Kenya is set to take a major step towards reducing its dependence on imported HIV medicines after securing a licence to manufacture a new long-acting HIV prevention pill for African and other low- and middle-income markets.
The development places Kenya among only three African countries selected to manufacture alimatravir, a new monthly HIV prevention medicine that could significantly expand access to HIV pre-exposure prophylaxis (PrEP) if ongoing clinical trials confirm its effectiveness.
The licensing agreement, announced by pharmaceutical giant Merck, will allow seven generic drug manufacturers to produce lower-cost versions of the medicine. In Kenya, production will be undertaken by Universal Corporation, positioning the country at the centre of an emerging African pharmaceutical manufacturing network.
More significantly, the arrangement marks the first time African manufacturers have been included in the licensing of an HIV medicine from the earliest stages of its development.
The move could alter how new HIV prevention technologies reach African communities, particularly populations that have historically depended heavily on imported medicines and donor-supported supply chains.
Drug being tested in Kenya
The development of alimatravir is closely linked to research being conducted in Africa.
A late-stage clinical trial that began last year is being undertaken by the Kenya Medical Research Institute (KEMRI) among young women in Kenya, Uganda and South Africa.
This means some of the clinical evidence needed to determine the drug’s effectiveness is being generated among the same populations and in the same region where the medicine is expected to be deployed.
The trial results are expected next year.
If the findings confirm the drug’s effectiveness and safety, the licensing arrangement is designed to enable manufacturers to move quickly towards large-scale production rather than beginning the lengthy process of establishing generic supply chains after regulatory approval.
For Kenya, this could mean that local manufacturing capacity is already in place when the medicine becomes eligible for wider deployment.
The licensing agreement covers generic production in 129 low- and middle-income countries, with manufacturers receiving royalty-free licences.
Merck has also committed to producing a bridge supply at no profit for participating countries, allowing stockpiles to be prepared ahead of demand if the clinical trial results are positive.
A potential shift in HIV prevention
Alimatravir is being developed as a once-monthly HIV prevention pill, potentially offering an alternative to prevention options that require more frequent dosing.
According to Merck senior vice-president Gregg Szabo, trial data indicate that the drug begins providing protection against HIV approximately one hour after it is taken and could provide about a week of grace if a person misses a scheduled monthly dose.
Merck has indicated that the medicine could eventually be supplied to national health systems for as little as $5 (about Sh650) per person annually, although the eventual price and availability will depend on regulatory approval, procurement arrangements and the outcome of the ongoing clinical programme.
The affordability target could be particularly important for countries carrying substantial HIV burdens and operating under tight public-health budgets.
Kenya’s manufacturing ambition
The agreement also puts Kenya’s pharmaceutical manufacturing ambitions under renewed focus.
President William Ruto, in remarks delivered by Health Cabinet Secretary Aden Duale at a high-level UN General Assembly side event, argued that Africa’s vulnerability to international pharmaceutical supply chains had been exposed during the Covid-19 pandemic.
“Africa carries about a quarter of the world’s disease burden. We make less than 6 per cent of our medical supplies. We make about 1 per cent of the vaccines we use,” Dr Ruto said.
He pointed to the experience of Covid-19 as evidence of the consequences of depending heavily on external suppliers.
“Africa waited longer. Paid more. Received less. Our people paid the price for a supply chain we did not own,” he said.
The President said the opportunity to participate in research, manufacturing and distribution represented a broader shift in Africa’s role in global health.
“Africa helping to test the innovation. Africa is preparing to make it. Africa is ready to deliver it. Not standing at the end of the line waiting to buy it,” he said.
Billions of people, but limited manufacturing capacity
The announcement comes against the backdrop of a long-running imbalance in global pharmaceutical production.
Africa continues to shoulder a significant share of the world’s infectious disease burden while producing a relatively small proportion of the medicines and vaccines consumed on the continent.
The proposed manufacture of alimatravir in Kenya is therefore being presented not simply as an HIV intervention but as part of a wider effort to build resilient African pharmaceutical supply chains.
Dr Nicholas Muraguri, senior adviser on global health diplomacy for the Kenyan government, said the partnership could have implications beyond the availability of a single HIV prevention medicine.
“This partnership is not just about distributing a drug; it is about rewriting the mechanics of global health equity,” Dr Muraguri said.
He said combining an affordable monthly HIV prevention pill with local manufacturing could strengthen communities’ ability to protect themselves while reducing vulnerabilities in international supply chains.
Major international investment
The initiative has attracted substantial financial and technical backing.
The Bill & Melinda Gates Foundation has committed $100 million to the late-stage clinical trial and is expected to invest another $80 million to support testing and the eventual transition towards the market.
Dr Nina Russell, who oversees HIV drug development investments for the foundation, said the scientific evidence surrounding alimatravir had given researchers confidence in its potential.
But clinical effectiveness will remain the critical test.
The medicine must still demonstrate that it is safe and effective through the ongoing trial process before it can become part of routine HIV prevention programmes.
Unitaid is supporting the manufacturing and supply-chain side of the initiative, including infrastructure and technical assistance to the three African manufacturing facilities involved.
The United States International Development Finance Corporation has also been identified as a partner expected to help mobilise private capital for manufacturing and other health-related investments in emerging markets.
Beyond HIV prevention
For Kenya, the potential benefits could extend beyond HIV prevention.
Dr Priya Agrawal, representing Merck at the UNGA side event, said the initiative could support African scientific research, skilled employment, local pharmaceutical companies and regional trade.
“This is not just about alimatravir. This is about strengthening African research and manufacturing, supporting skilled jobs and local private businesses, expanding regional trade and the journey from innovation to impact,” she said.
That ambition places the planned Kenyan production facility within a broader debate about whether African countries can move from being primarily consumers of medicines developed elsewhere to becoming active participants in pharmaceutical research, development and manufacturing.
For the country’s HIV response, however, the immediate question will be whether the promising science translates into an affordable, safe and accessible prevention option.
For millions of people at risk of HIV, a monthly prevention medicine could offer another tool in the fight against new infections—provided clinical trials, regulatory approval, financing and health-system readiness all align.
The outcome of the late-stage trial next year will therefore be closely watched, not only by HIV researchers but also by governments seeking more sustainable ways to protect their populations and reduce dependence on imported medicines.
Kenya’s role in manufacturing the drug could give the country a rare opportunity to participate in the entire health-product chain—from clinical research conducted on African soil to local production and eventual distribution across the continent.
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