Merck tees up US/European applications for letermovir after detailing PhIII antiviral success
Merck has unveiled the positive data behind its Phase III win for its antiviral letermovir. While it’s no panacea, the drug clearly outperformed a placebo in chopping down on the number of CMV infections suffered in the target population of patients. And now Merck plans to file for an approval later this year in Europe as well as the US.
Investigators recruited 495 CMV-seropositive patients who received a bone marrow transplant for the study, and tracked a 37.5% rate of CMV infections among the patients taking letermovir. In the placebo arm, the rate of infections was 60.6% at 24 weeks. And a key secondary — clinically significant CMV infections — clearly favored Merck’s drug: 19.1% compared to 50%.
There were also fewer deaths for all causes in the drug arm: 9.8% compared to 15.9%.
Merck got this drug, a non-nucleoside CMV inhibitor designed to put the brakes on viral replication, in a €442.5 deal with AiCuris back in 2012. And according to Thomson Reuters analysts expect sales in 2022 to break the $200 million mark.
The positive data puts Merck way out in front of Chimerix, which saw its stock price implode in late 2015 on the failure of its drug brincidofovir in preventing CMV.
Dr. Francisco M. Marty, an associate professor of medicine at Harvard Medical School presented the data at the BMT Tandem Meetings in Orlando. He said:
In this study, letermovir was associated with lower all-cause mortality. Based on these findings, letermovir as primary prophylaxis of CMV infection represents a potential new strategy for the prevention of CMV in this high-risk patient population.