Emergent BioSolutions Inc. (NYSE: EBS) today announced the exercise
of contract option and modification valued at approximately $20
million to supply BioThrax® (Anthrax Vaccine Adsorbed) to the U.S.
Department of Defense (DoD). The first delivery, which was valued
at approximately $7 million began in December 2024, and remaining
deliveries are expected in 2025.
“We’re pleased to continue our work with the U.S. Department of
Defense to supply BioThrax® to protect our nation’s service members
who have a high risk of exposure to anthrax,” said Paul Williams,
senior vice president, products head at Emergent. “This procurement
ensures a continued supply of this important medical countermeasure
to the U.S. military and demonstrates our commitment to delivering
solutions that address our customers’ needs to prepare for public
health threats.”
This option is under Emergent’s existing indefinite-delivery,
indefinite-quantity (IDIQ) procurement contract (W911SR24D0001)
with the DoD and led by the Joint Program Executive Office for
Chemical, Biological, Radiological and Nuclear Defense to supply
BioThrax® for use by all branches of the U.S. military as
pre-exposure prophylaxis (PrEP) for anthrax
disease.
On December 16, 2024, Emergent announced a $50 million contract
option from the Biomedical Advanced Research and Development
Authority (BARDA) to procure doses of CYFENDUS® (Anthrax Vaccine
Adsorbed, Adjuvanted). In addition to BioThrax® and CYFENDUS®,
Emergent’s anthrax franchise includes two treatments, Anthrasil®
[Anthrax Immune Globulin Intravenous (Human)], a polyclonal
antibody therapeutic, and raxibacumab, a monoclonal antibody
therapeutic.
About BioThrax® (Anthrax Vaccine Adsorbed)
Indication
BioThrax® (Anthrax Vaccine Adsorbed) is a vaccine indicated for
the active immunization for the prevention of disease caused by
Bacillus anthracis in persons 18 through 65 years of age.
BioThrax® is approved for: (1) Pre-exposure prophylaxis of
disease in persons at high risk of exposure. (2) Post-exposure
prophylaxis of disease following suspected or confirmed Bacillus
anthracis exposure, when administered in conjunction with
recommended antibacterial drugs.
The efficacy of BioThrax® for post-exposure prophylaxis is based
solely on studies in animal models of inhalational anthrax.
Important Safety Information
Contraindications: Severe allergic reaction
(e.g., anaphylaxis) after a previous dose of BioThrax® or a
component of the vaccine.
Latex: The stopper of the vial contains natural
rubber latex and may cause allergic reactions in latex sensitive
individuals.
Pregnancy: Avoid use in pregnancy unless the
potential benefit outweighs the potential risk to the fetus.
History of Anthrax Disease: History of anthrax
disease may increase the potential for severe local adverse
reactions.
Altered Immunocompetence: If BioThrax® is
administered to immunocompromised persons, including those
receiving immunosuppressive therapy, the immune response may be
diminished.
Limitations of Vaccine Effectiveness:
Vaccination with BioThrax® may not protect all individuals.
Adverse reactions: The most common (>10%)
local (injection-site) adverse reactions observed in clinical
studies were tenderness, pain, erythema, edema, and arm motion
limitation. The most common (≥5%) systemic adverse reactions were
muscle aches, fatigue, and headache.
U.S. Prescribing InformationThe full
Prescribing Information for BioThrax® vaccine can be found
here.
About Emergent BioSolutionsAt 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, X, Instagram, Apple Podcasts and
Spotify.
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, supply and government
procurement of BioThrax® 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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