The European Commission (EC) today announced that Celgene’s amrubicin hydrochloride has been designated as an orphan medicinal product for the treatment of small cell lung cancer. This follows the European Medicines Agency’s (EMEA) favorable opinion, issued by the EMEA’s Committee for Orphan Medicinal Products (COMP). Amrubicin hydrochloride, a third generation drug, has already received approval and is now marketed in Japan for the treatment of both small cell lung cancer and non-small cell lung cancer by Nippon Kayaku.

This official designation of amrubicin is important for Celgene because, once the designation is granted by the EC, it provides special incentives for sponsors planning to test a product for use in a rare disease or condition. These incentives include eligibility for protocol assistance and possible exemptions or reductions of certain regulatory fees during development, or at the time of application for marketing approval. Celgene is entitled to this designation for a 10-year period, which makes it a long term strategic advantage for the company.

Graham Burton M.D., SVP, Global Regulatory Affairs and Pharmacovigilance for Celgene said of the designation: “The decision by the European Commission to designate amrubicin hydrochloride an orphan medicinal product continues our efforts to deliver innovative therapies worldwide to patients in areas of great unmet medical need such as solid tumor cancers.”

This approval comes on the heels of a similar announcement in March of 2008, when the US Food and Drug Administration also granted orphan drug designation for amrubicin in the treatment of small cell lung cancer.

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