Gilead works with generic drug developers to make HIV drugs available to low-income countries

Gilead Sciences announced on Wednesday that this was the case non-exclusive, royalty-free and voluntary license agreements with developers to make and sell a generic version of its HIV drug lenacapavir in more than 100 resource-limited countries.

Under the terms of the agreements, Gilead will license six generic developers to produce lenacapavir for pre-exposure prophylaxis (PrEP) and the treatment of HIV in heavily pretreated 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 offer its products at no profit until its generic partners can fully meet demand. The licensing agreements cover 120 low- and middle-income countries where HIV incidence is high. The agreements were signed ahead of the submission of global regulatory submissions for lenacapavir “to enable these countries to quickly introduce generic versions of the drug,” the company said.

The contracts underscore Gilead's commitment to making lenacapavir “available as quickly and widely as possible where the need is greatest,” CEO Daniel O'Day said in a statement, noting that the company was “working diligently to achieve this to bring generics onto the market in large quantities”. Now we can reach out to manufacturers to ensure a rapid transition to these voluntary licensing partners once lenacapavir is approved for PrEP.”

Lenacapavir is an HIV-1 capsid inhibitor that inhibits various steps in the virus life cycle, including final virus assembly and release into the extracellular space. Unlike other HIV antiviral therapies, lenacapavir targets multiple steps of viral replication. There are currently no documented cross-resistances for lenacapavir with other drug classes.

Approved under the brand name Sunlenca, Lenacapavir won approval from the FDA in December 2022 as a twice-yearly option treatment for patients with multidrug-resistant HIV, although its use as PrEP is not yet approved.

Gilead conducted the Phase III PURPOSE program to evaluate the potential of lenacapavir for HIV prophylaxis. In June 2024, the pharmaceutical company released data from PURPOSE 1, It touts 100 percent prevention effectiveness among cisgender women. Last month, Gilead released a preliminary reading of PURPOSE II, which showed a 96% reduction in HIV risk in a broader population, including cisgender men, transgender men, transgender women, and gender-neutral people who have sex with partners assigned male at birth.

Gilead is expected to begin filing applications for lenacapavir as PrEP by the end of the year.

Wednesday's licensing agreements come as the drug company faces increasing pressure from various organizations to improve access to its HIV drugs. In July 2024: UNAIDS Executive Director Winnie Byanyima urged Gilead should “move expeditiously to license lenacapavir to generic manufacturers,” which can “lower the price and provide coverage to all countries where the majority of vulnerable people live.”

Byanyima in one opinion on Wednesday applauded Gilead while noting that “much more work is urgently needed to ensure Gilead's commitment to rapid and affordable access is met.”