GAITHERSBURG, Md., June 15, 2016 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug status for BioThrax® (Anthrax Vaccine Adsorbed) for post-exposure prophylaxis (PEP) of anthrax disease resulting from suspected or confirmed exposure to Bacillus anthracis. The Orphan Drug status provides market exclusivity through November 2022, representing seven years from the date on which FDA approved the PEP indication for BioThrax. The FDA Orphan Drug Designation program provides a special status to drugs and biologics intended to treat or prevent rare medical conditions, specifically those affecting fewer than 200,000 persons in the U.S. BioThrax, the only FDA-licensed vaccine for anthrax disease, is indicated for both pre-exposure and post-exposure prophylaxis of anthrax disease.
Adam Havey, executive vice president and president, biodefense division at Emergent BioSolutions, stated, “BioThrax plays a significant role in the U.S. government’s biosecurity efforts and Emergent is pleased to receive FDA Orphan Drug exclusivity, which recognizes our commitment to enhancing the features of BioThrax, in particular, the additional indication of post-exposure prophylaxis of anthrax disease to which the orphan drug exclusivity applies.”
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.
Robert G. Burrows
Vice President, Investor Relations
Tracey Schmitt Lintott
Senior Vice President, Global Public Affairs
Emergent BioSolutions Inc.