Merck proposes early licensing and manufacturing plan for monthly HIV PrEP pill

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Merck announced early voluntary, royalty-free licensing and manufacturing plans to enable rapid access to alimatravir (MK-8527), an investigational once-monthly oral HIV-1 PrEP candidate, in low- and middle-income countries if approved. The company signed seven non-exclusive licenses with three sub-Saharan African manufacturers and four Indian firms to cover 129 LMICs, is supporting regional manufacturing in Africa and Latin America, and is investing in initial product manufacturing while Phase 3 EXPrESSIVE-10 and EXPrESSIVE-11 trials are under way. Phase 2 data in 350 participants showed similar adverse event rates to placebo and supportive pharmacokinetics, and Gates Foundation funding supports trial enrollment.

Merck granted royalty-free licenses for alimatravir covering 129 LMICs.