FRAMINGHAM, MA - February 8, 2006 -- GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) announced that it is unaware of any reason for the unusual trading activity today in its common stock. GTC does not expect to have any new announcement regarding its ATrynŽ submission to the European Medicines Agency before the conclusion of the meeting of the Committee for Medicinal Products for Human Use (CHMP) which takes place from February 20 through February 23.
ATrynŽ is GTC's recombinant form of human antithrombin. A Market Authorization Application (MAA) 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.
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 its expectations for the opinion on its MAA during the February CHMP meeting. 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.
CONTACT:
GTC Biotherapeutics, Inc.
Thomas E. Newberry
Vice President, Corporate Communications
(508) 370-5374 Feinstein Kean Healthcare
Francesca DeVellis (investors)
(617) 577-8110
Copyright 2006 GTC Biotherapeutics, All Rights Reserved