Emergent BioSolutions Receives Paul-Ehrlich-Institut Approval to Market BioThrax in Germany

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Emergent BioSolutions Receives Paul-Ehrlich-Institut Approval to Market BioThrax in Germany

ROCKVILLE, Md.--(BUSINESS WIRE)-- Emergent BioSolutions Inc. (NYS: EBS) announced today that the Paul-Ehrlich-Institut (PEI) has approved Emergent's marketing authorization application for BioThrax® (Anthrax Vaccine Adsorbed) in Germany. BioThrax is the only vaccine licensed by the U.S. Food and Drug Administration (FDA) for the prevention of anthrax disease.

"Emergent is pleased with this first marketing authorization of BioThrax within the European Union," said Adam Havey, executive vice president and president of the biodefense division of Emergent BioSolutions. "Based on this regulatory approval we look forward to further expanding international registration of BioThrax within the EU to support member states' efforts to protect their citizens against the threat of anthrax as a biological weapon."


With this approval, BioThrax becomes the only anthrax vaccine approved by PEI for the prevention of anthrax disease. The marketing authorization approved by PEI provides for the administration of BioThrax in a three-dose schedule with boosters at three-year intervals recommended thereafter.

About BioThrax

BioThrax is the only FDA-licensed vaccine for the prevention of anthrax disease. It is indicated for the active immunization of adults who are at high risk of exposure to anthrax. BioThrax is not licensed for use in a post-exposure setting. The safety and efficacy of BioThrax have not been established in pediatric or geriatric populations. Individuals are not considered protected until they have completed the three-dose primary immunization series. Vaccination with BioThrax may not protect all individuals.

BioThrax is manufactured from a culture filtrate, made from a non-virulent strain of Bacillus anthracis. To date, Emergent has delivered over 66 million doses of BioThrax to the U.S. government and continues to deliver additional doses under active procurement contracts. Since 1998, over 11 million doses have been administered to more than 2.9 million military personnel. For full prescribing information, please visit http://www.biothrax.com/prescribinginformation_biothrax_us.pdf.

About Emergent BioSolutions

Emergent BioSolutions is a specialty pharmaceutical company seeking to protect and enhance life by offering specialized products to healthcare providers and governments to address medical needs and emerging health threats. Additional information may be found at www.emergentbiosolutions.com. Follow us on twitter: @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 and objectives of management, 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 success of our ongoing and planned preclinical studies and clinical trials; the rate and degree of market acceptance and clinical utility of our products; the success of our ongoing and planned development programs; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; our commercialization, marketing and manufacturing capabilities and strategy; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing. 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.



Emergent BioSolutions Inc.
Investors Contact:
Robert G. Burrows
Vice President, Investor Relations
301-795-1877
BurrowsR@ebsi.com
or
Media Contact:
Tracey Schmitt
Vice President, Corporate Communications
301-795-1800
SchmittT@ebsi.com

KEYWORDS:   United States  Europe  North America  Maryland  Germany

INDUSTRY KEYWORDS:

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