Kenya among three African countries licensed to manufacture new HIV prevention pill

NAIROBI, Kenya, Sep 28 — Kenya has secured a place in an unprecedented early licensing arrangement that could allow a local pharmaceutical manufacturer to produce a new once-monthly HIV prevention pill before the medicine completes final clinical trials.

Universal Corporation Limited (UCL), a Kenyan pharmaceutical manufacturer based in Kikuyu, is among seven generic drugmakers granted royalty-free voluntary licences by global pharmaceutical company Merck to manufacture or supply generic versions of alimatravir (MK-8527) if the investigational medicine is proven safe and effective and receives regulatory approval.

The agreement marks the first time generic manufacturers in sub-Saharan Africa have been included from the outset in a voluntary licensing arrangement for an investigational HIV prevention medicine, according to Merck.

The other African manufacturers are Aspen Pharmacare of South Africa and Uganda’s Quality Chemical Industries Limited, while four companies are based in India.

The move puts Kenya among a small group of African countries preparing for local production of a potential new HIV prevention option while Phase 3 studies are still under way.

Foreign Affairs Principal Secretary Korir Sing’oei said the development would position Kenya among three African countries set to manufacture the medicine for African markets.

“Kenya has been granted a licence to manufacture a groundbreaking HIV prevention pill for African markets, making it one of three countries on the continent set to produce the drug.”

Medical Services Principal Secretary Dr Ouma Oluga also linked the agreement to Kenya’s push to expand domestic pharmaceutical manufacturing.

“Very pleased to have brought this achievement home from the just concluded UNGA 81, making local manufacturing of drugs no longer a talk but a reality,” Oluga said.

Monthly alternative to daily PrEP

Alimatravir is being developed as an oral pre-exposure prophylaxis (PrEP) medicine that could be taken once a month by people at risk of HIV infection, potentially offering an alternative to daily oral prevention.

The medicine remains investigational, however, and is not yet approved for use. Merck says its Phase 3 studies are still ongoing, with results expected next year.

The announcement also comes as Kenya expands access to longer-acting HIV prevention technologies.

In February, Kenya became the first country in East Africa to launch lenacapavir, an injectable HIV prevention medicine administered twice a year.

For Kenya’s pharmaceutical sector, the alimatravir agreement provides an opportunity to build manufacturing capacity around a medicine intended for markets where HIV prevention needs remain significant.

The government has been seeking partnerships aimed at strengthening local pharmaceutical production, technology transfer and domestic health-sector capabilities.

In September, the Ministry of Health said discussions with Merck had focused on biotechnology, pharmaceutical manufacturing, skills development and technology transfer.