FRAMINGHAM, MA - January 9, 2006 -- GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) announced today that the United States Patent and Trademark Office has issued a Notice of Allowance for the claims in its patent application 07/938,322 covering the production of therapeutic proteins in the milk of transgenic mammals. The allowed claims, which are expected to issue in the next several weeks, include all classes of proteins in all mammals and will provide GTC with a strong intellectual property position regarding the development and use of this technology for US markets. The patent that is expected to issue from this application will not expire until 2021. "GTC has an extensive intellectual property portfolio for the production of therapeutic proteins in milk and we will continue to use our broad IP position to encourage the adoption of transgenic production technology by our collaborators and partners," stated Geoffrey F. Cox, Ph.D., GTC's Chairman and Chief Executive Officer. "This broad patent will provide long term protection for GTC's proprietary products in the USA, including our lead program for ATrynŽ." GTC's lead program is ATrynŽ, its recombinant form of human antithrombin. A Market Authorization Application is under review by the European Medicines Agency for the use of ATrynŽ in patients with a hereditary antithrombin deficiency. ATrynŽ is also in a pivotal phase III study for the prevention of thromboembolic events in patients with hereditary antithrombin deficiency who are undergoing high-risk procedures, such as surgery or childbirth. GTC anticipates using the results from this clinical study to prepare a Biologics License Application for the United States Food and Drug Administration. Antithrombin is a protein in human plasma that has anticoagulant and anti-inflammatory properties. GTC is able to produce a therapeutic protein in an animal's milk through a process known as transgenic technology. GTC couples the gene expressing a specific protein with a specific milk protein promoter gene and incorporates it into an animal's genome such that the protein is expressed during lactation. This approach enables the production of therapeutic proteins that are difficult to express through traditional production methods. For those products that can be expressed with conventional recombinant technologies, transgenic technology has significantly lower capital requirements to establish large volume capacity. About GTC Biotherapeutics, Inc.
GTC Biotherapeutics is a leader in the development, production, and commercialization of therapeutic proteins through transgenic animal technology. In addition to the ATrynŽ program, GTC is developing a recombinant human alpha-1 antitrypsin, a recombinant human albumin, a CD137 antibody to stimulate the immune system as a potential treatment for solid tumors, and a malaria vaccine. In its external programs, GTC's technology is used to develop transgenic production of its partners' proprietary products, including both large-volume protein therapeutics as well as products that are difficult to produce in significant quantities from conventional recombinant production systems. One of the external programs is in clinical trials with a transgenically produced product. 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 likely issuance of GTC's newest patent and its patent position going forward. 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 intellectual property and patents. 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.
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GTC Biotherapeutics, Inc.
Thomas E. Newberry
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(508) 370-5374 Feinstein Kean Healthcare
Francesca DeVellis (investors)
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