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Kikuyu drug maker to produce new once-a-month HIV prevention pill

Universal Corporation Limited (UCL), a pharmaceutical manufacturer based in Kikuyu, has been selected by global drug company Merck as one of only seven manufacturers worldwide licensed to produce alimatravir, a...

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Kikuyu drug maker to produce new once-a-month HIV prevention pill

Kenya has secured a place in the global rollout of a new HIV prevention medicine after a pharmaceutical company in Kikuyu was chosen to manufacture a tablet that could change how millions of people protect themselves from the virus.

Instead of taking a pill every day, users would only need one tablet each month if the medicine is approved, with a full year's supply expected to cost as little as Sh645.

Universal Corporation Limited (UCL), a pharmaceutical manufacturer based in Kikuyu, has been selected by global drug company Merck as one of only seven manufacturers worldwide licensed to produce alimatravir, an experimental HIV prevention medicine that is currently in Phase 3 clinical trials.

The agreement was announced during the 26th International Aids Conference in Rio de Janeiro, Brazil, where Merck said it was moving ahead with manufacturing partnerships before clinical trials are completed so production can begin immediately if regulators approve the medicine.

"Planning early for rapid, broad and sustainable access in low- and middle-income countries: By initiating a multi-faceted access strategy while Phase 3 trials are ongoing and before enrolment is complete, Merck aims to make alimatravir available in low- and middle-income countries as broadly and as quickly as possible, if approved," Merck said in a statement.

The company, known as MSD outside the United States and Canada, said the approach is meant to reduce the time between approval and public access to the medicine.

"If approved, alimatravir would provide an important new option, with the potential to offer one month of protection from HIV-1 in one pill, predicted to be protective starting within one hour after dosing."

Kenya is among the countries participating in the late-stage clinical trials alongside Uganda and South Africa, where adolescent girls and young women are being enrolled with support from the Gates Foundation.

Should the medicine receive approval, it could become one of the most convenient HIV prevention options available. People at risk of HIV currently rely on daily prevention tablets or long-acting injections given at health facilities. Alimatravir would reduce that to just one pill every month, meaning only 12 tablets are needed in a year.

Because the medicine comes as a standard tablet instead of an injection, health experts believe it can reach more people through pharmacies, schools, community health programmes and even places such as hair salons, making HIV prevention easier to access.

The medicine is also expected to remain affordable because only a small quantity of its active pharmaceutical ingredient is required to manufacture each tablet.

Apart from UCL Kenya, the other African companies selected are Aspen Pharmacare of South Africa and Quality Chemical Industries Limited of Uganda. Four additional manufacturers licensed under the agreement are based in India.

The licence allows the seven manufacturers to supply the medicine to 129 low- and middle-income countries, where the largest share of new HIV infections continues to be recorded.

Merck said this is the first time African manufacturers have been brought into voluntary licensing agreements for an HIV prevention medicine before Phase 3 clinical trials are completed. The move gives manufacturers time to prepare production ahead of approval.

Merck chairman and chief executive officer Robert Davis said the company wants to ensure new HIV prevention tools reach the people who need them without unnecessary delays.

"Recognising the urgent, unmet needs in HIV prevention, we are acting early to enable rapid, broad and sustainable access to alimatravir, an investigational once-monthly oral PrEP option, in low- and middle-income countries," he said.

"These important first steps reflect years of engagement with advocates and global health stakeholders. As Phase 3 trials progress, we remain committed to advancing our efforts in partnership with the HIV community to help maximise the public health impact of alimatravir, if approved."

Merck noted that only 3.5 million people were using oral pre-exposure prophylaxis (PrEP) in 2023, far below the global target of reaching 20 million users by 2030. It said wider prevention choices are needed to address barriers such as stigma, affordability and convenience.

Kenya recorded its highest annual enrolment into oral PrEP in 2022 when 170,551 people started using the medicine. According to the National Syndemic Diseases Control Council (NSDCC), that figure dropped to 35,704 in 2025.

PrEP lowers the risk of HIV infection by up to 99 per cent when taken consistently. Kenya introduced it into the national HIV prevention programme in 2016 as part of efforts to reduce new HIV infections.

Researchers caution that the exact effectiveness of alimatravir is still being assessed because Phase 3 clinical trials are ongoing, with final findings expected in late 2027.

However, scientists working on HIV prevention remain hopeful because the medicine is built on a molecule closely related to another HIV drug that delivered strong protection against infection in studies involving non-human primates.

"We have more optimism about this than is typical," said Dr Nina Russell, who oversees investment in HIV drug development at the Gates Foundation.

"It could be pretty transformative."

The Gates Foundation has invested $100 million in the late-stage clinical trial and plans to invest another $80 million to complete testing and support efforts to make the medicine available if it proves successful.

The foundation's chief executive officer Mark Suzman welcomed the decision to begin licensing manufacturers before the medicine receives approval.

"Merck’s early and proactive efforts to enable quick access to its new PrEP option, if approved, are important to help protect the communities most affected by HIV," Suzman said.

"We look forward to continuing to work with Merck and other partners who will help advance these plans and expand access to HIV prevention options."

African health leaders also welcomed the inclusion of manufacturers from the continent from the beginning of the process.

"People across Africa need more options to prevent HIV. A once-monthly pill could provide a different choice for people in how to protect themselves, subject to successful trials and regulatory approval," said Africa Centres for Disease Control and Prevention director general Jean Kaseya.

"We welcome this decision to engage African manufacturers early. Africa must continue to expand its role across the health innovation value chain, from supporting research ecosystems and clinical trial capacity to manufacturing and access. This is how we strengthen health sovereignty and bring new HIV prevention options closer to our people."

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