Merck strikes early licensing deals for experimental HIV pill in developing world

Merck (MRK) has signed voluntary licensing agreements with seven generic drug manufacturers to produce and sell lower-cost versions of its experimental once-monthly oral HIV pill, alimatravir, across 129 low- and lower-middle-income countries — an unusually early move that comes while the drug is still in late-stage clinical development.

The royalty-free agreements span both public and private sectors and cover countries that collectively account for a substantial majority of new HIV diagnoses worldwide. Merck said it is already investing in manufacturing capacity for the drug as trials continue.

The licensees include three sub-Saharan African manufacturers — Aspen Pharmacare (APNJ), Quality Chemical Industries and UCL — and four Indian companies: Aurobindo, Cipla, Emcure and Viatris. Gregg Szabo, head of Merck's global vaccines and infectious diseases unit, described the inclusion of African manufacturers from the outset as a first for the industry. "This is the first time that sub-Saharan African manufacturers have been included in licenses from the very beginning," he said.

Alimatravir is designed to provide one month of protection from HIV-1, with protection beginning within one hour of dosing. Patient enrollment for the drug's trials is still ongoing, and results are not expected until the second half of next year. Paul Schaper, head of global pharmaceutical public policy at Merck, said the early licensing strategy was deliberate. "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 move follows a similar initiative by Gilead Sciences (GILD), which in 2024 granted royalty-free licenses to six generic manufacturers to produce its HIV prevention medicine lenacapavir in 120 low- and lower-middle-income countries. The World Health Organization has pressed governments and drugmakers to improve access to affordable HIV medicines through mechanisms including voluntary licensing and expanded generic competition.

According to UNAIDS data, approximately 40.9 million people were living with HIV globally in 2025, with sub-Saharan Africa accounting for more than half of all cases worldwide.