Gaithersburg, MD - Emergent BioSolutions Inc. (NYSE:EBS) recently announced completion of the in-life phase of the pivotal nonclinical efficacy study designed to demonstrate that BioThrax® (Anthrax Vaccine Adsorbed) manufactured at large scale in the company's new modern facility, Building 55, is comparable to the BioThrax currently manufactured in its approved facility, Building 12. Interim analysis has shown that the primary endpoints were met; these include demonstrating comparability to vaccine manufactured in Building 12 as well as consistency between lots manufactured in Building 55. Data from this study will be used to support a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for licensure of Building 55. BioThrax is the only FDA-licensed vaccine for the prevention of anthrax disease.
Adam Havey, executive vice president and president biodefense division at Emergent BioSolutions, stated, "The Building 55 scale-up program represents years of collaborative effort with BARDA and FDA to meet the U.S. government's stated requirement of 75 million doses in the Strategic National Stockpile. Emergent is pleased with the completion of the in-life phase of our pivotal study. The remainder of 2015 will entail finalizing the nonclinical pivotal study report, progressing efforts related to the Prior Approval Inspection of the Lansing facility, and compiling the sBLA. We are continuing to work with FDA and anticipate approval in either late 2015 or early 2016."
Building 12 produces 7 to 9 million doses of BioThrax annually. Building 55 has the potential to triple manufacturing capacity to an estimated 20 to 25 million doses annually. Both facilities are located on Emergent's Lansing, Michigan campus.
This program is fully funded at $104 million under contract number HHSO100201000034C by the Biomedical Advanced Research and Development Authority within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.
About Emergent BioSolutions Emergent BioSolutions is a global specialty biopharmaceutical 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 about the company may be found at www.emergentbiosolutions.com. Follow us @emergentbiosolu.
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