The company plans to scale up annual production capacity from 7-9 million doses of the vaccine in an older facility to between 20-25 million doses at its new modern facility, known as Building 55.
Data from the study will be used to support licensure of Building 55, which is located on Emergent’s Lansing, Michigan campus. BioThrax is the only vaccine licensed by the US FDA for the prevention of anthrax disease.
Maryland-based Emergent has three other anthrax vaccines in its pipeline, including two in Phase II development and one in Phase III development. The company currently fills 20 commercial products, and has two 240 square-foot lyophilizers capable of holding up to about 60,000 3 cc vials.
The primary objectives of the 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 lot from the previous facility based on non-inferiority.
Adam Havey, EVP and president biodefense division at Emergent BioSolutions, said in a statement: “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 comparability program has progressed through Emergent’s partnership with BARDA (Biomedical Advanced Research and Development Authority), which is funded up to $107 million, in order to meet the US government’s requirements for an anthrax vaccine. Pfenex is also working to develop an anthrax vaccine and last year selected Paragon to conduct the manufacturing.
Earlier this month, Emergent also signed a five-year, $29m contract with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health(NIH), to develop a dry formulation of one of the company’s potential vaccines known as NuThrax (Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant), also known as AV7909.