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DewDiligence

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Monday, 07/09/2007 8:58:31 AM

Monday, July 09, 2007 8:58:31 AM

Post# of 19309
ATryn Introduced at International Society on Thrombosis and Haemostasis Congress

[The PR says the DIC trial will enroll the first patient “soon.”]

http://biz.yahoo.com/bw/070709/20070709005428.html?.v=1

>>
Monday July 9, 8:30 am ET

GENEVA--(BUSINESS WIRE)--GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) and LEO Pharma A/S announced today that ATryn®, the first recombinant human antithrombin therapeutic and the first transgenically produced drug, is being introduced to the international medical community at the International Society on Thrombosis and Haemostasis, or ISTH, Bi-Annual Meeting. ATryn® is being commercialized and further developed in Europe by LEO, GTC's development and commercialization partner in Europe, Canada and the Middle East.

The Congress is taking place in Geneva, Switzerland from July 6 through July 12. ATryn® related events at ISTH include:

• Two posters by R. Campbell Tait, MD, Glasgow Royal Infirmary, et al, presented by Johan Frieling, MD, Ph.D, GTC Consulting Medical Director, describing dosing strategies for managing antithrombin levels in patients with hereditary antithrombin deficiency undergoing surgery or delivery, procedures that are associated with a high risk for developing a thromboembolism.
• A scientific symposium moderated by Mario von Depka, MD, Ph.D Director, Werlhof Institute for Thrombosis and Haemostasis, Hannover, Germany entitled, "ATryn®, The First Recombinant Antithrombin: Innovation or Alternative?" The symposium includes presentations and a panel discussion with Dr. von Depka (clinical data), Dr. Harry Meade, Sr. Vice President, Research, GTC, (transgenic technology), and Dr. Carol Ziomek, Vice President, Development, GTC, (product purity).
• A press conference and panel discussion on Monday, July 9 (Room F) hosted by Geoffrey Cox, Ph.D, Chairman, President and CEO, GTC Biotherapeutics, titled, "Recombinant Antithrombin: Clinical Opportunities from Transgenic Production." Panel members include Dr. von Depka, Dr. Meade, and Dr. Ziomek.
• An exhibition booth hosted by LEO. LEO anticipates sales of ATryn® as reimbursement prices are established on a country-by-country basis through the remainder of 2007 and into 2008.

Antithrombin, produced in the liver and circulated in blood plasma, has both anticoagulant and anti-inflammatory properties. The recombinant form is produced using GTC's transgenic production platform, enabling large volume supply of antithrombin.

ATryn® has been approved for use in Europe for the prophylactic treatment of venous thromboembolism in hereditary antithrombin deficient patients undergoing surgical procedures. GTC is in comparative Phase III studies for a similar indication, including pregnant patients, in the United States. These studies include an evaluation of the incidence of thromboembolism in 17 hereditary antithrombin deficient patients undergoing surgery and pregnancy, and will be compared with the historical records of at least 35 patients who have undergone similar procedures but who were treated with plasma-derived antithrombin products. GTC plans to release data from this research in the fourth quarter of 2007.

Separately, LEO is initiating a Phase II dose-ranging study of ATryn® in disseminated intravascular coagulation, or DIC, associated with severe sepsis. The first patient to be treated in this study is expected to be dosed soon. DIC associated with severe sepsis represents a significant unmet medical need in both the United States and Europe, affecting approximately 500,000 patients per year with mortality rates reaching 50%. GTC will have access to the Phase II data for use in the United States and the rest of the world.

About ISTH

The International Society on Thrombosis and Haemostasis, Inc. is organized and operated exclusively for scientific and educational purposes. Its objectives are to foster and advance science relating to the important medical problems of thrombosis and abnormalities of hemostasis and vascular biology; to provide a forum for discussion of these problems; to encourage research on these problems by scientists of the several relevant disciplines; to foster the diffusion and exchange of ideas through scientific meetings and publications; and to standardize nomenclature and methods as appropriate and timely.

About LEO Pharma

LEO Pharma is an independent research based pharmaceutical company with headquarters located in Ballerup, Denmark. LEO Pharma is 100% owned by the LEO Foundation and is one of the world's leading companies in dermatology and thromboembolism. LEO Pharma discovers, develops and manufactures safe and efficacious drugs and markets them globally - 96% of revenues are generated outside of Denmark. LEO Pharma is represented in more than 90 countries and has around 3,000 employees around the world; 1,200 of these in Denmark. www.leo-pharma.com

About GTC Biotherapeutics

GTC Biotherapeutics develops, produces, and commercializes therapeutic proteins through transgenic animal technology. ATryn® is both the first therapeutic product produced by transgenic technology to obtain regulatory approval anywhere in the world and the first recombinant antithrombin product. ATryn® is produced in goats that have the human antithrombin gene linked to a milk-protein promoting gene so that they express this 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 economically viable quantities in conventional production systems.

In addition, GTC has established a strategic collaboration with LFB Biotechnologies of France to jointly develop recombinant forms of human plasma proteins and monoclonal antibodies. The first program of the collaboration will be to develop recombinant human factor VIIa as a potential treatment for hemophilia in patients with antibodies to other coagulation factors.

In 2006, GTC was granted a patent in the United States through 2021 for the production of any therapeutic protein in the milk of any transgenic mammal. GTC's transgenic production platform is particularly well suited to enabling cost effective development of proteins that are difficult to express in traditional recombinant production systems as well as those that are required in large volumes. Additional information is available on the GTC web site, http://www.gtc-bio.com.
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