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Emergent BioSolutions Receives FDA Approval to Manufacture ACAM2000 at Canton, Massachusetts Facility

GAITHERSBURG, Md., Nov. 20, 2017 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the manufacture of ACAM2000^®, (Smallpox (Vaccinia) Vaccine, Live) in the company’s newly-acquired cGMP live viral manufacturing facility in Canton, Massachusetts. ACAM2000 is the only FDA-licensed vaccine for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection.

“Finalizing and receiving FDA licensure for the tech transfer of ACAM2000 manufacturing at the Canton facility is a significant step forward in support of the U.S. government’s strategy of establishing domestic capabilities to manufacture an FDA-licensed smallpox vaccine,” said Sean Kirk, senior vice president manufacturing operations and CMO business unit head of Emergent BioSolutions. “Emergent is pleased to achieve this milestone, which is the culmination of almost a decade of investment and dedication of our colleagues at the Canton site. Licensure of this facility helps to ensure that ACAM2000 remains the cornerstone of the U.S. government’s smallpox preparedness efforts, while at the same time positions Emergent to meet the demands of international customers.”

In its acquisition of the ACAM2000 business, Emergent also acquired a live viral fill/finish facility in Rockville, Maryland that will be responsible for the processing of bulk ACAM2000 into final packaged vaccine vials. Emergent also assumed responsibility for a 10-year contract with the Centers for Disease Control and Prevention (CDC), originally valued at $425 million, to maintain readiness against smallpox. The contract has a remaining value of $160 million for the delivery of ACAM2000 to the Strategic National Stockpile (SNS). With the approval of the Canton facility, Emergent expects to complete all remaining product deliveries under the existing CDC contract in early 2019.

About ACAM2000
ACAM2000 is the primary smallpox vaccine designated for use in a bioterrorism emergency, with more than 230 million doses having been supplied to the SNS. ACAM2000 is also licensed in Australia and Singapore, and is currently stockpiled both in the U.S. and internationally.

About Smallpox
Smallpox is a highly contagious disease caused by the variola virus, a member of the Orthopox virus family. According to the CDC, it is one of the most devastating diseases with a mortality rate as high as 30%. Smallpox is classified by the CDC as a Category A bioterrorism agent and the U.S. government continues to invest in countermeasures to protect the nation from this threat. Governments around the world are also taking precautionary measures to be ready to deal with a potential smallpox outbreak.

About Emergent BioSolutions
Emergent BioSolutions Inc. is a global life sciences company seeking to protect and enhance life by focusing on providing specialty products for civilian and military populations that address accidental, intentional, and naturally emerging public health threats. 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 on Twitter @emergentbiosolu and Instagram @life_at_emergent.

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 anticipated product delivery schedule under the existing procurement contract with the CDC, 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 FDA licensure of our manufacturing facilities; our ability to obtain an extension of the existing procurement contract for ACAM2000 upon its expiration or a new procurement contract; 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.