418)      (51,380)      (61,057)
Gain or loss on
 derivative          382,152           --     2,199,833            --
Realized loss on
 marketable
 securities               --     (260,000)     (108,000)     (436,000)
                 -----------  -----------  ------------  ------------
Total other
 income (expense)    159,064      (38,249)    1,555,603       472,068

Net loss         $(5,161,615) $(5,100,263) $(16,099,346) $(22,373,990)
                 ===========  ===========  ============  ============
Net loss per
 share, basic
 and diluted     $     (0.16) $     (0.16) $      (0.50) $      (0.75)
                 ===========  ===========  ============  ============

Weighted average
 shares used in
 computing net
 loss per share,
 basic and
 diluted          32,385,366   31,197,295    32,265,010    29,958,487
                 ===========  ===========  ============  ============
Comprehensive
 loss:
Net loss         $(5,161,615) $(5,100,263) $(16,099,346) $(22,373,990)
Unrealized
 holdings gains
 (losses) arising
 during the
 period              (20,000)          --      (128,000)     (456,000)
Less:
 reclassification
 adjustment for
 losses included
 in net loss              --           --       108,000       436,000
                 -----------  -----------  ------------  ------------

Comprehensive
 loss            $(5,181,615) $(5,100,263) $(16,119,346) $(22,393,990)
                 ===========  ===========  ============  ============



Contact:
         Hana Biosciences
         Investor & Media Contacts:
         Investor Relations Team
         (650) 588-6641
         investor.relations@hanabiosciences.com

         Invigorate Communications
         Gregory Gin
         (908) 376-7737
         ggin@invigoratepr.com


--------------------------------------------------
Source: Hana Biosciences, Inc.

   vervollständigt die Immatrikulation der ersten 29 Patienten, die Daten werden
   dem Independent Data Monitoring Committee (IDMC),
   , die die Zwischen-Sicherheit Ergebnisse der Studie. Während
   das dritte Quartal, Marqibo erhalten Orphan-Drug aus
   der Europäischen Arzneimittel-Agentur für die Beurteilung bei erwachsenen ALL. Hana
   zuvor Orphan-Drug-und Fast-Track-Bezeichnungen für
   Marqibo für erwachsene ALL von der US Food and Drug Administration.
   Die Gesellschaft erwartet, dass die IDMC Zwischenanalyse der Rally-Prozess,
   sowie die Wirksamkeit und Sicherheit von Updates aus dem Prozess während der
   ersten Quartal 2009.

 * Menadion Aktuelle Lotion für EGFRI-assoziierten Hautausschlag: Die Daten
   präsentiert auf der Tagung des Europäischen Gesellschaft für Medizinische Onkologie-Konferenz
   gezeigt, dass aktuelle Menadion hatte keinen Einfluss auf die Anti-Tumor
   Wirkung von Erlotinib (Tarceva (R)), einem zugelassenen epidermalen Wachstumsfaktor
   Faktor-Rezeptor-Inhibitor (EGFRI), in präklinischen Modellen. Andere
   präklinischen Daten, präsentiert auf der Tagung zeigte Menadion's
   Potenzial zur Wiederherstellung der Kinase-Aktivität in Anwesenheit von spezifischen
   Kinase-Hemmer. Diese Daten deuten darauf hin, dass die Behandlung mit
   Menadion kann dazu führen, dass die Wiederherstellung der normalen Zelle Umsatz Sätze
   und Vermeidung von Hautkontakt Toxizitäten, die durch eine Hemmung der Protein -
   Kinasen im Zusammenhang mit der Tumor-Wachstum Signalwege, wie z. B.
   die Tyrosin-Kinasen MEK, CDK und RAF. Hana ist derzeit
   Bewertung Menadion in einer klinischen Phase-1-Studie für die Behandlung
   und / oder Vorbeugung von Haut EGFRI verbundenen Toxizitäten, und erwartet,
   Top-line-Daten im vierten Quartal 2008. Derzeit gibt
   es keine FDA-zugelassenen Produkten oder Therapien zur Behandlung dieser
   Haut Toxizitäten.

 * Alocrest (tm) für feste Tumor Krebs und Lymphome: Auf dem
   Europäischen Gesellschaft für Medizinische Onkologie-Konferenz, Hana präsentiert
   Phase-1-Daten für Alocrest, der Gesellschaft OPTISOME (tm) gekapselt
   Formulierung von Vinorelbin Tartrat. Insgesamt ist dieser Studie erreicht
   Seuchenbekämpfung ein Satz von 47 Prozent, darunter drei der vier
   ältere Menschen nicht-kleinzelligem Lungenkarzinom (NSCLC) Themen, die erreicht
   stabile Krankheit. Von 27 Patienten mit refraktären soliden Tumoren und 3
   Patienten mit NHL auswertbaren für die Wirksamkeit, ein Patient erreichte eine
   Partial Response (unbestätigten) und 13 Patienten erreicht Stabile
   Krankheit. Alocrest wurde im Allgemeinen gut verträglich mit reversibel
   Neutropenie als die häufigste Dosis Begrenzung der Toxizität, und ein
   maximal verträgliche Dosis vergleichbar mit unverkapseltem Vinorelbin in
   stark vorbehandelten Patienten.

Nachfolgende Veranstaltungen



 * Im November 2008, Hana eine Phase-1-Studie mit Brakiva (tm)
   (Topotecan Liposomen Injektion, OPTISOME (tm)) in fortgeschrittenen soliden
   Tumoren bei Patienten mit kleinen Lungenkarzinom und Eierstockkrebs Krebserkrankungen. Der
   Vorrangiges Ziel ist die Evaluierung der Sicherheit, Verträglichkeit und
   Bestimmung der maximal verträglichen Dosis von Brakiva, wenn es
   an Patienten mit Tumoren, die rezidivierendem, sind die refraktär
   Standard-Behandlung, oder, für die es keine Standard-Therapie
   verfügbar. In zweiter Linie, die Studie wird die pharmakokinetischen
   (PK) Profil der Brakiva und prüfen die PK / pharmakodynamischen
   Beziehung zwischen den Maßnahmen der Exposition und Wirkung. Die Daten werden
   voraussichtlich Ende 2009.

WERBUNG
 
 
Drittes Quartal 2008 Financial Results

Das Unternehmen berichtete einen Nettoverlust von 5,2 Millionen Dollar oder 0,16 Dollar je Aktie, für die abgeschlossenen drei Monate per 30. September 2008 im Vergleich zu 5,1 Millionen Dollar oder 0,16 Dollar je Aktie, für den gleichen Zeitraum in 2007.

Forschung und Entwicklung Aufwendungen für das Quartal zum 30. September 2008 war 4,3 Millionen Dollar, verglichen mit 5,7 Millionen Dollar für die drei Monate per 30. September 2007. Der Rückgang der Forschungs-und Entwicklungskosten in erster Linie auf verringerte Ausgaben für die früheren Phase-Pipeline-Programmen teilweise ausgeglichen durch höhere Ausgaben für die klinische Entwicklung von Marqibo und Menadion.

Allgemeine und Verwaltungskosten insgesamt $ 1,0 Millionen für das Quartal zum 30. September 2008, verglichen mit 0,5 Millionen Dollar für die abgeschlossenen drei Monate per 30. September 2007. Der Anstieg war in erster Linie auf eine Erhöhung der Mitarbeiter im Zusammenhang Stock-Options-Aufwendungen.

Cashflow aus Geschäftstätigkeit war 5,5 Millionen Dollar für das Quartal zum 30. September 2008. Ab 30. September 2008 hatte das Unternehmen liquide Mittel und zur Veräußerung verfügbare Wertpapiere von 3,8 Mio. Dollar. Im Oktober 2007 hat die Gesellschaft in eine $ 30 Millionen Finanzierung Engagement mit Deerfield Management, einer der führenden Healthcare Investment Fonds, die Finanzierung von laufenden Working Capital Anforderungen der Entwicklung der Gesellschaft Pipeline von Produktkandidaten. Am 14. Oktober 2008 hat die Gesellschaft Fremdmittel 12,5 Mio. Dollar im Rahmen der Vereinbarung und am 5. November 2008 beantragte eine zusätzliche 2,5 Millionen Dollar.

`` Unsere aktuellen Cash-Balance zusammen mit den zur Verfügung stehenden Mittel durch die Deerfield Abkommen ermöglicht uns, liefern wertvolle Phase 2 der klinischen Daten für Marqibo, und weiter zu führen unsere Pipeline-Programmen,''sagte John IPARRAGUIRRE, Vice President und Chief Financial Officer.

Conference Call

Hana Biosciences "Management wird eine Telefonkonferenz Diskussion heute, 13. November 2008, 5.00 Uhr am ET, 2:00 pm PT.



 Datum: Donnerstag, 13. November, 2008
 Zeit: 5:00 Uhr ET, 2:00 pm PT
 Dial-in (US und Kanada): (877) 407-8031
 Dial-In (International): (201) 689-8031
 Webcast: www.hanabiosciences.com

Eine Aufzeichnung dieser Aufforderung werden für eine Woche durch die Einwahl (877) 660-6853 USA / Kanada und (201) 612-7415 für internationale Teilnehmer. Wenn Sie gefragt werden, geben Sie Account Number # 286 und die Konferenz ID # 301599. Eine archivierte Version des Webcast wird ebenfalls über die Website des Unternehmens für 14 Tage nach dem Aufruf.

Über Hana Biosciences, Inc.

Hana Biosciences, Inc. (NasdaqCM: HNAB - News) ist ein South San Francisco, CA-basierte biopharmazeutisches Unternehmen, das sich auf den Erwerb, die Entwicklung und Vermarktung innovativer Produkte zur Stärkung der Stiftung der Krebsbehandlung. Das Unternehmen hat sich verpflichtet, Schaffung von Mehrwert durch den Aufbau einer Best-in-Class-Team, die Beschleunigung der Entwicklung von Produkt-Kandidaten führen, baut seine Pipeline durch die Allianz ein Partner der Wahl, und die Pflege einer einzigartigen Unternehmenskultur. Weitere Informationen zu Hana Biosciences finden Sie unter www.hanabiosciences.com.

Die Hana Biosciences, Inc. Logo ist erhältlich unter www.globenewswire.com/newsroom/prs/?pkgid=3290

Diese Pressemitteilung enthält zukunftsgerichtete Aussagen im Sinne des Private Securities Litigation Reform Act "von 1995. Diese Aussagen sind zwar häufig, aber nicht immer, durch die Verwendung von Wörtern oder Sätzen wie `` erwartet,''`` erwartet,''`` Pläne,''`` ist der Auffassung,''`` beabsichtigt,''und ähnliche Wörter oder Ausdrücke. Diese zukunftsgerichteten Aussagen gehören ohne Beschränkung, Aussagen über die zeitlichen Fortschritt und erwartete Ergebnisse der klinischen Entwicklung, regulatorische Prozesse, potenziellen klinischen Studie Initiationen, potenzielle IND und NDA Anmeldungen und Kommerzialisierung Bemühungen der Hana-Produkt Kandidaten. Solche Aussagen beinhalten Risiken und Unsicherheiten, die dazu führen, dass Hana die tatsächlichen Ergebnisse wesentlich von den erwarteten Ergebnissen und Erwartungen in diese zukunftsgerichteten Aussagen. Diese Aussagen beruhen auf derzeitigen Erwartungen, Prognosen und Annahmen, unterliegen Risiken und Unsicherheiten, die dazu führen, dass tatsächliche Ergebnisse erheblich von diesen Aussagen. Unter anderem kann es keinerlei Zusicherung, dass der Hana die Entwicklung Anstrengungen in Bezug auf seine anderen Produktkandidaten von Erfolg gekrönt sein wird, dass Hana werden können, um behördlichen Genehmigung für eines seiner Produkt-Kandidaten, und dass die Ergebnisse von klinischen Prüfungen wird Hana Forderungen oder Überzeugungen über die Wirksamkeit ihrer Produktkandidaten. Zusätzliche Risiken, die sich auf die in diesen zukunftsgerichteten Aussagen gehören Hana's brauchen zusätzliches Kapital zur Finanzierung ihrer Produktentwicklung Programmen bis zur Fertigstellung, Hana die Abhängigkeit von Drittanbieter-Forscher für die Entwicklung seiner Produktkandidaten, und ihren Mangel an Erfahrung in der Entwicklung und Kommerzialisierung von pharmazeutischen Produkten . Weitere Risiken sind in den Unternehmen des Jahresberichts auf Formular 10-K für das Geschäftsjahr zum 31. Dezember 2007 bei der Securities and Exchange Commission. Hana übernimmt keine Verpflichtung zur Aktualisierung dieser Aussagen, es sei denn, gesetzlich vorgeschrieben.



                       Hana Biosciences, Inc.
                      Verkürzte Bilanz
                             (Ungeprüft)

                                          30. September, 31. Dezember,
                                              2008 2007
                                          ------------- -------------

 AKTIVA
 Kurzfristige Vermögenswerte:
 Zahlungsmittel und Zahlungsmitteläquivalente $ 3743357 $ 20795398
 Zur Veräußerung verfügbare Wertpapiere 72000 96000
 Rechnungsabgrenzungsposten und sonstige kurzfristige
  Vermögenswerte 738491 489293
                                          ------------- -------------
  Total Umlaufvermögen 4553848 21380691

 Sachanlagen, netto 445436 432529
 Sicherheit hinterlegte liquide Mittel 125000 125000
 Debt Issuance Kosten 1395296 1423380
                                          ------------- -------------
 Summe der Aktiva $ 6519580 $ 23361600
                                          ============= =============

 Verbindlichkeiten und Eigenkapital
  (VERLUST)
 Kurzfristige Verbindlichkeiten:
 Verbindlichkeiten aus Lieferungen und Leistungen $ 270311 $ 1682739
 Rückstellungen für sonstige Aufwendungen 187330 496239
 Rückstellungen für Personalkosten im Zusammenhang Aufwendungen 637600 763050
 Anlagen Leased: kurzfristige 48085 13919
 Rückstellungen für die Kosten der klinischen Entwicklung 2092441 1156011
                                          ------------- -------------
  Laufende Verbindlichkeiten insgesamt 3235767 4111958
                                          ------------- -------------

 Schuldscheindarlehen 2189716 2025624
 Warrant Verbindlichkeiten 2032523 4232355
 Anlagen Leased: langfristige 58680 33861
                                          ------------- -------------
 Total langfristige Verbindlichkeiten 4280919 6291840
                                          ------------- -------------
 Passiva insgesamt 7516686 10403798
 Haftungsverhältnisse und sonstige finanzielle Verpflichtungen

 Eigenkapital (Defizit):
 Stammaktien, $ 0,001 Nennwert:
  100.000.000 genehmigten Aktien
  32.386.130 und 32.169.553 Aktien
  und im Umlauf am 30. September 2008
  und 31. Dezember, 2007 bzw. 32386 32170
 Kapitalrücklage 103.903.612 101.843.390
 Kumuliertes sonstiges Gesamtergebnis: (20000) (104000)
 Bilanzverlust (104.913.104) (88813758)
                                          ------------- -------------
 Summe Eigenkapital (Defizit) (997106) 12957802
                                          ------------- -------------
 Passiva, gesamt "
  Eigenkapital (Defizit) $ 6519580 $ 23361600
                                          ============= =============


                       Hana Biosciences, Inc.
   Verkürzte Gewinn-und Verlustrechnungen und andere umfassende Verlust
                             (Ungeprüft)

                     Drei Monate zum Neun Monate beendet
                        30. September, 30. September,
                  ------------------------ --------------------------
                     2008 2007 2008 2007
                  ----------- ----------- ------------ ------------
 Lizenz-Einnahmen $ - $ 1150000 $ - $ 1150000

 Betriebsergebnis
  Kosten:
 Allgemeine und
  Verwaltungsvorschriften 973414 481155 4623889 6553502
 Forschung und
  Entwicklung 4347265 5730859 13031060 17442556
                  ----------- ----------- ------------ ------------
 Der Geschäftsaufwand
  Ausgaben 5320679 6212014 17654949 23996058

 Verlust aus
  Operationen (5320679) (5062014) (17654949) (22846058)
                  ----------- ----------- ------------ ------------

 Sonstige Erträge
  (Aufwand):
 Zinserträge 39.997 265.307 271.361 972.932
 Zinsaufwand (254.569) (1138) (756.211) (3807)
 Übriger Aufwand,
  net (8516) (42.418) (51.380) (61.057)
 Gewinn oder Verlust aus
  Derivat von 382152 bis 2199833 --
 Realisierte Verluste auf
  marktfähige
  Wertpapiere - (260.000) (108.000) (436.000)
                  ----------- ----------- ------------ ------------
 Anzahl der anderen
  Erträge (Aufwendungen) 159064 (38249) 1555603 472068

 Net loss $ (5161615) $ (5100263) $ (16099346) $ (22373990)
                  =========== =========== ============ ============
 Ergebnis je
  Aktie, unverwässert
  und verwässert $ (0,16) $ (0,16) $ (0.50) $ (0.75)
                  =========== =========== ============ ============

 Gewichteter Durchschnitt der
  Aktien, die in
  Netto-Computing
  Das Ergebnis je Aktie,
  Grund-und
  verdünnten 32385366 31197295 32265010 29958487
                  =========== =========== ============ ============
 Umfassende
  Verlust:
 Net loss $ (5161615) $ (5100263) $ (16099346) $ (22373990)
 Nicht realisierte
  Betriebe Gewinne
  (Verluste) aus
  während der
  Zeitraum (20000) - (128.000) (456.000)
 Abzüglich:
  Neueinstufung
  Berichtigung für
  Verluste enthalten
  der Netto-Verlust - - 108.000 436.000
                  ----------- ----------- ------------ ------------

 Umfassende
  Verlust $ (5181615) $ (5100263) $ (16119346) $ (22393990)
                  =========== =========== ============ ============



Kontakt:
          Hana Biosciences
          Investor & Media Contacts:
          Investor Relations Team
          (650) 588-6641
          investor.relations @ hanabiosciences.com

          Beleben Communications
          Gregory Gin
          (908) 376-7737
          ggin@invigoratepr.com


-------------------------------------------------- ------------------------------
Quelle: Hana Biosciences, Inc.

Da bin ich ja mal gespannt.


Hana Biosciences to Present Data On Marqibo, Its Lead Novel Anti-Cancer Compound, At 2008 American Society of Hematology (ASH) Meeting
Monday December 1, 7:30 am ET


SOUTH SAN FRANCISCO, Calif., Dec. 1, 2008 (GLOBE NEWSWIRE) -- Hana Biosciences (NasdaqCM:HNAB - News), a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that several presentations related to the Company's lead anti-cancer compound, Marqibo(r) (vincristine sulfate injection, OPTISOME(tm)), will be presented at the upcoming annual meeting of the American Society of Hematology (ASH) in San Francisco during December 6-9, 2008.
The following posters will be presented in Hall A of the Moscone Center at the ASH annual meeting. Text of these abstracts can be viewed on the ASH website at www.hematology.org.


