Date: 2015-02-13
Type of information: Completion of the trial
phase: non clinical
Announcement: initiation of the trial
Company: Emergent BioSolutions (USA - MD)
Product: BioThrax® (Anthrax Vaccine Adsorbed)
Action mechanism:
Disease: prevention of anthrax disease
Therapeutic area: Infectious diseases
Country: USA
Trial details:
Latest
news: * On February 13, 2015, Emergent BioSolutions 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. BioThrax is the only FDA-licensed vaccine for the prevention of anthrax disease. Data from this study will be used to support a supplemental Biologics License Application (sBLA) to the FDA for licensure of Building 55. Emergent BioSolutions anticipates approval in either late 2015 or early 2016. * On September 23, 2014, Emergent BioSolutions 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 FDA for the prevention of anthrax disease. 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.
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.
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. Emergent BioSolutions is 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.
