Gilead Sciences has unveiled plans to make affordable versions of its groundbreaking HIV prevention drug, lenacapavir, available in 120 low and middle-income countries. Lenacapavir, which is administered as a twice-yearly injection, has shown promising results in clinical trials, significantly reducing HIV infection rates among both women and men.
In trials conducted in South Africa and Uganda, lenacapavir effectively prevented HIV infections among girls and women. A subsequent trial involving men across several countries, including Argentina, Brazil, Mexico, Peru, South Africa, Thailand, and the US, indicated nearly complete protection.
In a statement, Gilead announced that it has entered into non-exclusive, royalty-free voluntary licensing agreements with six pharmaceutical manufacturers, allowing them to produce and sell generic lenacapavir in these countries. The manufacturers include Dr. Reddy’s Laboratories Limited, Emcure, Eva Pharma, Ferozsons Laboratories Limited, Hetero, and Mylan, a subsidiary of Viatris.
Gilead emphasized that the agreements were signed before any global regulatory approvals to facilitate the swift introduction of generic versions of lenacapavir for HIV prevention. Additionally, Gilead will provide its supply of the drug to bridge the gap until the licensed manufacturers are operational, prioritizing registration in 18 high HIV prevalence countries, including Botswana, Eswatini, Ethiopia, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, the Philippines, Rwanda, South Africa, Tanzania, Thailand, Uganda, Vietnam, Zambia, and Zimbabwe.
“The agreements advance Gilead’s strategy to enable broad, sustainable access to lenacapavir for pre-exposure prophylaxis (PrEP) globally if approved, and align with Gilead’s vision of ending the HIV epidemic for everyone, everywhere,” the company stated.
Gilead’s two-part strategy aims to ensure low-cost access to lenacapavir in resource-limited countries by establishing a robust voluntary licensing program and providing Gilead-supplied products at no profit until generic manufacturers can fully meet demand. The agreements also extend to lenacapavir for HIV treatment in heavily treatment-experienced adults with multi-drug resistant HIV.
Daniel O’Day, CEO of Gilead, expressed the urgency of making lenacapavir widely available, stating, “Given the transformative potential of lenacapavir, the focus is on making it available as quickly and broadly as possible.” He added that Gilead teams have been working diligently to onboard high-volume generic manufacturers to facilitate a rapid transition to the voluntary license partners once lenacapavir for PrEP is approved.