Emergent BioSolutions, Inc. has initiated the non-clinical efficacy study to demonstrate that BioThrax (Anthrax Vaccine Adsorbed) manufactured at large scale at its new facility, is comparable to BioThrax currently manufactured at its approved facility. Data from this study will be used to support licensure of the new facility. Both facilities are located on Emergent’s Lansing, MI campus. BioThrax is the only vaccine licensed by the U.S. FDA for the prevention of anthrax disease.
 
The randomized, blinded study aims to demonstrate consistency of three BioThrax vaccine lots manufactured in the new facility, Building 55, based on lot-to-lot equivalence, as well as to demonstrate comparability with lots from the approved facility based on non-inferiority.
 
Emergent produces seven to nine million doses of BioThrax annually. Building 55 has the potential to triple manufacturing capacity to an estimated 20 to 25 million doses annually. 
 
Adam Havey, executive vice president and president biodefense division at Emergent BioSolutions, said, “We are pleased to have advanced this Comparability Program through an effective partnership with BARDA. This represents an innovative approach to developing medical countermeasures and meeting the U.S. government’s requirements for an anthrax vaccine. We have completed manufacturing BioThrax lots for use in this fifth and final study required for licensure of the scaled-up manufacture of BioThrax in Building 55. We are targeting a rolling submission to FDA of the sBLA, including data from Chemistry, Manufacturing and Controls by early next year, followed by data from this pivotal non-clinical study later in 2015.”
 
This program is fully funded (as much as $107 million) under a contract with 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.