Emergent BioSolutions Completes Acquisition of Exclusive Worldwide Rights to TEMBEXA® (brincidofovir), the First FDA-Approved Smallpox Oral Antiviral for All Ages
September 26 2022 - 4:12PM
Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has
completed its acquisition of exclusive worldwide rights to TEMBEXA®
(brincidofovir), the first oral antiviral approved by the U.S. Food
and Drug Administration (FDA) for all age groups for the treatment
of smallpox, from Chimerix. TEMBEXA was approved in June 2021 and
is indicated for the treatment of human smallpox disease in adult
and pediatric patients, including neonates.
The completion of the acquisition follows the satisfaction or
waiver by the parties, as applicable, of all closing conditions,
including expiration of the waiting period under the
Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act), as
amended, and receipt of consent from the Biomedical Advanced
Research and Development Authority (BARDA), part of the
Administration for Strategic Preparedness and Response within the
U.S. Department of Health and Human Services, for a sub-contract
agreement between Chimerix and Emergent.
“The addition of TEMBEXA to our smallpox medical countermeasure
franchise, which consists of our smallpox vaccine and therapeutic
for smallpox vaccine complications, creates a more comprehensive
offering to combat this deadly public health threat,” said Paul
Williams, SVP government/MCM business at Emergent. “We look forward
to supporting the U.S. government’s smallpox preparedness strategy
on a broader scale by executing on this BARDA contract.”
The 10-year contract (75A50122C00047), valued at up to $680
million, to supply up to 1.7 million treatment courses of tablet
and suspension formulations of TEMBEXA® to the U.S. government, was
awarded to Chimerix on August 29, 2022. The contract includes an
initial product procurement valued at approximately $115 million,
with optional future procurement, valued at up to approximately
$551 million, exercisable at the sole discretion of BARDA. In
addition to product procurement, the contract includes reimbursed
post marketing activities of approximately $12 million.
Financial TermsBased on the terms of the final
BARDA agreement, Emergent is expected to pay Chimerix:
- An upfront payment of $238 million;
- Potential milestone payments of up to $124 million contingent
on the potential exercise by the U.S. government of procurement
options following the base period;
- 15% royalty on gross profit from sales of TEMBEXA outside the
U.S.;
- 20% royalty on gross profit from sales of TEMBEXA in the U.S.
that are in excess of the 1.7 million treatment courses as
contemplated in the existing BARDA contract; and
- Up to an additional $12.5 million upon achievement of certain
development-based milestones.
ABOUT TEMBEXATEMBEXA 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. 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. Please read full prescribing 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%. 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 (CDC), 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 over 20 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 Statement This 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 timing of product deliveries; the potential benefits
of the acquisition to Emergent; the amount of contingent payments
potentially payable by Emergent to Chimerix; the exercise by BARDA
of any optional future procurements under the contract
(75A50122C00047) to supply up to 1.7 million treatment courses of
tablet and suspension formulations of TEMBEXA to the U.S.
government (the BARDA Contract); Chimerix’s compliance with the
terms of the BARDA Contract and the associated sub-contract with
Emergent and whether the BARDA Contract remains in effect for its
full term; the effectiveness and/or safety of TEMBEXA; Emergent’s
ability to successfully integrate TEMBEXA into its product
portfolio and manufacture, further develop, obtain additional
regulatory approvals for and commercialize TEMBEXA 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 Emergent’s current intentions, beliefs and
expectations regarding future events, and involve known and unknown
risks, uncertainties and other factors, which may cause Emergent’s
actual results, performance and achievements and the timing of
certain events to differ materially from the results, performance,
achievements or timings discussed, projected, anticipated or
indicated in any forward-looking statements. Emergent cannot
guarantee that any forward-looking statement will be accurate. The
reader is, 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. The
reader should consider this cautionary statement, as well as the
risk factors identified in Emergent’s periodic reports filed with
the SEC, when evaluating the forward-looking statements contained
herein.
Investor ContactRobert BurrowsVice
President, Investor Relationsburrowsr@ebsi.com(240) 413-1917
Media ContactMatt HartwigSenior
Director, Media Relationsmediarelations@ebsi.com
Emergent Biosolutions (NYSE:EBS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Emergent Biosolutions (NYSE:EBS)
Historical Stock Chart
From Apr 2023 to Apr 2024