BIRMINGHAM, Ala.-- Biocryst Pharmaceuticals Inc. said Monday European regulators granted its developing leukemia treatment Fodosine orphan drug status.
The designation by the European Medicines Agency gives the drug 10 years of market exclusivity if it is approved. It also holds the potential for agency assistance with clinical development, a research grant and reduction in regulatory fees.
Fodosine is currently in midstage to late stage studies aimed at testing its effectiveness against a specific type of leukemia, called T-Cell acute lymphoblastic leukemia.
What is Fodosine?
Fodosine is a transition state purine nucleoside phosphorylase (PNP) inhibitor, which functions by blocking the DNA synthesis machinery of the body's T-cells. It is specific for immune cells. The small molecule drug is being developed for treatment of T-cell mediated cancers, and has been designated an "Orphan Drug" for several indications, including T-cell leukemia, cutaneous T-cell lymphoma (CTCL), chronic lymphocytic leukemia (CLL) and acute lymphoblastic leukemia (ALL).
The U.S. Food and Drug Administration granted the drug orphan status in 2005 for several types of leukemia.
Biocryst shares added 27 cents, or 2.3 percent, to $12 in premarket electronic trading, from their close Friday at $11.73 on the Nasdaq.
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