For the first time, a pharmaceutical company has given generic manufacturers permission to make copies of an HIV medicine before the studies proving it works have finished — with three of the seven licences awarded to African drug makers.
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- Merck has, for the first time, licensed generic manufacturers—including three African companies like South Africa’s Aspen Pharmacare—to produce the HIV prevention pill alimatravir (MK-8527) before final study results are completed, expediting potential access.
- Aspen will assemble alimatravir locally using imported ingredients, enabling distribution to 129 low- and middle-income countries, supporting Africa’s pharmaceutical industrialization and HIV prevention efforts against 140,000 new yearly infections in South Africa.
- Phase 3 studies ongoing across 17 countries aim to confirm the pill’s safety and efficacy by 2027; earlier data shows it reaches protective drug levels within one hour, faster than existing daily pills or six-monthly injections currently used.
- Offering multiple HIV prevention options (daily pill, six-monthly injection, and potentially alimatravir monthly pill) increases uptake, as seen in South Africa where introduction of lenacapavir injection boosted overall PrEP use and attracted new users.
- The inclusive licensing marks progress against unequal access patterns, but activists criticize Merck for excluding some middle-income Latin American countries hosting trials, limiting their access to affordable generic alimatravir.
