BioCryst drug gets orphan status in EU |
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Tue, 06 Feb 2007 15:08
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BIRMINGHAM, Ala. (AFX) - BioCryst Pharmaceuticals Inc. said Tuesday European regulators granted its drug candidate Fodosine orphan status for the treatment of cutaneous T-cell lymphoma, a type of cancer that affects the skin and blood.The designation gives the drug 10 years of potential market exclusivity if approved, and the opportunity for agency assistance in clinical development. Additionally, regulatory fees could be lowered under the designation.This is the second time the European Medicines Agency has granted Fodosine orphan drug status. In November, it gave the drug the designation for the treatment of T-cell acute lymphoblastic leukemia.The U.S. Food and Drug Administration granted Fodosine similar status covering several indications in 2005. Those include T-cell non-Hodgkin's lymphoma, T-cell prolymphocytic leukemia, adult T-cell leukemia, and hairy cell leukemia; and for the treatment of B-ALL. The agency also granted the drug 'fast track' status for the treatment of relapsed or refractory T-cell leukemia.Shares rose 27 cents, or 2.5 percent, to $11.01 in premarket trading, after closing at $10.74 on the Nasdaq Monday.Copyright 2006 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
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