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Friday, February 6, 2009
GTC gets FDA nod for first transgenic protein
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Transgenic therapeutics company GTC Biotherapeutics Inc. has won approval for its ATryn antithrombin recombinant drug from the U.S. Food and Drug Administration. GTC, based in Framingham, makes ATryn, which is used to prevent peri-operative and peri-partum thromboembolic problems in hereditary antithrombin- deficient patients, in the milk of goats with human genes.
GTC (Nasdaq: GTCB) 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.
Additionally, the FDA’s Center for Veterinary Medicine approved GTC’s new animal drug application, which it claimed will be the first such application to regulate genetically engineered animals.
GTC also has granted Ovation Pharmaceuticals Inc. the right to market ATryn in the U.S. and to further develop it. They expect ATryn to be available in the second quarter of 2009. No financial details were disclosed.
People with hereditary antithrombin deficiency are at increased risk for venous thromboembolic events, including pulmonary embolism and deep vein thrombosis. Antithrombin is a natural anticoagulant that helps control the formation of blood clots. GTC hopes that ATryn will will assist hereditary antithrombin-deficient patients undergoing surgery or childbirth,
GTC had been facing stock market delisting during the past year, However, last month GTC reported that the Listing Qualifications Staff of The Nasdaq Stock Market said it had regained compliance with the minimum market value requirement for continued listing on The Nasdaq Capital Market.
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