“We are pleased with engaging in early discussions with the FDA regarding this EUA package submission for NuThrax, which has been identified as a potential critical component of the nation’s anthrax preparedness strategy,” said Abbey Jenkins, senior vice president and vaccines and anti-infectives business unit head at Emergent BioSolutions. “NuThrax is designed to have attractive features, including the potential to have a shorter dosing schedule and to elicit a faster immune response, that may make it a more appropriate candidate for an effective response to a large-scale public health emergency involving anthrax. We look forward to NuThrax being an EUA-eligible product to enable deliveries to the Strategic National Stockpile in 2019.”
NuThrax is comprised of Anthrax Vaccine Adsorbed in combination with the immunostimulatory oligodeoxynucleotide compound CPG 7909. NuThrax was designed to have a two-dose schedule and may elicit a faster immune response than currently available anthrax vaccines. Several Phase 1 and Phase 2 clinical studies have investigated the safety, efficacy, and stability profile of NuThrax.
The FDA submission package was completed under the company’s 2016 contract with the Biomedical Advanced Research and Development Authority (BARDA) that includes a five-year base period of performance valued at approximately $200 million to develop NuThrax for post-exposure prophylaxis of anthrax disease and to deliver to the Strategic National Stockpile an initial three million doses following EUA pre-approval by FDA.
Contract HHSO100201600030C for the advanced development and delivery of NuThrax is funded by BARDA, a division within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.
About Emergent BioSolutions
Safe Harbor Statement
There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including appropriations for the development and procurement of NuThrax under the contract; our ability to secure EUA pre-authorization approval and licensure of NuThrax by FDA within the anticipated timeframe, if at all; BARDA’s decisions to exercise options under the contract; and our development and manufacturing capabilities and strategies. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the SEC, when evaluating our forward-looking statements.
<span>“We are pleased with engaging in early discussions with the FDA regarding this EUA package submission for NuThrax, which has been identified as a potential critical component of the nation’s anthrax preparedness strategy,” said Abbey Jenkins, senior vice president and vaccines and anti-infectives business unit head at Emergent BioSolutions....</span>