Emergent BioSolutions Initiates Final Pivotal Study to Support Licensure of BioThrax
News Sep 26, 2014
Emergent BioSolutions Inc. has announced the initiation of the pivotal non-clinical efficacy study 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.
Data from this study will be used to support licensure of Building 55. BioThrax is the only vaccine licensed by the U.S. Food and Drug Administration (FDA) for the prevention of anthrax disease.
Adam Havey, executive vice president and president biodefense division at Emergent BioSolutions, stated, “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. In collaboration with FDA, and after having received concurrence on pre-established study endpoints, we are moving forward with a high degree of confidence in this study. 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 supplemental Biologics License Application, including data from Chemistry, Manufacturing and Controls by early next year, followed by data from this pivotal non-clinical study later in 2015.”
The primary objectives of this randomized, observer-blinded study are to demonstrate consistency of three BioThrax vaccine lots manufactured in Building 55 based on lot-to-lot equivalence as well as to demonstrate comparability of the three Building 55 lots with a Building 12 lot based on non-inferiority.
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, up to $107 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.