HANA'S MARQIBO GRANTED ORPHAN DRUG DESIGNATION

Hana Biosciences announced that the FDA has granted orphan drug designation to its drug Marqibo (vincristine sulfate liposomes injection) for 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," Greg Berk, senior vice president and chief medical officer, said.

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 plans to begin a pivotal trial in the first half of 2007.

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 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, according to Hana.

Marqibo uses 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, according to the company.