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Emergent BioSolutions Meets With FDA To Review Regulatory Strategy for Recombinant Anthrax Vaccine

Emergent now positioned to advance to next step in its rPA vaccine contract negotiations with HHSROCKVILLE, Md.–(BUSINESS WIRE)–Jun. 11, 2009– Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has met with the U.S. Food and Drug Administration (FDA) to review Emergent’s regulatory strategy for the development of its recombinant anthrax (rPA) vaccine. Emergent recently submitted to FDA, among other documents, its rPA Development Plan in response to the Department of Health and Human Services’ (HHS) amendment to its request for proposal (RFP) 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,” stated Daniel Abdun-Nabi, president of Emergent BioSolutions. “This meeting reassured us of the appropriateness of the regulatory strategy that we submitted to FDA and that we can proceed without major modification. 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.”

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and therapeutics that assist the body’s immune system to prevent or treat disease. Emergent’s marketed product, BioThrax^® (Anthrax Vaccine Adsorbed), is the only vaccine licensed by the U.S. Food and Drug Administration for the prevention of anthrax. Emergent’s development pipeline includes programs focused on anthrax, botulism, tuberculosis, typhoid, hepatitis B and chlamydia. Additional information may be found at www.emergentbiosolutions.com.

Safe Harbor Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, including any potential future securities offering, our expected revenue growth and net earnings for 2009, and any other statements containing the words “believes”, “expects”, “anticipates”, “plans”, “estimates” and similar expressions, are forward-looking statements. There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including our ability to win a development award and procurement contract with the U.S. government for our recombinant protective antigen anthrax vaccine candidate; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; our ongoing and planned development programs, preclinical studies and clinical trials; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2009 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

 

 

Source: Emergent BioSolutions Inc.