Emergent BioSolutions, FDA review strategy for recombinant anthrax vaccine

ROCKVILLE, Md. — Emergent BioSolutions Inc. announced June 11, 2009, that it has met with the U.S. Food and Drug Administration to review its regulatory strategy for the development of its recombinant anthrax vaccine.

Emergent BioSolutions recently submitted to the FDA, among other documents, its rPA Development Plan 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.

In amending the RFP, HHS required that all bidders deemed to be in the competitive range submit to FDA a comprehensive plan outlining the regulatory strategy for their rPA vaccine. Emergent completed that submission on May 12, 2009, ahead of the June 15, 2009, submission deadline.

“We are extremely pleased with the feedback that we received from FDA regarding our regulatory strategy for the development of our rPA vaccine candidate,” said Daniel Abdun-Nabi, president of Emergent BioSolutions.

“As a result of these discussions, Emergent is positioned to advance to the next step in its contract negotiations with HHS for the development and delivery of 25 million doses of an rPA anthrax vaccine to the Strategic National Stockpile." 

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.