* In Vivo Anti-Tumor Efficacy of Vincristine Sulfate Liposomes
  Injection (VSLI, Marqibo) in Multiple Myeloma   (abstract #2760;
  Sunday, Dec. 7, 6:00 PM)

* Peripheral Neuropathy Profile of Vincristine Sulfate Liposomes
  Injection (VSLI, Marqibo), a Nanoparticle Vincristine Formulation,
  in Adult Subjects with Relapsed/Refractory Acute Lymphoblastic
  Leukemia (ALL) and Non-Hodgkin's Lymphoma (NHL)  (abstract #2928;
  Monday, Dec. 8, 5:30 PM)

* Phase 1 Study of Weekly Vincristine Sulfate (VCR) Liposomes
  Injection (VSLI, Marqibo) Plus Dexamethasone in Adults with Relapsed
  or Refractory Acute Lymphoblastic Leukemia (ALL) (abstract #2930;
  Monday, Dec. 8, 5:30 PM)

About Hana Biosciences, Inc.

Hana Biosciences, Inc. (NasdaqCM:HNAB - News) is a South San Francisco, CA-based biopharmaceutical company focused on acquiring, developing, and commercializing innovative products to strengthen the foundation of cancer care. The company is committed to creating value by building a best-in-class team, accelerating the development of lead product candidates, expanding its pipeline by being an alliance partner of choice, and nurturing a unique company culture. Further information on Hana Biosciences can be found at www.hanabiosciences.com.

The Hana Biosciences, Inc. logo is available at www.globenewswire.com/newsroom/prs/?pkgid=3290



Contact:
         Hana Biosciences
         Investor & Media Contacts:
         Investor Relations Team
         (650) 588-6641
         investor.relations@hanabiosciences.com

         Invigorate Communications
         Gregory Gin
         (908) 376-7737
         ggin@invigoratepr.com


--------------------------------------------------
Source: Hana Biosciences, Inc.

Und da kommen sie wieder aus ihren Löchern gekrochen...  

und versprechen 1000de von Prozenten....

irgendwoher kenne ich das doch!?    Hana Biosciences...Analysen von kleinen deutschen Zockern...    

Man staune und wundere sich wie kleine deutsche Zocker - Analysen über amerikanische Bio Titel aus der Tasche zaubern...als seien sie vor Ort gewesen und dem Treiben dieser unbedeutenden   Bio-Wunder zugeschaut haben.     Eher ist es wohl so, dass man sich auf Micro-Penny Stock Niveau  mit "Zertifikaten" eingedeckt hat ...und nun die vermeindlich billigen Zettel mit vollmundigen Gewinnversprechen den deutschen Lemmingen   aufs Auge drücken will....Der Trick ist uralt!    

Es hat schon seinen Grund warum solche Titel abgestürzt sind!   Die Biowunder versprechen viel und machen n u r Verluste. In USA notieren 1000e solcher Biotüten in verschiedenen Indizies.

Paradebeispiel Biophan 0,001 wo stand der Titel mal!?

Heisse Luft..viele krabbeln am Existenzminimum und bei den Meisten wird irgendwann mit Sicherheit das Licht ausgehen. Weil der Energieversorger gesperrt hat.

Sie forschen sich zu Tode...und forschen und forschen, bis ein Wunder geschieht?    Nur wenigen gelang es sich über 1 Dollar zu halten. Im Gegenteil, die Richtung ist vorbestimmt 0,10 $ und darunter. Bis ein letztes Aufbäumen - die Gier nach schnellem Geld einige Lemminge zum Kauf verführt.    

Man sollte genau überlegen in was man sein gutes Geld tauscht, besser in Premiumwerte investieren Eli Lilly, Fizer, Amgen usw. und nicht in irgendwelche Zockerbuden...die Geld nur verbrennen.

 

 

Drittes Quartal 2008 Financial Results

 

Das Unternehmen berichtete einen Nettoverlust von:

5,2 Millionen Dollar oder 0,16 Dollar je Aktie. 

 

 

 

 

 

 

und mit 300 Stückchen wieder hochgezogen ...ein jämmerliches Bild...

 

USA 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

am Freitag.
Auffällig ist das hohe Volumen. Hier wurden mehr Aktien gehandelt als an den restlichen Wochentagen  zusammen.
Sind etwa schon im Vorfeld Ergebnisse vorder Veröffentlichung durchgesickert? Oder sind es positive Erwartungen auf gute News?
Mal schauen, morgen wissen wir mehr.

"We are encouraged by these study results that show study subjects experienced no appreciable systemic absorption of menadione at any concentration, which supports previously reported preclinical data that showed menadione does not interfere with the anti-cancer activity of EGFR inhibitors," said Steven R. Deitcher, M.D., President and Chief Executive Officer of Hana Biosciences. "We are very excited about the potential for this promising novel agent and are convinced that successful prevention and treatment of this skin toxicity is needed to maintain compliance of the anti-cancer therapy."

Acneiform rash is a common, painful, and treatment-limiting skin toxicity side effect of all EGFR inhibitors (e.g. Tarceva(r), Iressa(r), Erbitux(r), Vectibix(r)) with incidence rates as high as 90%. The skin rash can lead to reduced compliance and cause dose reductions, delays or discontinuation of EGFR inhibitor therapy in a significant portion of affected patients. Currently, there are no products or therapies FDA-approved to treat these skin toxicities.

Results from past preclinical studies demonstrated that menadione does not affect the anti-tumor effect of erlotinib (Tarceva(r)), an approved EGFR inhibitor. Other preclinical data showed menadione's ability to restore kinase activity in the presence of specific kinase inhibitors. These data indicate that treatment with menadione may result in restoration of normal cell turnover rates and prevent skin toxicities that result from inhibition of protein kinases associated with tumor growth signaling pathways, such as the tyrosine kinases EGFR, MEK, CDK and RAF.

In the completed Phase 1 study, adverse events considered at least possibly related to menadione that occurred most frequently included skin erythema and burning sensation that increased in frequency with concentration levels.

A Phase 1 study in patients receiving EGFR inhibitors for anti-cancer therapy in both rash emergent and rash pre-emergent settings is ongoing, and the Company expects to initiate a randomized Phase 2 trial during the first half of 2009.

About Menadione Topical Lotion

Menadione, a small organic molecule, is a novel, potential first-in-class compound that is designed to prevent or treat skin toxicity associated with epidermal growth factor receptor (EGFR) inhibitor anti-cancer therapy. EGFR inhibitors, or EGFRIs, are currently used to treat over 100,000 patients per year with a variety of cancers including non-small cell lung, pancreatic, colorectal, and head & neck cancer. Loss of EGFR signaling has been hypothesized as a mechanism of skin toxicity in patients receiving EGFRIs. The rash occurs primarily on the face, neck, and upper torso.

Menadione has been shown to activate the EGFR signaling pathway by blocking phosphatase activity in preclinical studies. In vitro studies suggest that topically-applied menadione may restore EGFR signaling at the dermal/epidermal junction, which could prove beneficial to patients who receive EGFRI cancer therapy. Hana Biosciences in-licensed menadione from the Albert Einstein College of Medicine in New York in October 2006. A Phase 1 clinical trial is ongoing in the U.S. and Canada.

About Hana Biosciences, Inc.

Hana Biosciences, Inc. (Nasdaq:HNAB) is a South San Francisco, CA-based biopharmaceutical company focused on acquiring, developing, and commercializing innovative products to strengthen the foundation of cancer care. The company is committed to creating value by building a best-in-class team, accelerating the development of lead product candidates, expanding its pipeline by being an alliance partner of choice, and nurturing a unique company culture. Further information on Hana Biosciences can be found at www.hanabiosciences.com.

der Puscher-Trick hat nicht funktioniert.
Heute weiterer Absturz um -26%...

Auf so was fällt niemand mehr rein.
HANA (HAHA) Bioscience war auch mal DIE Biotech-Perle vom Aktionär.
Wobei die Betonung auf UNENTDECKT lag.

Aber damals bewegte man sich noch bei 6 Euros.
Heute sinds noch 15 cents

news.prnewswire.com/.../story/03-03-2009/0004981720&EDATE=

Schönes Plus in den USA. Kommt hier bald was Großes?

Hana Biosciences: Primed for a Major Comeback

 

 

It looks like the perfect storm is brewing for Hana Biosciences (HNAB).

In December, the stock took a major hit for no reason other than possibly some impatient investors selling off. Going into what should be a very positive year with a new drug application (NDA) filing for their drug Marquibo after successful trial results, this stock is primed for some major movement in the near future; first a reset to the 60-80 cent level, then a move higher as the NDA is filed.

The December publication of results from the rALLy trial in acute lymphoblastic leukemia (ALL) in second relapse shows that the drug was highly efficient as a single-agent in a very sick patient population who have few other options. There are no safety concerns beyond what is expected for this type of drug. The FDA has a history of approving ALL treatments based on phase II single-arm clinical trials, and Hana intents to use the results of the rALLy trial in their NDA filing later on this year. Accelerated approvals have already been given for the drugs Clolar and Arranon for other ALL indications based on single-arm phase II studies.

The company released a corporate presentation last week. Click the link for a pdf version of the presentation.

Marquibo is a new form of a trusted cancer drug, vincristine sulfate, in a liposome delivery vehicle. This delivery mechanism enables higher doses of the drug to be used while reducing the side effects. In the long run, Hana hopes to replace the use of generic vincristine with Marquibo in the R-CHOP leukemia treatment regimen across the board, a predicted market potential of $2.5 billion annually. The 2nd relapsed adult ALL market alone is $100 million with 65% penetration, see the company's slide number 23. The choice of second relapse adult ALL is a good strategy to enter the market. The drug was previously scrutinized by the FDA's oncology drug advisory committee in December of 2004 for another indication,aggressive non-Hodgkin's lymphoma previously treated with at least two combination chemotherapy regimens. At the time, the drug was owned by Inex Pharmacuticals. The NDA in 2004 was also based on phase II clinical trials, and although it showed equivalence, it did not show superiority to other current treatments - Inex had chosen the wrong pathway for approval. It is important to note that the committee members were otherwise very positive to the drug and no safety questions were raised. This time around, the rALLy trial has shown a major advantage to the patients over historical data, and the primary investigator for the rALLy trial is none other than Dr. Susan O'Brien, a leading expert on leukemia treatment with strong clinical trial experience.
For those who enjoy reading stock charts, the consensus is that HNAB is currently due for a major reset, unrelated to other upcoming events. This annotated chart was prepared by user EpicStocks on InvestorsHub, and tells the tale very nicely. It is rare to come across a biopharma stock with upcoming drug submissions and a perfect chart situation, this is the first in some time. The company has cash to last until the NDA submission, and more on tap through Deerfield Management, who has a seat on the board of directors. Some minor dilution is expected as we move forward, but this is still a company with a low float, currently at only 92 million shares outstanding with a float of 81 million shares.

Disclosure: Long HNAB

http://seekingalpha.com/article/...-for-a-major-comeback?source=yahoo

 

DALLAS, Jan. 25, 2010 (GLOBE NEWSWIRE) -- BeaconEquity.com announces an investment report featuring biopharmaceutical company Hana Biosciences Incorporated (OTCBB:HNAB - News). The report includes financial, comparative and investment analyses, and industry information you need to know to make an educated investment decision. 

 

The full report is available at: http://www.beaconequity.com/i/HNAB

 

 

Get our alerts BEFORE the rest of the market. Follow us on Twitter: http://twitter.com/BeaconEquity

 

 

Hana Biosciences Incorporated (HNAB) engages in the biotechnological development and commercialization of cancer therapies to enhance efficacy to current standard-of-care protocols for the treatment of various cancers. The Company presently has four drug candidates under development, including Marqibi ®, Menadione Topical Lotion, Brakiva (TM) and Alocrest (TM).

 

In the report, the analyst notes:

 

"As of September 30, the Company's drug candidate Marqibo is in phase II for the treatment of metastatic uveal melanoma. The Company achieved its target enrollment in 2009, with plans for a confirmatory trial of the drug in 2011 and intentions to file for a New Drug Applications (NDA) with the Food and Drug Administration (FDA) in 2010. Further progression toward commercialization of Marqibo is dependent upon pending results of phase II studies. 

 

"The Company expects to report an additional $5.0 million of expenses related to Marqibo in its coming fourth-quarter earnings report. In its latest 10-Q filing in October, the Company said it needs an additional $8.0 million for an accelerated approval of Marqibo and $45.0 million for full FDA approval. Marqibo is expected to undergo three to four more years of development and FDA approval time before the Company can embark with commercialization of the product."

 

To read the entire report visit: http://www.beaconequity.com/i/HNAB

 

 

See what investors are saying about these stocks at penny stock forum. 

 

BeaconEquity.com is one of the industry's largest small-cap report providers striving to provide a balanced view of many promising small-cap companies that would otherwise fall under the radar of the typical Wall Street investor. We provide investors with an excellent first step in research and due diligence by providing daily trading ideas, and consolidating the public information available on them. For more information on Beacon Research, please visit http://www.BeaconEquity.com

 

 

Beacon Equity Disclosure

DO NOT BASE ANY INVESTMENT DECISION UPON ANY MATERIALS FOUND ON THIS REPORT. We are not registered as a securities broker-dealer or an investment adviser either with the U.S. Securities and Exchange Commission (the "SEC") or with any state securities regulatory authority. We are neither licensed nor qualified to provide investment advice. Beacon Equity nor its affiliates have a beneficial interest in the mentioned company; nor have they received compensation of any kind for any of the companies listed in this communication. The information contained in our report is not an offer to buy or sell securities. We distribute opinions, comments and information free of charge exclusively to individuals who wish to receive them.

http://finance.yahoo.com/news/...-Hana-pz-604084091.html?x=0&.v=1

"Kommt bei Hana ein Rebound?" war die Frage? Antwort: JA. Begründung? Marqibo funktioniert. Das Krebs-Chemo-Sulfat Vincristine in der "Optisome" -modifizierten Darreichungsform heilt eine signifikante Anzahl von Probanden - noch dazu rückfällige oder auf eine herkömmliche Vincristine-Therapie nicht ansprechende ALL-Todeskandidaten. Dieses, soweit ich es prüfen kann, seriöses Zwischenergebnis der multinationalen rALLy-Studie ist ein Hammer und wird in sehr absehbarer Zeit ( Fast Track bereits erteilt ) zu einer Markteinführung von Marqibo als alternative Medikation bei lymphoblastischer Leukämie führen. Und das wäre der Startschuß für eine neue Medikamentengattung, denn der Lipidkügelchen-Trick ist übertragbar - und patentrechtlich geschützt! Hana ist an der Börse nahezu "wertlos", klassisches gemitteltes Kurs / Umsatz-Verhältnis von Drugmakern liegt so bei 2,5. Kursphantasie? 20 Dollar in 2-3 Jahren. Read my lips. Ich lasse mich an diesem Statement messen.

 

Skymark Research Initiates Independent Research Coverage on Hana Biosciences

 

CALGARY, Alberta, Jan. 26, 2010 (GLOBE NEWSWIRE) -- Skymark Research, a leading provider of small- and micro-cap independent investment research, today initiated coverage on Hana Biosciences (OTCBB:HNAB - News).   Skymark Research is currently offering a complimentary trial subscription. To view our research go to: www.skymarkresearch.com

 

 

About SMR:

 

Skymark Research is a leading provider of independent investment research in North America. Our services include research analysis on the small- and micro-cap markets, real-time news and financial data, market commentary and the SMR newsletter. Skymark Research's staff of small-cap investment professionals is dedicated to providing the small market's investment community with the tools and avenues necessary to make the important investment decisions. To view our research reports on a complimentary trial basis and take advantage of our other services, go to www.skymarkresearch.com and click on the complimentary trial subscription button on our home page, or go directly to our registration page at www.skymarkresearch.com/signup.php

 

 

The Skymark Research logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=6683

 

 

About  Hana Biosciences (OTCBB:HNAB - News)

 

Hana Biosciences (OTCBB:HNAB - News) is a biopharmaceutical company dedicated to developing and commercializing new, differentiated cancer therapies designed to improve and enable current standards of care. The Company's lead product candidate, Marqibo^(R), potentially treats acute lymphoblastic leukemia and lymphomas. The Company has additional pipeline opportunities, some of which, like Marqibo, improve delivery and enhance the therapeutic benefits of well characterized, proven chemotherapies and enable high potency dosing without increased toxicity.

 

SMR Disclosure:

 

http://finance.yahoo.com/news/...ates-pz-2408557104.html?x=0&.v=1

Das Hana Biosciences kurz vor dem durchbruch ist ;-)

 

 

Neuer Run auf Biotech: Drei heiße Aktien vor der Entscheidung

 

Marqibo® (vincristine sulfate liposomes injection, OPTISOME™)
A Novel Targeted Nanoparticle-encapsulated Anti-Cancer Compound currently for Acute Lymphoblastic Leukemia (ALL) and Melanoma. Marqibo® has a robust safety database (over 600 patients) and has been extensively evaluated in lymphoid blood cancers such as non-Hodgkin’s lymphoma (NHL) and ALL. Hana has ongoing (or planned) clinical trials which may enable an accelerated approval in 2 indications. Future clinical trial development possible in multiple indications including NHL and melanoma. More Details »

Hana Biosciences reports positive results from Phase II leukemia trialPosted on: Fri, 11 Dec 2009 00:29:00 EST

About  Hana Biosciences (OTCBB: HNAB)

Hana Biosciences (OTCBB: HNAB) is a  biopharmaceutical company dedicated to developing and commercializing new,  differentiated cancer therapies designed to improve and enable current standards  of care. The Company's lead product candidate, Marqibo^(R), potentially treats acute lymphoblastic leukemia and  lymphomas. The Company has additional pipeline opportunities, some of which,  like Marqibo, improve delivery and enhance the therapeutic benefits of well  characterized, proven chemotherapies and enable high potency dosing without  increased toxicity.

SMR Disclosure:

Skymarkresearch.com is not a registered  investment advisor and nothing contained in any materials should be construed as  a recommendation to buy or sell any securities. Skymark Research has not been  compensated by any of the above mentioned companies. Please read our report and  visit our Web site, www.skymarkresearch.com, for complete risks and disclosures.

http://www.benzinga.com/pressreleases/g99363/skymark-research-initiates-independent-research-coverage-on-hana-biosciences

Hana Biosciences (OTC:HNAB) set for a comeback

Written by R. Saito

Thursday, 21 January 2010 10:27

It looks like the perfect storm is now brewing for Hana Biosciences (OTC:HNAB). In December, this penny bio stock took a major hit for no reason other than an impatient investor sell off.
Going into what should be a very positive year with a new drug application (NDA) filing for their drug Marquibo after successful trial results, this stock is prime for some major movement in the near future; first a reset to the 60-80 cent level, then a move higher as the NDA is filed. 

The December publication of results from the rALLy trial in acute lymphoblastic leukemia (ALL) in second relapse shows that the drug was highly efficient as a single-agent in a very sick patient population who have few other options. There are no safety concerns beyond what is expected for this type of drug. The FDA has a history of approving ALL treatments based on phase II single-arm clinical trials, and Hana intents

to use the results of the rALLy trial in their NDA filing later on this year.  

 approvals have already been given for the drugs Clolar and Arranon for other ALL indications based on single-arm phase II studies. The company released a corporate presentation last week, the presentation can be found here. 

Marquibo is a new form of a trusted cancer drug, vincristine sulfate, in a liposome delivery vehicle. This delivery mechanism enables higher doses of the drug to be used while reducing the side effects. In the long run, Hana hopes to replace the use of generic vincristine with Marquibo in the R-CHOP leukemia treatment regimen across the board, a predicted market potential of $2.5B annually. 

