Gilead Sciences has announced voluntary licensing agreements with six generic manufacturers to produce low-cost versions of lenacapavir for HIV prevention in 120 resource-limited countries.
The agreements aim to improve access to the drug in countries with high HIV incidence, primarily in low- and lower-middle-income regions. The licensing covers both the prevention of HIV and treatment in adults with multi-drug-resistant HIV.
To ensure rapid access, Gilead will provide lenacapavir at no profit until the generic manufacturers can fully meet demand. The company has also prioritized registration in 18 countries that account for 70% of the HIV burden, with plans to begin regulatory filings for lenacapavir as HIV pre-exposure prophylaxis (PrEP) by the end of 2024.
The agreements are part of Gilead’s broader goal to end the HIV epidemic by supporting sustainable access to long-acting PrEP and working closely with global health advocates. The manufacturers — Dr. Reddy’s Laboratories, Emcure, Eva Pharma, Ferozsons Laboratories, Hetero, and Mylan (a subsidiary of Viatris) — were chosen for having a strong track record of producing generic medicines.
Lenacapavir for HIV prevention is still investigational and pending regulatory approval.