Chimerix Announces Closing of TEMBEXA Sale to Emergent BioSolutions
27 September 2022 - 6:05AM
Chimerix, Inc. (NASDAQ:CMRX), a biopharmaceutical company
whose mission is to develop medicines that meaningfully improve and
extend the lives of patients facing deadly diseases, today
announced the closing of its sale of TEMBEXA® to Emergent
BioSolutions Inc. (EBS or Emergent).
“The closing of our sale of TEMBEXA to Emergent allows Chimerix
to accelerate the value of this product while still participating
in its longer-term potential. As we look ahead, our balance sheet
is enhanced significantly to support the ongoing development of our
oncology franchise. This includes ONC201 which has demonstrated
durable responses and an attractive safety profile in a genetically
defined population of patients with H3 K27M mutant high-grade
glioma. This would represent the first approved therapy
specifically targeting patients with this invariably lethal
disease,” said Mike Sherman, Chief Executive Officer of
Chimerix.
EBS paid Chimerix $238 million at closing. The closing amount
was subject to the terms of the agreement executed between
Biomedical Advanced Research and Development Authority (BARDA) and
Chimerix for the procurement of TEMBEXA. Additional future
economics from the transaction include:
- 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.
Development and procurement of TEMBEXA have been supported in
part with federal funds from BARDA, in the Administration for
Strategic Preparedness and Response in the Department of Health and
Human Services under Contracts HHSO100201100013C and
75A50122C00047.
About TEMBEXA
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.
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.
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.
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 and potential future payments in connection with
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 initial delivery or
any subsequent deliveries of TEMBEXA will not occur as planned, or
at all; risks that future payments in connection with the
transaction will not be made; risks related to the timing and
completion of the Phase 3 Study of ONC201, 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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