Emergent BioSolutions Inc. (NYSE: EBS) today announced that the
Biomedical Advanced Research and Development Authority (BARDA)
within the Administration for Strategic Preparedness and Response
at the United States Department of Health and Human Services has
awarded a $75 million option to Emergent’s existing contract
(HHSO100201600030C) for the acquisition of newly licensed anthrax
vaccine CYFENDUS™ (Anthrax Vaccine Adsorbed, Adjuvanted).
Deliveries are expected to begin this calendar year and be complete
by the end of the first quarter of 2024.
Previously known as AV7909, CYFENDUS™ vaccine was approved by
the U.S. Food & Drug Administration (FDA) in July 2023 as a
two-dose anthrax vaccine for post-exposure prophylaxis use in
individuals 18 years of age and older. Anthrax is considered a
high-priority national security threat and has the potential for
major public health impact.
“CYFENDUS™ vaccine is a critical component of Emergent’s anthrax
medical countermeasures franchise, and supports the U.S.
government's anthrax preparedness strategy,” said Paul Williams,
senior vice president, products head at Emergent. “This procurement
helps ensure the nation has sufficient anthrax vaccine and aligns
with Emergent’s longstanding commitment to strengthen public health
preparedness.”
In 2016, BARDA and Emergent extended their partnership to
support clinical development and manufacturing efforts for the
AV7909 vaccine, including a Phase 3 trial to demonstrate safety and
efficacy, working toward the goal of eventual FDA licensure. A
pre-Emergency Use Authorization (EUA) package was submitted in
December 2018, and the first pre-EUA doses of AV7909 were delivered
to the U.S. government in 2019. In April 2022, Emergent submitted
the Biologics License Application to the FDA for review, leading to
approval and licensure in July 2023. This latest contract option
supplements previous contract procurements and supports the U.S.
biodefense preparedness efforts.
This project has been supported in whole or in part with federal
funds from the Department of Health and Human Services;
Administration for Strategic Preparedness and Response; Biomedical
Advanced Research and Development Authority under contract
HHSO100201600030C.
About CYFENDUS™ (Anthrax Vaccine Adsorbed,
Adjuvanted)
Indication
CYFENDUS™ (Anthrax Vaccine Absorbed, Adjuvanted) is a vaccine
indicated for post-exposure prophylaxis of anthrax disease
following suspected or confirmed exposure to Bacillus anthracis in
persons 18 through 65 years of age when given with recommended
antibacterial drugs.
The efficacy of CYFENDUS™ vaccine for post-exposure prophylaxis
(PEP) is based solely on studies in animal models of inhalational
anthrax.
Important Safety Information
Contraindication: Do not take CYFENDUS™ vaccine
if you are allergic to CYFENDUS™ vaccine, BioThrax® (Anthrax
Vaccine Adsorbed) or any ingredient of the vaccine.
Allergic reactions: Appropriate medical
treatment and supervision must be available after receiving
CYFENDUS™ vaccine to manage possible serious allergic reactions.
Get medical help right away if you have any symptoms of a serious
allergic reaction.
Altered Immunocompetence: Immunocompromised
persons, including individuals receiving immunosuppressive therapy,
may have a diminished immune response to CYFENDUS™ vaccine.
Pregnancy: CYFENDUS™ vaccine can cause fetal
harm when administered to a pregnant individual. Before getting
CYFENDUS™ vaccine, tell your healthcare provider if you may be
pregnant, plan to get pregnant soon, or are nursing a baby.
Adverse reactions: The most common adverse
reactions reported were tenderness, pain, warmth, itching,
swelling, redness, bruising, arm motion limitations, muscle aches,
tiredness, headache, and fever.
U.S. Prescribing InformationThe full
Prescribing Information for CYFENDUS™ vaccine can be found
here.
About Emergent BioSolutions At
Emergent, our mission is to protect and enhance life. For 25 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. All statements,
other than statements of historical fact, including statements
regarding the development, availability, and government procurement
of CYFENDUS™ vaccine and the continued development of Emergent’s
anthrax franchise, are forward-looking statements. We generally
identify forward-looking statements by using words like
“anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,”
“forecast,” “goal,” “intend,” “may,” “plan,” “should,” “will,”
“would,” and similar expressions or variations thereof, or the
negative thereof, but these terms are not the exclusive means of
identifying such statements. Forward-looking statements are based
on our current intentions, beliefs, and expectations regarding
future events based on information that is currently available. We
cannot guarantee that any forward-looking statement will be
accurate. Readers should realize that if underlying assumptions
prove inaccurate or if known or unknown risks or uncertainties
materialize, actual results could differ materially from our
expectations. Readers 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. Readers should consider this cautionary statement,
as well as the risk factors identified in our periodic reports
filed with the U.S. Securities and Exchange Commission, when
evaluating our forward-looking statements.
Investor Contact:Richard S. LindahlExecutive
Vice President, CFOlindahlr@ebsi.com
Media Contact:Assal HellmerVice President,
Communicationsmediarelations@ebsi.com
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