GAITHERSBURG, Md., June 17, 2016 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Emergent’s supplemental Biologics License Application (sBLA) seeking approval of the manufacture of BioThrax® (Anthrax Vaccine Adsorbed) in Building 55, the company’s large-scale manufacturing facility. FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 15, 2016.
“Emergent’s large-scale manufacturing facility, intended to increase the manufacturing capacity for BioThrax to an estimated 20 to 25 million doses annually, is a response to the U.S. government’s desire to stockpile 75 million doses of a licensed anthrax vaccine,” said Adam Havey, executive vice president and president, biodefense division at Emergent BioSolutions. “We look forward to our continued collaboration with the U.S. government to help in its commitment to protect the nation against public health threats such as anthrax.”
The sBLA, submitted on April 15, 2016, is supported by data that demonstrate that BioThrax manufactured at large scale in Building 55 is comparable to BioThrax manufactured in the currently-licensed facility. BioThrax, the only FDA-licensed anthrax vaccine, is indicated for both pre-exposure and post-exposure prophylaxis of anthrax disease.
This 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.