Kenya’s UCL is among the manufacturers licensed for a potential monthly HIV prevention pill that remains under clinical study.
Kikuyu-based UCL is among seven manufacturers licensed by Merck to make or supply generic alimatravir, a monthly HIV prevention pill still undergoing trials.
Kenya’s Universal Corporation Limited (UCL) has secured a royalty-free licence to manufacture or supply a generic version of a potential once-monthly HIV prevention pill, placing the country among three African nations included in an early licensing agreement.
The Kikuyu-based pharmaceutical manufacturer is one of seven generic drugmakers granted voluntary licences by Merck for alimatravir, also known as MK-8527. Access to the medicine remains conditional on it proving safe and effective and receiving regulatory approval.
The agreement comes while Phase 3 clinical studies are still under way. Alimatravir is investigational and has not been approved for use, meaning the licensing announcement does not make it available to patients.
African manufacturers included from the outset
Alongside UCL, the African companies covered by the arrangement are South Africa’s Aspen Pharmacare and Uganda’s Quality Chemical Industries Limited. The remaining four manufacturers are based in India.
Merck described the agreement as the first voluntary licensing arrangement for an investigational HIV prevention medicine to include generic manufacturers in sub-Saharan Africa from the outset.
For Kenya, the arrangement creates an opportunity to prepare for local production of a new prevention option before the final clinical results are available. Any manufacture or supply under the agreement remains subject to the medicine meeting the required safety, effectiveness and regulatory conditions.
Foreign Affairs Principal Secretary Korir Sing’oei said the development positioned Kenya among three African countries preparing to manufacture the medicine for African markets.
A potential monthly alternative to daily PrEP
Alimatravir is being developed as an oral pre-exposure prophylaxis, or PrEP, medicine for people at risk of HIV infection. If approved, its once-monthly dosing could offer an alternative to daily oral HIV prevention.
Merck says Phase 3 studies are ongoing, with results expected next year. Those findings will be important in determining whether the investigational medicine can move towards approved use.
The licensing development comes as Kenya broadens access to longer-acting HIV prevention options. In February, the country became the first in East Africa to launch lenacapavir, an injectable prevention medicine administered twice a year.
The two medicines represent different dosing approaches: lenacapavir is an injection, while alimatravir is being studied as a monthly pill. Alimatravir’s potential role in prevention remains dependent on the outcome of its development programme.
Boost for local pharmaceutical production
Medical Services Principal Secretary Dr Ouma Oluga welcomed the agreement as progress towards expanding domestic pharmaceutical manufacturing.
The government has been pursuing partnerships focused on local drug production, technology transfer and stronger health-sector capabilities. In September, the Ministry of Health said its discussions with Merck had covered biotechnology, pharmaceutical manufacturing, skills development and technology transfer.
For UCL, the licence offers a chance to build manufacturing capacity around a potential medicine intended for markets with significant HIV prevention needs, while clinical testing continues.
