Gilead Sciences Ireland UC has signed non-exclusive, royalty-free voluntary licensing agreements with six pharmaceutical manufacturers to make and sell generic lenacapavir, subject to required regulatory approvals, in 120 high-incidence, resource-limited countries, which are primarily low- and lower-middle income countries. The agreements were signed in advance of any global regulatory submissions to enable these countries to quickly introduce generic versions of lenacapavir for HIV prevention if approved.
The generic companies that will manufacture and supply lenacapavir to the 120 countries are Dr Reddy’s Laboratories, Emcure Pharma, Hetero Drugs and Mylan Labs (a subsidiary of Viatris), Eva Pharma (Egypt), and Ferozsons Laboratories (Pakistan).
Lenacapavir is a USFDA-approved drug indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations. Additionally, Lenacapavir is currently under investigation for the prevention of HIV (PrEP) which is yet to be approved globally. Gilead Sciences first launched Lenacapavir under the brand name Sunlenca in the United States and Europe markets in the year 2022. It is a first-in-class HIV-1 capsid inhibitor.