Merck outlines LMIC access plans for alimatravir with 129‑country voluntary licenses
- Merck signed seven non‑exclusive, royalty‑free voluntary licences enabling generic supply of alimatravir in 129 low‑ and middle‑income countries, covering public and private sectors.
- Licences include three manufacturers in sub‑Saharan Africa (Aspen, Quality Chemical Industries Limited, UCL Kenya) and four in India (Aurobindo, Cipla, Emcure, Viatris).
- Two Phase 3 trials (EXPrESSIVE‑10 NCT07071623 and EXPrESSIVE‑11 NCT07044297) are enrolling; EXPrESSIVE‑10, funded by the Gates Foundation, targets adolescent girls and young women in Kenya, South Africa and Uganda.
- Merck will invest in early product manufacturing, provide initial supply pending generic approvals, and support regional manufacturing to accelerate scale‑up in high‑burden regions.
Access strategy and voluntary licensing
Merck has begun a multi‑faceted access strategy to enable rapid, broad and sustainable availability of alimatravir (MK‑8527) in low‑ and middle‑income countries if approved. The company has signed seven non‑exclusive, royalty‑free voluntary licence agreements that cover 129 LMICs and include both public and private sectors. For the first time in HIV prevention, licences were agreed before Phase 3 enrolment finished, and they include generic manufacturers located in sub‑Saharan Africa alongside manufacturers in India.
Manufacturing and supply planning
Merck plans targeted regional manufacturing support in Africa and Latin America, is in discussions with organisations including Fiocruz in Brazil, and is investing early in product manufacturing. The company intends to provide initial supply and continue supplying product as licensed generics complete development and regulatory approvals to reduce delays in access.
Clinical development and mode of action
Alimatravir is being developed as a once‑monthly oral PrEP that inhibits reverse transcriptase via translocation inhibition (immediate chain termination) and by inducing structural changes in viral DNA (delayed chain termination). It is predicted to be protective starting within one hour after dosing. Two Phase 3 trials (EXPrESSIVE‑10 and EXPrESSIVE‑11) are enrolling; EXPrESSIVE‑10 (NCT07071623) is supported by the Gates Foundation and enrols adolescent girls and young women in Kenya, South Africa and Uganda. A Phase 2 trial (NCT06045507) enrolled 350 participants and showed similar adverse event rates versus placebo with supportive pharmacokinetics.
Public health context
Global HIV incidence remains high: 1.2 million people acquired HIV in 2025 (about 3,300 per day). According to the 2024 UNAIDS report, 3.5 million people used oral PrEP in 2023, short of the 20 million target for 2030, underscoring the stated need for new prevention options and expanded access.
Source: Merck
