Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has reached an agreement with the Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, to conduct a non-interference study to be used to support a Post-Exposure Prophylaxis (PEP) indication for BioThrax ® (Anthrax Vaccine Adsorbed). This agreement provides the company with up to $8.43 million in additional funding. The non-interference trial, targeted to commence in the fourth quarter of 2012, is expected to involve 120 healthy volunteers and is designed to demonstrate non-interference of BioThrax when administered in conjunction with antibiotics. Approval of a PEP indication would enable BioThrax to be used in combination with antibiotics in people suspected to have been exposed to anthrax spores. Currently, BioThrax only has a pre-exposure prophylaxis indication.
Separately, under its development contract with BARDA, Emergent has completed dosing and the last subject visit in a pivotal PEP immunogenicity and safety study evaluating a three-dose vaccination schedule for BioThrax. Data from this study, which involves 200 healthy volunteers, will also be used by the company in support of a PEP indication for BioThrax. The company anticipates preliminary data from this study will be available in the fourth quarter of 2012.
These studies are fully funded under contract number HHSO100200700037C, provided by the Biomedical Advanced Research and Development Authority of the Department of Health and Human Services.
About Emergent BioSolutions Inc.Emergent BioSolutions protects and enhances life by developing and manufacturing vaccines and therapeutics that are supplied to healthcare providers and purchasers for use in preventing and treating disease. Emergent’s marketed and investigational products target infectious diseases, oncology and autoimmune disorders. Additional information about the company may be found at www.emergentbiosolutions.com. 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. The safety and efficacy of BioThrax in a post-exposure setting have not been established. Individuals are not considered protected until they have completed the three-dose primary immunization series. Vaccination with BioThrax may not protect all individuals.