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www.fdanews.com/articles/62799-pharmathene-wins-213-million-dod-contract-for-protexia

PHARMATHENE WINS $213 MILLION DOD CONTRACT FOR PROTEXIA

September 26, 2006

PharmAthene has announced it has been awarded a multiyear contract valued at up to $213 million from the Department of Defense (DOD) U.S. Army Space and Missile Command for advanced development of the company's broad-spectrum chemical nerve agent prophylaxis, Protexia.

Under the contract, PharmAthene will be responsible for the conduct and oversight of all product development activities. The initial stage of development, for which $34.7 million has been allocated, includes manufacturing process development, preclinical safety and toxicity testing, submission of an investigational new drug application to the FDA and initiation of a Phase I clinical trial. Following the successful completion of the trial, the government may exercise its option to fund additional development activities beyond the initial $34.7 million, leading to FDA approval. The contract also provides the Department of Defense with the option to procure an initial 90,000 doses of Protexia.

The contract was awarded through a full and open competitive solicitation seeking novel, second-generation prophylactic products for use in humans to prevent and treat poisoning from organophosphorus nerve agents such as sarin gas, soman, tabun and VX. Protexia is a form of recombinant human butyrylcholinesterase, a potent organophosphorus scavenger protein, being developed for use as a prophylactic to protect against the toxic effects of chemical nerve agents.