Universal Corporation.A Kikuyu-based drug manufacturer has struck a deal to produce a once-monthly HIV prevention pill.
An HIV-negative person would need to take only one pill each month to prevent HIV infection, even during unprotected sex.
The drug is expected to sell for as little as Sh645 ($5) for a full year's supply of 12 pills.
The Kikuyu-based Universal Corporation Limited (UCL) was selected by global pharmaceutical company Merck as one of only seven manufacturers worldwide that will produce alimatravir, the experimental HIV prevention pill currently in Phase 3 trials.
The licensing agreement was announced during the ongoing 26th International Aids Conference in Rio de Janeiro, Brazil.
Merck said the decision to sign agreements with manufacturers before the completion of Phase 3 clinical trials is intended to ensure millions of doses can be produced and supplied quickly once the medicine is approved.
"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.
Merck is known as MSD outside the United States and Canada.
The company added, "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 one of the countries where the drug is being trialled in adolescent girls and young women in Phase 3, alongside Uganda and South Africa, with financial support from the Gates Foundation.
If approved, alimatravir could become one of the easiest HIV prevention medicines ever developed.
People at risk of HIV currently have to remember to take a prevention pill every day or receive long-acting injections at health facilities.
Alimatravir would require only one pill every month, or 12 pills a year. Because it is a simple oral tablet rather than an injection, health experts believe it could be distributed through pharmacies, community programmes, schools and even places such as hair salons, making HIV prevention easier to access.
The drug is inexpensive because alimatravir uses only a small amount of its active pharmaceutical ingredient and is manufactured as a standard tablet.
Besides UCL Kenya, the African manufacturers are Aspen Pharmacare of South Africa and Quality Chemical Industries Limited of Uganda. The other four companies are based in India.
The licence allows the companies to sell the drug in 129 low- and middle-income countries that account for most new HIV infections worldwide.
Merck said this is the first time African manufacturers have been included in voluntary licensing agreements for an HIV prevention medicine before Phase 3 trials have been completed, giving them time to prepare production instead of waiting until after approval.
Merck chairman and chief executive officer Robert Davis said the company wanted to shorten the time between scientific discovery and public access.
"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."
According to Merck, only 3.5 million people were using oral pre-exposure prophylaxis (PrEP) in 2023, while the global goal is to reach 20 million people by 2030. It said new prevention options are needed to overcome barriers such as stigma, affordability and convenience.
Kenya enrolled 170,551 people on oral Pre-Exposure Prophylaxis (PrEP) in 2022, the highest number the country has ever recorded in a single year.
That number fell to 35,704 in 2025, according to the National Syndemic Diseases Control Council (NSDCC).
PrEP is an HIV prevention medicine that can reduce the risk of infection by up to 99 per cent when taken consistently.
Kenya introduced it into its national HIV prevention programme in 2016, recognising that preventing new infections would be as important as treating people already living with the virus.
The exact clinical efficacy and effectiveness of alimatravir in preventing HIV remain officially unknown because the drug is still undergoing late-stage Phase 3 clinical trials, with final results expected in late 2027.
However, researchers involved in HIV prevention expect the medicine to provide a high level of protection because the molecule at its core is closely related to another highly effective HIV medicine that showed 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 expects to invest another $80 million to help complete testing and support efforts to bring the medicine to market if it proves successful.
The foundation's chief executive officer, Mark Suzman, welcomed Merck's decision to begin licensing manufacturers before the trials are completed.
"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 praised the decision to include manufacturers from the continent from the beginning.
"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."
