AiCuris Anti-infective Cures AG has received milestone payments in the amount of EUR €30 million from its licensing partner MSD (Merck) after the U.S. FDA’s approval for first-in-class antiviral agent PREVYMIS® in a new indication – the prophylaxis of CMV disease after kidney transplant in Donor CMV-seropositive/Recipient CMV-seronegative patients.
“Since 2017, the drug has already protected thousands of allogeneic stem cell transplanted patients from CMV disease. With this label expansion, CMV-seropositive kidney transplant patients now have a novel, safe and effective treatment option,” said Larry Edwards, CEO of AiCuris Anti-infective Cures AG.
“This important milestone further validates our comprehensive research and development engine and supports the development of our pipeline including our proprietary phase 3 product candidate, Pritelivir, developed for treatment of resistant herpes simplex virus (HSV) infections in immunocompromised patients.”
Phase 3
The FDA approval was supported by a Phase 3, randomized, multicenter, double-blind, active comparator-controlled non-inferiority trial (P002, NCT03443869) in 589 adult kidney transplant recipients at high risk (CMV D+/R-). According to the MSD announcement, the study demonstrated that PREVYMIS® was non-inferior to valganciclovir, the current standard of care, for the primary endpoint of incidence of CMV disease (CMV end-organ disease or CMV syndrome, confirmed by an independent adjudication committee) through Week 52 post-kidney transplant.