A biodefense company PharmAthene, Inc., specializing in the development and commercialization of medical countermeasures against chemical and biological threats, has been awarded additional contract for $78.4 by Department of Health and Human Services (HHS) to develop a second generation recombinant protective antigen (rPA) anthrax vaccine targeted for future procurement in the U.S. Strategic National Stockpile (SNS).
The contract modification, which is effective February 22, 2010 and extends until December 31, 2012, provides for up to $61 million during a “base period” of performance with options for an additional $17 million on a cost reimbursement plus fixed fee basis in additional advanced development funding for SparVax™. Provided that certain milestones are achieved, and that all contract options and extensions are exercised by the government, the contract has a total potential value of $78.4 million. The modification will include non-clinical safety and efficacy studies, assay development and qualification, and process scale up and validation.
SparVax™ is a highly purified recombinant protective antigen vaccine being developed for pre and post exposure protection against anthrax infection. Phase I and Phase II clinical trials involving 770 healthy human subjects have been completed and demonstrated that SparVax™ appears to be well tolerated and immunogenic in humans. These studies suggest that three doses of SparVax™, administered over a 56 day period, are sufficient to induce protective immunity. The vaccination regimen for the currently licensed anthrax vaccine, BioThrax®, requires five doses over a period of eighteen months.
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