GTC Biotherapeutics (fka GTCB)

[DB9]

GTC Biotherapeutics Grants EXPANDED License to PharmAthene for Further Development of Protexia(R)

03/13/2007 8:00:35

AMFRAMINGHAM, Mass., Mar 13, 2007 (BUSINESS WIRE) -- GTC Biotherapeutics, Inc. (GTCB) and PharmAthene, Inc. have entered into an agreement providing PharmAthene an expanded license to GTC's patent rights, which will support the further development, manufacturing, regulatory approval and commercialization process for PharmAthene's Protexia(R) program. Protexia(R) is a recombinant form of human butyrylcholinesterase (rBChE) produced by PharmAthene in the milk of transgenic goats. PharmAthene is developing Protexia(R) as a pre- and post-exposure therapy for military or civilian victims of a chemical nerve agent attack. The expanded license agreement includes rights to utilize GTC's transgenic technology in the worldwide development and commercialization of Protexia(R) for all uses. This expanded license agreement follows the recently announced agreement under which GTC is providing PharmAthene clinical supply and manufacturing services for Protexia(R). The financial terms of the expanded license agreement were not disclosed. 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(R) 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.