Emergent BioSolutions Receives Paul-Ehrlich-Institut Approval to Market BioThrax in Germany
Emergent BioSolutions Inc. (NYSE: 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.
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.
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