Chimerix and BARDA Continue Collaboration on Development of CMX001 as a Medical Countermeasure Against Smallpox
DURHAM, N.C., June 3, 2013 (GLOBE NEWSWIRE) — Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced the extension of its contract with the Biomedical Advanced Research and Development Authority (BARDA) for the continued development of CMX001 as a potential medical countermeasure against smallpox, which is classified as a Category A bioterror agent by the U.S. Centers for Disease Control and Prevention. The extension of the contract provides $5 million in funding over 12 months for Chimerix to conduct animal studies that are necessary for an approval of CMX001 for treatment of smallpox infection under the U.S. Food and Drug Administration’s (FDA) Animal Efficacy Rule.
CMX001 is being developed as a treatment or preventive therapeutic for multiple viral diseases based on its antiviral activity against all five families of double-stranded DNA (dsDNA) viruses that cause disease in humans, including smallpox. Data from cell culture and animal models of smallpox have shown CMX001 to be highly effective against viruses in the poxvirus family. There is no antiviral agent approved for the treatment of smallpox. An antiviral is needed, in particular, for patients who cannot be vaccinated due to medical conditions that prevent them from mounting an appropriate immune response to a smallpox vaccine.
“CMX001 continues to show progress as a potential medical countermeasure against smallpox, including recent data generated in a highly relevant rabbitpox model,” said Kenneth I. Moch, President and CEO of Chimerix. “We look forward to continuing our work with BARDA and the FDA to advance CMX001 as a medical countermeasure for smallpox. Simultaneously, we are also continuing the development of CMX001 for the prevention, preemption or treatment of other dsDNA viruses, including herpesviruses, polyomaviruses, and adenoviruses, that cause morbidity and mortality in immunocompromised individuals.”
Since smallpox has been declared eradicated in humans, development of CMX001 for the treatment of smallpox is occurring under the FDA’s Animal Efficacy Rule, pursuant to which the FDA uses data from animal studies to support the effectiveness of products that cannot be studied in humans. In February 2011, BARDA awarded Chimerix an Advanced Research and Development Contract for the development of CMX001 as a medical countermeasure in the event of an accidental or intentional release of smallpox, such as a bioterrorist attack, which could trigger a global health emergency (Contract Number HHSO100201100013C). The current extension represents continuation of work under this contract.
The contract with BARDA supports research and development of CMX001 as a treatment for smallpox infections, but does not include a purchase option for the Strategic National Stockpile. Information regarding BARDA can be found online at: http://www.phe.gov/about/barda/Pages/default.aspx.
Chimerix’s lead product candidate, CMX001, is a broad-spectrum oral nucleotide analog that blocks replication of all five families of dsDNA viruses that infect humans, including cytomegalovirus (CMV), adenovirus (AdV), BK virus and herpes simplex viruses. In a Phase 2 trial, CMX001 demonstrated potential clinical utility in prevention of CMV infection in high-risk patients who had received a hematopoietic stem cell transplant (HSCT). Chimerix anticipates initiating SUPPRESS, its Phase 3 trial of CMX001 for the prevention of CMV infection in adults undergoing HSCT, in the third quarter of 2013. In December 2012, Chimerix completed enrollment of a Phase 2 trial in pediatric and adult HSCT recipients evaluating CMX001 as a preemptive therapy for AdV disease, an often-fatal infection with no approved therapies. Since 2009, Chimerix has made CMX001 available through a Compassionate Use Program to over 80 medical centers worldwide for the treatment of over 430 patients with life-threatening dsDNA viral infections and no alternative treatment.
Chimerix is committed to the discovery, development and commercialization of novel, oral antiviral therapeutics designed to transform patient care in areas of high unmet medical need. Chimerix’s proprietary lipid technology has given rise to two clinical-stage nucleotide analog lipid-conjugates, CMX001 and CMX157, which have demonstrated the potential for enhanced activity and safety in convenient, orally administered dosing regimens. Chimerix’s second product candidate, CMX157, an oral nucleotide analog for the treatment of HIV infection, was licensed to Merck in July 2012.
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. Such statements include, but are not limited to, statements regarding the use of CMX001 as a treatment for smallpox infection and its ability to provide a broad spectrum of antiviral activity. Risks that contribute to the uncertain nature of the forward-looking statements include: the accuracy of Chimerix’s estimates regarding its ability to initiate the SUPPRESS trial; the success of the SUPPRESS trial and Phase 2 trials; the demonstrated efficacy of CMX001 in the SUPPRESS trial and Phase 2 trials; the accuracy of Chimerix’s estimates regarding expenses and capital requirements; regulatory developments in the United States and foreign countries; Chimerix’s ability to obtain and maintain intellectual property protection for CMX001; and the loss of key scientific or management personnel. These and other risks and uncertainties are described more fully in Chimerix’s filings with the Securities and Exchange Commission, including without limitation its Quarterly Report on Form 10-Q for the first quarter of 2013, as filed with 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.
Rebecca Heath, 919.972.7124
Elizabeth Kelly, 919.972.7109