Gilead Sciences, Inc. (Nasdaq: GILD) has announced the signing of non-exclusive, royalty-free voluntary licensing agreements with six pharmaceutical manufacturers to produce and distribute generic lenacapavir in 120 high-incidence, resource-limited countries, primarily targeting low- and lower-middle-income regions. These agreements precede any global regulatory submissions, enabling a swift introduction of generic lenacapavir for HIV prevention, pending regulatory approval.
The agreements are part of Gilead’s strategy to ensure widespread and sustainable access to lenacapavir for pre-exposure prophylaxis (PrEP) globally, aligning with the company’s mission to eradicate the HIV epidemic worldwide. Gilead will implement a dual strategy to facilitate low-cost access in high-incidence regions, which includes a robust voluntary licensing program and providing Gilead-supplied product at no profit until generic manufacturers can meet demand. These agreements also extend to lenacapavir for HIV treatment in heavily treatment-experienced adults with multi-drug resistant HIV.
“Given the transformative potential of lenacapavir for prevention, our focus is on making it available as quickly and broadly as possible where the need is greatest,” stated Daniel O’Day, Chairman and CEO of Gilead. “Our teams have been working urgently to onboard high-volume generic manufacturers to ensure a swift transition to these licensing partners once lenacapavir for PrEP receives approval.”
The selected generic manufacturers include Dr. Reddy’s Laboratories Limited, Emcure, Eva Pharma, Ferozsons Laboratories Limited, Hetero, and Mylan (a subsidiary of Viatris). Gilead chose these partners based on strict criteria due to the complexities involved in producing lenacapavir. All six partners have a proven track record of successfully collaborating with Gilead to produce high-quality generics for HIV and other infectious diseases, and they possess the capability to manufacture sterile injectable medicines. Gilead took into account the recommendations of global health advocates and organizations, emphasizing collaboration with manufacturers across different countries and continents.
To address the gap until generic versions become available, Gilead is focusing on registering lenacapavir in 18 countries that account for roughly 70% of the HIV burden in the licensed regions. These countries, identified in consultation with external partners, include Botswana, Eswatini, Ethiopia, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, the Philippines, Rwanda, South Africa, Tanzania, Thailand, Uganda, Vietnam, Zambia, and Zimbabwe.
