Gilead Partners with Six Generic Manufacturers for Royalty-Free Licensing to Boost Lenacapavir Access for HIV Prevention in Resource-Limited Countries
Gilead Sciences, Inc. announced that it has signed non-exclusive, royalty-free voluntary licensing agreements with six pharmaceutical manufacturers to make and sell generic lenacapavir, subject to required regulatory approvals, in 120 high-incidence, resource-limited countries, which are primarily low- and lower-middle income 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 Gilead’s vision of ending the HIV epidemic for everyone, everywhere. 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 program, and planning to provide Gilead-supplied product at no profit to Gilead until generic manufacturers are able to fully support demand. Additionally, the agreements cover not only lenacapavir for HIV prevention (pending approval), but also lenacapavir for HIV treatment in heavily treatment-experienced (HTE) 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,” said Daniel O’Day, Chairman and Chief Executive Officer of Gilead. “Gilead teams have been working with urgency to bring on high-volume generic manufacturers now, so that we can ensure a rapid transition to these voluntary license partners after lenacapavir for PrEP is approved.”
The generic companies that will manufacture and supply lenacapavir to the 120 countries are Dr. Reddy’s Laboratories Limited, Emcure, Eva Pharma, Ferozsons Laboratories Limited, Hetero and Mylan, a subsidiary of Viatris.
Gilead selected its partners based on rigorous criteria, given the challenges of manufacturing a complex medicine like lenacapavir. All six partners have successfully collaborated with Gilead to produce high-quality generic versions of medicines for HIV or other infectious diseases and are well equipped to produce sterile injectable medicines. In selecting the licensees, Gilead listened to global health advocates and organizations that advised partnering with manufacturers from multiple countries and continents.