AiCuris Anti-infective Cures AG, a clinical-stage pharmaceutical company developing novel, therapeutic candidates for the prevention and treatment of severe and potentially life-threatening infectious diseases in immunocompromised patients, announced that it has received milestone payments in the amount of EUR €15 million from its licensing partner MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA, (NYSE: MRK)) following EMA approval for the first-in-class antiviral agent PREVYMIS® (letermovir) for the prophylaxis of CMV disease after kidney transplant in Donor CMV-seropositive/Recipient CMV-seronegative patients at high risk.
PREVYMIS® (letermovir) is an antiviral agent that was initially approved by the U.S. Food and Drug Administration (FDA) in 2017 and by the EMA in 2018 for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic HSCT. In June 2023, the FDA and in December 2023 the EMA approved PREVYMIS® for prophylaxis of CMV disease in adult kidney transplant recipients at high risk. Moreover, extended 200-day dosing for PREVYMIS® for CMV prophylaxis in adult HSCT recipients at risk for late CMV infection and disease was approved by the FDA in August 2023.
Approvals by national authorities 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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