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European Commission Approves ATryn(R).


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 Commission has granted market authorization to ATryn(R), GTC's recombinant form of human antithrombin, for the prophylaxis of venous thromboembolism thromboembolism /throm·bo·em·bo·lism/ (-em´bo-lizm) obstruction of a blood vessel with thrombotic material carried by the blood from the site of origin to plug another vessel.

throm·bo·em·bo·lism
n.
 in surgery of patients with congenital antithrombin deficiency. Antithrombin is a naturally occurring 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.
 that has both anticoagulant anticoagulant (ăn'tēkōăg`yələnt), any of several substances that inhibit blood clot formation (see blood clotting).  and anti-inflammatory properties. GTC produces ATryn(R) in the milk of goats that have a transgene transgene

a gene that has been incorporated into the genome of another organism.
 for human antithrombin. ATryn(R) is the first transgenically produced protein to be approved for human therapeutic use anywhere in the world. ATryn(R) is also the first recombinant antithrombin product approved anywhere in the world and the first antithrombin product, whether recombinant or derived from the human blood supply, that has been approved through the centralized 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.  procedure for use in all 25 countries of the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the

European Community
.

"The approval of ATryn(R) by the European Commission is the final confirmation of a major achievement for GTC for which we are very proud," stated Geoffrey F. Cox, Ph.D., GTC's Chairman of the Board and Chief Executive Officer. "This approval represents validation of our technology and the beginning of a new phase of opportunities for GTC to build a significant company."

The European Commission approval follows on the positive opinion determined by the Committee for Medicinal Products for Human Use “CHMP” redirects here. For French language Canadian radio station, see CHMP-FM.

CPMP, Committee for Proprietary Medicinal Products, now CHMP Committee for Medicinal Products for Human Use
 of 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.
 on June 2, 2006. The positive opinion was based on an extensive review of the application submitted in January 2004.

Patients with a hereditary antithrombin deficiency are prone to developing blood clots Blood Clots Definition

A blood clot is a thickened mass in the blood formed by tiny substances called platelets. Clots form to stop bleeding, such as at the site of cut.
. These patients may normally be maintained on an oral blood thinning agent. When a hereditary deficient patient is undergoing a high risk procedure, such as surgery, the blood thinning medication is typically discontinued to minimize the risk of excessive bleeding. Supplementation of low antithrombin levels with ATryn(R) may be utilized during these high risk procedures to allow for appropriate functioning of the natural coagulation coagulation (kōăg'ylā`shən), the collecting into a mass of minute particles of a solid dispersed throughout a liquid (a sol), usually followed by the precipitation or  management system. ATryn(R) is administered by infusion in a hospital setting during the high risk procedure. The hereditary deficient population is estimated to be about 1 in 5,000 and has been dependent upon plasma-derived antithrombin products for use during high risk procedures. GTC's recombinant form of antithrombin will offer an alternative to treatment with plasma-derived product and a consistent availability of product throughout the European Union, once reimbursement rates are obtained.

Negotiation of the reimbursement rates with each country's health system and establishment of sales and marketing efforts in Europe will be performed by GTC's partner, LEO Pharma A/S. GTC will continue to produce the product, receiving a transfer price from LEO as well as a royalty on commercial sales. Market launch is targeted for the second quarter of 2007 as reimbursement rates are finalized. LEO will also make a non-refundable $2 million milestone payment to GTC for receipt of the European market authorization.

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 ATryn(R) program, GTC has programs for 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 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 the timing of the market launch of ATryn(R) and the negotiation of reimbursement rates. 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 negotiating sufficient reimbursement rates, and the risks and uncertainties associated with dependence upon the actions of partners and national healthcare systems. 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.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Aug 2, 2006
Words:783
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