PharmAthene, Inc, a biodefense company developing medical countermeasures against biological and chemical threats, announced that the US Food and Drug Administration (FDA) has completed its review of the company's proposed development plan for SparVax, PharmAthene's next generation recombinant protective antigen (rPA) anthrax vaccine.

In response to amendments to the request for proposal (RFP BARDA 08-15) issued by the US Department of Health and Human Services (HHS) to develop and deliver up to 25 million doses of an rPA vaccine for the Strategic National Stockpile, as previously announced on May 22, 2009 PharmAthene submitted to FDA its development strategy, including the company's non-clinical and clinical development plans for licensure, for SparVax. In amending the RFP, HHS required that all bidders in the competitive range submit to FDA a comprehensive plan outlining the regulatory strategy for their rPA vaccine. PharmAthene has provided FDA's feedback to the Biomedical Advance Research and Development Authority (BARDA) as required by Amendments five and six to the RFP.

"We're very pleased by FDA's expedited review of our development plan for SparVax," said David P Wright, president and chief executive officer. "FDA was very responsive during the evaluation period, providing written feedback on our development plan in lieu of a formal meeting. We do not believe that FDA's comments on our proposed development plan will require any significant changes to the development programme previously submitted to HHS as part of our proposal in response to the RFP, and we look forward to partnering with FDA and BARDA in our continuing efforts to execute on our SparVax development programme."

Wright continued, "Submission 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 programme are continuing pursuant to the Company's existing development contract for SparVax, which was transferred from the National Institutes of Health to BARDA on April 1, 2009."

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.