By Christy Santhosh
July 24 (Reuters) – Merck said on Friday it signed seven voluntary licensing agreements with generic drug manufacturers to make and sell lower-cost versions of its 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.
Here are some details:
• Merck said the agreements are with three sub-Saharan Africa manufacturers – Aspen Pharmacare Holdings, Quality Chemical Industries and UCL – and four Indian companies, which are Aurobindo, Cipla, Emcure and Viatris.
• The royalty-free agreements with these companies cover both the public and private sectors and will enable supply of generic alimatravir in these 129 countries that 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 Organization has urged governments and drugmakers to improve access to affordable HIV medicines, including through voluntary licensing and greater generic competition.
(Reporting by Christy Santhosh in Bengaluru; Editing by Tasim Zahid)
