Dr Reddy's Inks Pact With Gilead For Once-Yearly HIV Prevention Drug Lenacapavir

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

The agreement aims to facilitate manufacturing readiness, technology transfer, and future supply planning across 120 high-incidence licensed countries, including India, primarily low- and lower-middle-income nations, the company said in a release.

The development builds upon the drugmaker's October 2024 pact with Gilead for twice-yearly lenacapavir for HIV prevention and treatment.

"This agreement builds on our existing collaboration with Gilead and reflects our continued commitment to supporting global HIV prevention efforts," said Deepak Sapra, Chief Executive Officer, API and Services, Dr Reddy's Laboratories Ltd.

"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," he added.

Once-yearly lenacapavir is currently undergoing clinical evaluation in Gilead's Phase 3 PURPOSE 365 study. Its use for HIV prevention remains investigational, has not been approved by any regulatory authority, and its safety and efficacy are yet to be established, the release noted.

However, the use of twice-yearly lenacapavir for HIV prevention has been approved by the USFDA and the European Medicines Agency, the release pointed out, adding that WHO also recommends twice-yearly lenacapavir in its guidelines for HIV prevention.