Pharmaceutical giant Merck announced Friday that it has entered into seven voluntary licensing agreements with generic drug manufacturers, allowing them to produce and sell affordable versions of its experimental once-a-month HIV pill across 129 low- and lower-middle-income countries.
The drug in question, alimatravir, remains in late-stage development. Despite ongoing clinical trials, Merck says it is already ramping up investment in manufacturing capacity to prepare for potential future demand.
The licensing partners include three manufacturers based in sub-Saharan Africa — Aspen Pharmacare Holdings, Quality Chemical Industries, and UCL — along with four Indian companies: Aurobindo, Cipla, Emcure, and Viatris.
All seven agreements are royalty-free and apply to both public and private sector markets. Together, the 129 covered countries account for the vast majority of new HIV infections diagnosed around the world each year, according to Merck.
Gregg Szabo, who leads Merck’s global vaccines and infectious diseases unit, highlighted the historic nature of the agreements: “This is the first time that sub-Saharan African manufacturers have been included in licenses from the very beginning.”
Alimatravir is designed to offer a full month of protection against HIV-1, beginning within one hour of taking a single dose. Merck is still in the process of enrolling patients for the clinical trial.
Paul Schaper, Merck’s head of global pharmaceutical public policy, acknowledged that results are still some time away. “We’re likely not to have any trial results until the second half of next year, but this will give time for the generic licensees to start working to scale up their production,” he said.
The announcement comes after Gilead Sciences made a similar move in 2024, granting royalty-free licenses to six generic manufacturers to produce cheaper versions of its HIV prevention drug, lenacapavir, in 120 low- and lower-middle-income countries.
The World Health Organization has previously called on governments and pharmaceutical companies to expand access to affordable HIV treatments, pointing to voluntary licensing and increased generic competition as key tools in that effort.
