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Future Advances-Recombinant
December 20, 2004 10:53 AM US Eastern Timezone
GTC Biotherapeutics Provides ATryn Program Update
FRAMINGHAM, Mass.--(BUSINESS WIRE)--Dec. 20, 2004--GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) announced that it has submitted its responses to the Consolidated List of Questions generated by the European Medicines Agency (EMEA) as part of the review of a Marketing Authorization Application (MAA) for ATryn(R), GTC's recombinant form of human antithrombin. The MAA covers the use of ATryn(R) in the prophylactic treatment of patients with hereditary antithrombin deficiency (HD) during high-risk situations such as surgery and childbirth. GTC expects the EMEA to respond with additional questions, or provide an opinion on the MAA, by the end of April. Subject to approval of the MAA, GTC is planning for a European market launch of ATryn(R) in mid-2005.
GTC is also submitting an amendment to its Investigational New Drug (IND) application this week to initiate a clinical study which may be used as a basis for approval of ATryn(R) in the HD indication in the United States. GTC expects to begin the study when the FDA has completed its review of this submission, which is anticipated in early 2005. GTC is taking advantage of these advances in its regulatory process to continue its partnering negotiations for ATryn(R) into the first half of 2005. As a result, GTC now expects its 2004 year-end net cash balance to be approximately $22 million.
"We believe the responses to the EMEA provide a solid foundation for completion of the regulatory review process in Europe and a stronger basis to realize value from the ATryn(R) program," stated Geoffrey F. Cox, Ph.D., GTC's Chairman of the Board and Chief Executive Officer. Antithrombin is a plasma protein with anticoagulant and anti-inflammatory properties. GTC expresses this protein in the milk of goats that have the human antithrombin gene linked to a milk-protein promoter. 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 albumin and recombinant human alpha 1 antitrypsin.
GTC Biotherapeutics is a leader in the development, production, and commercialization of therapeutic proteins through transgenic animal technology. GTC currently has four internal proprietary products in its pipeline and a portfolio of external program production opportunities. In addition to the ATryn(R) program, GTC is developing a recombinant human albumin, a recombinant human alpha 1 antitrypsin, 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. GTC's external program collaborations are developing transgenic versions of products such as monoclonal antibodies and immunoglobulin fusion proteins for conditions such as rheumatoid arthritis, HIV/AIDS and cancer. 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 timing of EMEA and FDA actions regarding the ATryn(R) program, the timing of further clinical trials of ATryn(R), the anticipated timing for agreement with a marketing partner and market launch of ATryn(R) in Europe, and GTC's anticipated year-end cash balance. 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 regulatory review of ATryn(R), the conduct of further clinical studies of ATryn(R) in the United States, the timeline for market launch of ATryn(R), the risks and uncertainties associated with completing a partnering agreement for ATryn(R) and GTC's dependence upon the actions of partners and regulatory agencies, and the uncertainty that the Company 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 other internal programs. 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.
Contacts:
GTC Biotherapeutics, Inc.
Thomas E. Newberry Vice President,
Corporate Communications (508) 370-5374 or
Feinstein Kean Healthcare Francesca DeVellis (investors)
Barbara Askjaer (media) (617) 577-8110
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