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 potential monthly HIV prevention pill.
The Kikuyu-based pharmaceutical company is among seven generic manufacturers licensed by Merck to produce alimatravir, also known as MK-8527.
The agreement includes manufacturers from Kenya, South Africa and Uganda. Four additional companies involved in the deal are based in India.
However, alimatravir remains an investigational medicine and is not yet approved for patient use.
UCL Joins African Manufacturers
UCL is one of three African pharmaceutical companies included in the voluntary licensing agreement.
South Africa’s Aspen Pharmacare and Uganda’s Quality Chemical Industries Limited are the other African manufacturers.
Merck described the deal as the first voluntary licence for an investigational HIV prevention medicine to include sub-Saharan African generic manufacturers from the outset.
For Kenya, the agreement creates an opportunity to prepare local manufacturing capacity before the medicine potentially reaches the market.
However, production and supply will depend on successful clinical trials and regulatory approval.
Foreign Affairs Principal Secretary Korir Sing’oei said Kenya is among three African countries preparing to manufacture the medicine for African markets.
Potential Monthly Alternative to Daily PrEP
Alimatravir is being developed as an oral pre-exposure prophylaxis (PrEP) medicine.
If approved, the medicine could offer people at risk of HIV infection a monthly alternative to daily oral PrEP.
Meanwhile, Merck is conducting Phase 3 clinical trials to assess the medicine’s safety and effectiveness.
The company expects results next year. Those findings will determine whether alimatravir can progress towards regulatory approval.
The licensing agreement therefore does not mean the medicine is currently available to patients.
Kenya Expands HIV Prevention Options
The development comes as Kenya expands access to longer-acting HIV prevention methods.
In February, Kenya became the first country in East Africa to launch lenacapavir, an injectable HIV prevention medicine administered twice a year.
Unlike lenacapavir, alimatravir is being developed as a monthly oral pill.
The two medicines could therefore provide different options for people seeking longer-acting HIV prevention if alimatravir eventually receives approval.
UCL Targets Local Manufacturing Growth
The agreement could also strengthen Kenya’s pharmaceutical manufacturing ambitions.
Medical Services Principal Secretary Dr Ouma Oluga welcomed the licensing deal as progress towards expanding domestic drug production.
The government has been pursuing partnerships involving local manufacturing, technology transfer and pharmaceutical skills development.
Additionally, the Ministry of Health said recent discussions with Merck covered biotechnology, pharmaceutical production and technology transfer.
For UCL, the licence provides an opportunity to prepare manufacturing capacity around a potential HIV prevention medicine.
However, the medicine’s future remains dependent on Phase 3 results and regulatory approval.
