DURHAM, N.C., Sept. 14, 2015 (GLOBE NEWSWIRE) -- Chimerix, Inc. (NASDAQ:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced an extension of its contract with the Biomedical Advanced Research and Development Authority (BARDA) for the development of the broad spectrum antiviral, brincidofovir, as a medical countermeasure to treat smallpox.
This latest contract extension provides an additional $13.0 million to Chimerix for a period of 15 months. The company received an initial award from BARDA in February 2011 to support early research and development of brincidofovir in animal models of smallpox (Contract Number HHSO100201100013C) and received a contract extension of $17.0 million in September 2014.
M. Michelle Berrey, MD, MPH, President and CEO of Chimerix, said, "Our partnership with BARDA has resulted in significant progress for brincidofovir as a medical countermeasure for smallpox in the event of a bioterror attack or accidental release. This award will continue to support our brincidofovir smallpox development program for which we recently reported positive topline results showing a statistically significant survival benefit. This is an important step toward a potential FDA approval as the first antiviral treatment for smallpox."
Smallpox is estimated to have killed more than one billion people worldwide prior to its eradication declared by the World Health Organization in 1980 following a global vaccination campaign. Smallpox stocks remain for research purposes in the United States and Russia; however, undeclared stocks are suspected to exist. Routine smallpox vaccination programs were discontinued after the global eradication, and with no antiviral agent approved for the treatment of smallpox, the U.S. population may be susceptible to a bioterror attack with devastating consequences.
About Brincidofovir (CMX001)
Chimerix's lead product candidate, brincidofovir, is an oral nucleotide analog that has shown in vitro antiviral activity against all five families of DNA viruses that affect humans, including the herpesviruses and adenovirus. Brincidofovir has not been associated with kidney or bone marrow toxicity in over 1,000 patients treated to date. Based on the clinically and statistically significant Phase 2 results in CMV prevention, Chimerix initiated the 450 patient Phase 3 SUPPRESS trial, which completed enrollment in June 2015. If positive, data from SUPPRESS will support Chimerix's initial regulatory submission for brincidofovir for the prevention of CMV infection in adult HCT recipients. Chimerix has also completed enrollment in AdVise, the open-label trial of brincidofovir for the treatment of disseminated or localized adenovirus infection in patients at increased risk of rapid progression to disseminated disease. AdVise completed enrollment in August 2015. Chimerix intends to initiate enrollment in two Phase 3 trials in recipients of kidney transplants, a population that continues to have unmet medical need in prevention of CMV and BKV, among other dsDNA viral infections. Chimerix is working with BARDA to develop brincidofovir as a medical countermeasure against smallpox. Brincidofovir has received Fast Track designation from the FDA for CMV, adenovirus, and smallpox.
Chimerix is a biopharmaceutical company dedicated to discovering, developing and commercializing novel, oral antivirals in areas of high unmet medical need. Chimerix's proprietary lipid conjugate technology has produced brincidofovir (CMX001), a clinical-stage nucleotide analog, CMX157 which was licensed to ContraVir Pharmaceuticals in 2014, and early clinical candidates including CMX669. For further information, please visit Chimerix's website, www.chimerix.com.
The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies.
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility that the FDA and other regulatory authorities may not approve brincidofovir or brincidofovir-based regimens in the currently anticipated timelines or at all, and marketing approvals, if granted, may have significant limitations on their use. As a result, brincidofovir may never be successfully commercialized In addition, Chimerix may be unable to file for regulatory approval for brincidofovir with other regulatory authorities in the currently anticipated timelines. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Chimerix's Quarterly Report on Form 10-Q for the quarter ended June 30, 2015, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Chimerix, and Chimerix assumes no obligation to update any such forward-looking statements.
CONTACT: Joseph T. Schepers Executive Director, Investor Relations and Corporate Communications email@example.com 919-287-4125Source:Chimerix, Inc.