PharmAthene’ SparVax Completes FDA Regulatory Strategy Review

FDA has completed its review of PharmAthene’ proposed development plan for SparVax, a 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 (to develop and deliver up to 25 million doses of an rPA vaccine for the Strategic National Stockpile) PharmAthene submitted to FDA its development strategy. It included the company’s non-clinical and clinical development plans for licensure, for SparVax.

David Wright, President and CEO of PharmAthene, said: We’re very pleased by FDA’s expedited review of our development plan for SparVax. 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 program previously submitted to Health and Human Services (HHS) as part of our proposal in response to the request for proposal (RFP), and we look forward to partnering with FDA and Biomedical Advance Research and Development Authority (Barda) in our continuing efforts to execute on our SparVax development program.