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DewDiligence

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DewDiligence

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Friday, 03/02/2007 5:00:24 PM

Friday, March 02, 2007 5:00:24 PM

Post# of 19309
GTC Biotherapeutics Enters into Process Development and Clinical Supply Manufacturing Services Agreement with PharmAthene for Protexia®

[GTC also stands to earn a royalty on Protexia sales for its IP license should there ever be any sales (#msg-4107224). Although PharmAthene has its own small goat herd that was inherited from Nexia (#msg-4831852), they presumably decided to do things the right way and go to the pros (GTC). PharmAthene has grants to develop Protexia from both the DoD and the NIH (see hyperlinks below). Those who voted “yes” on the latest survey win, although this may not have been the news they were expecting.]

http://biz.yahoo.com/bw/070302/20070302005629.html?.v=1

>>
Friday March 2, 4:33 pm ET

FRAMINGHAM, Mass.--(BUSINESS WIRE)--GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB ) and PharmAthene, Inc. have entered into an agreement under which GTC will provide process development and clinical supply manufacturing services for PharmAthene's Protexia® program. Protexia® is a recombinant form of human butyrylcholinesterase (rBChE) produced in the milk of transgenic goats, which is being developed by PharmAthene as a pre- and post-exposure therapy for military or civilian victims of a chemical nerve agent attack.

"We are pleased to expand our relationship with PharmAthene to provide the processing and analytical expertise for the development of Protexia®," stated Geoffrey F. Cox, Ph.D., GTC's Chairman and Chief Executive Officer. "rBChE is a prime example of a protein that is difficult to express in other production systems and is well suited to the transgenic technology platform."

"GTC is an industry leader in transgenic protein technology and we look forward to working with them to ensure that the manufacturing of Protexia® is developed in accordance with all the appropriate regulatory requirements," stated David P. Wright, President and Chief Executive Officer of PharmAthene.

While the utility of human plasma derived butyrylcholinesterase (hBChE) to protect against nerve agent toxicity is well documented, a major limitation hindering its commercial development has been the inability to produce commercial quantities of hBChE due to a limited availability of appropriate blood supplies, low levels of the protein in plasma, and low production yields using traditional biotechnology methods. PharmAthene's recombinant hBChE overcomes these limitations by enabling substantially larger production yields than are possible using other expression systems or through purification of the native protein from human plasma. Transgenic production and manufacturing is estimated to be capable of supplying sufficient rBChE to make Protexia® available for use by the military and civilian populations.

About Nerve Agents

Organophosphate nerve agents, or anti-cholinesterase agents, cause toxicity by binding to and inhibiting acetylcholinesterase, an enzyme in the body that is essential for nervous system function. This leads to increases in acetylcholine and "cholinergic crisis" that can cause loss of muscle control, respiratory failure, paralysis, convulsions, permanent brain damage and eventually death.

These so-called nerve gases, which are actually all liquids at room temperature, are lethal in low quantities when inhaled or absorbed through the skin. Nerve agents can be classified as either G-agents (sarin, soman, tabun) or V agents (VX), both of which are exceedingly volatile and toxic.

About Protexia: Recombinant Human Butyrylcholinesterase

Protexia® is a form of recombinant human butyrylcholinesterase (rBChE), a potent organophosphate (OP) scavenger protein produced in the milk of transgenic goats, which is being developed for use as a prophylactic and therapeutic against acute organophosphate (OP) nerve agent toxicity. In September 2006 PharmAthene was awarded a multi-year contract valued at up to $213 million from the Department of Defense (DoD) U.S. Army Space and Missile Command, for advanced development of Protexia® [see #msg-13565694. PharmAthene also has a larger Protexia grant from the NIH (#msg-14110344).]

About PharmAthene, Inc.

PharmAthene, a privately-held biotechnology company, was formed to meet the critical needs of the United States by developing biodefense products. PharmAthene is dedicated to the rapid development of important and novel biotherapeutics to address biological pathogens and chemicals that may be used as weapons of bioterror. PharmAthene's lead programs include Valortim(TM), a treatment for anthrax, and Protexia®, a treatment for nerve agent exposure. For more information on PharmAthene, please visit www.PharmAthene.com.

About GTC Biotherapeutics, Inc.

GTC Biotherapeutics develops, produces, and commercializes therapeutic proteins through transgenic animal technology. In August 2006, ATryn®, GTC's recombinant form of human antithrombin, was approved by the European Commission for use in patients with hereditary antithrombin deficiency undergoing surgical procedures. This was the first approval anywhere in the world of a therapeutic protein produced from a transgenic animal.

GTC has also recently been 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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