GTC Biotherapeutics (fka GTCB)

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Licenses to Factor IX, Factor VIII and Fibrinogen


GTC Biotherapeutics Obtains Licenses to Factor IX, Factor VIII and Fibrinogen


Last update: 8:30 a.m. EST Dec. 5, 2007Print E-mail RSS Disable Live Quotes


FRAMINGHAM, Mass., Dec 05, 2007 (BUSINESS WIRE) -- GTC Biotherapeutics, Inc. (GTCB:gtc biotherapeutics inc com
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0.97, -0.01, -1.0%) has entered into a definitive agreement with ProGenetics, LLC, a private company based in Blacksburg, Virginia, to obtain an exclusive license to develop and commercialize ProGenetics' recombinant human factor IX, recombinant human factor VIII, and recombinant human fibrinogen for North America, Europe and Japan. ProGenetics is developing production of the human coagulation factors IX and VIII in the milk of transgenic pigs and has patents that cover the transgenic production of human fibrinogen. ProGenetics will receive a non-exclusive license to GTC's patent in the United States for the transgenic expression of therapeutic proteins in milk to enable the commercial development of these products outside of North America, Europe and Japan. ProGenetics received $500,000 from GTC upon signing of the agreement and will receive approximately $500,000 from GTC in the second quarter of 2008. GTC will also receive a small equity interest in ProGenetics.
"We are very pleased to work with ProGenetics to add factor IX, factor VIII, and fibrinogen to our portfolio of recombinant coagulation factors," stated Geoffrey F. Cox, Ph.D., GTC's Chairman and Chief Executive Officer. "Together with our program for recombinant human factor VIIa, GTC has a leading position in developing recombinant versions of all the major coagulation factors used to treat hemophilia and potentially other bleeding conditions. Our strategic portfolio of recombinant plasma proteins also includes ATryn(R), our recombinant form of human antithrombin, and recombinant human alpha-1 antitrypsin, establishing a broad franchise in hematology and associated genetic disorders."
ProGenetics will be responsible for the production of the proteins in the milk of their transgenic pigs. GTC will be responsible for manufacturing, clinical development, regulatory affairs, and commercialization activities in its territories.
Hemophilia is caused by genetic conditions in which the patients' failure to express enough coagulation factors may lead to excessive bleeding. Type A hemophilia is due to the lack of factor VIII. Type B hemophilia is due to the lack of factor IX. The preferred treatment strategy is to provide supplemental coagulation factors prophylactically to avoid episodes of excessive bleeding. The price and availability of current recombinant coagulation factors often allows for use in only limited indications and markets. The aggregate market for plasma-derived and recombinant factor IX, factor VIII, and fibrinogen products in North America, Europe and Japan is currently estimated to be greater than $3 billion annually.
About GTC Biotherapeutics, Inc.
GTC Biotherapeutics develops, produces, and commercializes therapeutic proteins through transgenic animal technology. GTC obtained the first approval anywhere in the world for a transgenically produced protein when ATryn(R), a recombinant form of human antithrombin, was approved by the European Commission for use in patients with hereditary antithrombin deficiency undergoing surgical procedures. ATryn(R) is available for commercial sales in the approved indication in Europe. ATryn(R) is undergoing a phase III clinical study in the hereditary antithrombin deficiency indication for the United States. Completion of ATryn(R)'s Biologics License Application is planned for the first half of 2008. 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 enabling cost effective development of proteins that are difficult to express in traditional recombinant production systems as well as those 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 potential for market development of the products developed with ProGenetics and the potential size of the associated markets, as well as the planned timing of the BLA for ATryn(R). 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 and its other periodic reports as filed with the Securities and Exchange Commission, including the uncertainties associated with conducting clinical studies, 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 additional equity financings. 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, Inc.
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