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HHS Extends Deadline for Bidders in Competitive Range for Recombinant Anthrax Vaccine (rPA) Contract to Submit Development Plan to FDA for Review to June 15, 2009

Emergent Already in Advanced Stage of Completing Submission of Development Plan to FDA for ReviewROCKVILLE, Md.–(BUSINESS WIRE)–Apr. 22, 2009– Emergent BioSolutions Inc. (NYSE:EBS) announced today that the U.S. Department of Health and Human Services (HHS) issued an additional amendment to its request for proposal for an Anthrax Recombinant Protective Antigen (rPA) Vaccine for the Strategic National Stockpile.

This new amendment, which follows an amendment previously issued on April 15, 2009 requesting that all bidders submit a comprehensive plan outlining the regulatory strategy to FDA for review, extends the deadline for submission of such a plan to June 15. This new amendment applies to all bidders in competitive range for the rPA contract. The original amendment required submissions within 15 days of April 15th, the date the amendment was first issued.

Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions, stated, “We are confident in our submission package that we had been planning to submit in satisfaction of the original deadline. With that said, we fully support HHS’s decision to grant additional time to submit a development plan package for FDA review.”

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 annual report on Form 10-K for the year ended December 31, 2008 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.