HIV medication company Gilead Sciences Inc (Nasdaq: GILD) announced on Wednesday that it has signed royalty-free voluntary licensing agreements with six generic manufacturers to increase access to lenacapavir for HIV prevention and treatment in 120 low- and lower-middle-income countries. This initiative aligns with Gilead's commitment to broadening access to life-saving medications in high-incidence, resource-limited regions.

The agreements allow manufacturers, including Dr. Reddy's Laboratories, Emcure, Eva Pharma, Ferozsons Laboratories, Hetero and Mylan (a subsidiary of Viatris), to produce and distribute affordable, high-quality versions of lenacapavir, once approved, for both pre-exposure prophylaxis (PrEP) and HIV treatment. Gilead will supply lenacapavir at no profit until these manufacturers can meet demand, supporting global HIV prevention efforts.

Lenacapavir, a long-acting injectable medication, is being developed to address the evolving needs of individuals at risk of HIV, especially in areas where access to treatment is limited. While currently under investigation for use in HIV prevention, it has already shown promise in treating multi-drug resistant HIV in heavily treatment-experienced adults.

This licensing agreement is part of Gilead's broader strategy to accelerate global access to HIV prevention and treatment, building on the company's history of collaborations with generic manufacturers to deliver low-cost therapies for infectious diseases. Gilead will prioritise regulatory approvals in 18 countries, including South Africa, Kenya and Uganda, where the burden of HIV is highest, to ensure rapid access to lenacapavir.

Gilead's PURPOSE trials, including the recently unblinded Phase 3 studies, demonstrated the efficacy of lenacapavir in reducing HIV incidence, further reinforcing its potential as a powerful tool in the fight against the HIV epidemic. Regulatory filings for lenacapavir for PrEP are expected to begin by the end of 2024.