AiCuris gets 30 million Euros milestone payment from MSD following US FDA approval of Prevymis in second indication

August 25, 2023

AiCuris Anti-infective Cures AG, a leading clinical-stage pharmaceutical company, announced that it has received milestone payments in the amount of EUR €30 million from its licensing partner MSD (Merck & Co) following US Food and Drug Administration (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.

AiCuris aims to discover, develop, and deliver innovative, anti-viral drugs to immunocompromised patients aiming to prevent severe condition and life-threatening diseases.

PHARMABIZ.com