Key Takeaways:
Merck signed seven voluntary licensing agreements with generic drug manufacturers to produce lower-cost versions of its experimental once-monthly oral HIV pill in 129 low- and lower-middle-income countries.
"This is the first time that sub-Saharan African manufacturers have been included in licenses from the very beginning," Gregg Szabo, head of Merck's global vaccines and infectious diseases unit, said.
The royalty-free agreements cover both the public and private sectors and include three sub-Saharan Africa manufacturers — Aspen Pharmacare Holdings, Quality Chemical Industries and UCL — and four Indian companies: Aurobindo, Cipla, Emcure and Viatris. The 129 countries covered account for a substantial majority of new HIV diagnoses globally, Merck said.
The drug, alimatravir, is still in late-stage development and is expected to provide one month of protection from HIV-1 starting within one hour after dosing. Trial results are not expected until the second half of 2027, giving generic licensees time to scale up production, Paul Schaper, head of global pharmaceutical public policy at Merck, said.
The agreements follow a similar move by Gilead Sciences in 2024, which granted royalty-free licenses to six generic drug manufacturers to make cheaper versions of its HIV prevention medicine lenacapavir in 120 low- and lower-middle-income countries. The World Health Organization has urged governments and drugmakers to improve access to affordable HIV medicines, including through voluntary licensing and greater generic competition.
The licensing deal signals Merck's confidence in alimatravir's regulatory prospects while preempting access criticism that has dogged the industry. Investors will watch for Phase 3 data in the second half of 2027, which will determine the drug's commercial potential in developed markets.
This article is for informational purposes only and does not constitute investment advice.
