ROCKVILLE, Md. — Emergent BioSolutions Inc. announced April 16, 2009, that the Department of Health and Human Services requested that each bidder in the competitive range for a contract to develop an rPA vaccine candidate submit its product development plans to the Food and Drug Administration for review in advance of an award.
Emergent BioSolutions will meet with FDA officials as part of its pre-award activity. The company intends to incorporate any FDA comments into its rPA development plan. Emergent BioSolutions will continue to move its rPA program forward to position the company to execute on the anticipated contract, once awarded.
“We strongly support this step by HHS, which potentially reduces development risk for our rPA vaccine candidate. We remain confident that we are well-positioned and competitive to receive any award granted by HHS for the development and procurement of the rPA vaccine,” said Fuad El-Hibri, chairman and CEO of Emergent BioSolutions.
As with any government solicitation of this size and scope, there are no assurances that HHS will not impose additional requirements, which may further extend contract negotiations.
This action has no impact on the company’s existing contracts with HHS to supply BioThrax, the only FDA licensed anthrax vaccine, for the Strategic National Stockpile.