Hana Biosciences Receives Orphan Drug Designation for Marqibo (Vincristine Sulfate Liposomes Injection) for the Treatment of Acute Lymphoblastic Leukemia
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- Published on Wednesday, 17 January 2007 02:00
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SOUTH SAN FRANCISCO, CA, USA | Jan 16, 2007 | Hana Biosciences (NASDAQ:HNAB), a biopharmaceutical company focused on advancing cancer care, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for Marqibo(R) (vincristine sulfate liposomes injection) in the treatment of adult patients with acute lymphoblastic leukemia (ALL).
"This designation underscores the need for improved therapies in ALL, and supports our development strategy in areas of unmet medical need," commented Greg Berk, MD, Senior Vice President and Chief Medical Officer. "Hana Biosciences is committed to the clinical development of Marqibo in ALL and other lymphoproliferative diseases."
In December 2006, Hana filed a Special Protocol Assessment (SPA) with the FDA for Marqibo in adults with ALL in second relapse and beyond. Subject to agreement with the FDA on the SPA, Hana targets initiation of its pivotal trial in the first half of 2007.
About Orphan Drug Designation
The Orphan Drug Act provides for incentives to encourage the development of drugs for rare disease conditions affecting fewer than 200,000 people in the United States. Orphan drug designation entitles Hana Biosciences to seven years of market exclusivity for Marqibo(R) (vincristine sulfate liposomes injection) in the treatment of adult patients with ALL. Additional incentives include tax credits related to clinical trial expenses, a possible exemption from the FDA-user fee, and assistance in clinical trial protocol design.
About Marqibo(R) (vincristine sulfate liposomes injection)
Marqibo(R) utilizes vincristine encapsulated in a rigid, lipid bilayer of sphingomyelin. Vincristine, an FDA approved, standard chemotherapeutic used in most lymphoma and ALL regimens, is a cell-cycle specific agent whose activity is dependent on the duration of drug exposure. The sphingosome encapsulated technology employed by Marqibo results in a more rigid liposome that is designed to allow the active vincristine to leak out of the liposome slowly, maintaining drug levels for prolonged periods of time. This improved pharmacokinetic profile of Marqibo, which mimics a continuous vincristine infusion, potentially results in greater activity in rapidly dividing cancers. The anticipated activity associated with vincristine has traditionally been limited by its short half-life, and its inability to be dose escalated beyond 2mg due to neurotoxicity. In Phase I and II clinical trials, Marqibo has shown to have a significantly longer half-life, and patients have been able to tolerate doses which are approximately 100 percent greater than conventional vincristine. These trials provide the rationale for utilizing this technology in lymphoproliferative diseases, such as ALL, Hodgkin's and non-Hodgkin's lymphoma.
About Acute Lymphoblastic Leukemia (ALL)
Approximately 4,000 cases of ALL are diagnosed annually in the United States. While cure rates for childhood ALL have steadily improved to nearly 90 percent, adult ALL reported cure rates seldom exceed 40 percent. The poorer outcome in adult ALL has been attributed to an increased frequency of high-risk leukemia with greater resistance, poorer tolerance of and compliance with treatment, reluctance to accept toxic effects, and less effective treatment regimens as compared with childhood ALL. Currently, there are no approved agents for adult ALL salvage, nor is there a consensus on the most appropriate regimen in the relapse setting. Ongoing efforts are needed to investigate agents for this indication, as well as incorporate active agents, once identified, into front-line therapy.
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 advance cancer care. The company is committed to creating value by building a world-class team, accelerating the development of lead product candidates, expanding its pipeline by being the alliance partner of choice, and nurturing a unique company culture. Additional information on Hana Biosciences can be found at www.hanabiosciences.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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 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 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 Marqibo or its other product candidates will be successful. Other risks that may affect forward-looking information contained in this press release include the possibility of being unable to obtain regulatory approval of Hana's product candidates, including Marqibo, the risk that the results of clinical trials may not support Hana's claims, 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2006 filed with the Securities and Exchange Commission. Hana assumes no obligation to update these statements, except as required by law.
SOURCE: Hana Biosciences