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PharmAthene Submits SparVax(TM) Regulatory Strategy to FDA
Date:5/22/2009

lopment Authority (BARDA) in April 2009. We look forward to the FDA's review of our proposal, and to the contract award decision by HHS for the advanced development and procurement of next generation rPA anthrax vaccines."

About SparVax(TM)

SparVax(TM) is a novel second generation recombinant protective (rPA) anthrax vaccine being developed for administration by intramuscular injection. Phase I and Phase II clinical trials involving more than 700 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.

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 fully human monoclonal antibody for the prevention and treatment of anthrax infection
  • Protexia(R) - a novel bioscavenger for the prevention and treatment of morbidity and mortality associated with exposure to chemical nerve agents
  • RypVax(TM) - a recombinant dual antigen vaccine for plague

For more information about PharmAthene, please visit www.PharmAthene.com.

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