EMEA GRANTS ORPHAN STATUS TO BIOCRYST'S FODOSINE FOR CTCL

BioCryst Pharmaceuticals announced that Fodosine has been granted orphan status for the treatment of cutaneous T-cell lymphoma (CTCL) by the Committee for Orphan Medicinal Products of the European Medicines Agency (EMEA).

This is the second indication for which the EMEA has granted orphan drug status to Fodosine following regulatory submissions by Mundipharma, BioCryst's European Fodosine partner. In November 2006, the EMEA granted orphan drug designation to Fodosine for the treatment of T-cell acute lymphoblastic leukemia (ALL).

Fodosine, BioCryst's lead oncology candidate, is currently being studied in clinical trials for indications including ALL, CTCL, B-cell acute lymphoblastic leukemia and chronic lymphocytic leukemia. Last month, BioCryst initiated a pivotal Phase IIb clinical trial of Fodosine for the treatment of patients with relapsed or refractory T-cell leukemia/lymphoma.

The EMEA's orphan drug program is designed to promote the development of drugs that may provide significant benefit to patients suffering from rare or serious diseases, according to the company. Orphan drug designation provides 10 years of potential market exclusivity if the product is approved, and the sponsor may qualify for a reduction in regulatory fees or a research grant.

Fodosine is a transition-state analog inhibitor of the target enzyme purine nucleoside phosphorylase.