FDA, New Products

Merck wins FDA OK for new CMV drug Prevymis, triggering a $122M payday for AiCuris

Five years after bagging the CMV drug letermovir in a $500 million-plus deal with AiCuris, Merck says the FDA has come through with an approval.

While not a blockbuster by most accounts, the drug — to be marketed as Prevymis — demonstrated a significantly reduced the rate of cytomegalovirus infection among patients getting a bone marrow stem cell transplant, comparing the rates in a placebo arm.

This is the first new CMV therapy to come along in 15 years, according to Merck $MRK. And that will trigger a $122 million milestone payment for Germany’s AiCuris, which can also start to earn some royalty dollars.

Francisco Marty

Analysts have pegged sales 5 years from now at around $200 million. The oral version is being sold at a wholesale cost — ahead of any payer discounts — of $195 a day, with the injection formula priced at $270.

That’s a modest score for Merck, which has been devoting much of its time and attention these days to its checkpoint drug Keytruda.

“Our findings demonstrate that letermovir is a significant and welcomed advance in the prevention of clinically significant CMV infection and lowers mortality in this highly vulnerable patient population,” said Francisco Marty, an associate professor of medicine at Harvard Medical School.

These transplant procedures require physicians to prep patients by flattening their immune system, leaving them open to dangerous infections.

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%.


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