Hana Biosciences, a biopharmaceutical company focused on strengthening the foundation of cancer care, announced that the European Commission has granted orphan medical product designation to Marqibo (vincristine sulfate injection, Optisome) for the treatment of adult acute lymphoblastic leukaemia (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 leukaemia 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 US Food and Drug Administration.

Marqibo, a novel, targeted, Optisomal formulation of vincristine, has shown promising anti-cancer activity in patients with acute lymphoblastic leukaemia (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.