Healthcare Industry News:  thrombosis 

Biopharmaceuticals

 News Release - July 16, 2010

GTC Biotherapeutics Regains US Rights to ATryn(R) ; the First Recombinant Antithrombin Product Approved in the World

ATryn is approved for use in patients with hereditary antithrombin deficiency, a rare and potentially life threatening condition (see important safety information below)

FRAMINGHAM, Mass.--(HSMN NewsFeed)--GTC Biotherapeutics, Inc. ("GTC", OTCBB: GTCB.OB) announced today that it has signed a definitive agreement whereby the Company has regained US commercialization rights to ATryn from Lundbeck, Inc., a wholly owned subsidiary of H. Lundbeck A/S in Denmark (Copenhagen Stock Exchange: LUN ). The two companies have agreed to a defined transition period of up to six months wherein Lundbeck will perform certain services on behalf of GTC in order to ensure that ATryn will continue to be available to physicians and their patients in an uninterrupted fashion as commercialization responsibilities are smoothly transitioned to GTC. Thereafter, Lundbeck will earn a royalty on net sales beginning in two years, with a predefined cumulative maximum.

William Heiden, Chairman, President & CEO at GTC stated, “Our collaboration with Lundbeck has been excellent and I would like to thank the Lundbeck team which has worked so diligently on the successful launch of ATryn in the US. Both parties agree that it is now the right time and in the best interests of both companies, given their respective strategic objectives, to transfer ATryn rights back to GTC. We look forward to working through this transition with Lundbeck to ultimately take on full responsibility for the commercialization of ATryn in the US. Looking to the future, GTC is committed to maximizing the commercial potential for ATryn in the US marketplace.”

About ATryn

ATryn® (Antithrombin [Recombinant]) was granted U.S. marketing approval in February 2009 by the Food and Drug Administration (FDA). ATryn is approved for the prevention of peri-operative and peri-partum thromboembolic events in patients with hereditary antithrombin deficiency (HD AT), a rare and potentially fatal blood clotting disorder. ATryn is not indicated for treatment of thromboembolic events in hereditary antithrombin deficient patients.

Antithrombin is a naturally occurring protein that helps regulate the blood clotting mechanism in the body. People with hereditary antithrombin deficiency have lower than normal levels of 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. ATryn provides physicians an alternative to human plasma-derived antithrombin for HD AT patients undergoing surgery or giving birth requiring antithrombin therapy. 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.

Developed and manufactured by GTC Biotherapeutics, ATryn was created to provide a safe and reliable supply of recombinant antithrombin, an alternative to human plasma-derived antithrombin. ATryn is made by processing the human antithrombin protein from the milk of a select herd of transgenic goats.

The process for producing ATryn involves scientists inserting DNA for the human antithrombin protein into a single-celled goat embryo. This embryo is implanted into a surrogate doe. The resulting transgenic offspring are able to produce high levels of human antithrombin in their milk.

This protein is collected and purified from the milk to produce ATryn, which is administered to patients by intravenous infusion.

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 residues 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 of heparin the potency of the recombinant product is not different from that of plasma-derived product.

Indications and Usage

ATryn (Antithrombin [Recombinant]) is indicated for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients. It is not indicated for treatment of thromboembolic events in hereditary antithrombin deficient patients.

Important Safety Information

ATryn is contraindicated in patients with known hypersensitivity to goat and goat milk proteins. Allergic-type hypersensitivity reactions are possible. Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis. If these symptoms occur during administration, treatment must be discontinued immediately. Adding ATryn to or withdrawing ATryn from anticoagulants that use antithrombin to exert their anticoagulative effects may alter this effect. To avoid excessive or insufficient anticoagulation, coagulation tests suitable for the anticoagulant used (e.g., aPTT and anti-Factor Xa activity) are to be performed regularly, at close intervals, and in particular in the first hours following the start or withdrawal of ATryn, in such situations, patients should be monitored for the occurrence of bleeding or thrombosis.

The serious adverse reaction that has been reported in clinical studies is hemorrhage (intra-abdominal, hemarthrosis, and post procedural). The most common adverse events reported in clinical trials at a frequency of >5% are hemorrhage and infusion site reaction.

For more information, please see full Prescribing Information at www.lundbeckinc.com.

About GTC Biotherapeutics

GTC Biotherapeutics’ core technology enables the development and manufacture of therapeutic proteins produced through transgenic animal technology. ATryn®, GTC’s recombinant human antithrombin, has been approved for use in the United States and Europe. ATryn is the first and only therapeutic product produced in transgenic animals to be approved anywhere in the world. In addition to ATryn, GTC is developing a portfolio of recombinant human plasma proteins with known therapeutic benefits. These proteins include a recombinant form of human coagulation factor VIIa, which is being developed with partner LFB for the treatment of patients with hemophilia. GTC has also developed a portfolio of monoclonal antibodies (MABs) targeting HER2, EGFR and TNF, which address markets with total sales in excess of $16 billion, as well as a CD20 antibody with enhanced ADCC (antibody-dependent cell-mediated cytotoxicity).

GTC’s intellectual property includes a patent in the United States through 2021 for the production of any therapeutic protein in the milk of any transgenic mammal. GTC’s transgenic production platform is particularly well suited to enable highly flexible and cost effective development of proteins that are difficult to express in traditional recombinant production systems, as well as proteins that are required in large volumes. Additional information is available on the GTC web site, http://www.gtc-bio.com.

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the prospects for initiation of clinical studies in the factor VIIa and for development of GTC’s transgenic platform to advance additional protein therapeutic candidates. Such forward-looking statements are subject to a number of risks, uncertainties and other factors that could cause actual results to differ materially from future results expressed or implied by such statements. Factors that may cause such differences include, but are not limited to, the risks and uncertainties discussed in GTC's most recent Annual Report on Form 10-K, as updated or supplemented from time to time by those risks and uncertainties included in its other periodic reports as filed with the Securities and Exchange Commission, including the risks and uncertainties associated with dependence upon the actions of partners and regulatory agencies, and the uncertainty that GTC will be able to obtain additional revenues and financial resources, including through continuing and new external programs and marketing and strategic partners for some of its internal programs and through additional financing arrangements. GTC cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this document, and GTC undertakes no obligation to update or revise the statements, except as may be required by law.


Source: GTC Biotherapeutics

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