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GTC Biotherapeutics and LEO Pharma to Develop and Market ATryn(R) in Europe, the Middle East, and Canada.


FRAMINGHAM, Mass. & BALLERUP, Denmark -- 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) ) and LEO Pharma A/S ("LEO") have entered into a collaboration agreement to develop and market ATryn(R) for markets in Europe, the Middle East, and Canada. ATryn(R) is GTC's recombinant form of human antithrombin, 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. The agreement includes $73 million (USD USD

In currencies, this is the abbreviation for the U.S. Dollar.

Notes:
The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion.
) in potential milestone payments to GTC for meeting regulatory, clinical and sales goals. These payments include a total of $5 million for achieving approval of ATryn(R) for the hereditary antithrombin deficiency indication in Europe, with $2 million of this total paid upon signing of the agreement. GTC will be responsible for production of ATryn(R) and will receive a transfer price for all product used by LEO. GTC will also receive a royalty on net sales Net Sales

The amount a seller receives from the buyer after costs associated with the sale are deducted.

Notes:
This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight
. LEO will be responsible for sales and marketing of ATryn(R) in all indications for the agreed territories as well as the clinical development for acquired antithrombin deficiency indications. GTC retains all rights to ATryn(R) in all other territories and will continue to be responsible for obtaining approval of ATryn(R) for the hereditary deficiency indication in Europe.

"LEO is an excellent partner for the ATryn(R) program with a strong strategic interest in products for Critical Care and the management of 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 . LEO clearly understands the opportunity for creating significant markets for ATryn(R). We look forward to working with LEO in developing ATryn(R) in acquired deficiency indications," stated Geoffrey F. Cox, Ph.D., GTC's Chairman of the Board and Chief Executive Officer.

"LEO is firmly committed to establishing the Critical Care area as a strong and growing segment of our business. ATryn(R) has significant growth potential and is a natural extension of our current Critical Care portfolio. We are pleased to work with GTC to bring the first recombinant antithrombin product to our markets. Also, we are delighted that ATryn(R) will be the first antithrombin product that would be approved in all the 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
, providing a consistent and secure source of supply to all of our customers," says Ernst Lunding, President and Chief Executive Officer of LEO.

LEO has a long history in the treatment of thromboembolic thromboembolic

pertaining to or emanating from thromboembolism.


thromboembolic meningoencephalitis
see hemophilosis.

thromboembolic parasitism
see thromboembolic colic.
 disorders. innohep(R), a low-molecular-weight heparin product is a well-known LEO product in which antithrombin binds with heparin to produce a greater anticoagulant effect. LEO has over 250 sales representatives in Europe, the Middle East, and Canada focused on Critical Care and coagulation management out of a total sales and marketing work force of 1,000 people.

GTC has developed goats with 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, which are difficult to express in conventional production methods.

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. ) is reviewing GTC's Marketing Authorization Application (MAA MAA
abbr.
macroaggregated albumin
) for the use of ATryn(R) in the prophylactic treatment of patients with hereditary antithrombin deficiency (HD) during high-risk situations. The review of the MAA is expected to conclude with a determination by the EMEA in late February 2006 and will include the results of the inspections of GTC's farm and manufacturing facilities and certain clinical sites.

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.
, disseminated intravascular coagulation disseminated intravascular coagulation
n.
Abbr. DIC A hemorrhagic disorder that occurs following the uncontrolled activation of clotting factors and fibrinolytic enzymes throughout small blood vessels, resulting in tissue necrosis and
 and sepsis. A determination of which acquired deficiency to pursue first is anticipated in the middle of 2006 following the EMEA and European Commission's determination regarding the MAA for HD.

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 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.

About LEO Pharma A/S

LEO Pharma is an independent research-based company with headquarters in Ballerup, Denmark, and affiliates and regional offices in more than 40 countries. LEO Pharma is 100% owned by the LEO Foundation and employs approximately 3,300 people. The group is one of the world's leading companies in topical dermatology and parenteral parenteral /pa·ren·ter·al/ (pah-ren´ter-al) not through the alimentary canal, but rather by injection through some other route, as subcutaneous, intramuscular, etc.

par·en·ter·al
adj.
1.
 treatment of thromboembolic disorders. LEO Pharma products are marketed in more than 90 countries. Additional information is available on the LEO Pharma web site, www.leo-pharma.com.

Forward-Looking Statement for GTC Biotherapeutics

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 potential development of additional indications for ATryn(R), the potential milestone payments and other renumeration from the collaboration, and the timing of EMEA's determination on the MAA for ATryn(R) in HD. 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 dependence upon the actions of partners and regulatory agencies and with the development of additional indications. 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. GTC specifically disclaims responsibility for information describing LEO and its business other than the agreement with GTC.
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Geographic Code:1USA
Date:Nov 1, 2005
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