Chimerix Receives FDA Clearance for Rolling Submission of New Drug Application for Brincidofovir as a Medical Countermeasure ...
April 28 2020 - 4:30PM
Chimerix (NASDAQ:CMRX), a biopharmaceutical company focused on
accelerating the development of medicines to treat cancer and other
serious diseases, today announced that the Company has received
clearance from the U.S. Food and Drug Administration (FDA) for a
rolling submission of its New Drug Application (NDA) for the
approval of brincidofovir (BCV) as a medical countermeasure for
smallpox. The Company intends to begin the rolling NDA
submission for BCV in May 2020 with completion targeted for
mid-2020. Chimerix is developing 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 USG Contract No
HHSO10201100013C.
“The value of being prepared for viral outbreaks has never been
clearer. The potential for engineered or naturally occurring
resistance to the currently approved therapy has made the
development of BCV imperative,” stated Mike Sherman, Chief
Executive Officer of Chimerix. “The clearance to begin the rolling
submission of the NDA for BCV is an important milestone for both
the company and BARDA as it brings us one step closer to realizing
the mandate of Project Bioshield. Our NDA preparation is already in
process and we look forward to working with BARDA on a potential
procurement contract in advance of FDA approval.”
In a lethal model, BCV when administered at varying times
post-infection demonstrated a statistically significant survival
advantage relative to placebo. This observation was consistent
throughout all time points.
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).
Dociparstat sodium is a potential first-in-class
glycosaminoglycan compound derived from porcine heparin that has
low anticoagulant activity but retains the ability to inhibit
activities of several key proteins implicated in the viability of
AML blasts and leukemic stem cells in the bone marrow during
chemotherapy (e.g., CXCL12, selectins, HMGB1, elastase). Randomized
Phase 2 data suggest that DSTAT may also accelerate platelet
recovery post-chemotherapy via inhibition of platelet factor 4, a
negative regulator of platelet production that impairs platelet
recovery following chemotherapy. BCV is an antiviral drug candidate
in development as a medical countermeasure for smallpox. 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 submit and/or obtain regulatory approvals for
BCV; and Chimerix’s ability to enter into a procurement contract
for BCV as a medical countermeasure. 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 may not
receive a procurement contract for BCV for 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 LaSpaluto
919 972-7115 ir@chimerix.com
Will O’Connor Stern Investor Relations will@sternir.com
212-362-1200
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