Emergent BioSolutions Receives German Federal Ministry of Health Approval of Building 55 for Large-Scale Manufacturing of BioThrax
GAITHERSBURG, Md., Jan. 27, 2017 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced today that the Paul-Ehrlich-Institut (PEI), the regulatory agency under the German Federal Ministry of Health, has approved the company’s large-scale manufacturing facility, Building 55, located in Lansing, Michigan. This approval allows Emergent to market BioThrax® (Anthrax Vaccine Adsorbed) manufactured in Building 55 in Germany. BioThrax is the only anthrax vaccine licensed by the PEI for pre-exposure prophylaxis of anthrax disease. It is also the only anthrax vaccine licensed by the U.S. Food and Drug Administration (FDA) for both pre-exposure prophylaxis and post-exposure prophylaxis of anthrax disease.
“Emergent is pleased with PEI approval of our large-scale manufacturing facility, Building 55, which comes on the heels of Building 55 licensure by the FDA,” said Adam Havey, executive vice president and president, biodefense division of Emergent BioSolutions. “With this regulatory milestone, the company believes it is well-positioned to pursue BioThrax licensure across targeted countries within the European Union. This is in line with our strategy and supports our efforts to expand international sales as well as maximize utilization of our manufacturing infrastructure and capabilities.”
In 2013, Germany became the first country in the European Union to approve the sale of BioThrax through PEI market authorization of BioThrax manufactured in Building 12, the company’s original manufacturing facility. With the approval of Building 55, Emergent has expanded its capacity to supply BioThrax to a broader customer base while fulfilling U.S. government requirements. Building 55 is designed to manufacture approximately 20 million to 25 million doses of BioThrax annually. Since receiving FDA licensure in August 2016, the company has begun to supply BioThrax manufactured in Building 55 to the U.S. Strategic National Stockpile.
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 new procurement contracts for BioThrax; the ability to obtain licensure of BioThrax in other countries; our ability to secure procurement contracts for BioThrax or other products or product candidates sufficient to utilize Building 55’s full manufacturing capacity; 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 240-631-3281 SchmittT@ebsi.com
