South African pharmaceutical company Aspen Pharmacare is one of seven generic drug manufacturers licensed to produce and sell lower-cost versions of Merck’s experimental once-monthly oral HIV pill in 129 low- and lower-middle-income countries.
The drug, alimatravir, is currently in late-stage development. Merck said it is investing early in its product manufacturing capacity as trials continue.
Merck said the agreements are with three sub-Saharan African manufacturers — Aspen Pharmacare Holdings, Quality Chemical Industries and UCL — and four Indian companies: Aurobindo, Cipla, Emcure and Viatris.
The royalty-free agreements with these companies cover both the public and private sectors and will enable the supply of generic alimatravir in these 129 countries, which account for a substantial majority of new HIV diagnoses globally, the drugmaker said.
“This is the first time that sub-Saharan African manufacturers have been included in licenses from the very beginning,” said Gregg Szabo, head of Merck’s global vaccines and infectious diseases unit.
Merck is still enrolling patients to test alimatravir, which is expected to provide one month of protection from HIV-1 starting within one hour after dosing.
“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,” said Paul Schaper, head of global pharmaceutical public policy at Merck.
In 2024, Gilead Sciences granted royalty-free licenses to six generic drug manufacturers to make and sell cheaper copycat versions of its HIV prevention medicine, lenacapavir, in 120 low- and lower-middle-income countries.
The World Health Organisation (WHO) has urged governments and drugmakers to improve access to affordable HIV medicines, including through voluntary licensing and greater generic competition.