Emergent BioSolutions Announces the Execution of Contract Options Valued at $67.4 Million to Procure Additional TEMBEXA® (brincidofovir) to Support National Preparedness Efforts
26 Settembre 2024 - 2:05PM
Emergent BioSolutions Inc. (NYSE: EBS) (“Emergent”) today
announced that two contract options have been secured to procure
additional treatment courses of TEMBEXA® (brincidofovir) to sustain
the U.S. government’s national preparedness posture against human
smallpox. TEMBEXA® is indicated for the treatment of human smallpox
disease in adult and pediatric patients, including neonates. The
order is valued at $67.4 million and executes procurement options
CLIN0004A and CLIN0005A under Emergent’s existing 10-year contract.
“This announcement highlights the strength of the longstanding
partnership between Emergent and the U.S. government to meet the
country’s preparedness needs,” said Paul Williams, senior vice
president, products business, Emergent. We look forward to
continuing to deliver TEMBEXA® to support smallpox
preparedness.”
The existing contract includes optional procurement CLINs that
can be exercised throughout the 10-year contract period of
performance with a maximum potential value of $568 million. The
exercise of CLIN0004A and CLIN0005A commits funding through 2027
and will help ensure continued supply of TEMBEXA® to address the
threat of smallpox.
This project has been funded 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 (BARDA) under contract
number 75A50122C00047.
About TEMBEXA®TEMBEXA® is an oral antiviral
approved by the FDA in June 2021 for the treatment of human
smallpox disease caused by variola virus in adult and pediatric
patients, including neonates. TEMBEXA® is formulated as 100 mg
tablets and 10 mg/mL oral suspension dosed once weekly for two
weeks. The oral suspension formulation is particularly important
for patients who have difficulty swallowing due to age or medical
status.
Important Information about TEMBEXA®
(brincidofovir)TEMBEXA® is an orthopoxvirus
nucleotide analog DNA polymerase inhibitor and is indicated for the
treatment of human smallpox disease in adult and pediatric
patients, including neonates.
Limitations of Use: TEMBEXA® is not indicated for the treatment
of diseases other than human smallpox disease. The effectiveness of
TEMBEXA® for the treatment of smallpox disease has not been
determined in humans because adequate and well-controlled field
trials have not been feasible and inducing smallpox disease in
humans to study the drug’s efficacy is not ethical. TEMBEXA®
efficacy may be reduced in immunocompromised patients based on
studies in immune deficient animals.
TEMBEXA® has a BOXED WARNING for increased risk for mortality
when used for longer duration. An increased incidence of mortality
was seen in TEMBEXA®-treated subjects compared to placebo-treated
subjects in a 24-week clinical trial when TEMBEXA® was evaluated in
another disease.
The Warnings and Precautions for TEMBEXA® include:
- Elevations in Hepatic Transaminases and Bilirubin: May cause
increases in serum transaminases (ALT or AST) and serum bilirubin.
Monitor liver laboratory parameters before and during
treatment.
- Diarrhea and Other Gastrointestinal Adverse Events: Diarrhea
and additional gastrointestinal adverse events including nausea,
vomiting, and abdominal pain may occur. Monitor patients, provide
supportive care, and if necessary, do not give the second and final
dose of TEMBEXA®.
- Coadministration with Related Products: TEMBEXA® should not be
coadministered with intravenous cidofovir.
- Embryo-fetal Toxicity: May cause fetal harm. Advise individuals
of childbearing potential of the potential risk to the fetus and to
use effective contraception.
- Carcinogenicity: TEMBEXA® should be considered a potential
human carcinogen. Do not crush or divide TEMBEXA® tablets.
- Male Infertility: Based on testicular toxicity in animal
studies, TEMBEXA® may irreversibly impair fertility in individuals
of reproductive potential.
Common adverse reactions (occurring in at least 2% of
TEMBEXA®-treated subjects) were diarrhea, nausea, vomiting, and
abdominal pain.
Please read full Prescribing Information for TEMBEXA® for
additional safety information here.
About SmallpoxSmallpox is a highly contagious
disease caused by the variola virus. Historically, smallpox was one
of the deadliest diseases in history with a case fatality rate of
approximately 30 percent. Despite successful eradication of
smallpox in the 1970s, there is considerable concern that variola
virus could reappear, either through accidental release or as a
weapon of bioterrorism. According to the U.S. Centers for Disease
Control and Prevention, variola virus is ranked in the highest risk
category for bioterrorism agents (Category A) due to its ease of
transmission, high mortality rate, and potential to cause public
panic and social disruption. Based on a recent report – The
Department of Health and Human Services Fiscal Year 2023 Public
Health and Social Services Emergency Fund Justification of
Estimates for Appropriations Committee – smallpox remains a threat
of high concern to both the domestic and international
community.
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 help protect public health, 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 exercise by BARDA of any optional future procurements
under the contract (75A50122C00047) to supply TEMBEXA® to the U.S.
government, 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 Emergent’s
current intentions, beliefs, and expectations regarding future
events. Emergent cannot guarantee that any forward-looking
statement will be accurate. Readers should realize that if
underlying assumptions prove inaccurate or unknown risks or
uncertainties materialize, actual results could differ materially
from Emergent’s 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, Emergent does 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 Emergent’s actual results to
differ materially from those indicated by any forward-looking
statements.
Readers should consider this cautionary statement, as well as
the risk factors identified in Emergent’s periodic reports filed
with the U.S. Securities and Exchange Commission when
evaluating Emergent’s 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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