AiCuris Anti-infective Cures AG has received milestone payments in the amount of EUR €30 million from its licensing partner MSD following FDA 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.
“We are excited that our partner MSD received FDA approval for PREVYMIS® (letermovir) for the prophylaxis of CMV infection in kidney transplanted 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.”
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.
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