Emergent BioSolutions Announces Submission to FDA of Application Covering Emergency Use Authorization for NuThrax™
29 December 2018 - 1:01AM
Emergent BioSolutions Inc. (NYSE:EBS) announced today the
submission of an application to the U.S. Food and Drug
Administration (FDA) for potential emergency use of NuThrax™
(anthrax vaccine adsorbed with CPG 7909 adjuvant) in the event of a
public health emergency involving Bacillus anthracis. NuThrax, also
known as AV7909, is being developed as a next generation anthrax
vaccine for post-exposure prophylaxis of disease resulting from
suspected or confirmed Bacillus anthracis exposure, in conjunction
with the recommended course of antimicrobial therapy. This
submission is anticipated to undergo review by FDA through the
first half of 2019.
“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 BioSolutionsEmergent
BioSolutions Inc. is a global life sciences company seeking to
protect and enhance life by focusing on providing specialty
products for civilian and military populations that address
accidental, intentional, and naturally occurring public health
threats. We aspire to be a Fortune 500 company recognized for
protecting and enhancing life, driving innovation, and living our
values. Additional information about the company may be found at
www.emergentbiosolutions.com. Find us on LinkedIn and follow us on
Twitter @emergentbiosolu and Instagram @life_at_emergent.
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
NuThrax, the total potential realizable value of the BARDA
development and procurement contract, the anticipated timing of EUA
eligibility, our strategy, future operations, prospects, plans and
objectives with respect to NuThrax, 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 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.
Investor Contact:Robert G.
BurrowsVice President, Investor
Relations240-631-3280burrowsr@ebsi.com
Media Contact:Lynn KiefferVice
President, Corporate
Communications240-631-3391KiefferL@ebsi.com
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