NAIROBI, Kenya — Kenya is set to become one of the first African countries to manufacture a new monthly HIV prevention pill, in a move that could strengthen the continent’s capacity to produce medicines for its own population.
Pharmaceutical giant Merck has announced royalty-free licensing agreements with seven generic drug manufacturers to produce a low-cost version of alimatravir, with one of the manufacturers based in Kenya.
The deal makes Kenya one of three African countries expected to manufacture the drug for developing markets.
Universal Corporation to Manufacture Drug in Kenya
Kenyan pharmaceutical manufacturer Universal Corporation will produce alimatravir under the licensing agreement.
The licences cover generic production and supply to 129 low- and middle-income countries, potentially giving African manufacturers a direct role in supplying the medicine to markets across the developing world.
Merck will also manufacture an interim supply of the drug at no profit, allowing countries to build stockpiles if clinical trials confirm its effectiveness.
The arrangement is intended to avoid a lengthy wait between regulatory approval and the availability of affordable generic supplies.
Kenya Part of Late-Stage HIV Trial
The development of the drug is closely linked to research being conducted in Africa.
The late-stage clinical trial began last year and is being conducted among young women in Kenya, Uganda, and South Africa, with the Kenya Medical Research Institute (KEMRI) involved in the research.
This means evidence for the medicine is being generated among populations in the region where the drug is expected to be used.
The licensing arrangement therefore brings together African research, manufacturing, and potential distribution rather than treating the continent solely as a market for medicines developed elsewhere.
Pill Designed for Monthly HIV Prevention
Alimatravir is being developed as a once-monthly HIV prevention pill.
According to Merck, trial data so far indicate that protection begins approximately one hour after the medicine is taken, while users could have about a week’s grace period if they miss a monthly dose.
Merck executive Gregg Szabo said the medicine could eventually be supplied to national health systems for as little as $5 (about Sh650) per person per year, subject to the necessary regulatory and clinical milestones.
However, the drug has not yet completed the late-stage clinical development process.
The results expected next year will be critical in determining whether it can move towards wider regulatory approval and deployment.
Africa Seeks Greater Pharmaceutical Self-Reliance
President William Ruto welcomed the development as an example of what greater pharmaceutical manufacturing capacity could mean for Africa.
Speaking at a UN General Assembly high-level side event, in remarks read by Health Cabinet Secretary Aden Duale, Ruto said Africa continues to carry a large share of the world’s disease burden while producing only a small proportion of the medicines and vaccines it uses.
“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.”
Ruto said the COVID-19 pandemic had demonstrated the risks of depending heavily on overseas pharmaceutical supply chains.
He said the alimatravir partnership represented a different approach, with African countries involved in testing, manufacturing and delivering new health technologies.
Gates Foundation Invests $100 Million
The Bill & Melinda Gates Foundation has committed $100 million to the late-stage trial of alimatravir and expects to invest another $80 million to support testing and eventual market introduction.
Dr Nina Russell, who oversees the foundation’s HIV drug development investments, said the science behind the drug had given the research team confidence in its potential.
The partnership also includes Unitaid, which is supporting infrastructure and supply-chain preparations at the three African manufacturing facilities.
The US International Development Finance Corporation is also involved in efforts to mobilise private capital for the programme.
Manufacturing Deal Could Create Jobs
Merck representative Dr Priya Agrawal said the partnership goes beyond making a new HIV prevention medicine available.
She said local manufacturing could strengthen African research capabilities, support skilled employment and local businesses, expand regional trade and shorten the journey from medical innovation to delivery.
The manufacturing arrangements are also intended to reduce the risk of supply shortages by creating production capacity closer to the populations that need the medicine.
Kenya Eyes Bigger Role in Global Health Manufacturing
Dr Nicholas Muraguri, senior advisor on global health diplomacy for the Kenyan Government, said the partnership could contribute to greater health security and local control of pharmaceutical supply chains.
“By combining an ultra-low-cost, once-monthly pill with localised African manufacturing, we are equipping communities to protect themselves, secure their own supply chains and systematically halt new HIV infections.”
The initiative comes as Kenya and other African countries seek to expand local pharmaceutical manufacturing and reduce dependence on imported medicines.
