Chimerix Awarded BARDA Contract for TEMBEXA as Medical Countermeasure for Smallpox
August 29 2022 - 10:45AM
Chimerix (NASDAQ:CMRX), a biopharmaceutical company whose
mission it is to develop medicines that meaningfully improve and
extend the lives of patients facing deadly diseases, today
announced that is has signed a multi-year contract with the
Biomedical Advanced Research and Development Authority (BARDA) in
the U.S. Department of Health and Human Services’ Administration
for Strategic Preparedness and Response (ASPR), for the delivery of
up to 1.7 million treatment courses of tablet and suspension
formulations of TEMBEXA® to the U.S. government. The contract
75A50122C00047, includes an initial product procurement of 319,000
treatment courses for approximately $115 million. The 10-year
contract, which contains options for future procurements, is valued
at approximately $551 million in total if BARDA elects to exercise
all options. In addition to product procurement, the contract
supports post-marketing activities of approximately $13 million,
for a total potential contract value of up to $680 million.
“Our collaboration with BARDA for the development of TEMBEXA has
provided the United States government with a second therapeutic
option to ensure the federal government’s readiness for a potential
smallpox emergency. TEMBEXA’s simple two dose oral regimen is the
first approved smallpox treatment for all ages, including infants,”
said Mike Sherman, Chief Executive Officer of Chimerix. “TEMBEXA
also may provide protection for patients should a strain of variola
virus emerge that is resistant to other antivirals.”
In May, Chimerix entered into an agreement with Emergent
BioSolutions, Inc. (EBS) for the sale of worldwide rights to
TEMBEXA for $225 million upfront and potential additional
milestones of up to $100 million (the Transaction was subject
to adjustment upon finalization of a procurement agreement for
TEMBEXA with BARDA). Based on the terms of the final BARDA
agreement, EBS is expected to pay Chimerix
- Upfront payment of $238 million upon the signing of the
pre-novation agreement;
- Potential milestone payments of up to $124 million (up to $31
million for each of the remaining BARDA procurement options due
within 30 days of exercise);
- 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 1.7 million treatment courses; and
- Up to an additional $12.5 million upon achievement of certain
developmental milestones.
Closing of the Transaction remains subject to BARDA’s approval
of a pre-novation agreement between Chimerix and EBS.
About Chimerix
Chimerix is a biopharmaceutical company with a mission to
develop medicines that meaningfully improve and extend the lives of
patients facing deadly diseases. The Company’s most advanced
clinical-stage development program, ONC201, is in development for
H3 K27M-mutant glioma.
About TEMBEXA
In June 2021, the U.S. Food and Drug Administration granted
approval of TEMBEXA for the treatment of smallpox as a medical
countermeasure. TEMBEXA is an oral antiviral formulated as
100 mg tablets and 10 mg/mL oral suspension dosed once
weekly for two weeks. TEMBEXA is indicated for the treatment of
human smallpox disease caused by variola virus in adult and
pediatric patients, including neonates. 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 (brincidofovir) is a nucleotide analog lipid-conjugate
designed to mimic a natural monoacyl phospholipid to achieve
effective intracellular concentrations of the active antiviral
metabolite, cidofovir diphosphate. Cidofovir diphosphate exerts its
orthopoxvirus antiviral effects by acting as an alternate substrate
inhibitor for viral DNA synthesis mediated by viral DNA
polymerase.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995 that are subject
to risks and uncertainties that could cause actual results to
differ materially from those projected. Forward-looking statements
include those relating to, among other things, procurements under
the BARDA contract, the consummation of the Transaction, and
potential future payments under the Transaction. Among the factors
and risks that could cause actual results to differ materially from
those indicated in the forward-looking statements are risks that
the Transaction will not be completed as planned, including as a
result of failing to satisfy the closing conditions to the
Transaction; risks that the initial delivery or any subsequent
deliveries of TEMBEXA will not occur as planned, or at all; risks
that future payments under the Transaction will not be made; and
additional risks set forth in the Company's filings with
the Securities and Exchange Commission. These forward-looking
statements represent the Company's judgment as of the date of this
release. The Company disclaims, however, any intent or obligation
to update these forward-looking statements.
CONTACT:Investor Relations:Michelle
LaSpaluto919 972-7115ir@chimerix.com
Will O’ConnorStern Investor
Relations212-362-1200will@sternir.com
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