The 2nd relapsed adult ALL market alone is $100M with 65% penetration, see the company's slide number 23. The choice of second relapse adult ALL is a good strategy to enter the market. The drug was previously scrutinized by the FDA's oncology drug advisory committee in December of 2004 for another indication,aggressive non-Hodgkin's lymphoma previously treated with at least two combination chemotherapy regimens. At the time, the drug was owned by Inex Pharmacuticals. The NDA in 2004 was also based on phase II clinical trials, and although it showed equivalence, it did not show superiority to other current treatments - Inex had chosen the wrong pathway for approval. 

It is important to note that the committee members were otherwise very positive to the drug and no safety questions were raised. This time around, the rALLy trial has shown a major advantage to the patients over historical data, and the primary investigator for the rALLy trial is none other than Dr. Susan O'Brien, a leading expert on leukemia treatment with strong clinical trial experience.

For those who enjoy reading stock charts, the consensus is that HNAB is currently due for a major reset, unrelated to other upcoming events. 

It is rare to come across a biopharma stock with upcoming drug submissions and a perfect chart situation, this is the first in some time. 

The company has cash to last until the NDA submission, and more on tap through Deerfield Management, who has a seat on the board of directors. Some minor dilution is expected as we move forward, but this is still a company with a low float, currently at only 92 million shares outstanding with a float of 81 million shares. 

http://biomedreports.com/images/stories/food/hanachart.gif

http://biomedreports.com/articles/most-popular/...for-a-comeback.html

Hana Biosciences to Present at the 12th Annual BIO CEO & Investor Conference

Press Release Source: Hana Biosciences, Inc. On Monday February 1, 2010, 7:30 am EST

SOUTH SAN FRANCISCO, Calif., Feb. 1, 2010 (GLOBE NEWSWIRE) -- Hana Biosciences (OTCBB:HNAB - News), a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that the executive management team will participate in the 12^th Annual BIO CEO & Investor Conference to be held February 8 through February 9, 2010 in New York City at the Waldorf-Astoria.

 

Steven R. Deitcher, M.D., President and Chief Executive Officer, is scheduled to present an overview of the company and its pipeline programs at 10:00 am Eastern Time on Monday, February 8, 2010.

 

A live audio web cast of the presentation will be available for 10 business days on the company’s website at www.hanabiosciences.com.

 

About Hana Biosciences, Inc.

 

Hana Biosciences, Inc. is a biopharmaceutical company dedicated to developing and commercializing new, differentiated cancer therapies designed to improve and enable current standards of care. The company's lead product candidate, Marqibo®, potentially treats acute lymphoblastic leukemia and lymphomas. The Company has additional pipeline opportunities, some of which, like Marqibo, improve delivery and enhance the therapeutic benefits of well characterized, proven chemotherapies and enable high potency dosing without increased toxicity. Additional information on Hana Biosciences can be found at www.hanabiosciences.com.

 

The Hana Biosciences, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3290

 

 

 

Contact:

Hana Biosciences
Investor & Media Contacts:
Investor Relations Team
(650) 588-6641
investor.relations@hanabiosciences.com
Burns McClellan
Rebecca Birbach

http://finance.yahoo.com/news/Hana-Biosciences-to-Present-pz-484620252.html?x=0&.v=1

Hana Biosciences, Inc. (HNAB.OB) Corporate Event Announcement Notice

Trade updates on NewCardio, Inc (OTC:NWCI) , NeoStem (Amex: NBS), Hana Biosciences (OTC:HNAB), CytRx Corporation (NASDAQ:CYTR) 

In short, some people are feeling a bit edgy about so much of the red that has filled ther trading screens, following the worst two-day stretch the market has seen since June.

President Obama caused some of that when he asked Congress for limits on how large big banks can grow to become and to end some of the risky trading large financial companies have used in recent quarters to boost profits. As we saw during the banking crisis, whether we like it or not, the market goes as the banks go. Big money has big influence and if big money isn't happy, the market's going to suffer.

That being said, careful analysis (both technical and fundamental) as well as careful research into forward looking and breaking news events will continue to help us guide our subscribers and readers to make better decisions. For example, even as the rest of the market imploded yesterday, our subscriber alert and article about Hana Biosciences (HNAB) brought so much volume and attention to the stock, that the price went from a day low of $.195 to a high of $.28. In addition, HNAB's chart still looks strong and possibly ready to run more. If you like bottom rebound plays like that, you'll definitely be interested in the one we're currently researching and will be posting for subscribers today, shortly after the market opens. Everyone else will see it an hour or two later.

NeoStem (NBS), who we spotlighted with a CEO interview this week went from $1.72 to $2.07 before investors were spooked by the company's new Securities Registration Statement filing (Form Type: S-1/A)- which appeared just as we were publishing our interview with Robin L. Smith M.D., Chairman of the Board and Chief Executive Officer. The stock has pulled back a bit and closed at $1.76 yesterday, but that's only because investors may be mis-reading the filing. Let me assure you of one thing. NeoStem is going places now that they've acquired a controlling interest in China based Suzhou Erye Pharmaceuticals Company Ltd. They have now transitioned into a multi-dimensional international biopharmaceutical company that will be doing some incredibly interesting things to not only help develop their science in a country that is much more receptive to open stem cell research, but they'll also be leveraging that pharmaceutical company's income and distribution resources to generate even more revenue and value for their shareholders. That filing, upon closer inspection, leads me to believe that big news is coming followed by some form of dilution that, in short order, will be absorbed and result in a higher share price as the company moves forward on multiple fronts. Let's not forget that there was some interesting insider buying recently and that the promise of their VSEL (very small embryonic-like) stem cell technology, which is what got most investors into NBS to begin with.

I've received more email about NewCardio, Inc (NWCI) than any other company the last two days. The stock went crazy after I revealed news of a possible buy-out. Then it pulled back the last two days, causing many to get nervous. I'm going to stand by my initial report and add the following: It now looks like there may be at least two interested partners/deals in the works. If my sources are correct, and for the record these are not public relations people or stock pumpers, then this undervalued play could become a big story not only in the short term, but a very solid winner for the long haul as well. I'm not hyping or sticking my neck out for this, folks. I'm simply reporting what I am hearing. How does a move to a bigger exchange sound? That could also be in play here, but revealing too many details could expose my sources or theirs, so I'll stop here. Instead, I'll I refer you to this article and to this one. Remember, these types of deals don't happen overnight. Patience is always key. By the same token, remember that one of the shoes can drop at any moment, so be ready. For those who think this is some sort of pump and dump scheme on my part, know this: I'm still long and own every single one of my original shares and if it pulls back, I'll pick up even more. I suggest you do your own due diligence here. Rumor plays are always risky, but do offer high rewards.

Finally, if you missed the press release about CytRx Corporation (CYTR) yesterday, you may want to read it. I'd like you to consider and compare what they've started to reveal publicly as a company against what I said in my articles about them late last year (I felt this was a $10+ stock by the fourth quarter of 2010 when i wrote that). Is it me or does everything appear to be on track over there? Hope you all have a great weekend!

Disclosure: Long NBS, NWCI

 

http://studio-5.financialcontent.com/boston/...wer&ChannelID=6573

Hana Biosciences hat nach Jahren das Medikament Marqibo® kurz vor der Endphase und di letzten Tagen sind Große Pakete Aktien in Umlauf gekommen...Das passiert meistens vor gute News also Augen aufhalten und

mit profitieren vor eine mögliche Wiedereintritt der Aktie in höheren Preisklassen ;-)   

Schaut euch das Volumen an ;-))

http://finance.yahoo.com/q/...=on&z=m&q=l&p=&a=&c=

Form 8-K for HANA BIOSCIENCES INC

11-Mar-2010

Change in Directors or Principal Officers

Item 5.02 Departure of Directors or Certain Officers; Election of Directors;
Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

On March 11, 2010, Hana Biosciences, Inc. (the "Company") announced the appointment of Craig W. Carlson as its Vice President and Chief Financial Officer, effective April 1, 2010. Mr. Carlson, age 62, has held senior leadership and executive financial management positions for the past 25 years, including positions at two public healthcare companies. Most recently, from February 2009 to February 2010, Mr. Carlson served as Chief Financial Officer and Chief Operating Officer for 20 Cent Ventures, a new business incubator focused primarily on applying life science technologies to high value niche opportunities worldwide, where he was responsible for managing several businesses, including four international subsidiaries. From July 2006 to March 2008, he was Chief Financial Officer of Neurobiological Technologies, Inc. and from 1993 to 2005 Mr. Carlson worked at Cygnus, Inc where he served as Chief Financial Officer and Chief Operating Officer. Mr. Carlson received his M.B.A. from the Stanford Graduate School of Business, his M.S. Ed. in Counseling from Hofstra University, and his B.A. in Political Science from Union College.

The terms of Mr. Carlson's employment with the Company are set forth in a letter agreement dated February 5, 2010, as amended on February 17, 2010 (together, the "Agreement"). Pursuant to the Agreement, Mr. Carlson's employment with the Company commenced March 1, 2010, but his appointment as Chief Financial Officer will not be effective until April 1, 2010. The Agreement provides that he will receive an annualized base salary of $295,000 and is eligible to receive an annual performance cash bonus in an amount up to 30% of his annualized base salary. In addition, upon the commencement of his employment, Mr. Carlson was granted a 10-year stock option to purchase 350,000 shares of the Company's common stock at an exercise price of $0.19 per share. The stock option was awarded pursuant to the Company's 2010 Equity Incentive Plan and is evidenced by a stock option agreement dated March 1, 2010 in the Company's standard form of agreement for use under the 2010 Equity Incentive Plan. Mr. Carlson is entitled to an additional stock option grant for up to 250,000 shares if the Company completes a financing transaction resulting in proceeds to the Company of specified amounts.

The Agreement further provides that if the Company terminates Mr. Carlson's employment without "cause," or if he terminates his employment for "good reason," then he is entitled to continue receiving his then current annualized base salary and medical benefits for a period of six months following such termination. For purposes of the Agreement, the term "cause" means the following actions committed by Mr. Carlson:

� willful and repeated failure, disregard or refusal by to perform his employment duties, or his willful misconduct in respect of his duties or obligations;

� willful, intentional or grossly negligent act having the effect of materially injuring (whether financial or otherwise) the Company's business or reputation or any of its affiliates;

� conviction of any felony or a misdemeanor involving a crime of moral turpitude;

� engagement in illegal harassment;

� misappropriation or embezzlement by of Company property; or

� a material breach by of any of his obligations under any other agreement or Company policy.

The term "good reason" means (i) a reduction in Mr. Carlson's annual base salary or annual target bonus rate or a material reduction in the benefits provided to him, taken as a whole, in each case without his consent, but not if all senior executives of the Company also incur such reduction in compensation or other benefits, or (ii) a significant reduction in Mr. Carlson's duties and responsibilities, but in each case after the Company has failed to correct such event after 30 days' written notice from Mr. Carlson.

---

Upon his appointment to Chief Financial Officer, Mr. Carlson will succeed Tyler M. Nielsen, who has been the Company's Interim Chief Financial Officer since November 2009. Mr. Nielsen will continue his role as the Company's Controller upon the effective time of Mr. Carlson's appointment.

http://biz.yahoo.com/e/100311/hnab.ob8-k.html

Immerhin steht das Statement, MARQIBO noch in 2010 zur Zulassung als Medikation gegen rALL ( rückfällige adulte lymphoblastische Leukämie ) zu bringen. Sollte dies gelingen, wird eine Markteinführung SEHR kurzfristig erfolgen können, da die NDA bereits "Fast Track Status" erteilt hat. Dem Kursverfall nach zu urteilen, ist Hana "tot", meines Erachtens ein ungerechtfertigtes Urteil, da die alles entscheidende multinationale "rALLy"-Studie bisher durchweg positive Ergebnisse produziert hat und nun alles von der Datenaufbereitung und Beurteilung durch die Zulassungsbehörde abhängen wird. Einem Venture Capital-investor waren die Chancen der "Optisome"-Technologie ( bereits zugelassene Wirkstoffe in neuer Dareichungsform, nämlich eingeschlossen in winzigen Lipidkügelchen, um bei gleicher Dosierung die Nebenwirkungen zu verringern bzw. bei gleichen Nebenwirkungen mehr Wirkstoff anzubringen ) immerhin 30 Millionen Dollar Kredit wird. Auch der eine oder andere durchaus namhafte Mediziner entert von Zeit zu Zeit das Board of Directors der kleinen, nichtsdestoweniger hoffnungsvollen Drugmaker-Klitsche aus Nordkalifornien. Ich hab vor einiger Zeit eine fünfstellige Aktienanzahl zum Junk-Bond-Preis gebunkert und lasse ganz entspannt das Jahr vorübergehen. Nach hart erkämpften Gewinnen mit AIG, MGM und ähnlichen Killer-Aktien mal ne gaaaanz relaxte Sache. Das sich in den einschlägigen Foren ( noch ) nichts regt, halte ich übrigens für ein gutes Zeiten. Wenn der "Aktionär" und ähnliche A(...) HNAB empfehlen würden, wäre ich deutlicher skeptischer ;-))

2010 Objectives

 

• Hold a pre-New Drug Application (NDA) meeting for Marqibo in the second quarter of 2010;
• Provide menadione intellectual property update in mid-2010;
• Present top-line proof-of-concept data of menadione in mid-2010;
• Initiate rolling NDA submission for Marqibo in adult ALL in mid-2010;
• Initiate Marqibo's pediatric program sponsored by the Center for Cancer Research at the National Cancer Institute in the second half of 2010;
• Initiate Phase 2 randomized trial of menadione in the second half of 2010; and
• Present final Marqibo rALLy data from all 65 patients at a medical conference.

 

About Hana Biosciences, Inc.

 

Hana Biosciences, Inc. is a biopharmaceutical company dedicated to developing and commercializing new, differentiated cancer therapies designed to improve and enable current standards of care. The company's lead product candidate, Marqibo(R), potentially treats acute lymphoblastic leukemia and lymphomas. The Company has additional pipeline opportunities some of which, like Marqibo, improve delivery and enhance the therapeutic benefits of well characterized, proven chemotherapies and enable high potency dosing without increased toxicity. Additional information on Hana Biosciences can be found at http://www.globenewswire.com/newsroom/ctr?d=187468&l=14&a=www.hanabiosciences.com&u=http%3A%2F%2Fwww.hanabiosciences.com.

 

The Hana Biosciences, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3290

 

http://finance.yahoo.com/news/...ports-pz-344308704.html?x=0&.v=1

Im Dezember 2009 legte Hana positive Daten an der amerikanischen Gesellschaft der Hämatologie-Jahresversammlung von seiner Angelsammlung-klinischen Studie der phase 2 von Marqibo bei Patienten mit zurückgefallener/refraktärer erwachsener Philadelphia-Chromosom-negativer akuter lymphoblastischer Leukämie vor (ALLE). Resultate vom Sammlungversuch zeigten zwingenden Beweis des Einzelnmittels, Anti-leukämische Tätigkeit in zurückgefallener/refraktärer, schwer vorbehandelter, erwachsener Bevölkerung ALLER Patienten mit einer Universalgeschichte der vorherigen Aussetzung zur Standardformulierung des Vincristinesulfats. Die Analyse der ersten 56 evaluable Themen zeigte eine Gesamtantwort in 6 Prozent der Themen und eine komplette Antwort (CR) oder CR mit unvollständiger hämatologischer Wiederaufnahme in 21 Prozent der Themen. Das geschätzte mittlere Gesamtüberleben in den kompletten Anrufbeantwortern war 7.3 Monate.  Fünfzig Prozent der kompletten Anrufbeantworter waren in der Lage, eine LebensrettungStammzelletransplantation möglicherweise zu empfangen.  Fünfzig Prozent der kompletten Anrufbeantworter hatten Erlassdauer länger als die Dauer ihres vorherigen Erlassses.  Zusätzlich wurde Marqibo im Allgemeinen mit einer niedrigen Ausdehnung des frühen Todes gut-zugelassen.
Unternehmensentwicklungen

Im März 2009 verkündete Hana, dass Craig Carlson der Firma sich anschloß und den Titel Vizepräsidenten annehmen wird, Finanzleiter wirkungsvolles 1. April 2010. Herr Carlson hat ältere Führung- und Hauptleiter-Finanzverwaltungpositionen für die letzten 25 Jahre, einschließlich Positionen bei zwei allgemein-gehaltenen Gesundheitspflegefirmen gehalten.
Im Dezember 2009 ernannte Hana Howard Furst, M.D., M.B.A., zu seinem Verwaltungsrat. Dr. Furst hat in 20 Jahren Erfahrung in der Gesundheitspflegeindustrie und ist z.Z. ein Partner am Deerfield Management.
Im Oktober 2009 schloß Hana eine Privatplatzierung $12.4 Million der Maßeinheiten seiner Aktien ab, die aus Anteilen von Stammaktien und von Ermächtigungen bestehen.
Viertes Quartal-und des Jahresende-2009 Finanzergebnisse

Die Firma berichtete einen Reinverlust von $5.0 Million oder $0.07 pro Anteil, denn das vierte Quartal von über 2009 verglichen mit einem Reinverlust $6.1 von Million oder von $0.19 pro Anteil, für das vierte Quartal von 2008. Die Firma berichtete einen Reinverlust von $24.1 Million oder über $0.57 pro Anteil, denn das Jahr beendete 31. Dezember 2009, verglichen mit einem Reinverlust von $22.2 Million oder $0.69 pro Anteil, denn das Jahr beendete 31. Dezember 2008.

Gesamtbetriebskosten für das Viertel, das 31. Dezember 2009 beendet wurde, waren $5.4 Million verglichen mit $6.6 Million für das beendete Viertel 31. Dezember 2008. Gesamtbetriebskosten waren $19.6 Million für das Jahr beendet 31. Dezember 2009, verglichen mit $24.2 Million für das Jahr beendet 31. Dezember 2008.

Forschung und Entwicklung (R&D) Unkosten waren $4.3 Million für das Viertel, das 31. Dezember 2009 beendet wurde, verglichen mit $5.4 Million für das beendete Viertel 31. Dezember 2008. R&d-Unkosten waren $15.6 Million für das Jahr beendet 31. Dezember 2009, verglichen mit $18.4 Million für das Jahr beendet 31. Dezember 2008.

Allgemein und Verwaltungs (G&A) Unkosten waren $1.1 Million für das Viertel, das 31. Dezember 2009 beendet wurde, verglichen mit $1.2 Million für das beendete Viertel 31. Dezember 2008. G&A Unkosten waren $4.0 Million für das Jahr beendet 31. Dezember 2009, verglichen mit $5.8 Million für das Jahr beendet 31. Dezember 2008.

Am 31. Dezember 2009 hatte die Firma Bargeld, Bargeldäquivalente und Vorhanden-fürverkauf Sicherheiten von $9.6 Million. Das Bargeld, das in den Betrieben benutzt wurde, war $5.1 Million und $21.1 Million für das Vierteljahr und das Jahr beendeten 31. Dezember 2009. Die Firma hat z.Z. die Betriebsmittel, die, Betriebe zu mid-2010 zu finanzieren vorhanden sind.

