Hana Biosciences' Marqibo Receives Orphan Designation From European Commission for the Treatment of Adult Acute Lymphoblastic Leukemia
SOUTH SAN FRANCISCO, Calif., July 14, 2008 (PRIME NEWSWIRE) -- Hana Biosciences (Nasdaq:HNAB), a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that the European Commission has granted orphan medical product designation to Marqibo(r) (vincristine sulfate injection, OPTISOME(tm)) for the treatment of adult acute lymphoblastic leukemia (ALL). This designation was granted based on the recommendation of the European Medicines Evaluation Agency (EMEA) following a positive opinion from the Committee for Orphan Medicinal Products.
Orphan designation in the European Union offers significant benefits to Hana Biosciences, including market exclusivity for a period of ten years, financial incentives such as fee reductions or exemptions, EMEA scientific advice on product development, and direct access to the EMEA centralized procedure for the application for marketing authorization.
``Receipt of orphan designation for Marqibo from the European Commission reinforces the importance of developing novel medicines for the treatment of rare disease indications such as ALL,'' said Steven R. Deitcher, M.D., President and Chief Executive Officer of Hana Biosciences. ``We look forward to working with the EMEA on the future development of Marqibo for patients with relapsed leukemia who currently have few treatment options.''
Hana Biosciences is currently enrolling patients in its registration-enabling Phase 2 ``rALLy'' clinical trial of Marqibo in patients with relapsed ALL. The company expects to report a futility analysis from the Phase 2 trial during the second half of 2008. Hana has received orphan drug and fast track designations for Marqibo for the treatment of ALL from the U.S. Food and Drug Administration.
About EMEA Orphan Drug Designation
European orphan designation is granted to therapeutics intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives. Applications for designation of orphan medicines are reviewed by the EMEA through the Committee for Orphan Medicinal Products (COMP).
About Marqibo(r) (vincristine sulfate injection, OPTISOME(tm))
Marqibo, a novel, targeted, Optisomal formulation of vincristine, has shown promising anti-cancer activity in patients with acute lymphoblastic leukemia (ALL), non-Hodgkin's lymphoma, Hodgkin's disease, and melanoma in several clinical trials. Vincristine is approved by the U.S. Food and Drug Administration as a single agent and in combination regimens for the treatment of hematologic malignancies such as lymphomas and leukemias. Vincristine, a microtubule inhibitor, kills cancer cells when they enter a very specific point in the cell cycle, and its efficacy is concentration- and exposure duration-dependent. Marqibo extends the circulation time of vincristine in the bloodstream, increases targeting of the drug to malignant cells, and enhances exposure duration at the site of the disease. Unlike regular vincristine, Marqibo is dosed based on patient body surface area without the need to limit the dose to avoid neurotoxicities.
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 http://www.hanabiosciences.com.
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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, any benefits that Hana will actually realize from orphan medicinal drug designation, rates of patient enrollment and clinical trial site initiations concerning Hana's product candidates, including its Marqibo product candidate. 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 is no assurance that the current rALLy trial will meet its study objectives or 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.