Chimerix, Inc. Signs Worldwide License Agreement With Merck & Co., Inc. for Up to $168.5 Million
Published: Jul 24, 2012
Under the terms of the agreement, Merck receives an exclusive worldwide license and will be responsible for development and commercialization of CMX157, an investigational oral nucleoside reverse transcriptase inhibitor (NRTI). Chimerix will receive a $17.5 million upfront payment and will be eligible to receive up to $151 million in milestones, as well as royalties on future sales.
"This agreement is a significant milestone in Chimerix's mission of developing best-in-class therapies for major unmet medical needs based on our lipid technology platform," said Kenneth I. Moch, President and CEO of Chimerix. "Merck is the ideal collaborator to develop this drug and help us to maximize the potential of CMX157, given its commitment to its HIV franchise. The value created through the licensure of CMX157 will help us continue to advance our lead compound, CMX001, through its critical Phase 3 trial, for which we currently plan to begin enrolling patients early next year."
"Merck is committed to bringing forward new treatment options for patients with HIV/AIDs," said Daria Hazuda, Vice President and Worldwide Discovery Head for Infectious Diseases, Merck Research Laboratories. "We look forward to working closely with Chimerix to advance development of this NRTI candidate."
CMX157 is a novel lipid acyclic nucleoside phosphonate that delivers high intracellular concentrations of the active antiviral agent tenofovir diphosphate. CMX157 is more than 200-fold more potent in vitro versus tenofovir against all major HIV subtypes resistant to current therapies, which may allow activity against tenofovir-resistant viruses (e.g., K65R), and against HBV. CMX157's novel structure results in decreased circulating levels of tenofovir, lowering systemic exposure and thereby reducing the potential for renal side effects. CMX157 has completed a Phase 1 clinical trial in healthy volunteers, demonstrating a favorable safety, tolerability and drug distribution profile.
Led by an experienced antiviral drug development team, Chimerix is developing novel oral antiviral therapeutics with the potential to improve quality of life for patients in multiple settings, including transplant, oncology, acute care and global health. The company's proprietary lipid technology has given rise to two clinical stage compounds, CMX001 and CMX157, which have demonstrated the potential for enhanced activity, bioavailability and safety compared to currently approved drugs.
Chimerix's lead compound, CMX001, is a broad spectrum lipid acyclic nucleoside phosphonate that inhibits double-stranded DNA (dsDNA) viruses including cytomegalovirus (CMV), adenovirus, BK virus, herpes simplex virus and variola (smallpox). CMX001 has completed Phase 2 clinical development for the prophylaxis of CMV and is in Phase 2 development for the preemption and treatment of adenovirus infection in hematopoietic stem cell transplant (HSCT) recipients. To date, more than 750 patients have been dosed with CMX001 in controlled clinical trials and open-label treatment protocols. Antiviral activity from completed and ongoing studies, coupled with the lack of myelotoxicity and nephrotoxicity that are associated with currently available therapies, indicate that CMX001 has the potential to improve outcomes for stem cell and solid organ transplant recipients. Chimerix has completed an End of Phase 2 meeting with the FDA for CMX001 and is preparing to initiate Phase 3 clinical development of CMX001 for the prophylaxis of CMV in HSCT recipients.
For additional information on Chimerix, please visit http://www.chimerix.com.
SOURCE Chimerix, Inc.