2010 Zielsetzungen

Halten Sie eine vor-Neue Sitzung der Droge-Anwendung (NDA) für Marqibo im Zweiten Quartal von 2010 ab;
Stellen Sie Update des geistigen Eigentums des Menadions in mid-2010 zur Verfügung;
Stellen Sie Oberseitelinie Beweis-vonkonzept Daten des Menadions in mid-2010 dar;
Leiten Sie Unterordnung für Marqibo im Erwachsenen ALLE des Rollens NDA in mid-2010 ein;
Leiten Sie Marqibos das pädiatrische Programm ein, das durch die Mitte für Krebsforschung am Nationalen Krebsinstitut zur Hälfte zweite von 2010 gefördert wird;
Leiten Sie randomisierten Versuch der Phase 2 des Menadions zur Hälfte zweite von 2010 ein; und
Anwesende abschließende Marqibo Sammlungdaten von allen 65 Patienten bei einer medizinischen Konferenz.

habe damals auf eine Empfehlung des " Der Aktionär" gekauft und das bei MW.0,89. Ich finde alles  oder nichts wen ich nachkaufe kann ich nichts falsch machen. Den Akti.... soll der Teufel mit samt seinen Empfehlungen holen.

Einige Aussagen zur rALLY-Studie ( relapsed Adult Lymphoblastic Leukemia ):

Universitätsklinikum Heidelberg:

"Vincristine verursacht Nervenschädigungen, Marqibo nicht."

University of Texas:

"One hundred and nineteen patients were enrolled and treated on trial. Ninety-six had histological confirmed de novo (N = 89) or transformed (N = 7) aggressive NHL. Median number of cycles was 4 (median dose/cycle 4 mg). Overall response (CR and complete response unconfirmed and PR) was 25% (95% confidence interval [CI], 17, 35), CR and complete response unconfirmed confirmed by external reviewers was 5%. Median overall survival was 6.6 months (Kaplan-Meier estimate, 95% CI, 4.7, 9.8). Grade 3 of 4 neurotoxicity occurred in 32% of patients. All patients had prior neurotoxic agents, and 85% had baseline residual neuropathy symptoms (grades 1-2) from prior treatment.
CONCLUSIONS:
Marqibo is an active agent in patients with heavily pretreated aggressive NHL, and tolerated at approximately twice the dose intensity of standard vincristine. Its activity supports further investigation as a substitution for vincristine in combination treatment of lymphoid disorders. Cancer 2009. © 2009 American Cancer Society."

Gute Rebound-Chance wenn Marqibo funktioniert ;-)

schaut euch die gewaltige Umsätze in Amiland an ,
in Letzte Zeit sie Spreschen dafür ;-)

Drücke uns allen die Daumen ;-)

 

Hana Biosciences to Present Complete Data From Pivotal Phase 2 Trial of Marqibo in Acute Lymphoblastic Leukemia at American Society of Clinical Oncology 2010 Annual Meeting



SOUTH SAN FRANCISCO, Calif., Apr 22, 2010 (GlobeNewswire via COMTEX News Network) -- Hana Biosciences (OTCBB:HNAB), a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that complete data from its pivotal study of Marqibo(R) in patients with relapsed/refractory adult Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL), have been accepted for an oral podium presentation at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) to be held June 4-8, 2010 in Chicago, Illinois.

The oral podium presentation (Abstract #6507) entitled, "Phase II Study of Marqibo in Adult Patients with Refractory or Relapsed Philadelphia Chromosome Negative (Ph-) Acute Lymphoblastic Leukemia (ALL)" will be presented in Room E354b at 11:45 a.m. on Monday, June 7.

About Marqibo(R) (vincristine sulfate liposomes injection)

http://www.ariva.de/quote/simple.m?secu=744018

USA Brief 0,35 $ ;-)

Berlin  0,273 €  ;-)

 

Hana Biosciences has received orphan drug and fast track designations for Marqibo for the treatment of adult ALL from the U.S. Food and Drug Administration. Marqibo has also received orphan drug designation in adult ALL from the European Medicines Evaluation Agency.

About Hana Biosciences

Hana Biosciences, Inc. is a biopharmaceutical company dedicated to developing and commercializing new, differentiated cancer therapies designed to improve and enable current standards of care. The company's lead product candidate, Marqibo®, potentially treats acute lymphoblastic leukemia and lymphomas. The Company has additional pipeline opportunities, some of which, like Marqibo, improve delivery and enhance the therapeutic benefits of well characterized, proven chemotherapies and enable high potency dosing without increased toxicity. Additional information on Hana Biosciences can be found at www.hanabiosciences.com.

The Hana Biosciences, Inc. logo is available at www.globenewswire.com/newsroom/prs/?pkgid=3290

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are often, but not always, made through the use of words or phrases such as "anticipates," "expects," "plans," "believes," "intends," and similar words or phrases. These forward-looking statements include without limitation, statements regarding, the timing, progress and anticipated results of Hana's planned NDA filing relating to Marqibo, including whether such NDA submission will be accepted for review or approved by the FDA; and statements regarding the potential of Marqibo to replace existing therapies and the expected benefits Marqibo may have for patients with relapsed ALL compared to existing therapies. Such statements involve risks and uncertainties that could cause Hana's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurances that any of Hana's clinical and regulatory development efforts relating to Marqibo will be successful; that even if an NDA for Marqibo is accepted by the FDA, that it will be approved; that the data of the clinical trials of Marqibo will be sufficient to support approval by the FDA of an NDA for Marqibo; that Hana will have completed all other activities necessary for the filing of an NDA or other submission with the FDA; that the results of the clinical trials of Marqibo will support Hana's claims or beliefs concerning Marqibo's safety and effectiveness; and that Hana will be able to secure the additional capital necessary to fund the activities required to complete the proposed NDA submission and other clinical and regulatory activities relating to Marqibo. Additional risks that may affect such forward-looking statements include Hana's need to raise additional capital to fund its product development programs, including Marqibo, to completion, Hana's reliance on third-party researchers to develop its product candidates, and its lack of experience in developing and commercializing pharmaceutical products. Additional risks are described in the company's Annual Report on Form 10-K for the year ended December 31, 2009. Hana assumes no obligation to update these statements, except as required by law.

CONTACT:  Hana Biosciences, Inc.
         Investor & Media Contacts:
         Investor Relations Team
         (650) 588-6641
         investor.relations@hanabiosciences.com

         Burns McClellan
         Rebecca Birbach
         (212) 213-0006
         rbirbach@burnsmc.com




Read more: www.nasdaq.com//aspxcontent/...7%2F2010+8%3A30AM#ixzz0mIt1xCud

Hana Biosciences, Inc. recently announced that it received a Notice of Allowance from the U.S. Patent and Trademark Office for U.S. Application No. 11/886,803, entitled "Vitamin K for Prevention and Treatment of Skin Rash Secondary to Anti-EGFR Therapy" (U.S. Patent Application Publication No. 2009/0209652 A1).  Skin rash is a painful and common side effect of all approved epidermal growth factor receptor (EGFR) inhibitors (such as Tarceva®, Iressa®, Erbitux®, Vectibix®, and Tykerb®) that can limit treatment or make dose reduction necessary.  As its title suggests, the '803 application discloses treatment of EGFR-associated skin rash with vitamin K3 (also known as menadione), a provitamin precursor of vitamin K2.  Once issued, the patent will extend protection for this technology into 2026.  Corresponding foreign applications are pending in Australia, Canada, Europe, Hong Kong, Japan, and Korea, and Hana reports that additional applications relating to the use of menadione have been filed.
The sole independent claim allowed in the '803 application reads:
1.  A method for treating a skin rash secondary to an anti-epidermal growth factor receptor (EGFR) therapy in a subject receiving said therapy, the method comprising applying vitamin K3 to the skin in an amount effective to treat the skin rash.
A Phase I clinical study conducted by Hana demonstrated that a menadione topical lotion was generally well-tolerated, and that menadione was delivered into the skin without appreciable systemic absorption.  Recently, Hana completed enrollment for a proof-of-concept study of vitamin K3 lotion in cancer patients receiving EGFR inhibitor therapy; the company expects to present data from this study and initiate a Phase II trial by the end of 2010.

der Kurs steigt weiter.

Heute hat doch einer 8000 Stück zu 0,11 Euro in Stuttgart verkauft obwohl der Kurs im Amyland umgerechnet bei 0,22 Euro steht.

In April 2010, Hana also announced that complete data from its pivotal study of Marqibo in patients with relapsed/refractory adult Philadelphia chromosome-negative ALL, had been accepted for an oral podium presentation at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) to be held June 4-8, 2010 in Chicago, Illinois. The oral podium presentation (Abstract #6507) entitled, "Phase II Study of Marqibo in Adult Patients with Refractory or Relapsed Philadelphia Chromosome Negative (Ph-) Acute Lymphoblastic Leukemia (ALL)" will be presented in Room E354b at 11:45 a.m. on Monday, June 7.


In March 2010, Hana announced that it received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for the use of menadione to prevent and treat skin rash in patients taking biologic and small molecule epidermal growth factor receptor (EGFR) inhibitors, such as Erbitux(R) and Tarceva(R), for anti-cancer therapy.  The U.S. Patent Application Number 11/886,803 is entitled "Vitamin K for Prevention and Treatment of Skin Rash Secondary to Anti-EGFR Therapy" and extends intellectual property protection around menadione into 2026.
First Quarter 2010 Financial Results

The Company reported a net loss of $5.5 million, or $0.07 per share, for the quarter ended March 31, 2010 compared with a net loss of $5.6 million, or $0.17 per share, for the quarter ended March 31, 2009.

Total operating expenses for the quarter ended March 31, 2010, were $4.4 million compared with $5.6 million for the quarter ended March 31, 2009.

Research and development expenses were $3.3 million for the quarter ended March 31, 2010, compared with $4.2 million for the quarter ended March 31, 2009.

General and administrative expenses were $1.1 million for the quarter ended March 31, 2010, compared with $1.4 million for the quarter ended March 31, 2009.

As of March 31, 2010, the Company had cash, cash equivalents and available-for-sale securities of $4.2 million.  Cash used in operations was $5.5 million for the quarter. The Company has implemented cost controls to conserve its cash and continues to evaluate both traditional and non-dilutive financing options. With a lower cash burn rate, the Company's current cash resources are sufficient to fund operations through June 2010.

About Hana Biosciences, Inc.

Hana Biosciences, Inc. is a biopharmaceutical company dedicated to developing and commercializing new, differentiated cancer therapies designed to improve and enable current standards of care. The company's lead product candidate, Marqibo®, potentially treats acute lymphoblastic leukemia and lymphomas. The Company has additional pipeline opportunities some of which, like Marqibo, improve delivery and enhance the therapeutic benefits of well characterized, proven chemotherapies and enable high potency dosing without increased toxicity. Additional information on Hana Biosciences can be found at www.hanabiosciences.com.

The Hana Biosciences, Inc. logo is available at www.globenewswire.com/newsroom/prs/?pkgid=3290
Forward-Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are often, but not always, made through the use of words or phrases such as "anticipates," "expects," "plans," "believes," "intends," and similar words or phrases. These forward-looking statements include without limitation, statements regarding, the timing, progress and anticipated results of Hana's planned NDA filing relating to Marqibo, including whether such NDA submission will be accepted for review or approved by the FDA; statements regarding the potential of Marqibo to replace existing therapies and the expected benefits Marqibo may have for patients with relapsed ALL compared to existing therapies; statements regarding the extent of the Company's intellectual property rights and protections relating to menadione; and statements relating to the period of time for which its existing cash resources are sufficient to fund operations and whether the Company's cost control measures will be sufficient to preserve its cash resources until additional capital is obtained. Such statements involve risks and uncertainties that could cause Hana's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurances that any of Hana's clinical and regulatory development efforts relating to Marqibo will be successful; that even if an NDA for Marqibo is accepted by the FDA, that it will be approved; that the data of the clinical trials of Marqibo will be sufficient to support approval by the FDA of an NDA for Marqibo; that Hana will have completed all other activities necessary for the filing of an NDA or other submission with the FDA; that the results of the clinical trials of Marqibo will support Hana's claims or beliefs concerning Marqibo's safety and effectiveness; that its existing patent and other intellectual property rights will be adequate; and that Hana will be able to secure the additional capital necessary to fund the activities required to complete the proposed NDA submission and other clinical and regulatory activities relating to Marqibo. Additional risks that may affect such forward-looking statements include Hana's need to raise additional capital to fund its product development programs, including Marqibo, to completion, Hana's reliance on third-party researchers to develop its product candidates, and its lack of experience in developing and commercializing pharmaceutical products. Additional risks are described in the company's Annual Report on Form 10-K for the year ended December 31, 2009 and in the Company's Form 10-Q for the three month period ended March 31, 2010. Hana assumes no obligation to update these statements, except as required by law.

     
HANA BIOSCIENCES, INC.      
BALANCE SHEETS      
 March 31,

2010  December 31,

2009  
ASSETS  (Unaudited)  
Current assets:    
Cash and cash equivalents  $ 4,096,056 $9,570,453
Available-for-sale securities 76,000 68,000
Prepaid expenses and other current assets 104,414 114,067
Total current assets 4,276,470 9,752,520
     
Property and equipment, net 217,492 252,455
Restricted cash 125,000 125,000
Debt issuance costs 1,018,755 1,193,594
Total assets $5,637,717 $11,323,569
     
LIABILITIES AND STOCKHOLDERS' DEFICIT      
Current liabilities:    
Accounts payable and accrued liabilities  $3,416,775 $4,027,075
Other short-term liabilities 27,382 43,586
Total current liabilities 3,444,157 4,070,661
Notes payable, net of discount 22,836,344 22,597,050
Other long-term liabilities 6,224 6,540
Warrant liabilities 2,104,666 2,145,511
Total long term liabilities 24,947,234 24,749,101
Total liabilities 28,391,391 28,819,762
     
     
Stockholders' deficit:    
Common stock; $0.001 par value:      
200,000,000 shares authorized, 79,788,264 and 79,649,976 shares issued and outstanding at March 31, 2010 and December 31, 2009, respectively  79,788 79,650
Additional paid-in capital 117,779,666 117,572,373
Accumulated other comprehensive income (16,000) (24,000)
Accumulated deficit (140,597,128) (135,124,216)
Total stockholders' deficit (22,753,674) (17,496,193)
Total liabilities and stockholders' deficit $5,637,717 $11,323,569
     
HANA BIOSCIENCES, INC.    
STATEMENT OF OPERATIONS    
AND COMPREHENSIVE LOSS    
(Unaudited)    
   
 Three Months Ended

March  31,  
 2010  2009  
     
Operating expenses:    
General and administrative $1,170,895 $1,377,600
Research and development 3,258,545 4,192,483
Total operating expenses 4,429,440 5,570,083
     
Loss from operations (4,429,440) (5,570,083)
     
Other income (expense):    
Interest income 267 11,582
Interest expense (1,084,584) (727,007)
Other expense, net — (4,907)
Change in fair market value of warrant liabilities 40,845 664,060
     
Total other expense (1,043,472) (56,272)
     
Net loss $ (5,472,912) $ (5,626,355)
Net loss per share, basic and diluted $ (0.07) $ (0.17)
Weighted average shares used in computing net loss per share, basic and diluted 79,782,118 32,449,739
     
Comprehensive loss:    
Net loss $ (5,472,912) $ (5,626,355)
Unrealized holding gains (losses) arising during the period 8,000 (32,000)
     
Comprehensive loss $ (5,464,912) $ (5,658,355)

CONTACT:  Hana Biosciences, Inc.
         Investor & Media Contacts:
         Investor Relations Team
         (650) 588-6641
         investor.relations@hanabiosciences.com

         Burns McClellan
         Rebecca Birbach
         (212) 213-0006
         rbirbach@burnsmc.com



Read more: www.nasdaq.com//aspxcontent/...4%2F2010+8%3A30AM#ixzz0nuQXKUvB

Hana Biosciences Announces Financing of Up to $100 Million

SOUTH SAN FRANCISCO, Calif., June 7, 2010 (GLOBE NEWSWIRE) -- Hana Biosciences Inc., (OTCBB:HNAB - News), a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that it has entered into an Investment Agreement with Warburg Pincus and Deerfield Management for the sale of up to $100 million in preferred stock. Warburg Pincus, the lead investor in the financing, is a new investor in Hana, and Deerfield is the company's largest existing shareholder prior to this financing. The sale of $40 million of preferred stock under the Investment Agreement closed today.

 

Hana intends to use the net proceeds from the financing to advance its clinical development and commercialization programs, including regulatory activities related to Marqibo's New Drug Application preparation and submission, and for general corporate purposes. In conjunction with the financing, the Company's Board of Directors will expand to nine members with Warburg Pincus having the right to designate five new members.

 

"We are pleased that Warburg Pincus and Deerfield have made such a significant investment in the Company and view it as further validation of the potential of Hana's pipeline of product candidates," said Steven R. Deitcher, M.D., President and Chief Executive Officer of Hana Biosciences.

 

Hana expects that the financing will provide the funds needed to develop Marqibo to approval and commercialization for relapsed/refractory adult ALL patients; to study Marqibo(R) in front-line adult ALL and lymphoma patients; and to unlock the full potential of menadione topical lotion, a first-in-class therapeutic targeted at the dose-limiting skin toxicities in cancer patients taking EGFR inhibitors.

 

"We are very pleased to be able to provide the financing necessary to advance Hana's promising product pipeline," said Jonathan Leff, a Managing Director of Warburg Pincus. "We look forward to working closely with the company's board and management team to address important unmet needs in oncology."

 

Terms of the Financing

 

The Company has entered into an Investment Agreement for the sale of up to $100 million of Preferred Stock. On June 7, 2010, the investors purchased 400,000 shares of Series A-1 Preferred Stock, at a per share sale price of $100. In conjunction with the signing, the investors have the right to purchase up to $60 million of additional Preferred Stock under certain circumstances. Upon approval by the Company's stockholders to increase the Company's authorized outstanding shares of common stock, effect a reverse stock split, and other related matters within 6 months of the closing date (i) the conversion price for the Preferred Stock to be converted to common stock will be: $0.184 for the $40 million purchased by the investors today, $0.184 for the next $20 million that the investors have the right to purchase, and $0.276 for the additional $40 million of Preferred Stock that the investors may have the right to purchase under certain circumstances and (ii) the Preferred Stock would accrete at the rate of 9% per annum, among other provisions.

 

If the Company's stockholders do not approve the above stated items (i) the investors retain the right, but not the obligation, to purchase up to an additional $60 million of Preferred Stock under certain circumstances; (ii) the effective conversion price would remain at its currently established level of $0.1288, for the $40 million purchased by the investors today, $0.1288 for the next $60 million that the investors have the right to purchase under certain circumstances; (iii) the accretion rate would be 12% increasing annually by 0.50%, and the Preferred Stock would retain a liquidation preference equal to at least 2.5 times its accreted value, among other provisions.

 

The investors are subject to certain transfer and standstill restrictions. In addition, the investors have voting rights, liquidation preferences, change of control rights, participation rights, anti-dilution protection and redemption rights, among other rights. Upon completion of the closing of the first $40 million, and in accordance with the terms of the Investment Agreement, Michael Weiser and Lyn Wiesinger resigned as directors of Hana, and Jonathan Leff, Nishan de Silva and Andrew Ferrer, each designated by Warburg Pincus, were appointed to Hana's board of directors. Warburg also has the right to designate two additional directors to Hana's board.

 

Roth Capital Partners, LLC served as financial advisor to a special committee of Hana's board of directors and provided a fairness opinion in connection with the transaction.

 

About Hana Biosciences, Inc.

