Kenya is set to become one of three African countries manufacturing a new monthly HIV prevention pill after pharmaceutical giant Merck licensed a local drugmaker to produce its generic version.
Merck announced on Friday that it had entered royalty-free licensing agreements with seven generic manufacturers to produce an affordable version of alimatravir, an experimental HIV prevention medicine designed to be taken once a month.
In Kenya, production will be handled by Universal Corporation, making the country one of the first African nations involved in manufacturing the medicine from the early stages of its development.
The licensing arrangement covers 129 low- and middle-income countries. Merck also plans to provide an initial supply of the medicine at no profit, allowing countries to build stocks ahead of potential regulatory approval and wider generic production.
The medicine is currently undergoing a late-stage clinical trial led by the Kenya Medical Research Institute (KEMRI), involving young women in Kenya, Uganda and South Africa.
The trial is expected to provide results next year. If the findings confirm the pill’s effectiveness, the licensing agreement could allow production in Africa to begin without the lengthy delays that often accompany the establishment of generic manufacturing capacity.
President William Ruto welcomed the development, saying Africa should play a greater role in researching, manufacturing and supplying medicines needed on the continent.
In remarks delivered by Health Cabinet Secretary Aden Duale at a UN General Assembly side event, Ruto pointed to Africa’s reliance on imported medicines and vaccines, citing the experience of the COVID-19 pandemic.
He said the continent should not remain at the end of global medical supply chains, particularly after carrying a significant share of the world’s HIV burden.
The Bill & Melinda Gates Foundation has committed $100 million to the late-stage trial and plans to provide another $80 million to support testing and the medicine’s potential path to market.
Unitaid is supporting manufacturing infrastructure and supply-chain preparations at the three African facilities involved, while the US International Development Finance Corporation is among the partners seeking to mobilise private investment.
Merck said preliminary trial data indicate that alimatravir could begin protecting against HIV within about an hour of administration and provide roughly a week’s grace period when a monthly dose is missed.
The company has indicated that the medicine could eventually cost national health systems as little as $5 (about KSh650) per person annually.
Kenyan government health adviser Dr Nicholas Muraguri described the partnership as an opportunity to strengthen local pharmaceutical production while improving access to HIV prevention tools.