Gilead Sciences is granting licenses to six companies to produce lenacapavir for pre-exposure prophylaxis, as well as for treating human immunodeficiency virus in heavily pre-treated adults with multidrug-resistant infections.
Gilead Sciences on Wednesday announced that it has entered into non-exclusive, royalty free and voluntary licensing deals with developers to manufacture and sell a generic version of its HIV drug lenacapavir in more than 100 resource-limited countries.
Under the terms of the agreements, Gilead is granting licenses to six generics developers to produce lenacapavir for pre-exposure prophylaxis (PrEP), as well as for treating HIV in heavily pre-treated adults with multidrug-resistant infections. The six selected partners are Dr. Reddy’s Laboratories, Emcure, Eva Pharma, Ferozsons Laboratories, Hetero and Viatris’ Mylan.
Gilead will also provide its products at no profit until its generics partners can fully support demand. The licensing deals will cover 120 low- and middle-income countries where the incidence of HIV is high. The agreements were signed before filing global regulatory applications for lenacapavir “to enable these countries to quickly introduce generic versions” of the drug, according to the company.
The deals underscore Gilead’s commitment to make lenacapavir “available as quickly and broadly as possible where the need is greatest,” CEO Daniel O’Day said in a statement, noting that the company has 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.”
Lenacapavir is an HIV-1 capsid inhibitor that works by inhibiting various steps of the virus’ life cycle, including the final viral assembly and release into the extracellular space. Unlike other antiviral HIV therapies, lenacapavir targets multiple steps of viral replication. Lenacapavir currently has no documented cross-resistances to other drug classes.
Approved under the brand name Sunlenca, lenacapavir won the FDA’s nod in December 2022 as a twice-yearly option treatment for patients with multi-drug-resistant HIV, though its use as PrEP has not yet been cleared.
Gilead ran the Phase III PURPOSE program to assess the potential of lenacapavir for HIV prophylaxis. In June 2024, the pharma released data from PURPOSE 1, touting a 100% prevention efficacy in cisgender women. Last month, Gilead followed this up with an interim readout from PURPOSE II, which demonstrated a 96% HIV risk reduction in a broader population including cisgender men, transgender men, transgender women and gender non-binary individuals who have sex with partners assigned male at birth.
Gilead is set to start regulatory filings for lenacapavir as PrEP by the end of the year.
Wednesday’s licensing deals come as the pharma has faced increasing pressure from various organizations to improve access to its HIV medicine. In July 2024, UNAIDS Executive Director Winnie Byanyima urged Gilead to “move quickly to license lenacapavir to generics producers,” which can “bring the price down and sere all countries where the majority of people who are at risk live.”
Byanyima in a statement on Wednesday applauded Gilead, while noting that “much more work is urgently needed to ensure … that Gilead’s commitment to rapid, affordable access is fulfilled.”