 

Hana Biosciences, Inc. is a biopharmaceutical company dedicated to developing and commercializing new, differentiated cancer therapies designed to improve and enable current standards of care. The company's lead product candidate, Marqibo(R), potentially treats acute lymphoblastic leukemia and lymphomas. The Company has additional pipeline opportunities some of which, like Marqibo, improve delivery and enhance the therapeutic benefits of well characterized, proven chemotherapies and enable high potency dosing without increased toxicity. Additional information on Hana Biosciences can be found at http://www.hanabiosciences.com/.

 

The Hana Biosciences, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3290

 

 

About Warburg Pincus

 

Warburg Pincus is a leading global private equity firm. The firm has more than $30 billion in assets under management. Its active portfolio of more than 110 companies is highly diversified by stage, sector and geography. Warburg Pincus is a growth investor and an experienced partner to management teams seeking to build durable companies with sustainable value. Founded in 1966, Warburg Pincus has raised 13 private equity funds which have invested more than $35 billion in approximately 600 companies in more than 30 countries. The firm has offices in Beijing, Frankfurt, Hong Kong, London, Mumbai, New York, San Francisco, Sao Paulo, Shanghai and Tokyo. For more information, please visit http://www.globenewswire.com/newsroom/ctr?d=193647&l=15&a=www.warburgpincus.com&u=http%3A%2F%2Fwww.warburgpincus.com

 

 

Forward-Looking Statement

 

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are often, but not always, made through the use of words or phrases such as "anticipates," "expects," "plans," "believes," "intends," and similar words or phrases. These forward-looking statements include without limitation, statements regarding: the anticipated capital required to advance Hana's product candidates; the timing, progress and anticipated results of Hana's planned NDA filing relating to Marqibo, including whether such NDA submission will be accepted for review or approved by the FDA; and statements regarding the potential of Hana's product candidates. Such statements involve risks and uncertainties that could cause Hana's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurances that any of Hana's clinical and regulatory development efforts relating to Marqibo or its other product candidates will be successful; that even if an NDA for Marqibo is accepted by the FDA, that it will be approved; that the data of the clinical trials of Marqibo will be sufficient to support approval by the FDA of an NDA for Marqibo; that Hana will have completed all other activities necessary for the filing of an NDA or other submission with the FDA; that the results of the clinical trials of Marqibo will support Hana's claims or beliefs concerning Marqibo's safety and effectiveness; and that its existing patent and other intellectual property rights will be adequate. Additional risks that may affect such forward-looking statements include Hana's need to raise additional capital to fund its product development programs to completion, Hana's reliance on third-party researchers to develop its product candidates, and its lack of experience in developing and commercializing pharmaceutical products. Additional risks are described in the company's Annual Report on Form 10-K for the year ended December 31, 2009 and in the Company's Form 10-Q for the three month period ended March 31, 2010. Hana assumes no obligation to update these statements, except as required by law.

 

 

http://finance.yahoo.com/news/...nces-pz-2014185967.html?x=0&.v=1

Skymark Research Initiates Independent Research Coverage on Hana Biosciences, Inc.

CALGARY, Alberta, June 8, 2010 (GLOBE NEWSWIRE) -- Skymark Research, a leading provider of small- and micro-cap independent investment research, today initiated coverage on Hana Biosciences, Inc. (OTCBB:HNAB - News).

 

Skymark Research is currently offering a complimentary trial subscription. To view our research go to: http://www.skymarkresearch.com/

 

 

About SMR:

 

Skymark Research is a leading provider of independent investment research in North America. Our services include research analysis on the small- and micro-cap markets, real-time news and financial data, market commentary and the SMR newsletter. Skymark Research's staff of small-cap investment professionals is dedicated to providing the small market's investment community with the tools and avenues necessary to make the important investment decisions. To view our research reports on a complimentary trial basis and take advantage of our other services, go to http://www.skymarkresearch.com/ and click on the complimentary trial subscription button on our home page, or go directly to our registration page at www.skymarkresearch.com/signup.php.

 

The Skymark Research logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=6683

 

 

About Hana Biosciences, Inc. (OTCBB:HNAB - News):

 

Hana Biosciences, Inc. (OTCBB:HNAB - News) is a biopharmaceutical company that is engaged in acquiring, developing and commercializing products to strengthen the foundation of cancer care.

 

SMR Disclosure:

 

Skymarkresearch.com is not a registered investment advisor and nothing contained in any materials should be construed as a recommendation to buy or sell any securities. Skymark Research has not been compensated by any of the above mentioned companies. Please read our report and visit our Web site, http://www.skymarkresearch.com/, for complete risks and disclosures.

 

Hana Biosciences to raise $100M

San Francisco Business Times - by Steven E.F. Brown

Data From Pivotal Phase 2 RALLY Trial Show Marqibo Produced Compelling Single-Agent Anti-Leukemic Efficacy in Advanced Relapsed/Refractory Adult Ph(-) Acute Lymphoblastic Leukemia

Liberty Analytics Co. Initiates Independent Research Coverage on Hana Biosciences, Inc.

CALGARY, Alberta, June 10, 2010 (GLOBE NEWSWIRE) -- Liberty Analytics Co., a leading provider of large, small- and micro-cap independent investment research, today initiated coverage on Hana Biosciences, Inc. (OTCBB:HNAB - News). Liberty Analytics is currently offering a complimentary trial subscription. To view our research, go to: http://www.libertyanalyticsco.com/

 

 

About LAC:

 

Liberty Analytics Co. is a leading provider of independent investment research in North America. Our services include research analysis on the large, small- and micro-cap markets, real-time news and financial data, market commentary and the LAC newsletter. Liberty Analytics' staff of large and small-cap investment professionals is dedicated to providing the market's investment community with the tools and avenues necessary to make the important investment decisions. To view our research reports on a complimentary trial basis and take advantage of our other services, go to http://www.libertyanalyticsco.com/ and click on the complimentary trial subscription button on our home page, or go directly to our registration page at www.libertyanalyticsco.com/signup.php

 

 

About Hana Biosciences, Inc. (OTCBB:HNAB - News):

 

Hana Biosciences, Inc. (OTCBB:HNAB - News) is a biopharmaceutical company. It is engaged in developing and commercializing cancer therapies designed to enable current standards of care.

 

LAC Disclosure:

 

Libertyanalyticsco.com is not a registered investment advisor and nothing contained in any materials should be construed as a recommendation to buy or sell any securities. Liberty Analytics has not been compensated by any of the above-mentioned companies. Please read our report and visit our Web site, http://www.libertyanalyticsco.com/, for complete risks and disclosures.

 

 

http://finance.yahoo.com/news/...s-Co-pz-1493195526.html?x=0&.v=1

Form 8-K for HANA BIOSCIENCES INC

---

11-Jun-2010

Entry into a Material Definitive Agreement, Unregistered Sale of Equity Secu

http://biz.yahoo.com/e/100611/hnab.ob8-k.html

Was meint Ihr?

Es schaut so aus das bei Hana sich endlich was tut ;-)

Eure Meinung würde mich interesieren

Grüß Prinz ;-)

hab vor 2 monaten hana aktien gekauft, zum kurs von 0,26euro, dachte die letzten studien für das medikament wären abgeschlossen und die vermarktung würde nicht mehr lange auf sich warten lasse, aber das war ja wohl mal ein voller griff in die sch.... , oder kann es doch noch wieder aufwärts gehen??? hoffe einer von euch kann mir helfen???

Weiss jemand von euch ob und wenn ja,wann hier ein R/S kommt ? Kleiner Prinz,weisst du das ? Dann sag mal Bescheid ?

MFG
Chali

noch ein starker Rebound richtung norden kommen wird..

Es dauert noch ein wenig halt, bist die erste geschichte mit Marqibo ins laufen kommt..

Geduld ist angesagt... Und ich hoffe sie wird an Ende belohnt werden ;-)

Gruß Prinz :-)))

Es ist doch so,dass diese Marquibo Studie noch bis 2014 dauern wird,oder seh ich das falsch ? Wenn die jetzt "Fast track status" ,kann dann die Studie etwa eher als 2014 beendet werden,nee,..... bestimmt nicht ! aber dann frag ich mich was Fast track eigentlich ist bzw. bedeutet ?

MFG
Chali

null

At the forefront of the storm lies their NDA submission, as Hana looks  to capitalize on their unique situation revolving Marqibo and the FDA’s  requirements. Hana is benefiting from the fact that the Marqibo NDA has  already been submitted by Inex Pharmaceuticals in the past resulting in a  non-approval, thus requiring the additional 9 patient rALLy study to  satisfy the FDA’s conditions. Due to Inex’s inability to foster the  necessary cash to conduct the additional trials, they decided to pass  over this novel drug to Hana. The general concensus among the biotech  industry is that most drugs never make it on their first try with the  FDA, especially smaller players, and when Hana bought Marqibo from Inex  they got a big bonus, a CRL where “the FDA provided a list of  deficiencies that needed to be addressed prior to re-applying for  approval”.  For more information, visit this article courtesy of  BioSpace.com.

Sign-up for Free to Receive  Future  Commentary and  Trading  Alerts on HNAB.

If all goes as it should, Hana could be one of the biggest “BioShockers” of the year.

It looks like the perfect storm is now brewing for Hana Biosciences  (OTC:HNAB). In December, this penny bio stock took a major hit for no  reason other than an impatient investor sell off.

Despite the negative afterthoughts of a possible dilution following the  NDA submission, the company should have more cash available through  Deerfield Management, who has a seat on the board of directors. There is  chatter amongst several trusted expert sources that a partnership or  private / institutional investor financing could be on the way should  results be highly positive, especially considering the predicted market  potential of its flagship product is$2.5B annually.

Going into what should be a very positive year with a new drug  application (NDA) filing for their drug Marqibo after successful trial  results, this stock is prime for some major movement in the near future;  first a reset to the $60-80 cent level, then a move higher as the NDA  is filed. We have big expectations as this meeting at the ASCO will most  likely be the binary event that decides the company’s survival, and  several sources have confirmed that the data should be positive.

The December publication of results from the rALLy trial in acute  lymphoblastic leukemia (ALL) in second relapse shows that the drug was  highly efficient as a single-agent in a very sick patient population who  have few other options. There are no safety concerns beyond what is  expected for this type of drug. The FDA has a history of approving ALL  treatments based on phase II single-arm clinical trials, and Hana  intents to use the results of the rALLy trial in their NDA filing later  on this year.

 

 Hana Biosciences Reverse Stock Split Effective Monday, September 13, 2010

 

SOUTH SAN FRANCISCO, Calif., Sept. 10, 2010 (GLOBE NEWSWIRE) -- Hana Biosciences, Inc. (OTCBB:HNAB - News), a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that it has filed a certificate of amendment to its certificate of incorporation to effect a 1-for-4 reverse split of its common stock. The company expects the reverse split will become effective for trading on Monday, September 13, 2010. The reverse split was authorized by Hana's stockholders at a special meeting held September 2, 2010.

 

 

Details of Reverse Split

 

 

As a result of the reverse split, every four shares of Hana's pre-split common stock was automatically reclassified as and combined into one share of post-split common stock. As a result, the number of outstanding shares of common stock is approximately 21.2 million, excluding outstanding stock options and warrants to purchase common stock and subject to adjustment for fractional shares. The reverse stock split does not affect any stockholder's ownership percentage of Hana's common stock, except to the extent that the reverse split would result in any stockholder holding a fractional share.

 

 

Effective on September 13, 2010, it is expected that a "D" will be added to Hana's ticker symbol, making it HNABD.OB for a period of 20 trading days. Thereafter, the ticker symbol will revert to HNAB.OB. Shares of Hana's common stock will also trade under a new CUSIP number effective September 13, 2010.

 

 

About Hana Biosciences, Inc.

 

 

Hana Biosciences, Inc. is a biopharmaceutical company dedicated to developing and commercializing new, differentiated cancer therapies designed to improve and enable current standards of care. The company's lead product candidate, Marqibo(R), potentially treats acute lymphoblastic leukemia and lymphomas. The Company has additional pipeline opportunities some of which, like Marqibo, improve delivery and enhance the therapeutic benefits of well characterized, proven chemotherapies and enable high potency dosing without increased toxicity. Additional information on Hana Biosciences can be found at www.hanabiosciences.com.

 

 

The Hana Biosciences, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3290

 

 

Forward-Looking Statement

 

 

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are often, but not always, made through the use of words or phrases such as "anticipates," "expects," "plans," "believes," "intends," and similar words or phrases. These forward-looking statements include without limitation, statements regarding, the timing of the effectiveness of proposed reverse split for purposes of trading in Hana's common stock. Such statements involve risks and uncertainties that could cause Hana's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements.

http://finance.yahoo.com/news/...erse-pz-3678621686.html?x=0&.v=1

Form 8-K for HANA BIOSCIENCES INC

14-Sep-2010

Unregistered Sale of Equity Securities, Material Modification to Rights of S

 

 

 

http://biz.yahoo.com/e/100914/hnabd.ob8-k.html

 

---

Form 8-K for HANA BIOSCIENCES INC

 

22-Sep-2010

Entry into a Material Definitive Agreement

 

 

http://biz.yahoo.com/e/100922/hnabd.ob8-k.html

Marqibo® geschätzter Potential100 Millon $ ;-))

 

http://www.hanabiosciences.com/pipeline-o.html

Marqibo® (vincristine sulfate liposomes injection, OPTISOME™)
A Novel Targeted Nanoparticle-encapsulated Anti-Cancer Compound currently for Acute Lymphoblastic Leukemia (ALL) and Melanoma. Marqibo® has a robust safety database (over 600 patients) and has been extensively evaluated in lymphoid blood cancers such as non-Hodgkin’s lymphoma (NHL) and ALL. Hana has ongoing (or planned) clinical trials which may enable an accelerated approval in 2 indications. Future clinical trial development possible in multiple indications including NHL and melanoma. More Details »

Alocrest™ (vinorelbine liposomes injection, OPTISOME™)
A Novel Targeted Anti-Cancer Compound for Breast and Lung Cancer. Alocrest™ has completed a Phase I dose-escalation trial demonstrating promising anti-cancer activity as well as acceptable and predictable toxicity. More Details »

Brakiva™ (topotecan liposomes injection, OPTISOME™)
A Novel Targeted Anti-Cancer Compound for Small-Cell Lung Cancer and Ovarian Cancer. Preclinical data demonstrate the value of Brakiva™ over conventional topotecan. More Details »

Menadione Topical Lotion - A Topical Compound for Skin Rash Associated with EGFR Inhibitors. Treatment with EGFR inhibitors such as Tarceva®, Erbitux® and Vectibix® are associated with an acne-form rash involving the face, neck and upper torso in approximately 75% patients. 50% of patients who manifest skin toxicity experience significant discomfort. This results in drug discontinuation or dose reduction in at least 10% and up to 30% of all subjects. Drug delivery is targeted to the normal location of the EGFR-containing skin cells at the dermal/epidermal junction without interfering with EGFR inhibition systemically at the level of the tumor. More Details »

 

 

sehr Bald Geplanter Markteinführung ;-))

 

 Hana Biosciences Corporate Presentation

http://files.shareholder.com/downloads/HNAB/...86932C/HNAB_081408.pdf

Hana BioscieHana Biosciences: Accelerating Product Development
• Late‐stage, well‐capitalized, biopharmaceutical company focused on
the development and commercialization of novel, improved cancer
therapeutics and compounds that reduce cancer therapy toxicity
• Marqibo® (vincristine sulfate liposome injection)
Lead asset that demonstrated compelling single‐agent, anti‐leukemic
efficacy in a heavily pre‐treated, advanced adult ALL population
– 35% ORR in the third‐, fourth‐, fifth‐, and sixth‐line treatment setting
– 20% CR/CRi rate with impressive median response duration and survival
– Rolling NDA submission seeking accelerated approval to be initiated 2H 2010

Langsam fangen viele an sich zu positionieren bevor es loss geht ;-)

Also Hana schön in Auge halten ;-)

http://finance.yahoo.com/...ohlcvalues=0;logscale=on;source=undefined

                               

Written by Grant Zeng, CFA

Hana Biosciences Inc. (OTC BB: HNAB.OB - News) A decent pipeline with late stage candidates...

   

South San Francisco, CA based Hana Biosciences, Inc.  (Hana) is a late development stage biopharmaceutical company which is  focused on two cancer care areas: cancer therapeutics and cancer  supportive care. 

The company’s lead cancer therapeutic candidate is Marqibo  (vincristine sulfate liposome injection), a novel, targeted Optisome  encapsulated formulation product candidate of the FDA-approved  anticancer drug vincristine, for the treatment of relapsed/refractory adult acute lymphoblastic leukemia (ALL).

Hana presented results from the registration-enabling Phase II clinical  trial (rALLY) of Marqibo for ALL in June 2010 at the ASCO meeting. The  data were compelling. Marqibo was administered as third-, fourth-,  fifth-, and sixth-line single-agent therapy for ALL patients. The trial  achieved 35% overall response rate with a predictable and manageable  toxicity profile. The complete response (CR) and CR with incomplete  blood count recovery (CRi) were 20%. The median CR/CRi duration was 5.3  months, and median survival in responders was 7.4 months.

Based on the above encouraging Phase II results, Hana completed the  pre-NDA meeting with the FDA in April 2010 and plans to start the  rolling NDA filing process soon. The rolling NDA filing will be  completed by the first half of 2011. Hana has received orphan drug and  fast track designations for Marqibo for the treatment of adult ALL from  the FDA. Marqibo has also received orphan drug designation from the  European Medicines Evaluation Agency in adult ALL. We estimate Marqibo  will get the FDA approval in the second half of 2011. Submission of Marqibo for EU approval is planned to happen in 2011.

Marqibo remains both a near term and long term value  for Hana. The drug candidate represents a large opportunity. Marqibo is  intended to replace standard vincristine chemotherapy. Vincristine is  widely and globally used to treat lymphomas, leukemias, myeloma, solid  tumors, and childhood cancers. Vincristine is a major component of  highly effective combination chemotherapy regimens such as R-CHOP,  R-CVP, CVAD, VAD, and VP. It’s estimated that more than 2.4 million  doses of Vincristine were sold in the US and Europe per year. However,  although Vincristine is used in a broad range of chemotherapies, it is  limited by its pharmacokinetics and toxicity profile. Individual doses  (1.4 mg/m2) are limited to 2.0 mg regardless of patient size. Frequent,  early onset peripheral neuropathy limits cumulative dosing in lymphoma  and leukemia induction to approximately 6-8 total mg and rarely more  than 12 mg.

Marqibo is a high concentration vincristine loaded into sphingomyelin  and cholesterol liposome nanoparticles (Optisomes). Marqibo facilitates  individual vincristine doses of 2.8 to 5.5 mg and cumulative induction  dosing up to 70 mg. Marqibo’s formulation optimizes vincristine  pharmacokinetics by prolonging circulating half-life as an encapsulated  drug, by targeting delivery to tumors, bone marrow, lymph nodes, liver,  and spleen, by enhancing disease penetration and up to 10x drug  concentration in target tissues.

We estimate peak sales of Marqibo for the ALL indication only could be well above $100 million per year.  In addition to ALL indication, Hana is also expanding Marqibo label  into other indications including front line aggressive NHL, front line  elderly Ph (-) ALL, front line non-elderly Ph (-) ALL, pediatric cancers  and multiple myeloma. If all of, or even part of these label expansions  are successful, Marqibo could represent a $5 billion market  opportunity. 

