Emergent BioSolutions Announces FDA Acceptance of Biologics License Application for AV7909 Anthrax Vaccine Candidate
June 24 2022 - 6:30AM
Emergent BioSolutions Inc. (NYSE:EBS) announced today that the U.S.
Food and Drug Administration (FDA) accepted for review the
Biologics License Application (BLA) for AV7909 (Anthrax Vaccine
Adsorbed, Adjuvanted). AV7909 is the company’s new anthrax vaccine
candidate evaluated for post-exposure prophylaxis of disease
following suspected or confirmed exposure to Bacillus anthracis in
persons 18 through 65 years of age when administered in conjunction
with recommended antibacterial drugs. The Prescription Drug User
Fee Act goal date for a decision by the FDA is in April 2023.
“Over the last 20 years, Emergent has partnered with the U.S.
government to lead this program from early- to advanced-stage
development,” said Kelly Warfield, senior vice president research
and development at Emergent BioSolutions. “As we progress toward
licensure of AV7909, which is designed to follow a two-dose
immunization schedule and to elicit a faster immune response, we
redouble our efforts to support the government’s overall
preparedness and response strategy for large-scale emergencies
involving anthrax and other threats to public health.”
The rolling BLA submission, completed in April 2022, is based on
data from the pivotal phase 3 clinical study of AV7909 that
evaluated the lot consistency, immunogenicity, and safety of the
vaccine candidate following a two-dose schedule administered
intramuscularly in healthy adults. It also included data from the
phase 2 study that evaluated non-interference between AV7909 and
antibacterial drugs approved for post-exposure prophylaxis of
anthrax disease.
The BLA submission was completed under contract
HHSO100201600030C for the advanced development and delivery of
AV7909, funded by the Biomedical Advanced Research and Development
Authority (BARDA), within the Office of the Assistant Secretary for
Preparedness and Response in the U.S. Department of Health and
Human Services.
About Emergent BioSolutionsAt Emergent, our
mission is to protect and enhance life. For over 20 years, we’ve
been at work defending people from things we hope will never
happen—so we are prepared, just in case they ever do. We provide
solutions for complex and urgent public health threats through a
portfolio of vaccines and therapeutics that we develop and
manufacture for governments and consumers. We also offer a range of
integrated contract development and manufacturing services for
pharmaceutical and biotechnology customers. To learn more about how
we plan to protect or enhance 1 billion lives by 2030, visit our
website and follow us on LinkedIn, Twitter, and Instagram.
Safe Harbor StatementThis press release
includes forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Any statements,
other than statements of historical fact, including statements
regarding the potential dosing schedule and immune response of
AV7909, the total potential realizable value of the BARDA
development and procurement contract, the anticipated timing for a
decision by the FDA, our strategy, future operations, prospects,
plans and objectives with respect to AV7909, and any other
statements containing the words “believes,” “expects,”
“anticipates,” “intends,” “plans,” “estimates” and similar
expressions, are forward-looking statements. These forward-looking
statements are based on our current intentions, beliefs and
expectations regarding future events. We cannot guarantee that any
forward-looking statement will be accurate. Investors should
realize that if underlying assumptions prove inaccurate or unknown
risks or uncertainties materialize, actual results could differ
materially from our expectations. Investors are, therefore,
cautioned not to place undue reliance on any forward-looking
statement. Any forward-looking statement speaks only as of the date
of this press release, and, except as required by law, we do not
undertake to update any forward-looking statement to reflect new
information, events or circumstances.
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 AV7909 under the contract; our
ability to secure licensure of AV7909 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.
Investor Contact:Robert G.
BurrowsVice President, Investor
Relations240-631-3280burrowsr@ebsi.com
Media Contact:Matt HartwigSenior
Director, Media Relationsmediarelations@ebsi.com
Emergent Biosolutions (NYSE:EBS)
Historical Stock Chart
From Aug 2024 to Sep 2024
Emergent Biosolutions (NYSE:EBS)
Historical Stock Chart
From Sep 2023 to Sep 2024