PharmAthene Inc, a biodefense company developing medical countermeasures against biological and chemical threats, has submitted its comprehensive regulatory strategy to the US Food and Drug Administration (FDA) outlining the non-clinical and clinical development plans for licensure of SparVax, a next generation recombinant protective antigen anthrax vaccine.

The FDA submission is in response to recent amendments issued by the Department of Health and Human Services (HHS) on April 15 and 22, 2009, to solicitation number RFP BARDA 08-15, outlining a requirement to develop and procure 25 million doses of a next generation rPA anthrax vaccine for the country's civilian biomedical stockpile.

In September 2008, PharmAthene received notification from HHS that its proposal for SparVax had been deemed technically acceptable and within the competitive range for procurement consideration. Since that time, PharmAthene has been engaged in negotiations with HHS under the proposals process.

David P Wright, president and chief executive officer of PharmAthene, noted, "We are pleased to have met our stated goal of submitting our regulatory plan to FDA by May 21st, well ahead of the June 15th submission deadline. We feel we have presented a comprehensive and credible path for the ultimate licensure of SparVax. We continue to maintain an ongoing dialogue with FDA, and anticipate an expeditious review of our development plan. In the meantime, activities under the SparVax programme continue to advance uninterrupted under a development contract for SparVax originally awarded by the National Institute of Allergy and Infectious Disease (NIAID) and transferred to the Biomedical Advanced Research and Development 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."

SparVax is a novel second generation recombinant protective (rPA) anthrax vaccine being developed for administration by intramuscular injection.

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.