GTC Biotherapeutics (fka GTCB)

[croumagnon]

GTC Biotherapeutics Completes BLA Submission For ATryn(R)

http://biz.yahoo.com/bw/080807/20080807006287.html?.v=1

Thursday August 7, 3:41 pm ET

FRAMINGHAM, Mass.--(BUSINESS WIRE)--GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) has completed its submission of the final portion of the Biologics License Application, or BLA, for ATryn® in the United States. The final portion of the BLA submission includes all of the clinical safety and efficacy data generated from studies of ATryn®, including the pivotal study supporting product licensure. ATryn® is GTC’s recombinant form of human antithrombin, a plasma protein with anticoagulant and anti-inflammatory properties. The BLA requests market authorization for the use of ATryn® in 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. There are no other recombinant forms of antithrombin available to treat this patient population.

GTC has requested Priority Review. Priority Review is a procedure the U.S. Food and Drug Administration, or FDA, reserves for products that are intended to treat serious and/or potentially life threatening events and have the potential to fulfill an unmet medical need. ATryn® has already been granted Orphan Drug designation, as well as Fast Track status by the FDA. Assuming that Priority Review is granted, GTC anticipates the FDA reaching a decision on the BLA filing in the first quarter of 2009. A definitive agreement has been signed with OVATION Pharmaceuticals, Inc. for commercialization and development rights in the U.S.

ATryn® has been approved for use in a similar indication in the European Union. LEO Pharma A/S is marketing ATryn® in Europe and is conducting further clinical development.