Kenya is one of three African countries preparing to make a once monthly HIV prevention pill. The pill could replace daily oral PrEP for some users if trials succeed and regulators approve it.
Universal Corporation Limited (UCL), a manufacturer based in Kikuyu, is one of seven generic drugmakers Merck has picked to prepare to produce alimatravir. The drug is an investigational oral pre exposure prophylaxis pill, also known as MK-8527. Regulators have not approved it for public use.
What the licence covers
Merck announced the agreements on July 24. The licences are nonexclusive and royalty free, and they cover 129 low and middle income countries. The seven licensed firms are UCL Kenya, Aspen Pharmacare of South Africa and Quality Chemical Industries of Uganda, plus Aurobindo, Cipla, Emcure and Viatris in India.
Kenya, South Africa and Uganda are the only African countries in the group. Merck says it is the first time manufacturers in Africa have joined an initial licence for an HIV medicine.
Merck signed the deals before its Phase 3 trial finished enrolment or produced data. Gilead followed the same route for lenacapavir in 2024 but signed only after positive trial results. Merck says the early start lets manufacturers build capacity while trials continue, which shortens the gap between approval and supply.
Merck is also preparing an initial supply of the drug. The stock would cover the period between approval and the point when licensed firms can ship their own versions.
The trials
Alimatravir is in two Phase 3 studies. One, EXPrESSIVE-10, enrols adolescent girls and young women in Kenya, South Africa and Uganda. It tests the safety and effectiveness of a monthly dose for HIV prevention.
UCL production is expected to start next year, but only if the trials confirm the drug works.
Why monthly dosing matters
Standard oral PrEP requires a pill every day. Kenya began offering daily PrEP through public facilities in 2017. Protection depends on taking it consistently, and people who cannot keep to a daily routine lose cover. A monthly pill would give them another option.
Merck describes alimatravir as a potential first monthly oral PrEP. It has indicated a price near $5, about Sh650, for a year’s supply. Pricing depends on development, regulatory approval and access arrangements.
Government and industry reaction
Medical Services Principal Secretary Ouma Oluga confirmed the selection after the UN General Assembly. He called it proof that local drug manufacturing is now underway. Merck’s Priya Agrawal said the programme aims to build African research, manufacturing and jobs. The US International Development Finance Corporation is among the backers, with a role in mobilising private capital in emerging markets.
President William Ruto backed the move in a speech read by Health Cabinet Secretary Aden Duale at a UN General Assembly side event. He said local manufacturing would cut Africa’s dependence on imported medicines and improve health security. Health officials say the Merck and UCL arrangement could support technology transfer, skills training and more reliable supply chains.
Global health agencies welcomed the early planning. They said affordability, regulatory readiness and fair distribution will decide whether the drug reaches the people who need it.
