View printer-friendly version

Download PDF

FDA Completes Pre-Approval Inspection of Emergent BioSolutions’ Large-Scale Manufacturing Facility for BioThrax

GAITHERSBURG, Md., June 21, 2016 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) today announced that the U.S. Food and Drug Administration (FDA) has completed its Pre-Approval Inspection (PAI) of Building 55, the company’s facility for large-scale manufacturing of BioThrax^® (Anthrax Vaccine Adsorbed). At the conclusion of the inspection, the company received a No Action Indicated decision and no Form 483 observations. Successful completion of the PAI is one of the requirements for Building 55 licensure in connection with the company’s supplemental Biologics License Application (sBLA) recently accepted by the FDA. The sBLA has a Prescription Drug User Fee Act (PDUFA) target action date of August 15, 2016.

“Emergent is pleased to have reached this critical milestone in our BioThrax comparability program. The positive outcome from this pre-approval inspection is a testament to our employees’ tireless efforts, to our substantial financial investment in Building 55, and to our strong partnership with BARDA,” said Adam Havey, executive vice president and president, biodefense division at Emergent BioSolutions. “We look forward to timely completing the process for securing FDA licensure of our facility.”

The BioThrax comparability program is fully funded at $104 million under contract number HHSO100201000034C by 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. We also develop and commercialize therapeutics and other specialty products for hospitals and clinics in the areas of hematology/oncology, transplantation, infectious diseases and autoimmune disorders. 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 the timing of and our ability to obtain and maintain approval for Building 55; appropriations for BioThrax procurement; our ability to obtain new BioThrax sales contracts or modifications to existing contracts; 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.