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PharmAthene's 2nd Generation rPA Anthrax Vaccine, SparVax(TM), Completes FDA Regulatory Strategy Review
Date:7/9/2009

n of the FDA feedback to BARDA should enable the agency to recommence contract negotiations with the Company. In the meantime, development activities for the SparVax(TM) program are continuing pursuant to the Company's existing development contract for SparVax(TM), which was transferred from the National Institutes of Health to BARDA on April 1, 2009."

About SparVax(TM)

SparVax(TM) is a novel second generation recombinant protective (rPA) anthrax vaccine being developed for administration by intramuscular injection. This product employs modern vaccine technology to provide a highly purified and well characterized modern vaccine for intended use by the military and civilian Strategic National Stockpile. Phase I and Phase II clinical trials involving more than 750 healthy human subjects have been completed and showed that SparVax(TM) appears to be well tolerated and induces an immune response in humans. These studies suggest that three doses of SparVax(TM), administered several weeks apart, should be sufficient to induce protective immunity. In preclinical studies SparVax(TM) has also demonstrated the capability to protect rabbits and non-human primates against a lethal aerosol spore challenge of the anthrax Ames strain. The clinical and non-clinical studies for SparVax(TM) have been carried out under contracts with the National Institute of Allergy and Infectious Diseases and the National Institutes of Health.

About PharmAthene, Inc.

PharmAthene was formed to meet the critical needs of the United States and its allies by developing and commercializing medical countermeasures against biological and chemical weapons. PharmAthene's lead product development programs include:

  • SparVax(TM) - a second generation recombinant protective antigen (rPA) anthrax vaccine
  • Third generation rPA anthrax vaccine
  • Valortim(R) - a full
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SOURCE PharmAthene, Inc.
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