Another important drug candidate is Menadione for  cancer supportive care. Menadione is a novel topical lotion being  developed for the prevention and/or treatment of the skin toxicities  associated with the use of epidermal growth factor receptor inhibitors  (EGFRI) in the treatment of certain cancers. Rash is a common, painful  and treatment-limiting skin toxicity side effect of all approved EGFR  inhibitors such as Tarceva, Iressa, Erbitux, Vectibix, and Tykerb with  incidence rates as high as 90 percent. EGFR inhibitor-associated rash  can lead to reduced compliance and cause dose reductions, delays or  discontinuation of EGFR inhibitor therapy in a significant portion of  affected patients. Currently, there are no FDA-approved products or therapies to treat these skin toxicities.

Hana has completed a Phase I study of Menadione topical lotion in  healthy volunteers, which demonstrated delivery of Menadione into the  skin without appreciable systemic absorption. In addition, Menadione  topical lotion was generally well-tolerated. The company has recently  completed enrollment of a proof-of-concept study of Menadione topical  lotion in cancer patients receiving EGFR inhibitors for anti-cancer  therapy. This study assessed both treatment potential in patients with  new onset rash and prophylactic potential in those about to begin an  EGFR inhibitor. Data from this study will be available in late 2010.

In addition to current focus on Marqibo and Menadione, Hana is also developing Alocrest  (vinorelbine liposome injection, Phase I) for the treatment of solid  tumors; and Brakiva (topotecan liposome injection, Phase I) for the  treatment of solid tumors including small cell lung cancer and ovarian  cancer. The company is exploring options for further development of  these two drug candidates beyond the Phase I trial.

In early June 2010, Hana entered into an Investment Agreement with  Warburg Pincus and Deerfield Management for the sale of up to $100  million in preferred stock. Warburg Pincus, the lead investor in the  financing, is a new investor in Hana, and Deerfield is the company's  largest existing shareholder prior to this financing.

The Warburg Pincus deal further validates Hana’s technology and clinical efforts

Hana intends to use the net proceeds from the financing to advance its  clinical development and commercialization programs, including  regulatory activities related to Marqibo's New Drug Application  preparation and submission, and for general corporate purposes. Hana  expects that the financing will provide the funds needed to develop  Marqibo to approval and commercialization for relapsed/refractory adult  ALL patients; to study Marqibo in front-line adult ALL and lymphoma  patients; and to unlock the full potential of Menadione topical lotion.

On June 7, 2010, the investors purchased 400,000 shares of Series A-1  Preferred Stock, at a per share sale price of $100. In conjunction with  the signing, the investors have the right to purchase up to $60 million  of additional Preferred Stock under certain circumstances. The original  conversion price for the Preferred Stock to be converted to common stock  will be: $0.184 for the first $60 million purchased by the investors  and $0.276 for the additional $40 million of Preferred Stock that the  investors may have the right to purchase. After the 4-to-1 reverse stock  split, the conversion price has increased to $0.74 and $1.10  respectively. The Preferred Stock would accrete at the rate of 9% per  annum.

We see the Warburg Pincus deal very as a very positive step for Hana.  The deal not only provides vital, necessary funds for the company’s  operations, it also further validates the company’s technology and the  potential of its pipeline of drug candidates.

Some investors may fear the dilution of existing shareholder base by  the deal, but we have different opinion. We think there is nothing to  worry about the deal, especially by Warburg Pincus. Warburg Pincus is a  sophisticated institutional investor in the pharma/biotech space. We  believe the investment in Hana by Warburg is a long term investment as  with its investments in other biotech companies. This can be evidenced  by the biotech portfolio held by the investor.  Warburg has been a long  term investor in Inspire Pharmaceuticals, Allos Therapeutics,  ZymoGenetics, Eurand, WuXi Pharma, and ev3 which was recently bought by  Covidien at $2.6 billion.

At the current trading price of about $0.55 per share, we don’t see any  short term dilutive effect as the conversion price has increased to  $0.74 and $1.10 after the reverse stock split for Hana. Anything under  $0.74 at this time should be a gift. Even if the share price increases  to $1, we don’t believe that Warburg is willing to sell for about 15 or  20 cents profit. That makes no sense at all for an investor like  Warburg.

 The bottom line……

 

We think Hana in entering a transition period from a pure development stage company into a commercialization concern. With  an appropriate growth strategy in place, the company is well positioned  to deliver shareholder value in the next few quarters.

Although it’s always difficult to value a development stage biotech  company like Hana, we think Hana’s shares are undervalued based on the  company’s fundamentals. Currently, the company shares are trading at  about $0.55 per share which values the Company at about $11.5 million. This is certainly a huge discount compared to its peers.  One example is Cell Therapeutics (CTIC). This company is similar to  Hana in terms of business, pipeline and development stage. Cell  Therapeutics also has one candidate Pixantrone under the FDA review for  the treatment of NHL and other early to middle stage candidates.  However, Cell Therapeutics’ market cap is about $314 million. Another  similar company is Allos Therapeutics (ALTH). Allos’ Pralatrexate  received the FDA accelerated approval in late September 2009 for second  line peripheral T-Cell lymphoma. Currently, Allos is valued at about  $457 million. One more similar example is Bioenvision which was sold to  Genzyme in 2007 for $345 million. Bioenvision had only one product  Clofarabine approved for the third line treatment of pediatric ALL  patients when it was bought by Genzyme.

We understand that the Street discounts Hana because of the uncertainty  of Marqibo’s marketing authorization. However, we think Marqibo has a  high probability to get the FDA nod in the second half of 2011. We  believe Hana should be valued at least $100 million at current stage  which translate into a share price of about $5 per share. Investors should pay attention to the following near-term catalysts:

• Presentation of Marqibo integrated efficacy data and PK 4Q10
• Generate Menadione Topical Lotion Phase II plan 4Q10
• Initiation of Marqibo NDA rolling submission to FDA 4Q10
• Seek EU EMA formal Scientific Advice for Marqibo 1H11
• Complete Marqibo NDA rolling submission to FDA 1H11
• ODAC meeting in support of Marqibo NDA 2H11
• FDA accelerated approval of Marqibo 2H11

HANA BIOSCIENCES INC (HNAB): Read the Full Research Report

Zacks Investment Research

http://finance.yahoo.com/news/Hana-Bioscience-Poised-To-zacks-1220037434.html?x=0

We estimate peak sales of Marqibo for the ALL indication only could be well above $100 million per year.  In addition to ALL indication, Hana is also expanding Marqibo label  into other indications including front line aggressive NHL, front line  elderly Ph (-) ALL, front line non-elderly Ph (-) ALL, pediatric cancers  and multiple myeloma. If all of, or even part of these label expansions  are successful, Marqibo could represent a $5 billion market  opportunity.

 

finance.yahoo.com/news/...ence-Poised-To-zacks-1220037434.html

kann sich das schnell nach oben arbeiten jetzt ;-)

 

shares of common stock is approximately 21.2 million

ir.hanabiosciences.com/releasedetail.cfm?ReleaseID=506570

ist nicht mehr lange her also dürfte der kaufdrück steigen...

Ich hoffe sie schaffen es und dan winken satte Gewinne..

Zulang haben die long Aktionäre auf diesen Moment gewartet...

Allen viel Glück ;-))

Hana Biosciences to Host a Conference Call to Report Third Quarter 2010 Results and Business Update on November 12, 2010

quelle ihub

und einige scheinen sich zu positionieren

good luck

Wenn man bedenkt das sie schon bei 38 Euro lagen...

Bin mal gespannt ws der CEO heute mitzuteilen hat..

bei ganz gute News können wir vor der Marqibo zulassung bis mitte juni 2011 ein vielfaches höher liegen

und dazu kommen die andere Medikamente...

Das könnte sich zu eine Goldgrube Entwickeln ;-)

diese Bio Aktien sind sehr Extrem-springer, kein Wunder bei einen Potenzial von  $5 billion market  opportunity.

mal schauen was heute gesagt wird ;-)

(HNAB) Hana Bioscience Encouraging Phase II Results

Written by Grant Zeng, CFA

Hana Biosciences Inc. ( HNAB ) A decent pipeline with late stage candidates…

South San Francisco, CA based Hana Biosciences, Inc. (Hana) is a late development stage biopharmaceutical company which is focused on two cancer care areas: cancer therapeutics and cancer supportive care.

The company’s lead cancer therapeutic candidate is Marqibo (vincristine sulfate liposome injection), a novel, targeted Optisome encapsulated formulation product candidate of the FDA-approved anticancer drug vincristine, for the treatment of relapsed/refractory adult acute lymphoblastic leukemia (ALL).

Hana presented results from the registration-enabling Phase II clinical trial (rALLY) of Marqibo for ALL in June 2010 at the ASCO meeting. The data were compelling. Marqibo was administered as third-, fourth-, fifth-, and sixth-line single-agent therapy for ALL patients. The trial achieved 35% overall response rate with a predictable and manageable toxicity profile. The complete response (CR) and CR with incomplete blood count recovery (CRi) were 20%. The median CR/CRi duration was 5.3 months, and median survival in responders was 7.4 months.

Based on the above encouraging Phase II results, Hana completed the pre-NDA meeting with the FDA in April 2010 and plans to start the rolling NDA filing process soon. The rolling NDA filing will be completed by the first half of 2011. Hana has received orphan drug and fast track designations for Marqibo for the treatment of adult ALL from the FDA. Marqibo has also received orphan drug designation from the European Medicines Evaluation Agency in adult ALL. We estimate Marqibo will get the FDA approval in the second half of 2011. Submission of Marqibo for EU approval is planned to happen in 2011.

Marqibo remains both a near term and long term value for Hana. The drug candidate represents a large opportunity. Marqibo is intended to replace standard vincristine chemotherapy. Vincristine is widely and globally used to treat lymphomas, leukemias, myeloma, solid tumors, and childhood cancers. Vincristine is a major component of highly effective combination chemotherapy regimens such as R-CHOP, R-CVP, CVAD, VAD, and VP. It’s estimated that more than 2.4 million doses of Vincristine were sold in the US and Europe per year. However, although Vincristine is used in a broad range of chemotherapies, it is limited by its pharmacokinetics and toxicity profile. Individual doses (1.4 mg/m2) are limited to 2.0 mg regardless of patient size. Frequent, early onset peripheral neuropathy limits cumulative dosing in lymphoma and leukemia induction to approximately 6-8 total mg and rarely more than 12 mg.

Marqibo is a high concentration vincristine loaded into sphingomyelin and cholesterol liposome nanoparticles (Optisomes). Marqibo facilitates individual vincristine doses of 2.8 to 5.5 mg and cumulative induction dosing up to 70 mg. Marqibo’s formulation optimizes vincristine pharmacokinetics by prolonging circulating half-life as an encapsulated drug, by targeting delivery to tumors, bone marrow, lymph nodes, liver, and spleen, by enhancing disease penetration and up to 10x drug concentration in target tissues.

We estimate peak sales of Marqibo for the ALL indication only could be well above $100 million per year. In addition to ALL indication, Hana is also expanding Marqibo label into other indications including front line aggressive NHL, front line elderly Ph (-) ALL, front line non-elderly Ph (-) ALL, pediatric cancers and multiple myeloma. If all of, or even part of these label expansions are successful, Marqibo could represent a $5 billion market opportunity.

Another important drug candidate is Menadione for cancer supportive care. Menadione is a novel topical lotion being developed for the prevention and/or treatment of the skin toxicities associated with the use of epidermal growth factor receptor inhibitors (EGFRI) in the treatment of certain cancers. Rash is a common, painful and treatment-limiting skin toxicity side effect of all approved EGFR inhibitors such as Tarceva, Iressa, Erbitux, Vectibix, and Tykerb with incidence rates as high as 90 percent. EGFR inhibitor-associated rash can lead to reduced compliance and cause dose reductions, delays or discontinuation of EGFR inhibitor therapy in a significant portion of affected patients. Currently, there are no FDA-approved products or therapies to treat these skin toxicities.

Hana has completed a Phase I study of Menadione topical lotion in healthy volunteers, which demonstrated delivery of Menadione into the skin without appreciable systemic absorption. In addition, Menadione topical lotion was generally well-tolerated. The company has recently completed enrollment of a proof-of-concept study of Menadione topical lotion in cancer patients receiving EGFR inhibitors for anti-cancer therapy. This study assessed both treatment potential in patients with new onset rash and prophylactic potential in those about to begin an EGFR inhibitor. Data from this study will be available in late 2010.

In addition to current focus on Marqibo and Menadione, Hana is also developing Alocrest (vinorelbine liposome injection, Phase I) for the treatment of solid tumors; and Brakiva (topotecan liposome injection, Phase I) for the treatment of solid tumors including small cell lung cancer and ovarian cancer. The company is exploring options for further development of these two drug candidates beyond the Phase I trial.

In early June 2010, Hana entered into an Investment Agreement with Warburg Pincus and Deerfield Management for the sale of up to $100 million in preferred stock. Warburg Pincus, the lead investor in the financing, is a new investor in Hana, and Deerfield is the company’s largest existing shareholder prior to this financing.

The Warburg Pincus deal further validates Hana’s technology and clinical efforts

Hana intends to use the net proceeds from the financing to advance its clinical development and commercialization programs, including regulatory activities related to Marqibo’s New Drug Application preparation and submission, and for general corporate purposes. Hana expects that the financing will provide the funds needed to develop Marqibo to approval and commercialization for relapsed/refractory adult ALL patients; to study Marqibo in front-line adult ALL and lymphoma patients; and to unlock the full potential of Menadione topical lotion.

On June 7, 2010, the investors purchased 400,000 shares of Series A-1 Preferred Stock, at a per share sale price of $100. In conjunction with the signing, the investors have the right to purchase up to $60 million of additional Preferred Stock under certain circumstances. The original conversion price for the Preferred Stock to be converted to common stock will be: $0.184 for the first $60 million purchased by the investors and $0.276 for the additional $40 million of Preferred Stock that the investors may have the right to purchase. After the 4-to-1 reverse stock split, the conversion price has increased to $0.74 and $1.10 respectively. The Preferred Stock would accrete at the rate of 9% per annum.

We see the Warburg Pincus deal very as a very positive step for Hana. The deal not only provides vital, necessary funds for the company’s operations, it also further validates the company’s technology and the potential of its pipeline of drug candidates.

Some investors may fear the dilution of existing shareholder base

http://markets.hpcwire.com/taborcomm.hpcwire/...FO&ChannelID=6552

Hana Biosciences - Product Pipeline Review - Q4 2010 (Global Markets Direct)

• Market: Healthcare and Medical
• Published Date: 15 Nov 2010
• Report Type: Company Profile
• Country: Global
• Number of Pages: 40
• View Table of Contents
  Hana Biosciences - Product Pipeline Review - Q4 2010

 

Hana Biosciences - Product Pipeline Review - Q4 2010 provides data on the company's research and development focus. The report includes information on current developmental pipeline, complete with latest updates, and features on discontinued and dormant projects.
It also gives a complete picture of the company's future therapy areas of focus.
This report is built using data and information sourced from proprietary databases, primary and secondary research using the company's corporate website, SEC filings, investor presentations and featured press releases, both from company and industry-specific third party sources, put together with in-house analysis, by a team of industry experts.

Scope

- Hana Biosciences - company overview including business description, key employees, and other facts.
- Review of current pipeline of Hana Biosciences human therapeutic division.
- Overview of pipeline therapeutics across various therapy areas.
- Coverage of current pipeline molecules in various stages of drug development, including the combination treatment modalities, for the pharmaceutical markets across the globe.
- Product profiles for late stage and clinical stage products of Hana Biosciences with complete description of the product's developmental history, mechanism of action, clinical trials, major milestones and others.
- Recent updates of the Hana Biosciences's pipeline in the last quarter.
- Key discontinued and dormant projects.
- Latest news and deals relating to the products.

Reasons to buy

- Evaluate Hana Biosciences's strategic position with total access to a detailed intelligence on its product pipeline.
- Assess the growth potential of Hana Biosciences in its therapy areas of focus.
- Identify new drug targets and therapeutic classes in the Hana Biosciences's R&D portfolio and develop key strategic initiatives to reinforce pipeline in those areas.
- Exploit in-licensing opportunities by identifying windows of opportunity to fill portfolio gaps.
- Exploit collaboration and partnership opportunities with Hana Biosciences.
- Avoid Intellectual Property Rights related issues.
- Explore the dormant and discontinued projects of Hana Biosciences and identify potential opportunities in those areas.
- Do deals with an understanding of the mergers and partnerships that have shaped the sector.

 

http://www.companiesandmarkets.com/...eline-review-q4-2010-395852.asp

Sieht ja doch nicht so gut aus bei den Amis...
Hat jemand eine Erklärung?

Wollte den Wert fast in mein Depot nehmen.
Bin zum Glück nicht vor Eröffnung der US Börsen eingestiegen, puhhh....

gabs ne konferenz
vielleicht waren die erwartungen zu hoch,oder nix neues
muss mich erst belesen,grad erst rein

 

Hana Biosciences Reports Third Quarter 2010 Financial Results                                

SOUTH SAN FRANCISCO, Calif., Nov. 12, 2010 (GLOBE NEWSWIRE) -- Hana Biosciences, Inc. (OTCBB:HNAB - News),  a biopharmaceutical company focused on strengthening the foundation of  cancer care, today reported financial results for the three and nine  months ended September 30, 2010, and provided a corporate update.

"During the third quarter of 2010, our focus was on preparation of the 5  modules that make up the NDA submission for Marqibo(R)" stated Steven  R. Deitcher, M.D., President and Chief Executive Officer of Hana  Biosciences. "An analysis of data from the Menadione Topical Lotion  Phase 1 program showed that it was generally safe and well tolerated. In  addition, the dose limiting toxicity and apparent maximum tolerated  lotion strength were identified. Our strategy is to seek a partner to  enhance and accelerate the continued development of Menadione Topical  Lotion."

Recent Clinical and Corporate Highlights:

• Intensive data collection and verification efforts in the third  quarter led to completion of the database lock for the primary Phase 2  Marqibo clinical trial in October 2010.
• Completed data analysis of Menadione Topical Lotion Phase 1 study.
• Dr. Robert Spiegel, former Chief Medical Officer of Schering Plough, joined the Hana Board of Directors.
• Obtained stockholder approval of certain amendments to the Company's  certificate of incorporation, which led to an adjustment to the  Company's recent Convertible Preferred financing transaction to more  Company-favorable terms.
• Amended its License Agreement with Tekmira Pharmaceuticals Corporation  resulting in an aggregate reduction of $18 million in Hana's potential  milestone obligations in exchange for a one-time payment to Tekmira of  $5.75 million.

Three Months Ended September 30, 2010 Financial Results

For the three months ended September 30, 2010, the Company reported a  net loss of $7.9 million and deemed dividends on preferred stock of  $22.1 million, which when combined, resulted in a net loss applicable to  common stockholders of $30.0 million, or $1.41 per share. The deemed  dividends on preferred stock had an impact of $1.04 per share for the  three months ended September 30, 2010. This compares with a net loss of  $5.7 million, or a loss per share of $0.70, for the three months ended  September 30, 2009. There were no deemed dividends on preferred stock  for the three months ended September 30, 2009.

