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GTC Biotherapeutics Anticipates EMEA Opinion on ATryn(R) in February 2006.


FRAMINGHAM, Mass. -- GTC GTC

See: Good 'til cancelled order


GTC

See good-till-canceled order (GTC).
 Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB GTCB Gulf Tax Credit Bond (Alabama, Louisiana, Mississippi, USA) ) reported today that the European Medicines Agency The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. Until 2004, the European Medicines Agency was known as The European Agency for the Evaluation of Medicinal Products.

Roughly parallel to the U.S.
 (EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. ) extended its timeline for completion of the required site inspection process and its determination of an opinion on GTC's Marketing Authorization Application (MAA MAA
abbr.
macroaggregated albumin
) for ATryn(R). Due to the expected timing of ongoing inspections and reporting of the results, which will affect completion of other parts of the overall review process, GTC is now anticipating the EMEA's opinion in February 2006. GTC's MAA for ATryn(R), a recombinant form of human antithrombin, seeks approval for the prophylactic treatment prophylactic treatment
n.
The institution of measures to protect a person from a disease to which he or she has been, or may be, exposed. Also called preventive treatment.
 of patients with hereditary antithrombin deficiency in high-risk situations.

"Despite the delay in the inspection process, the review of our responses to the Outstanding List of Issues continues to progress and we are planning for the commercial launch of ATryn(R) in mid-2006," stated Geoffrey F. Cox, Ph.D., GTC's Chairman of the Board and Chief Executive Officer. "GTC remains confident and committed to achieving a positive outcome in the EMEA review process."

GTC's commercial launch in Europe will potentially be through a partnering arrangement. GTC continues in partnering negotiations for commercialization of ATryn(R) in Europe and its additional development in larger acquired deficiency indications. Potential acquired deficiency indications include severe burns, coronary artery bypass graft surgery Coronary Artery Bypass Graft Surgery Definition

Coronary artery bypass graft surgery is a surgical procedure in which one or more blocked coronary arteries are bypassed by a blood vessel graft to restore normal blood flow to the heart.
, and sepsis.

Antithrombin is a plasma protein plasma protein
n.
Any of the various dissolved proteins of blood plasma, including antibodies and blood-clotting proteins, that act by holding fluid in blood vessels by osmosis.
 with anticoagulant anticoagulant (ăn'tēkōăg`yələnt), any of several substances that inhibit blood clot formation (see blood clotting).  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.

About GTC Biotherapeutics, Inc.

GTC Biotherapeutics is a leader in the development, production, and commercialization of therapeutic proteins through transgenic animal Transgenic animal
Animals that have had genes from other species inserted into their genetic code.

Mentioned in: Glycogen Storage Diseases
 technology. GTC currently has five products in its internal pipeline and a portfolio of external program production opportunities. In addition to the lead ATryn(R) 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, http://www.gtc-bio.com.

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995, including without limitation statements regarding future actions regarding the EMEA's review of the MAA for ATryn(R), the anticipated timing for a European market launch of ATryn(R), and the progress and prospects of partnering discussions for commercialization and development of additional indications 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 risks and uncertainties associated with dependence upon the actions of regulatory agencies and uncertainties associated with potential collaborations. 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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Publication:Business Wire
Geographic Code:1USA
Date:Sep 16, 2005
Words:615
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