Gilead Sciences has signed non-exclusive, royalty-free voluntary licensing agreements with six pharmaceutical manufacturers to produce and sell generic lenacapavir, subject to required regulatory approvals, in 120 high-incidence, resource-limited 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 agreements advance Gilead’s strategy to enable broad, sustainable access to lenacapavir for pre-exposure prophylaxis (PrEP) globally if it is approved, and align with the companies’ target to end the HIV epidemic. Gilead will support low-cost access to the drug in high-incidence, resource-limited countries through a two-part strategy: establishing a robust voluntary licensing programme, and planning to provide Gilead-supplied product at no profit to Gilead until generic manufacturers are able to fully support demand. The agreements also cover lenacapavir for HIV treatment in heavily treatment-experienced (HTE) adults with multi-drug resistant HIV.