News | September 2, 2014
Chimerix and BARDA Announce Continued Partnership in the Development of Brincidofovir for Smallpox
$17.0 Million Awarded in Latest Contract Extension
DURHAM, N.C., Sept. 2, 2014 (GLOBE NEWSWIRE) — Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals, today announced an award of $17.0 million through the extension of its contract with the Biomedical Advanced Research and Development Authority (BARDA) for the development of its broad spectrum antiviral brincidofovir (BCV, CMX001) as a medical countermeasure to treat smallpox. Chimerix received the initial award in February 2011 which supported early research and development of brincidofovir in animal models of smallpox (Contract Number HHSO100201100013C). This contract extension provides an additional $17.0 million to Chimerix for a period of 15 months, and will support Phase 3 trials expected to initiate in the second half of 2014.
M. Michelle Berrey, MD, MPH, President, CEO and CMO of Chimerix, said, “We are pleased to announce the continued development of brincidofovir with our partners at BARDA. If positive, data from these animal studies will support Chimerix’s regulatory submission for brincidofovir for the treatment of smallpox, which could potentially allow brincidofovir to become the first medicine approved in this area of high unmet need. This work complements the ongoing brincidofovir clinical programs for prevention of CMV infection in transplant recipients in the SUPPRESS trial and for the treatment of life-threatening adenovirus infection through the AdVise trial, both of which also represent areas where new antiviral therapies are needed.”
Chimerix’s brincidofovir (BCV, CMX001) is an oral antiviral with demonstrated in vitro and in vivo activity against all five families of DNA viruses including orthopoxviruses, the family of viruses which includes smallpox. Brincidofovir has demonstrated efficacy in animal models of orthopox virus disease, which was a requirement for approval of the current contract extension. Brincidofovir has received fast track designation for smallpox, CMV, and adenovirus infections.
This contract extension with BARDA supports research and development of brincidofovir as a treatment for smallpox infections, but does not include a purchase option for the Strategic National Stockpile.
Chimerix is a biopharmaceutical company dedicated to discovering, developing and commercializing novel, oral antivirals in areas of high unmet medical need. Chimerix’s proprietary technology has given rise to brincidofovir (BCV, CMX001), a clinical-stage nucleotide analog lipid-conjugate, which has demonstrated potent antiviral activity and safety in convenient, orally administered dosing regimens. Chimerix is currently enrolling SUPPRESS, the Phase 3 study of brincidofovir for the prevention of cytomegalovirus (CMV) in hematopoietic cell transplant recipients. In addition, Chimerix is enrolling the pilot portion of the Phase 3 AdVise study of brincidofovir for treatment of adenovirus infection. Chimerix is also working with BARDA to develop brincidofovir as a medical countermeasure against smallpox. 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.
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Chimerix’s filings with the Securities and Exchange Commission, including without limitation its most recent Quarterly Report on Form 10-Q, its most recently filed Current Reports on Form 8-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Chimerix undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Joseph T. Schepers
Executive Director, Investor Relations and Corporate Communications