Emergent BioSolutions Awarded BARDA Contract for Advanced Development and Delivery of NuThrax, a Next Generation Anthrax Vacc...
September 30 2016 - 9:04AM
Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has
signed a multi-year contract with the Biomedical Advanced Research
and Development Authority (BARDA), which is a division of the U.S.
Department of Health and Human Services’ Office of the Assistant
Secretary for Preparedness and Response, for the advanced
development and delivery of NuThraxTM (anthrax vaccine adsorbed
with CPG 7909 adjuvant), also known as AV7909, the company’s next
generation anthrax vaccine candidate. The contract, valued at up to
approximately $1.6 billion, consists of 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 (SNS) an initial two million doses
following Emergency Use Authorization (EUA) pre-approval by the
U.S. Food and Drug Administration (FDA). The company anticipates
that FDA could authorize NuThrax for emergency use as early as
2018, triggering deliveries of NuThrax to the SNS in 2019. The
contract also includes procurement options for the delivery of an
additional 7.5 million to 50 million doses of NuThrax to the SNS,
valued from approximately $255 million to up to $1.4 billion,
respectively, and options for an additional clinical study and
post-marketing commitments valued at $48 million, which if both
were to be exercised in full, would increase the total contract
value to up to $1.6 billion.
“Emergent is pleased that BARDA has selected
NuThrax to address the U.S. government’s desire for a next
generation anthrax vaccine with an enhanced product profile that
includes requiring fewer doses and eliciting a faster immune
response,” said Daniel J. Abdun-Nabi, president and chief executive
officer of Emergent BioSolutions. “We look forward to collaborating
with BARDA to further develop NuThrax towards an EUA-eligible
product for the SNS and subsequently towards FDA licensure.”
Under the terms of the contract, activities to be
completed under the base period of performance include
licensure-enabling non-clinical and clinical studies, the
manufacture and delivery of initial doses to the SNS, and
submission of a Biologics License Application to the FDA with an
expected FDA-licensure under the Animal Rule.
NuThrax is comprised of BioThrax® (Anthrax Vaccine
Adsorbed) in combination with the immunostimulatory
oligodeoxynucleotide compound CPG 7909. Its safety, efficacy, and
stability have been established through several Phase 1 and Phase 2
clinical studies.
Since 2008, Emergent has received five grants and
contracts funded by BARDA and the National Institute of Allergy and
Infectious Diseases totaling approximately $127 million for the
early stage and advanced development of NuThrax, including
development of a dry formulation for the vaccine candidate.
This 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 is a global specialty
biopharmaceutical company dedicated to one simple mission—to
protect and enhance life. We develop, manufacture, and deliver
a portfolio of medical countermeasures for biological and chemical
threats as well as emerging infectious diseases. Through our work,
we envision protecting and enhancing 50 million lives with our
products by 2025. Additional information about the company may
be found at www.emergentbiosolutions.com. Follow us
@emergentbiosolu.
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 total potential realizable value of the
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. Burrows
Vice President, Investor Relations
240-631-3280
BurrowsR@ebsi.com
Media Contact:
Tracey Schmitt Lintott
Senior Vice President, Global Public Affairs
240-631-3281
SchmittT@ebsi.com
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