US pharmaceutical giant Merck announced on Friday that it has signed agreements with generic drug manufacturers in developing countries that allow them to make low-cost versions of its HIV prevention drug, Alimatravir.
The licensing agreements for the HIV prevention medicine that include manufacturers in sub-Saharan Africa will allow companies in the region to produce a potential once-monthly HIV prevention pill. But the pill still has to receive regulatory approval.
The US-based drugmaker said it signed royalty-free agreements with seven generic manufacturers, including Aspen Pharmacare, Quality Chemical Industries (Qcil) and UCL Kenya in South Africa, Uganda and Kenya, respectively, alongside four Indian companies—Aurobindo, Cipla, Emcure and Viatris.
The announcement comes ahead of the 26th International AIDS Conference in Rio de Janeiro, Brazil.
The move marks the first time African manufacturers have been included in initial licensing agreements for an HIV prevention medicine, a step Merck said is intended to strengthen regional production and speed access across 129 low and middle income countries.
Early licensing and regional production
Merck said the licensing agreements will allow the companies to develop and supply generic versions of Alimatravir to both public and private markets in the licensed countries, subject to regulatory approval.
It also plans to support regional manufacturing in Africa and Latin America to strengthen supply chains and improve long-term access.
Expanding HIV prevention options
If approved, Alimatravir would become a once-monthly oral pre-exposure prophylaxis (PrEP) option, offering protection against HIV-1 with a single pill each month.
According to Merck, laboratory data suggest the drug could begin providing protection within an hour after dosing.
The company said only 3.5 million people were using oral PrEP in 2023, far below the global target of 20 million by 2030, despite an estimated 1.2 million new HIV infections recorded in 2025.
Merck said it is investing in manufacturing capacity before regulatory approval to reduce the time between authorisation and distribution in countries with high HIV burdens.
The company plans to provide initial supplies while licensed manufacturers complete product development and obtain regulatory approvals.
Ongoing clinical trials
Alimatravir is currently being evaluated in two Phase 3 clinical trials.
The EXPrESSIVE-10 study is testing the drug among adolescent girls and young women in Kenya, South Africa and Uganda, while EXPrESSIVE-11 is enrolling participants at higher risk of HIV exposure across 16 countries.
Merck said it intends to provide trial participants with access to Alimatravir after the studies conclude, pending regulatory approval.
