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Emergent BioSolutions Receives FDA Approval for Large-Scale Manufacturing of BioThrax in Building 55

GAITHERSBURG, Md., Aug. 15, 2016 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application (sBLA) for the manufacture of BioThrax® (Anthrax Vaccine Adsorbed) in Building 55, the company’s large-scale manufacturing facility located in its 12.5-acre campus in Lansing, Michigan.

“FDA approval of Building 55 is the culmination of more than a decade of investment and collaboration by Emergent and the U.S. government towards the ability to manufacture anthrax vaccines at large scale to protect the nation,” said Daniel J. Abdun-Nabi, president and chief executive officer of Emergent BioSolutions. “This milestone represents the U.S. government’s continued commitment to anthrax preparedness and its belief in the company’s core competency in manufacturing and the potential of this facility. The expanded capacity of Building 55 also positions the company to potentially supply anthrax vaccines to allied governments in support of their preparedness plans.”

This program was executed under contract HHSO100201000034C, valued at $104 million, with the Biomedical Advanced Research and Development Authority within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.

About Emergent BioSolutions
Emergent BioSolutions is a global specialty biopharmaceutical company dedicated to one simple mission—to protect and enhance life. We develop, manufacture, and deliver a portfolio of medical countermeasures for biological and chemical threats as well as emerging infectious diseases. Through our work, we envision protecting and enhancing 50 million lives with our products by 2025. Additional information about the company may be found at www.emergentbiosolutions.com. Follow us @emergentbiosolu.

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, prospects, plans, objectives, and any other statements containing the words “believes,” “expects,” “anticipates,” “intends,” “plans,” “estimates” and similar expressions, are forward-looking statements. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances.

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 maintain approval for Building 55; the ability to obtain a new procurement contract for BioThrax; our ability to secure procurement contracts for BioThrax or other products or product candidates sufficient to utilize Building 55’s full manufacturing capacity; the ability to obtain a development and procurement contract under the request for proposal for a next generation anthrax vaccine; appropriations for procurement of BioThrax and a next generation anthrax vaccine; and our manufacturing capabilities and strategy. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the SEC, when evaluating our forward-looking statements.

Investor Contact: Robert G. Burrows Vice President, Investor Relations 240-631-3280 burrowsr@ebsi.com Media Contact: Tracey Schmitt Lintott Senior Vice President, Global Public Affairs 240-631-3394 SchmittT@ebsi.com

Source:Emergent BioSolutions Inc.