Total operating expenses for the three months ended September 30, 2010,  were $10.3 million, including the one-time payment to Tekmira of $5.75  million, compared with $4.4 million for the three months ended September  30, 2009. Research and development expenses were $9.0 million for the  three months ended September 30, 2010, compared with $3.5 million for  the three months ended September 30, 2009. General and administrative  expenses were $1.3 million for the three months ended September 30,  2010, compared with $0.9 million for the three months ended September  30, 2009.

As of September 30, 2010, the Company had cash, cash equivalents and  available-for-sale securities of $27.7 million. Cash used in operations  was $10.2 million for the three months ended September 30, 2010 compared  with $5.2 million for the three months ended September 30, 2009.

Nine Months Ended September 30, 2010 Financial Results

For the nine months ended September 30, 2010, the Company reported a  net loss of $19.7 million and deemed dividends on preferred stock of  $31.4 million, which when combined, resulted in a net loss applicable to  common stockholders of $51.1 million, or $2.48 per share. The deemed  dividends on preferred stock had an impact of $1.52 per share for the  nine months ended September 30, 2010. This compares with a net loss of  $19.1 million, or a loss per share of $2.36, for the nine months ended  September 30, 2009. There were no deemed dividends on preferred stock  for the nine months ended September 30, 2009.

Total operating expenses for the nine months ended September 30, 2010,  were $19.3 million, including the $5.75 million one-time payment to  Tekmira, compared with $14.2 million for the nine months ended September  30, 2009. Research and development expenses were $15.0 million for the  nine months ended September 30, 2010, compared with $10.7 million for  the nine months ended September 30, 2009. General and administrative  expenses were $4.3 million for the nine months ended September 30, 2010,  compared with $3.5 million for the nine months ended September 30,  2009.

Cash used in operations was $20.6 million for the nine months ended  September 30, 2010 compared with $16.0 million for the nine months ended  September 30, 2009.

The per share results for all periods have been adjusted to reflect the  impact of the Company's 1-for-4 reverse stock split that occurred at  the close of business on September 10, 2010.

About Hana Biosciences, Inc.

Hana Biosciences, Inc. is a biopharmaceutical company dedicated to  developing and commercializing new, differentiated cancer therapies  designed to improve and enable current standards of care. The company's  lead product candidate, Marqibo(R), potentially treats acute  lymphoblastic leukemia and lymphomas. The Company has additional  pipeline opportunities some of which, like Marqibo, improve delivery and  enhance the therapeutic benefits of well characterized, proven  chemotherapies and enable high potency dosing without increased  toxicity. Additional information on Hana Biosciences can be found at www.hanabiosciences.com.

The Hana Biosciences, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3290

Forward-Looking Statement

This press release contains forward-looking statements within the  meaning of the Private Securities Litigation Reform Act of 1995. These  statements are often, but not always, made through the use of words or  phrases such as "anticipates," "expects," "plans," "believes,"  "intends," and similar words or phrases. These forward-looking  statements include without limitation, statements regarding, the timing,  progress and anticipated results of Hana's planned NDA filing relating  to Marqibo, including whether such NDA submission will be accepted for  review or approved by the FDA; statements regarding the potential of  Marqibo to replace existing therapies and the expected benefits Marqibo  may have for patients with relapsed ALL compared to existing therapies;  and statements regarding the timing, progress and anticipated results of  the clinical development, clinical trial and data analysis timelines,  development plans and strategies and the anticipated benefits of  Menadione Topical Lotion. Such statements involve risks and  uncertainties that could cause Hana's actual results to differ  materially from the anticipated results and expectations expressed in  these forward-looking statements. These statements are based on current  expectations, forecasts and assumptions that are subject to risks and  uncertainties, which could cause actual outcomes and results to differ  materially from these statements. Among other things, there can be no  assurances that any of Hana's clinical and regulatory development  efforts relating to Marqibo will be successful; that even if an NDA for  Marqibo is accepted by the FDA, that it will be approved; that the data  of the clinical trials of Marqibo will be sufficient to support approval  by the FDA of an NDA for Marqibo; that Hana will have completed all  other activities necessary for the filing of an NDA or other submission  with the FDA; that the results of the clinical trials of Marqibo will  support Hana's claims or beliefs concerning Marqibo's safety and  effectiveness; that its existing patent and other intellectual property  rights will be adequate; and that Hana will be able to secure a partner  with which to develop Menadione Topical Lotion. Additional risks that  may affect such forward-looking statements include Hana's need to raise  additional capital to fund its product development programs to  completion, Hana's reliance on third-party researchers to develop its  product candidates, and its lack of experience in developing and  commercializing pharmaceutical products. Additional risks are described  in the company's Annual Report on Form 10-K for the year ended December  31, 2009 and in the Company's Form 10-Q for the period ended March 31,  2010. Hana assumes no obligation to update these statements, except as  required by law.



HANA BIOSCIENCES, INC.
CONDENSED BALANCE SHEETS
	September 30, 2010	December 31, 2009
	(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents	$8,669,331	$9,570,453
Available-for-sale, equity securities	64,000	68,000
Available-for-sale, debt securities	18,981,752	--
Prepaid expenses and other current assets	107,074	114,067
Total current assets	27,822,157	9,752,520
Property and equipment, net	135,266	252,455
Restricted cash	125,000	125,000
Debt issuance costs	938,109	1,193,594
Total assets	$29,020,532	$11,323,569
LIABILITIES AND STOCKHOLDERS' DEFICIT
Current liabilities:
Accounts payable and accrued liabilities	$4,024,057	$4,027,075
Other short-term liabilities	6,479	43,586
Total current liabilities	4,030,536	4,070,661
Notes payable, net of discount	23,188,508	22,597,050
Other long-term liabilities	5,253	6,540
Investors' right to purchase future shares of Series A-1 and A-2 preferred stock	6,239,000	--
Warrant liabilities, non-current	692,271	2,145,511
Total long term liabilities	30,125,032	24,749,101
Total liabilities	34,155,568	28,819,762
Commitments and contingencies:
Redeemable convertible preferred stock; $100 par value:
10 million shares authorized, 0.4 million and 0 shares issued and  outstanding at September 30, 2010 and December 31, 2009, respectively;  aggregate liquidation value of $41.5 million and $0 at September 30,  2010 and December 31, 2009, respectively	30,643,219	--
Stockholders' deficit:
Common stock; $0.001 par value:
350 million and 200 million shares authorized, 21.2 million and 19.9  million shares issued and outstanding at September 30, 2010 and  December 31, 2009, respectively	21,234	19,912
Additional paid-in capital	119,071,635	117,632,111
Accumulated other comprehensive income	(29,532)	(24,000)
Accumulated deficit	(154,841,592)	(135,124,216)
Total stockholders' deficit	(35,778,255)	(17,496,193)
Total liabilities, redeemable, convertible preferred stock and stockholders' deficit	$29,020,532	$11,323,569

HANA BIOSCIENCES, INC.
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
	Three Months Ended	Nine Months Ended
	September 30,	September 30,
	2010	2009	2010	2009
Operating expenses:
General and administrative	$1,253,194	$932,221	$4,299,929	$3,504,895
Research and development	9,002,798	3,506,920	14,966,768	10,701,473
Total operating expenses	10,255,992	4,439,141	19,266,697	14,206,368
Loss from operations	(10,255,992)	(4,439,141)	(19,266,697)	(14,206,368)
Other income (expense):
Interest income	37,514	470	38,020	12,626
Interest expense	(856,050)	(935,993)	(2,881,369)	(2,496,143)
Other expense, net	(3,511)	--	(3,511)	(4,908)
Change in fair value of warrant liabilities	348,717	(292,111)	(34,819)	(2,449,220)
Change in fair value of investors' right to purchase future shares of Series A-1 and A-2 preferred stock	2,809,000	--	2,431,000	--
Total other income (expense)	2,335,670	(1,227,634)	(450,679)	(4,937,645)
Net loss	$(7,920,322)	$(5,666,775)	$(19,717,376)	$(19,144,013)
Deemed dividends attributable to preferred stock	(22,059,541)	--	(31,366,973)	--
Net loss applicable to common stock	(29,979,863)	--	(51,084,348)	--
Net loss per share applicable to common stock, basic and diluted	$(1.41)	$(0.70)	$(2.48)	$(2.36)
Weighted average shares used in computing net loss per share, basic and diluted	21,233,804	8,145,034	20,570,038	8,123,541
Comprehensive loss:
Net loss	$(7,920,322)	$(5,666,775)	$(19,717,376)	$(19,144,013)
Unrealized holdings gains (losses) arising during the period	(13,532)	(20,000)	(5,532)	(24,000)
Comprehensive loss	$(7,933,854)	$(5,686,775)	$(19,722,908)	$(19,168,013)

                                                                       

Hana Biosciences, Inc. Investor & Media Contacts: Investor Relations Team (650) 588-6641 investor.relations@hanabiosciences.comhttp://finance.yahoo.com/news/Hana-Biosciences-Reports-pz-1088605335.html?x=0&.v=2

 

doch so läuf es leider nicht ;-)

Ein wenig Warten und Geduld ist angesagt ;-))

Marqibo ist in ein paar Monate dran und bist dahin wird hier sich noch vieles tun ;-))

kauf ich die dips
good luck

Interessant ;-))

http://www.thecleverbull.com/articles/view/article/14/Pullback-Opportunity-exclusive-interview-with-Hana-Biosciences-OTCHNAB

 

     

Pullback Opportunity, exclusive interview with Hana Biosciences (OTC:HNAB)

Posted on Nov 13, 2010, 9:30 pm  Author: The Clever Bull

Hana Biosciences provided a business update about the progress made during the third quarter. link to Nov. 12th CC: ir.hanabiosciences.com/eventdetail.cfm Complete original NDA will be submitted in first half of 2011. This change in process is not expected to effect the timing of submission completion, review or potential approval.   "During  the third quarter of 2010, our focus was on preparation of the 5  modules that make up the NDA submission for Marqibo(R)" stated Steven R.  Deitcher, M.D., President and Chief Executive Officer of Hana  Biosciences. "An analysis of data from the Menadione Topical Lotion  Phase 1 program showed that it was generally safe and well tolerated. In  addition, the dose limiting toxicity and apparent maximum tolerated  lotion strength were identified. Our strategy is to seek a partner to enhance and accelerate the continued development of Menadione Topical Lotion. While  this should have been considered as good news, some impatient investors  have taken their profit off the table after the recent rise of the  share price, +50% in one month (While HNAB was down 28% after the CC, it  is good to note that the volume was very low). We think the potential  is still here and this might represent a good buy opportunity since the  submission of the NDA is just few months away and it will be submitted  as a complete original NDA with all the modules. During the CC Dr. Deitcher was very confident that the NDA will be submitted in the first half of 2011. He stated "We are well on the way to accomplishing that goal..." Hana  Biosciences was working on preparing the 5 modules during the third  quarter and this will carry on through the end of the year, almost all  of the modules will be completed before the end of 2010, we believe a  change for a full submission rather than module by module might be a  good strategy and Dr. Deitcher mentioned during the CC that it was  suggested and recommended by the FDA, it is most convenient for them. As  of September 30, 2010, the Company had cash, cash equivalents and  available-for-sale securities of $27.7 million. With the recent $40M  financing round, that brings the market cap of Hana Biosciences to  around $50M, which we consider to be still very low regarding the  pipeline, and the long term potential for Marqibo in other indications. The  Clever Bull has conducted an exclusive interview with Hana Biosciences  to highlight more specific points such as the NDA application, the  potential for Marqibo in other indications, Menadione, Warburg financing  deal. Here is the interview: 1-    You are  about to fill the rolling NDA for Marqibo, are you confident to get an  accelerated approval review? You said the NDA will be filled before end  of 2010, are you still on track with this time frame? Response:   On November 8, 2010 we held a pre-NDA follow-up meeting with the FDA.  At that meeting we and the FDA agreed that Hana would submit all of the  NDA modules simultaneously instead of following a rolling submission  process. This change in process is not expected to effect the timing of  submission completion, review or potential approval. We anticipate  submitting the completed NDA in the first half of 2011. We are pursuing  an accelerated approval of Marqibo and the program already has  Fast-Track and Orphan Drug designations from the FDA. 2-     Can you confirm that other applications with Marqibo such as Front-line  NHL and Front-line Ph-ALL which represent a total market of around 5B  will both only require Phase III studies? Are they already started or  when do you plan to start them? Response:   We expect that studies such as the ones you indicated will only require  Phase III studies. However, until a Phase III trial protocol is  approved by the FDA there is not 100% certainty. No Phase III clinical  trials of Marqibo have commenced. The logical strategy is to receive the  FDA’s approval decision on Marqibo’s current indication before  committing funds to a large, expensive, label expansion trial. 3-     Are those other applications with Marqibo already founded or do you  plan to partner with the classic method of upfront payment and royalties  system? Response:  For large,  expensive, multi-national, Phase III clinical trials, it is common for  small companies to seek to share costs with another entity. We are  keeping all our options open.   4-    Marqibo has  been granted EMA Orphan Drug designation in Europe and you said you are  exploring the potential for an authorization under exceptional  circumstances. Can you tell us more about this process and does it mean  Marqibo may be approved in Europe in 1H11? Response:   Hana will seek formal Scientific Advice from EMA in 2011. Approval in  Europe will require a full regulatory submission.  The approval decision  in Europe is anticipated to follow the approval decision in the US. 5-     There is actually one clinical trial that is ongoing with the NCI with  respect to pediatric cancers ALL, when will we have some data about this  promising indication? Response:   The pediatric oncology branch of the NCI will be conducting a Phase 1  pharmacokinetic and dose finding study. The study could take up to 2  years to fully enroll. 6-    Now, with respect  to Menadione, we are waiting for Top-line data and the start of the  Phase II before end of this year. The focus is on Marqibo for now and  investors have yet to discover the potential of this topical cream.  Since it has the potential to prevent the rash in chemotherapy treated  patients and it is also effective to treat psoriasis, can you tell  enlighten us about the market potential in term of numbers? Response:   First, we have no clinical data demonstrating the efficacy of Menadione  Topical Lotion for treating psoriasis. We recently completed the Phase 1  program.  The Phase 1 program has successfully demonstrated that MTL is  generally safe and well-tolerated.  The dose limiting toxicity, skin  irritation and redness, was only observed at the 0.2% lotion strength.   The apparent maximum tolerated lotion strength is 0.1%.   MTL applied  twice daily at all strengths, including the highest lotion strength  tested (0.2%) resulted in no appreciable systemic exposure. Due  to the fact that there are no comparable lotions indicated for the  treatment of EGFR rash, there is no empirical data establishing the size  of the opportunity.  It is estimated that there are approximately  45,000 to 50,000 people undergoing EGFR therapy annually in the U.S and  Europe. 7-    Since Menadione is a topical  cream, does it need to go through a classic FDA review process with a  NDA filling? You said you plan to find a partner for Menadione, you  mentioned discussions with partners are ongoing, can you tell us more  about this? Response:  Menadione  Topical Lotion requires the completion of the standard FDA clinical  trial process. We are unable to comment on discussions with potential  partners. 8-    You recently signed a financing  deal with Warburg Pincus for up to $100M. While many investors fear  dilution to come, can you explain the Warburg’s strategy with your  company? Do you feel it’s a long term partner that will push Hana  Bioscience to a bigger company? Response:   Warburg Pincus has a track record as a long-term investor seeking to  generate significant value but we are unable to predict how things will  progress with Hana at this time. 9-    There has  been some misunderstanding with the convert prices post R/S. Can you  confirm that convert prices did increase 4X also with the R/S and are  now at $0.72 and $1.10? We have seen that Warburg is a long term partner  with companies they invest on, do you think they will convert and sell  their shares on the market or rather they will wait to get the full  potential in the coming years before selling any? Response:   The new conversion prices are $0.736 for the Series A-1 Preferred Stock  and $1.104 for the Series A-2 Preferred Stock. Based on the Investment  Agreement, the preferred shareholders have options for how they may  choose to create liquidity for their preferred shares, including  converting to common shares or, if there is an acquisition, preferred  shareholders may opt to receive proceeds in cash without converting into  common shares. We are unable to predict if or when preferred  shareholders may choose to convert their preferred shares to common  shares. 10-    We know that Warburg has a large  portfolio of biotech companies that are almost all traded on the NASDAQ  with a market cap of over $500M, do you think we might see HNAB back to  the NASDAQ in early 2011? Response:   There are certain requirements to be listed on exchanges such as Nasdaq  and Amex. Among the requirements are share price, stock holder equity,  and market cap, as well as others. We are unable to predict when Hana  may meet the necessary requirements, if at all.   Forward-Looking Statement This  document contains forward-looking statements within the meaning of the  Private Securities Litigation Reform Act of 1995. These statements are  often, but not always, made through the use of words or phrases such as  "anticipates," "expects," "plans," "believes," "intends," and similar  words or phrases. These forward-looking statements include without  limitation, statements regarding, the timing, progress and anticipated  results of Hana's planned NDA filing relating to Marqibo, including  whether such NDA submission will be accepted for review or approved by  the FDA; statements regarding the timing and progress of proposed  clinical trials; statements regarding the potential of Marqibo to  replace existing therapies and the expected benefits Marqibo may have  for patients with relapsed ALL compared to existing therapies;  statements regarding our ability to secure a development partner for  Menadione Topical Lotion; and statements regarding the Menadione Topical  Lotion regulatory approval process. Such statements involve risks and  uncertainties that could cause Hana's actual results to differ  materially from the anticipated results and expectations expressed in  these forward-looking statements. These statements are based on current  expectations, forecasts and assumptions that are subject to risks and  uncertainties, which could cause actual outcomes and results to differ  materially from these statements. Among other things, there can be no  assurances that any of Hana's clinical and regulatory development  efforts relating to Marqibo will be successful; that even if an NDA for  Marqibo is accepted by the FDA, that it will be approved; that the data  of the clinical trials of Marqibo will be sufficient to support approval  by the FDA of an NDA for Marqibo; that Hana will have completed all  other activities necessary for the filing of an NDA or other submission  with the FDA; that the results of the clinical trials of Marqibo will  support Hana's claims or beliefs concerning Marqibo's safety and  effectiveness; and that Hana will be able to secure a development  partner for Menadione Topical Lotion. Additional risks that may affect  such forward-looking statements include Hana's need to raise additional  capital to fund its product development programs, including Marqibo, to  completion, Hana's reliance on third-party researchers to develop its  product candidates, and its lack of experience in developing and  commercializing pharmaceutical products. Additional risks are described  in the company's Annual Report on Form 10-K for the year ended December  31, 2009 and in the Company's Form 10-Q for the period ended March 31,  2010. Hana assumes no obligation to update these statements, except as  required by law.   Full Disclosure: -Long position on HNAB -The  Clever bull has NOT been compensated in any way by Hana Biosciences or Warburg Pincus to  promote or write this article.   The Clever Bull team. By  reading The Clever Bull you agree to the disclaimer,       and  thereby will not hold The Clever Bull accountable for any       transactions  or decisions you make. It is up to you to do your own  due      diligence. TheCleverBull.com  is not a registered  investment      advisor and nothing contained in any  materials should  be construed  as  a    recommendation to buy or sell any  securities.  The Clever Bull  has   not   been compensated by any of the above   mentioned companies.   Please  read   our report and visit our Web site,  www.thecleverbull.com,  for complete risks and disclosures.

bis auf 2 -3 Euro hochgehen wird ;-)

habe ein wenig der Aktienverlauf zurückgeschaut und es können Extrem große Sprünge geben bald :-)

http://finance.yahoo.com/...ohlcvalues=0;logscale=on;source=undefined

Mit ein Potenzial  von 5 Millarden USD sind hier bald ganz andere Preiße zu ewarten ;-)

Mein rat haltet eure shares fest ;-)

Hana Biosciences recovering from recent price drop

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Written by Eric Sebastien

Wednesday, 17 November 2010 03:21

 

Hana Biosciences, Inc. (OTC:HNAB) has been busy getting ready to submit- in first half of 2011- a complete original NDA. 
"During the third quarter of 2010, our focus was on preparation of the 5 modules that make up the NDA submission for Marqibo" stated Dr. Steven R. Deitcher, M.D., President and Chief Executive Officer of Hana Biosciences during a recent conference call. "An analysis of data from the Menadione Topical Lotion Phase 1 program showed that it was generally safe and well tolerated. In addition, the dose limiting toxicity and apparent maximum tolerated lotion strength were identified. Our strategy is to seek a partner to enhance and accelerate the continued development of Menadione Topical Lotion.

