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news.Hana Biosciences has announced that the European Commission has granted orphan medical product designation to Marqibo for the treatment of adult acute lymphoblastic leukemia.
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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 EU 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.
Hana Biosciences is currently enrolling patients in its registration-enabling Phase II ‘rALLy’ clinical trial of Marqibo in patients with relapsed acute lymphoblastic leukemia (ALL). The company expects to report a futility analysis from the Phase II trial during the second half of 2008. Hana has also received orphan drug and fast track designations for Marqibo for the treatment of ALL from the FDA.
Steven Deitcher, president and CEO of Hana Biosciences, said: “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.”