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Emergent BioSolutions Submits to FDA Development Plan Required of Bidders in Competitive Range for Recombinant Anthrax Vaccine (rPA) Contract with HHS

– Emergent completes FDA submission ahead of June 15, 2009 deadlineROCKVILLE, Md.–(BUSINESS WIRE)–May. 13, 2009– Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has submitted to the U.S. Food and Drug Administration (FDA) a Development Plan for the company’s Recombinant Protective Antigen (rPA) anthrax vaccine candidate. Emergent submitted the Development Plan ahead of the June 15 deadline in response to the Department of Health and Human Services’ (HHS) 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. “As the premier supplier of medical countermeasures to the U.S. government, we are fully committed to moving our rPA program forward and remain optimistic of our competitiveness to receive any award granted by HHS to develop and supply the Strategic National Stockpile with an rPA vaccine.”

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, 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 the timing of, and the potential for successful outcomes resulting from future product development efforts and our ability to obtain additional funding from the U.S. government, our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; and other factors identified in the company’s current report on Form 10-Q for the period 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.