ATryn®, recombinant human antithrombin


	ATryn® - RECOMBINANT HUMAN ANTITHROMBIN GTC's lead product, ATryn®, a recombinant form of human antithrombin, also known as ATIII, is at the forefront of transgenic technology for the production of biotherapeutics. Antithrombin is a plasma protein with anticoagulant and anti-inflammatory properties that, like many other therapeutic proteins which are currently derived from the human blood supply, has been difficult to express using conventional recombinant protein production methods. FULL PRESCRIBING INFORMATION In the United States the Food and Drug Administration (FDA) approved ATryn® for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient, or HD, patients. ATryn® is the first ever transgenically produced therapeutic protein and the first recombinant antithrombin approved in the U.S. GTC has granted Lundbeck Inc. (formerly OVATION Pharmaceuticals, Inc.) the right to market ATryn in the U.S. and pursue further clinical development. The companies' ATryn® is to be made available in the United States during the second quarter of 2009. In August of 2006, following a positive opinion by the CHMP, the European Commission approved ATryn® for treatment of patients with hereditary antithrombin deficiency, undergoing high-risk surgical or childbirth procedures. LFB, currently a 20% shareholder in GTC, currently has strategic commercialization and development programs with GTC in recombinant plasma proteins, including factor VIIa, factor IX and alpha-1 antitrypsin, and also an anti-CD20 monoclonal antibody. GTC is also developing recombinant forms of additional human plasma proteins, such as albumin and alpha-1 antitrypsin. GTC expresses these proteins in the milk of a well-cared for and controlled herd of animals that have the appropriate human therapeutic gene linked to a milk-protein promoting gene. This approach provides a unique opportunity to produce highly purified and well-characterized recombinant forms of these biologic medicines. ATryn® Press Release Archive May 6, 2009 - GTC Biotherapeutics Reports Launch of ATryn® in the U.S. by Lundbeck Inc. May 6, 2009 - ATryn Available for Patients with Hereditary Antithrombin Deficiency, a Rare Blood Clotting Disorder March 30, 2009 - GTC Biotherapeutics Reports Progress in Preparations to Launch ATryn® in the U.S. March 9, 2009 - GTC Biotherapeutics Reports Progress in ATryn® Program in U.S. February 27, 2009 - GTC Biotherapeutics Reports Fourth Quarter and Year End 2008 Financial Results February 6, 2009 - ATryn® (Antithrombin [Recombinant]) Approved by the FDA - Only recombinant option for patients with hereditary antithrombin deficiency, a rare and potentially life-threatening condition January 9, 2009 - FDA Advisory Committee Recommends GTC Biotherapeutics' ATryn* (antithrombin [Recombinant]) - If approved, ATryn will be first recombinant human antithrombin available in the U.S.¹ November 3, 2008 - GTC Biotherapeutics Reports Third Quarter 2008 Financial Results October 6, 2008 - FDA Accepts ATryn® BLA Filing - GTC Receives $2 Million in Additional Milestone Payments September 4, 2008 - FDA Assigns Priority Review to GTC Biotherapeutics’ATryn® August 14, 2008 - GTC Biotherapeutics and Ovation Pharmaceuticals Close Agreement to Market and Develop ATryn® in the U.S. August 7, 2008 - GTC Biotherapeutics Completes BLA Submission for Atryn® August 7, 2008 - GTC Biotherapeutics Reports Second Quarter 2008 Financial Results June 23, 2008 - GTC Biotherapeutics Enters into $257 Million Agreement with OVATION Pharmaceuticals to Develop and Market ATryn® in the U.S. May 8, 2008 - GTC Biotherapeutics Reports First Quarter 2008 Financial Results March 6, 2008 - GTC Biotherapeutics Reports Fourth Quarter and Year End 2007 Financial Results February 25, 2008 - Last Patient Enrolled in ATryn® Pivotal Study February 4, 2008 - ATryn® Meets Primary Endpoint/Rolling BLA Submission Initiated January 7, 2008 - ATryn® Nears Completion of US HD Clinical Study
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