Monday, March 16, 2009

GTC shutters ATryn development contract for some countries

By Mass High Tech staff

GTC Biotherapeutics Inc. has closed its contract with LEO Pharma A/S, relating to the commercialization and development of its ATryn antithrombin recombinant drug in Europe, Canada and the Middle East.

The Framingham transgenic therapeutics company said it is pursuing damages, per International Chamber of Commerce (ICC) arbitration, in alleging that LEO is “in breach of its obligations.”

GTC (Nasdaq: GTCB) announced last month that it had won approval from the U.S. Food and Drug Administration for ATryn. The drug, made from human proteins in the milk of goats, is intended to prevent blood clots in hereditary antithrombin deficient, or HD, patients undergoing surgery or childbirth. People with hereditary antithrombin deficiency are at increased risk for venous thromboembolic events, including pulmonary embolism and deep vein thrombosis.

GTC claimed ATryn is the first transgenically produced therapeutic protein and the first recombinant antithrombin in the U.S. ATryn has been approved in the European Union already.

Last week, the company announced that it had received a $1 million milestone payment from partner Ovation Pharmaceuticals Inc. for ATryn. The cash was awarded, the company said, because ATryn had won approval from the U.S. Food and Drug Administration’s Blood Products Advisory Committee at its meeting in January 2009. Because the FDA approved the drug last month, GTC stands to win $3 million in additional milestone payments.