Kommt bei Hana Bioscience ein möglicher Rebound?
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HNAB | Quote | HNAB | Quote | Chart | News | PowerRating");">Chart | News | PowerRating -- Hana Biosciences has reported positive data from its pivotal Phase II rALLy clinical trial for Marqibo for the treatment of adult acute lymphoblastic leukemia, or ALL, in second relapse.
Results from the rALLy trial demonstrated compelling evidence of single-agent, anti-leukemic activity in a relapsed/refractory, heavily pre-treated, adult population of ALL patients, with a universal history of prior exposure to the standard formulation of vincristine sulfate, said Hana.
The analysis of the first 56 evaluable subjects demonstrated an overall response in 36% of the subjects and a complete remission (CR) or CR with incomplete hematologic recovery in 21% of the subjects. The estimated median overall survival in complete responders was 7.3 months.
A total of 50% of the complete responders were able to receive a potentially life-saving stem cell transplant. Approximately 50% of the complete responders had remission durations longer than the duration of their prior remission. In addition, Marqibo was generally well-tolerated with a low incidence of early death.
Final data on all 65 subjects enrolled and dosed in the Phase II rALLy trial will be presented in 2010.
Anne Hagey, chief medical officer of Hana Biosciences, said: "We are excited by the rALLy trial results for Marqibo in adult ALL that demonstrate an ability to induce meaningful remissions in patients without approved treatment options. Based on the rALLy trial data, other published Marqibo data in adult ALL, and supportive data in lymphomas and solid tumors, we plan to submit a new drug application seeking accelerated approval for Marqibo in 2010."
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For full details on (HNAB) HNAB. (HNAB) has Short Term PowerRatings at TradingMarkets. Details on (HNAB) Short Term PowerRatings is available at This Link.
http://www.tradingmarkets.com/.site/news/Stock%20News/2717073/
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.
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
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 12th 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:
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
Posted on: Tue, 02 Feb 2010 21:41:10 EST
For full details on (HNAB) HNAB. (HNAB) has Short Term PowerRatings at TradingMarkets. Details on (HNAB) Short Term PowerRatings is available at This Link
http://www.tradingmarkets.com/news/stock-alert/...-notice-747925.html
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
mit profitieren vor eine mögliche Wiedereintritt der Aktie in höheren Preisklassen ;-)
Schaut euch das Volumen an ;-))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.
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
Des Hana-Biowissenschaft-Report-viertes Quartal-und Jahresende-2009 Finanzergebnisse
SÜDsan francisco, Calif., 25. März 2010 (KUGEL NEWSWIRE) -- Hana Biosciences Inc., (OTCBB: HNAB), eine biopharmaceutical Firma konzentrierte sich auf die Verstärkung der Grundlage von Krebssorgfalt, Finanzergebnisse für das vierte Quartal heute gemeldet und Jahr beendet 31. Dezember 2009 und vorausgesetzt ein Unternehmensupdate.
„2009, bildeten wir bedeutende Zuführungen in Richtung zu unserem Ziel der Einführung von Einreichung einer neuen Droge-Bewerbung in mid-2010 beschleunigte Zustimmung von Marqibo® in der erwachsenen akuten lymphoblastischen Leukämie suchend,“, sagte Steven R. Deitcher, M.D., Vorsitzender des Vorstands der Hana-Biowissenschaften. „Nachdem, positive Ergebnisse von unserer Angelphase 2 meldend, sammeln Sie Versuch, erwarten wir begeistert unsere pre-NDA Sitzung im Zweiten Quartal von 2010 und sind wir in der Lage sind, eine neue Droge-Anwendung für Marqibo in unserem Rahmen der erwarteten Zeit einzureichen überzeugt. Zusätzlich freuen uns wir zu empfangen und die Endergebnisse der Sammlung darstellend, studieren Sie von allen 65 evaluable Themen, um zusätzlichen Beweis von Marqibos Wirksamkeit zur Verfügung zu stellen.“
Neue klinische und Unternehmenshöhepunkte
Marqibo klinische Entwicklung
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.
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 ;-)
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 € ;-)
SOUTH SAN FRANCISCO, Calif., April 27, 2010 (GLOBE NEWSWIRE) -- Hana Biosciences (OTCBB:HNAB), a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that the Company has completed a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) related to its lead product candidate, Marqibo for the treatment of relapsed/refractory adult Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL). The purpose of the meeting was to discuss the proposed NDA and to confirm the clinical, non-clinical and manufacturing requirements for the NDA submission.
Following the pre-NDA meeting, Hana intends to proceed with its plan to submit a rolling NDA for Marqibo in relapsed/refractory adult Philadelphia chromosome-negative ALL.
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
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
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: http://www.nasdaq.com//aspxcontent/...7%2F2010+8%3A30AM#ixzz0mIt1xCud
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.
SOUTH SAN FRANCISCO, Calif., May 14, 2010 (GLOBE NEWSWIRE) -- Hana Biosciences Inc., (OTCBB:HNAB), a biopharmaceutical company focused on strengthening the foundation of cancer care, today reported financial results for the first quarter ended March 31, 2010, and provided a corporate update.
"During the first quarter of 2010, we continued our focus on the clinical and manufacturing development for Marqibo® in relapsed/refractory adult acute lymphoblastic leukemia," said Steven R. Deitcher, M.D., President and Chief Executive Officer of Hana Biosciences. "We continue to move forward with our submission plans following input received from the Food and Drug Administration during our April pre-New Drug Application meeting. We are confident that the complete rALLy data from the entire 65 patient population, which will be reported in an oral presentation at the 2010 Meeting of the American Society of Clinical Oncology, will provide additional evidence of Marqibo's efficacy."
Recent Clinical and Corporate Highlights
In April 2010, Hana completed a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) related to its lead product candidate, Marqibo® for the treatment of relapsed/refractory adult Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL). The purpose of the meeting was to discuss the proposed NDA and to confirm the clinical, non-clinical and manufacturing requirements for the NDA submission. Following the pre-NDA meeting, Hana intends to proceed with its plan to submit a rolling NDA for Marqibo in relapsed/refractory adult Philadelphia chromosome-negative ALL.
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 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; 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: http://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.
Contact:
Investor & Media Contacts:
Investor Relations Team
(650) 588-6641
investor.relations@hanabiosciences.com
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.
Contact:
Dylan Boyle
480-626-1911
info@skymarkresearch.com