Chimerix Announces FDA Acceptance of New Drug Application for Brincidofovir as a Medical Countermeasure for Smallpox
December 07 2020 - 7:00AM
Chimerix (NASDAQ:CMRX), a biopharmaceutical company focused on
accelerating the development of medicines to treat cancer and other
serious diseases, today announced that the U.S. Food and Drug
Administration (FDA) has accepted the filing of a New Drug
Application (NDA) for brincidofovir (BCV) as a medical
countermeasure for smallpox. The FDA granted Priority Review and
set an action date of April 7, 2021 under the Prescription Drug
User Fee Act (PDUFA).
Brincidofovir, an investigational therapy, is a nucleotide
analog lipid-conjugate that has demonstrated antiviral activity as
a medical countermeasure against smallpox under the FDA’s Animal
Efficacy Rule, which allows for testing of investigational drugs in
animal models to support effectiveness in diseases which are not
ethical or feasible to study in humans.
Chimerix has developed BCV as a potential medical
countermeasure for smallpox under an ongoing collaboration and
funding provided by the Biomedical Advanced Research and
Development Authority (BARDA), part of the office of the Assistant
Secretary for Preparedness and Response within the U.S. Department
of Health and Human Services, under ongoing contract number
HHSO100201100013C.
The FDA's acceptance of the NDA indicates the application is
sufficiently complete to permit a substantive review. A Priority
Review designation accelerates the FDA's review time from 10 months
to a goal of six months and is granted to drugs that may offer a
significant improvement in the safety or effectiveness of the
treatment, prevention or diagnosis of a serious condition. At this
time, the FDA is not planning to hold an advisory committee meeting
to discuss this application.
“Our team has continued to execute extremely well in
collaboration with BARDA to advance this program,” said Mike
Sherman, Chief Executive Officer of Chimerix. “As we’ve observed in
recent months, the threat of serious viral infections requires
robust pandemic plans to protect the population and our economy.
With BCV, we hope to provide that protection from smallpox, and
look forward to working with BARDA on next steps in making this
countermeasure available to patients in advance of an
outbreak.”
About Chimerix
Chimerix is a development-stage biopharmaceutical company
dedicated to accelerating the advancement of innovative medicines
that make a meaningful impact in the lives of patients living with
cancer and other serious diseases. Its two clinical-stage
development programs are dociparstat sodium (DSTAT) and
brincidofovir (BCV).
DSTAT is a potential first-in-class glycosaminoglycan compound
derived from porcine heparin that, compared to commercially
available forms of heparin, may be dosed at higher levels without
associated bleeding-related complications. DSTAT is being studied
in a Phase 2/3 trial to assess safety and efficacy in adults with
acute lung injury with underlying COVID-19. A Phase 3 trial
protocol to study DSTAT in acute myeloid leukemia has been
developed in alignment with the US Food and Drug Administration
(FDA) and the first patient visit is expected in early 2021. BCV is
an antiviral drug candidate developed as a potential medical
countermeasure for smallpox and is currently under review for
regulatory approval in the United States. For further information,
please visit the Chimerix website, www.chimerix.com.
Forward Looking Statements
This 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,
Chimerix’s ability to obtain regulatory approval for BCV; and the
timing and receipt of a potential procurement contract for BCV in
smallpox. Among the factors and risks that could cause actual
results to differ materially from those indicated in the
forward-looking statements are risks that BCV may not obtain
regulatory approval from the FDA or such approval may be delayed or
conditioned; risks that Chimerix will not obtain a procurement
contract for BCV in smallpox in a timely manner or at all;
Chimerix’s reliance on a sole source third-party manufacturer for
drug supply; risks that ongoing or future trials may not be
successful or replicate previous trial results, or may not be
predictive of real-world results or of results in subsequent
trials; risks and uncertainties relating to competitive products
and technological changes that may limit demand for our drugs;
risks that our drugs may be precluded from commercialization by the
proprietary rights of third parties; 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
Media:David SchullRusso
Partners858-717-2310David.Schull@russopartnersllc.com
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