Pipeline

A paradigm shift in HCMV prophylaxis

A human cytomegalovirus (HCMV) infection is one of the most dangerous complications following transplantation. The “game-changer” Letermovir constitutes the first and only prophylactic treatment of HCMV in bone marrow transplant patients, significantly improving survival rates. Letermovir was developed by AiCuris up to Phase 2b and licensed to MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA, (NYSE: MRK)) in 2012. It was approved under the brand name Prevymis® in the US, the EU, Japan and other countries. A pivotal study for HCMV prophylaxis in kidney transplant recipients has recently been completed, with the aim to expand its use to additional indications. According to the MSD announcement, the trial results met the primary endpoint demonstrating that PREVYMIS was effective and non-inferior to valganciclovir for preventing CMV disease. A supplemental new drug application (sNDA) submitted by MSD to the U.S. Food and Drug Administration (FDA) has received Priority Review.

Saving lives. Every day.

• Novel mode of action
  a non-nucleosidic small molecule inhibiting a new viral target (HCMV viral terminase)
• Life-saving
  First-in-class drug available for prophylaxis of CMV infection and disease
• Block-buster potential
  Fast market uptake and additional indications