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Emergent BioSolutions Gets FDA Nod For Anthrax Vaccine supplemental BLA - Update

Friday, biopharmaceutical company Emergent BioSolutions, Inc. (EBS), announced that U.S. Food and Drug Administration, or FDA, has approved its supplemental Biologics License Application for Anthrax vaccine adsorbed or BioThrax.

The supplement for BioThrax, the only FDA-licensed vaccine to prevent anthrax, permits five intramuscular doses over the former schedule of six subcutaneous doses.

Emergent stated that the results were based on interim analysis of data from a large multi-center study initiated by Center for Disease Control and Prevention or CDC in 2002. The study evaluated on the dosage levels for effective immune response. Presently, BioThrax is administered over six months with booster doses up to three years apart.

CDC, a part of the US Department of Health and Human Services, will complete further data analysis by 2009. Following which, Emergent may submit the results for further reduction in the number of required BioThrax doses.

BioThrax is licensed by FDA as a pre-exposure prophylaxis for use in adults with high risk of exposure to anthrax spores. Since 1998, the U.S. government has procured nearly 32 million doses of BioThrax.

The Stock closed Thursday, at $25.30 on the New York Stock Exchange.

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