has entered into 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.
“At Dr. Reddy’s, we are committed to improving patient access to innovative medicines across the world,”
“This agreement builds on our existing collaboration with Gilead and reflects our continued commitment to supporting global HIV prevention efforts,” Deepak Sapra, Chief Executive Officer, API and Services, Dr. Reddy’s Laboratories, said in a release on Thursday.
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 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, the company said.
Lenacapavir is approved in multiple countries for the treatment of adults with multi-drug-resistant HIV in combination with other antiretrovirals.
The use of twice-yearly lenacapavir for HIV prevention is also approved by the USFDA and the European Medicines Agency. WHO also recommends twice-yearly lenacapavir in its guidelines for HIV prevention.
The use of once-yearly lenacapavir is investigational, and the safety and efficacy of lenacapavir for this use have not been established.
The multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiviral agents. It is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead’s HIV prevention and treatment research programme, the release said.