ATryn (antithrombin [recombinant]) is now available commercially through Lundbeck Inc of Deerfield, Illinois, a wholly owned subsidiary of H Lundbeck A/S in Denmark, GTC Biotherapeutics, Inc's commercialization and development partner in the United States. GTC is due to receive a total of $1 million from Lundbeck for its initial inventory of ATryn.
"We are delighted to have reached this important milestone with the launch of ATryn in the US, which is the first transgenically produced therapeutic product to reach the marketplace," stated Geoffrey F Cox, GTC's chief executive officer and chairman of the Board. "We look forward to working with Lundbeck to deliver this important new product."
Antithrombin is a naturally occurring protein that helps regulate the blood clotting mechanism in the body. People with hereditary antithrombin deficiency lack sufficient antithrombin, putting them at increased risk for venous thromboembolic events (VTE), including pulmonary embolism and deep vein thrombosis, which can be life threatening, particularly in the high-risk situations of surgery or childbirth. Prior to the availability of ATryn, HD patients undergoing surgery or giving birth relied upon antithrombin derived from human plasma. ATryn is not formulated with human plasma proteins.
Approximately one in 2,000 to one in 5,000 people have hereditary antithrombin deficiency. By the age of 50, approximately 50 percent of people with hereditary antithrombin deficiency will have experienced a VTE.
Purified recombinant antithrombin has the same amino acid sequence as antithrombin derived from human plasma. Antithrombin (recombinant) and plasma-derived antithrombin both contain six cysteine resudes forming three disulphide bridges and 3-4 linked carbohydrate moieties. The glycosylation profile of ATryn is different from plasma-derived antithrombin, which results in an increased heparin affinity. When assayed in the presence of excess heparin the potency of the recombinant product is not different from that of plasma-derived product.
GTC developed ATryn using its proprietary transgenic production technology. Transgenic production enables the development of recombinant forms of proteins, such as antithrombin, that otherwise are not practical to develop using other technologies.
Important Safety Information
ATryn was approved by the FDA on February 6, 2009 for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients. ATryn is contraindicated in patients with known hypersensitivity to goat and goat milk proteins.
GTC Biotherapeutics develops, supplies, and commercializes therapeutic proteins produced through transgenic animal technology.