While some investors considered this positive news, others simply took their profits off the table after the recent rise in share prices (+50% in one month) and wlaked away.  HNAB was suddenly down 28% on low volume. Now some are re-considering HNAB and its potential as a "good buy opportunity", especially since the complete submission of the NDA is just months away.

Hana Biosciences was working on preparing the 5 modules during the third quarter and this will carry on through the end of the year, almost all of the modules will be completed before the end of 2010, we believe a change for a full submission rather than module by module might be a good strategy and Dr. Deitcher mentioned during the CC that it was suggested and recommended by the FDA, it is most convenient for them.

As of September 30, 2010, the Company had cash, cash equivalents and available-for-sale securities of $27.7 million. With the recent $40M financing round, that brings the market cap of Hana Biosciences to around $50M, which we consider to be still very low regarding the pipeline, and the long term potential for Marqibo in other indications.

I recenlty conducted an exclusive interview with Hana Biosciences:

Question:  You are about to fill the rolling NDA for Marqibo, are you confident to get an accelerated approval review? You said the NDA will be filled before end of 2010, are you still on track with this time frame?

Craig Carlson, CFO of Hana Biosciences:  On November 8, 2010 we held a pre-NDA follow-up meeting with the FDA. At that meeting we and the FDA agreed that Hana would submit all of the NDA modules simultaneously instead of following a rolling submission process. This change in process is not expected to effect the timing of submission completion, review or potential approval. We anticipate submitting the completed NDA in the first half of 2011. We are pursuing an accelerated approval of Marqibo and the program already has Fast-Track and Orphan Drug designations from the FDA.
 

Question: Marqibo has been granted EMA Orphan Drug designation in Europe and you said you are exploring the potential for an authorization under exceptional circumstances. Can you tell us more about this process and does it mean Marqibo may be approved in Europe in 1H11?

Craig Carlson, CFO of Hana Biosciences:  Hana will seek formal Scientific Advice from EMA in 2011. Approval in Europe will require a full regulatory submission.  The approval decision in Europe is anticipated to follow the approval decision in the US.

Question: There is actually one clinical trial that is ongoing with the NCI with respect to pediatric cancers ALL, when will we have some data about this promising indication?

Craig Carlson, CFO of Hana Biosciences:  The pediatric oncology branch of the NCI will be conducting a Phase 1 pharmacokinetic and dose finding study. The study could take up to 2 years to fully enroll.

Question: Now, with respect to Menadione, we are waiting for Top-line data and the start of the Phase II before end of this year. The focus is on Marqibo for now and investors have yet to discover the potential of this topical cream. Since it has the potential to prevent the rash in chemotherapy treated patients and it is also effective to treat psoriasis, can you tell enlighten us about the market potential in term of numbers?

Craig Carlson, CFO of Hana Biosciences:  First, we have no clinical data demonstrating the efficacy of Menadione Topical Lotion for treating psoriasis. We recently completed the Phase 1 program.  The Phase 1 program has successfully demonstrated that MTL is generally safe and well-tolerated.  The dose limiting toxicity, skin irritation and redness, was only observed at the 0.2% lotion strength.  The apparent maximum tolerated lotion strength is 0.1%.   MTL applied twice daily at all strengths, including the highest lotion strength tested (0.2%) resulted in no appreciable systemic exposure.

Due to the fact that there are no comparable lotions indicated for the treatment of EGFR rash, there is no empirical data establishing the size of the opportunity.  It is estimated that there are approximately 45,000 to 50,000 people undergoing EGFR therapy annually in the U.S and Europe.

Question: Since Menadione is a topical cream, does it need to go through a classic FDA review process with a NDA filing? You said you plan to find a partner for Menadione, you mentioned discussions with partners are ongoing, can you tell us more about this?

Craig Carlson, CFO of Hana Biosciences:  Menadione Topical Lotion requires the completion of the standard FDA clinical trial process. We are unable to comment on discussions with potential partners.

Question: You recently signed a financing deal with Warburg Pincus for up to $100M. While many investors fear dilution to come, can you explain the Warburg’s strategy with your company? Do you feel it’s a long term partner that will push Hana Bioscience to a bigger company?

Craig Carlson, CFO of Hana Biosciences:  Warburg Pincus has a track record as a long-term investor seeking to generate significant value but we are unable to predict how things will progress with Hana at this time.

Question: There has been some misunderstanding with the convert prices post R/S. Can you confirm that convert prices did increase 4X also with the R/S and are now at $0.72 and $1.10? We have seen that Warburg is a long term partner with companies they invest on, do you think they will convert and sell their shares on the market or rather they will wait to get the full potential in the coming years before selling any?

Craig Carlson, CFO of Hana Biosciences:  The new conversion prices are $0.736 for the Series A-1 Preferred Stock and $1.104 for the Series A-2 Preferred Stock. Based on the Investment Agreement, the preferred shareholders have options for how they may choose to create liquidity for their preferred shares, including converting to common shares or, if there is an acquisition, preferred shareholders may opt to receive proceeds in cash without converting into common shares. We are unable to predict if or when preferred shareholders may choose to convert their preferred shares to common shares.

Question: We know that Warburg has a large portfolio of biotech companies that are almost all traded on the NASDAQ with a market cap of over $500M, do you think we might see HNAB back to the NASDAQ in early 2011?

Craig Carlson, CFO of Hana Biosciences: There are certain requirements to be listed on exchanges such as Nasdaq and Amex. Among the requirements are share price, stock holder equity, and market cap, as well as others. We are unable to predict when Hana may meet the necessary requirements, if at all.

Writer Eric Sebastien is the managing editor of TheCleverBull.com
Disclosure: Long HNAB

http://biomedreports.com/2010111760228/...ering-from-recent-drop.html

Business

Market Report, "Hana Biosciences - Product Pipeline Review - Q4 2010", published

	Print article
	Refer to a friend

Author: Bill Thompson e-mail Web: www.fastmr.com Phone: 18008448156 http://www.pr-inside.com/market-report-hana-biosciences-r2256935.htm

PROTOX CLOSES FIRST $10 MILLION TRANCHE OF WARBURG PINCUS INVESTMENT

Mr. Jonathan Leff is a Managing Director of Warburg Pincus where he focuses on investments in healthcare. Prior to joining Warburg Pincus, he was a consultant at Oliver, Wyman & Co. Mr. Leff received an A.B. in government from Harvard University and an M.B.A. from the Stanford University Graduate School of Business. Mr. Leff is a director of Allos Therapeutics, Inc., Hana Biosciences, Inc., Inspire Pharmaceuticals, Inc., InterMune, Inc. and Rib-X. Mr. Leff also serves on the Board of Directors of the Biotechnology Industry Organization,

http://www.stockhouse.com/News/USReleasesDetail.aspx?n=7959520

Hana Biosciences, Inc.

Hana Biosciences, Inc. (Nasdaq: HNAB) is a biopharmaceutical company dedicated to developing new, differentiated cancer therapies designed to improve and enable current standards of care. The Company has two lead product candidates that target large markets and are in pivotal and/or proof-of-concept clinical trials. Marqibo(R) is being developed to treat lymphoid cancers such as ALL and lymphomas. Menadione topical lotion is a first-in-class compound being developed as a prevention and/or treatment of skin toxicity associated with epidermal growth factor receptor inhibitors like Erbitux(R) and Tarceva(R). The Company has additional pipeline opportunities that, like Marqibo, improve delivery and enhance the therapeutic index of well characterized, proven chemotherapies. Further information on Hana Biosciences can be found at www.hanabiosciences.com.

http://www.bioportfolio.com/corporate/company/...Biosciences-Inc.html

Hallo liebe Mitstreiter.
Ich habe Interesse an einer Position HANA, jedoch fällt es mir schwer, mich hierfür zu entscheiden. Die News sind toll, Bodenbildung meines Erachtens erreicht und FinRes Report ist auch ok. Bin aber durch Oscient und Genta ein gebranntes Kind. Von Bio- bzw. Pharmawerten halte ich aktuell nur Prometic, welche nach vielen positiven News auch mal an die Decke gehen könnte (tut's aber noch nicht, das elende Teil).
Aus diesem Grund: Ist hier jemand weiter in der Materie vorangeschritten und kann mir näheres zu 1. EMA Orphan Drug designation in Europe; 2. dem Fast-Track Status  bezüglich Marquibo erzählen? Danke im voraus und Thumbs Up! bei HANA

Hana Biosciences to Present Data on Marqibo(R) at the 2010 American Society of Hematology Annual Meeting and Exposition

 

SOUTH SAN FRANCISCO, Calif., Nov. 29, 2010 (GLOBE NEWSWIRE) -- Hana Biosciences (OTCBB:HNAB - News), a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that data regarding Marqibo for treatment of adults with relapsed/refractory acute lymphoblastic leukemia (ALL) will be the subject of two presentations at the 2010 Annual Meeting and Exposition of the American Society of Hematology (ASH) being held in Orlando, Florida from December 4-7, 2010.

 

 

Presentation details are as follows:

 

 

Abstract: 2142: Marqibo(R) (vincristine sulfate liposomes injection; VSLI) Optimizes the Dosing, Delivery, and Pharmacokinetic (PK) Profile of Vincristine Sulfate (VCR) In Adults with Relapsed and Refractory Acute Lymphoblastic Leukemia (ALL)

 

 

Abstract: 2143: Marqibo(R) (vincristine sulfate liposomes injection; VSLI) In the Treatment of Adult Patients with Advanced, Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL): A Combined Analysis of the VSLI-06 and RALLY Studies

 

Date/Time/Place:	Sunday, December 5, 2010, 6:00PM -- 8:00PM
	Orange County Convention Center, Orlando, FL
Poster Boards:	II-22 & 23

 

The abstracts are available online at:

 

 

http://ash.confex.com/ash/2010/webprogram/Paper33455.html
http://ash.confex.com/ash/2010/webprogram/Paper34609.html

 

 

About Marqibo(R) (vincristine sulfate liposomes injection)

 

 

Marqibo is a novel, targeted, Optisome(TM) encapsulated formulation of vincristine sulfate, a widely-used chemotherapy, which has shown promising anti-cancer activity in patients with ALL, non-Hodgkin's lymphoma, Hodgkin's disease, and melanoma in several clinical trials. Marqibo is designed to enhance the penetration and concentration of vincristine sulfate at sites of active cancer and facilitate dose-intensification compared to standard vincristine formulations. Unlike standard vincristine, Marqibo is dosed based on actual patient body surface area without the need for dose capping.

 

 

Hana Biosciences has received orphan drug and fast track designations for Marqibo for the treatment of adult ALL from the U.S. Food and Drug Administration. Marqibo has also received orphan drug designation in adult ALL from the European Medicines Evaluation Agency.

 

 

About Hana Biosciences, Inc.

 

 

Hana Biosciences, Inc. is a biopharmaceutical company dedicated to developing and commercializing new, differentiated cancer therapies designed to improve and enable current standards of care. The company's lead product candidate, Marqibo(R), potentially treats acute lymphoblastic leukemia and lymphomas. The Company has additional pipeline opportunities some of which, like Marqibo, improve delivery and enhance the therapeutic benefits of well characterized, proven chemotherapies and enable high potency dosing without increased toxicity. Additional information on Hana Biosciences can be found at www.hanabiosciences.com.

 

 

The Hana Biosciences, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3290

 

 

Forward-Looking Statement

 

 

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are often, but not always, made through the use of words or phrases such as "anticipates," "expects," "plans," "believes," "intends," and similar words or phrases. These forward-looking statements include without limitation, statements regarding the clinical development of Marqibo, the potential of Marqibo to replace existing therapies and the expected benefits Marqibo may have for patients with relapsed ALL and other diseases compared to existing therapies. Such statements involve risks and uncertainties that could cause Hana's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements.

http://finance.yahoo.com/news/...sent-pz-2333698019.html?x=0&.v=1

Hast du noch ander aktien,ausser Hana,BOI und YRCW ?

Chalifmann3: was ist loss? gefallen sie dir nicht? Naja man sollte auf Long gehen finde ich...

Bio Aktien sind nicht einfach, aber können auch sehr Extreme Gewinne bringen,

 wenn natürlich an Ende alles Stimmt...

Jeder muss selber wissen was er tut und dafuer auch die Verantwortung übernehmen...

der mit der erste Zulassung der Durchbruch schaffen sollte winken schon mal 5$

bei der Ganze Marqibo(R) Palette 5 Milliarde USD Umsatz..

Das wäre ja ein Traum Gewinn je Aktie..

Der kaufdrück wird Automatisch steigen be so eine Schanze...

Und später kommen ja noch andere Medikamente..

Diese Aktie könnte sich in den nässten 7 Monate zu eine Goldmine Entwickeln.

Daumen drücken ist angesagt jetzt ;-)

Hana Biosciences to Change Name to Talon Therapeutics

 

SOUTH SAN FRANCISCO, Calif., Dec. 1, 2010 (GLOBE NEWSWIRE) -- Hana Biosciences (OTCBB:HNAB - News), a biopharmaceutical company focused on strengthening the foundation of cancer care, announced that its board of directors has approved changing its name to Talon Therapeutics, Inc. The name change will become effective on Thursday, December 2, 2010.

"The change in corporate name from Hana Biosciences to Talon Therapeutics reflects the Company's culture of seizing upon medical opportunities, efficiently and expertly leading product candidates through clinical development, and transferring value to patients, patient care providers, shareholders, corporate partners, and employees," stated Steven R. Deitcher M.D. President and Chief Executive Officer of Hana Biosciences. "Other than the name change, there is no fundamental change to the Company. Marqibo(R) is our lead product candidate and we anticipate submitting our NDA to the FDA during the first half of 2011."

The Company's ticker symbol on the OTC Bulletin Board will be TLON.OB effective at the commencement of trading on December 2, 2010. The Company's new corporate website is www.talontx.com.

About Marqibo(R) (vincristine sulfate liposomes injection)

Marqibo is a novel, targeted, Optisome(TM) encapsulated formulation of vincristine sulfate, a widely-used chemotherapy, which has shown promising anti-cancer activity in patients with ALL, non-Hodgkin's lymphoma, Hodgkin's disease, and melanoma in several clinical trials. Marqibo is designed to enhance the penetration and concentration of vincristine sulfate at sites of active cancer and facilitate dose-intensification compared to standard vincristine formulations. Unlike standard vincristine, Marqibo is dosed based on actual patient body surface area without the need for dose capping.

The Company has received orphan drug and fast track designations for Marqibo for the treatment of adult ALL from the U.S. Food and Drug Administration. Marqibo has also received orphan drug designation in adult ALL from the European Medicines Evaluation Agency. 

About Us

We are a biopharmaceutical company dedicated to developing and commercializing new, differentiated cancer therapies designed to improve and enable current standards of care. The company's lead product candidate, Marqibo, potentially treats acute lymphoblastic leukemia and lymphomas. The Company has additional pipeline opportunities some of which, like Marqibo, improve delivery and enhance the therapeutic benefits of well characterized, proven chemotherapies and enable high potency dosing without increased toxicity.

The Hana Biosciences, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3290

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are often, but not always, made through the use of words or phrases such as "anticipates," "expects," "plans," "believes," "intends," and similar words or phrases. These forward-looking statements include without limitation, statements regarding the clinical development of Marqibo, the potential of Marqibo to replace existing therapies and the expected benefits Marqibo may have for patients with relapsed ALL and other diseases compared to existing therapies, and the timing for NDA submission. Such statements involve risks and uncertainties that could cause the Company's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements.

http://finance.yahoo.com/news/...ange-pz-4001940225.html?x=0&.v=1

über Marqibo das sie schon die weichen setzen für eine bessere Mark Einführung

The abstracts are available online at:

http://ash.confex.com/ash/2010/webprogram/Paper33455.html
http://ash.confex.com/ash/2010/webprogram/Paper34609.html

Officer of Hana Biosciences. "Other than the name change, there is no fundamental change to the Company. Marqibo(R) is our lead product candidate and we anticipate submitting our NDA to the FDA during the first half of 2011."

The Company has received orphan drug and fast track designations for Marqibo for the treatment of adult ALL from the U.S. Food and Drug Administration. Marqibo has also received orphan drug designation in adult ALL from the European Medicines Evaluation Agency.

 

Last Trade:	0.75
Trade Time:	9:55AM EST
Change:	0.19 (33.93%)

http://finance.yahoo.com/q?s=TLON.OB

Last Change Volume Last-Trade Time Open High    Low
      0.58                         5,700§12/2/10 10:37:29   00,58   0,75     0,58    

Form 8-K for TALON THERAPEUTICS, INC.

2-Dec-2010

Amendments to Articles of Inc. or Bylaws; Change in Fiscal Year, Financi

 

 

http://biz.yahoo.com/e/101202/tlon8-k.html

 

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http://maps.google.com/...68321&z=12&iwloc=A&source=embed

 

TALON THERAPEUTICS überall zu erreichen ist hier meine erste links

 

http://finance.yahoo.com/q?s=TLON.OB

http://www.ariva.de/talon_therapeutics_dl-001-aktie

Mal sehen wann die Fertig sind mit ihre umbenennung..

Denke jetzt dürfte in Germany wieder ein handel möglich sein..

http://www.finanzen.net/aktien/Talon_Therapeutics-Aktie

On January 9, 2012, the Company entered into an Investment Agreement for the sale of up to $71 million of Preferred Stock, and closed on the sale of 110,000 shares of Series A-2 Preferred Stock ($11 million), at a per share sale price of $100. The Series A-2 Preferred Stock is convertible into shares of the Company's common stock at an initial conversion price of $0.30, subject to customary adjustments. From the date of the Investment Agreement until the first anniversary of the Company's receipt of marketing approval from the FDA for Marqibo, the investors have the right to invest up to an additional $60 million in Series A-3 Preferred Stock, which is initially convertible into common stock at a conversion price of $0.35, subject to customary adjustments. Upon issuance, the Series A-2 and A-3 Preferred Stock will accrete at 9% per annum, among other provisions.

In June 2010, the Company had previously entered into an investment agreement with Warburg Pincus and Deerfield Management that provided for a financing of up to $100 million in preferred stock. Of such total, $40 million was invested at a conversion price of $0.736. Effective with the completion of this new financing, the unused $60 million in available options from the June 2010 financing have been terminated.

Roth Capital Partners, LLC served as financial advisor to a special committee of Talon's board of directors and provided a fairness opinion in connection with the transaction.