Hyderabad: Dr Reddy’s Laboratories said Thursday it signed a royalty-free, non-exclusive voluntary licensing agreement with Gilead Sciences for investigational once-yearly lenacapavir for HIV prevention as pre-exposure prophylaxis (PrEP).
Dr Reddy’s said the pact expands its collaboration with Gilead, following its October 2024 voluntary licence covering twice-yearly lenacapavir for HIV prevention and treatment. Once-yearly lenacapavir is being evaluated in Gilead’s ongoing Phase 3 PURPOSE 365 study and is yet to be approved by any regulatory authority as its safety and efficacy for annual HIV prevention have not yet been established.
Dr Reddy’s said the new arrangement reflects continuing efforts to broaden access to long-acting HIV prevention options in licensed markets. Deepak Sapra, chief executive officer for API and services, Dr Reddy’s, said if approved, the once-yearly lenacapavir could provide another long-acting option for people at risk of HIV infection, especially where access and adherence remain challenges. Lenacapavir is approved in multiple countries for treating adults with multidrug-resistant HIV in combination with other antiretrovirals. Twice-yearly lenacapavir for HIV prevention has been approved by US Food and Drug Administration and European Medicines Agency (EMA) and is recommended by World Health Organization for HIV prevention.