Dr. Reddy’s expands collaboration with Gilead Sciences for investigational once-yearly lenacapavir for HIV prevention

Dr. Reddy’s Laboratories announced a royalty-free non-exclusive voluntary licensing agreement with Gilead Sciences for investigational once-yearly lenacapavir for HIV prevention as pre-exposure prophylaxis (PrEP).

The agreement builds on Dr. Reddy’s existing voluntary licensing arrangement with Gilead, signed in October 2024, for twice-yearly lenacapavir for HIV prevention and treatment and reflects the continued confidence between the two companies as they work towards broadening future access to long-acting HIV prevention options in licensed markets.

The agreement aims to facilitate manufacturing readiness, technology transfer and future supply planning for investigational once-yearly lenacapavir while clinical development efforts continue in the licensed territories, primarily low- and lower-middle-income countries.

The collaboration further strengthens Dr. Reddy’s Public Health Access portfolio, which focuses on improving access to medicines across communicable diseases, reproductive health, and maternal and child health. HIV continues to represent a significant global public health challenge, underscoring the need for innovative long-acting prevention options.

“At Dr. Reddy’s, we are committed to improving patient access to innovative medicines across the world,” said Deepak Sapra, Chief Executive Officer, API and Services, Dr. Reddy’s Laboratories Ltd. “This agreement builds on our existing collaboration with Gilead and reflects our continued commitment to supporting global HIV prevention efforts. If approved, investigational once-yearly lenacapavir may offer an additional long-acting HIV prevention option for people at risk of HIV acquisition, particularly in regions where access and adherence remain significant challenges.

Investigational once-yearly lenacapavir is currently being evaluated in Gilead’s ongoing Phase 3 PURPOSE 365 study. Once-yearly lenacapavir for HIV prevention is investigational and has not been approved by any regulatory authority. Its safety and efficacy have not been established.

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