Dr. Reddy’s Laboratories has expanded its collaboration with Gilead Sciences through a royalty-free, non-exclusive voluntary licensing agreement covering investigational once-yearly lenacapavir for HIV prevention. The agreement builds on the companies’ existing 2024 licensing arrangement for lenacapavir and is intended to support future manufacturing readiness, technology transfer and supply planning in licensed territories.
Under the expanded agreement, Dr. Reddy’s is among six generic manufacturers covered by Gilead’s licensing framework for once-yearly lenacapavir. The agreements cover 120 high-incidence countries, primarily low- and lower-middle-income countries, with the objective of preparing manufacturing and supply systems while clinical development continues.
Once-yearly lenacapavir is currently being evaluated in the Phase 3 PURPOSE 365 study as a pre-exposure prophylaxis (PrEP) option for HIV prevention. The once-yearly formulation remains investigational and has not been approved by regulatory authorities, so its safety and efficacy for this use have not yet been established.
Lenacapavir is a long-acting HIV capsid inhibitor. Dr. Reddy’s already holds a voluntary licensing agreement with Gilead covering manufacture and commercialisation of lenacapavir in India and up to 120 countries. The earlier agreement was announced in October 2024 and covered the treatment indication as well as potential future HIV-prevention applications subject to regulatory approvals.
The expanded collaboration could allow Dr. Reddy’s to prepare manufacturing capabilities and future supply infrastructure ahead of potential regulatory approvals for once-yearly HIV prevention. Meanwhile, Gilead has stated that the Phase 3 PURPOSE 365 study remains ongoing.
