Hana Biosciences Receives U.S. Orphan Drug Designation for Marqibo for the Treatment of Metastatic Uveal Melanoma; Marqibo Currently in Phase 2 Clinical Trial for Metastatic Uveal Melanoma
SOUTH SAN FRANCISCO, Calif., June 30, 2008 (PRIME NEWSWIRE) — Hana Biosciences (Nasdaq:HNAB), a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for Marqibo(r) (vincristine sulfate injection, OPTISOME(tm)) for the treatment of adult patients with metastatic uveal melanoma. Orphan drug designation offers significant benefits to Hana Biosciences, including financial incentives and market exclusivity for a period of seven years.
“We are pleased to have received orphan designation from the FDA for Marqibo in metastatic uveal melanoma, a cancer with a clear unmet medical need. We believe this recognizes the need to pursue these difficult disease indications,” said Anne E. Hagey, M.D., Vice President and Chief Medical Officer. “We look forward to working with the Agency on our ongoing program in uveal melanoma to find a safe and efficacious therapy that can help these patients.”
Hana is currently conducting a Phase 2 clinical trial to assess the efficacy of Marqibo as determined by Disease Control Rate (complete response (CR), partial response (PR), durable stable disease) in patients with metastatic malignant uveal melanoma. Secondary objectives are to assess the safety and anti-tumor activity of Marqibo as determined by response rate (CR, PR), progression-free survival, and overall survival. The patient population is defined as adults with uveal melanoma and confirmed metastatic disease that is untreated or that has progressed following one prior therapy. The Phase 2 trial is currently being conducted at the University of Texas MD Anderson Cancer Center.
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. Upon FDA approval, orphan drug designation entitles Hana Biosciences to seven years of market exclusivity for Marqibo(r) (vincristine sulfate injection, OPTISOME(tm)) in the treatment of adult patients with metastatic uveal melanoma. 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 Uveal Melanoma
Uveal melanoma is a relatively rare cancer which includes the pigmented part of the eye and the surrounding areas, called the uvea. Uveal melanoma is the most common primary intraocular malignant tumor in adults and represents five-to-twelve percent of all melanoma diagnoses. The incidence of uveal melanoma is reported to be up to 5,000 patient cases per year. Metastasis occurs via vascular spread, and at least 40-70 percent of patients with primary uveal melanoma will ultimately develop metastases. Metastases of uveal melanoma have a different pattern of spread, with nearly universal liver involvement. Metastatic uveal melanoma is considered unresponsive to systemic chemotherapy and immunotherapy.
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 FDA-approved 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 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, potential clinical trial initiations, rates of patient enrollment and clinical trial site initiations, potential IND and NDA filings and commercialization efforts of 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 uveal melanoma 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.
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CONTACT: Hana Biosciences Investor & Media Contact Remy Bernarda, Director, Investor Relations (650) 228-2769 Fax: (650) 588-2787 firstname.lastname@example.org