A Kenya-based pharmaceutical manufacturer, Universal Corporation Limited (UCL), has been selected among seven global drugmakers licensed by Merck to produce a royalty-free generic version of its experimental once-monthly HIV prevention pill, alimatravir, if it secures regulatory approval.
The licensing agreement, announced by Merck on Friday, gives the Kiambu County-based company the right to manufacture or import the medicine and supply it to hospitals, pharmacies, government health programmes, non-governmental organisations and donor-funded initiatives in countries with high HIV burdens.
The deal also allows UCL to use Merck's patents and manufacturing know-how without paying royalties until March 31, 2035.
Other companies granted the licence include South Africa's Aspen Pharmacare, Uganda's Quality Chemical Industries, and Indian pharmaceutical firms Aurobindo, Cipla, Emcure and Viatris.
Alimatravir is being developed as a once-monthly pre-exposure prophylaxis (PrEP) pill designed to prevent HIV infection among people at risk of exposure. The medicine is currently undergoing two late-stage clinical trials to determine whether it is both safe and effective.
If approved, generic versions of the drug could cost as little as $5 per person per year, potentially making it one of the most affordable HIV prevention options available globally.
Kenya has played a role in the drug's development through the EXPrESSIVE-10 clinical trial, which evaluated the medicine among adolescent girls and young women with support from the Gates Foundation.
A second study, EXPrESSIVE-11, is now testing the drug among people at higher risk of HIV infection across 16 countries.
Earlier research involving 350 adults aged between 18 and 65 found encouraging safety results. Scientists established that alimatravir, and the active form it becomes inside the body, remained in the bloodstream long enough to support monthly dosing. However, those studies did not determine whether the drug prevents HIV infection, which is the primary objective of the ongoing trials.
Merck said the licensing agreement is intended to ensure rapid access to the medicine should it receive approval from regulators.
The company said UCL and the other manufacturers would ensure that "sufficient product supply is made available, if approved, in areas of high unmet need following the anticipated U.S. approval to enable early program implementation and ambitious scale-up."
The announcement comes ahead of the 26th International AIDS Conference in Rio de Janeiro, where public health experts are expected to discuss strategies for reducing new HIV infections amid disruptions to HIV prevention programmes following cuts to U.S.-funded initiatives.
According to the National Syndemic Diseases Control Council (NSDCC), Kenya records nearly 14,000 new HIV infections each year, with most cases occurring among people aged between 15 and 24—a group that has long been prioritised for prevention methods that do not require taking daily medication.
The development has been welcomed by public health experts. Mark Suzman, chief executive officer of the Gates Foundation, described the agreement as an "important" step "to help protect the communities most affected by HIV."
The licensing deal also supports Kenya's ambition to expand local pharmaceutical manufacturing. Although the country has a $1.2 billion pharmaceutical market and is East Africa's leading producer of medicines as well as Africa's third-largest exporter, it still relies heavily on imported drugs.
Principal Secretary for Medical Services Dr. Ouma Oluga has previously said Kenya is working towards becoming "a manufacturing hub for Africa," an ambition that could receive a significant boost if alimatravir is approved for widespread use.