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Politics : Ask Michael Burke -- Ignore unavailable to you. Want to Upgrade?

To: Joan Osland Graffius who wrote (102305)	8/19/2005 2:57:18 PM
From: Pogeu Mahone	Respond to of 132070

Hi Joan GTCB is coming up for a EMEA hearing Possible dates for Atryn approval 22-25aug 12-15sep 10-12oct Press Release Source: GTC Biotherapeutics, Inc. GTC Biotherapeutics Files Response to EMEA List of Outstanding Issues Wednesday July 6, 11:34 am ET FRAMINGHAM, Mass.--(BUSINESS WIRE)--July 6, 2005--GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) has filed its response to the European Medicines Agency's (EMEA) List of Outstanding Issues generated during review of GTC's Market Authorization Application (MAA) for ATryn® , its recombinant form of human antithrombin. GTC estimates that the EMEA will make a determination on the MAA before the end of October. "With the filing of our response, we look forward to continuing to work with the EMEA to bring our submission to a positive conclusion," noted Geoffrey F. Cox, Ph.D., GTC's Chairman and Chief Executive Officer. "Approval will be a major milestone in the transition of GTC into a commercial products company." Antithrombin is a plasma protein with anticoagulant and anti-inflammatory properties. GTC has developed goats that have the human antithrombin gene linked to a milk-protein promoter so that they express the antithrombin protein in their milk. This transgenic approach provides the opportunity to produce recombinant forms of proteins, such as antithrombin, that are difficult to express in conventional production methods. Antithrombin is the first of a series of human plasma proteins that GTC is developing as recombinant products. Other recombinant human plasma proteins that GTC is developing include recombinant human alpha-1 antitrypsin and recombinant human albumin. GTC also recently began the recruitment process for a pivotal clinical study of ATryn® for the hereditary antithrombin deficiency indication as allowed by the United States Food and Drug Administration (FDA). This study builds upon the clinical data that was submitted in the MAA. A successful outcome of this study and a historical control comparison is expected to provide the clinical basis for filing a Biologics License Application (BLA) with the FDA. About GTC Biotherapeutics GTC Biotherapeutics is a leader in the development, production, and commercialization of therapeutic proteins through transgenic animal technology. GTC currently has five products in its internal pipeline and a portfolio of external program production opportunities. GTC's lead program is ATryn®, its recombinant form of human antithrombin. A Market Authorization Application is under review by the European Medicines Agency for the use of ATryn® in patients with a hereditary antithrombin deficiency. In addition to the ATryn® program, GTC is developing a recombinant human alpha-1 antitrypsin, a recombinant human albumin, a malaria vaccine, and a CD137 antibody to stimulate the immune system as a potential treatment for solid tumors. 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, gtc-bio.com. This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including the anticipated time frame for the EMEA's determination on the MAA for ATryn®, the prospects for the U.S. clinical trial of ATryn®, and the filing of a BLA in the U.S. 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 risks and uncertainties inherent in the performance of clinical studies and the actions of regulatory agencies. 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, 508-370-5374 or Feinstein Kean Healthcare for GTC Biotherapeutics, Inc. Francesca DeVellis, 617-577-8110