Emergent BioSolutions submits its plan for vaccine contract to FDA

ROCKVILLE, Md. — Emergent BioSolutions Inc. announced May 13, 2009, that it has submitted to the U.S. Food and Drug Administration a development plan for the company’s recombinant protective antigen anthrax vaccine candidate.

Emergent BioSolutions submitted the plan ahead of the June 15 deadline in response to the Department of Health and Human Services’ amendment to its request for proposal to develop and deliver up to 25 million doses of an rPA vaccine for the Strategic National Stockpile. The amendment requested that all bidders deemed to be in the competitive range submit to FDA a comprehensive plan outlining the regulatory strategy for their rPA vaccine.

“We are pleased to successfully meet this HHS requirement ahead of schedule and look forward to receiving comments and guidance from the FDA,” said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions.

Emergent BioSolutions is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and therapeutics. Its development pipeline includes programs focused on anthrax, botulism, tuberculosis, typhoid, hepatitis B and Chlamydia. Its BioThrax is the only vaccine licensed by the U.S. Food and Drug Administration for the prevention of anthrax.