GTC Biotherapeutics (GTCB) Announces FDA Accepts ATryn(R) BLA Filing

October 6, 2008 9:44 AM EDT

GTC Biotherapeutics, Inc. (Nasdaq: GTCB) today announced that the US FDA has accepted for review its Biologics License Application, or BLA, for ATryn(R). FDA's Blood Products Advisory Committee intends to review the BLA for ATryn(R) during a meeting that is being planned for January 2009. Based on the achievement of these milestones, GTC has received $2 million in additional milestone payments from OVATION Pharmaceuticals, Inc.

ATryn(R) is GTC's recombinant form of human antithrombin, a plasma protein with anticoagulant and anti-inflammatory properties. The company seeks regulatory approval of ATryn(R) in the United States for the prophylactic treatment of deep vein thrombosis and other thromboembolisms in patients with hereditary antithrombin deficiency who are undergoing high risk surgical and childbirth procedures.

GTC Biotherapeutics, Inc. develops, supplies, and commercializes therapeutic proteins produced through transgenic animal technology.

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