Gilead extends lenacapavir licensing deals to cover investigational once yearly HIV prevention shot

Gilead Sciences has widened its six royalty free voluntary licensing agreements for lenacapavir so they now include its investigational once yearly formulation for HIV pre-exposure prophylaxis (PrEP). The agreements cover 120 high incidence countries, most of them low and lower middle income, and are meant to support manufacturing readiness, technology transfer and supply planning while the Phase 3 PURPOSE 365 trial is still running.

PURPOSE 365 is evaluating the pharmacokinetics, safety and tolerability of once yearly intramuscular lenacapavir for HIV prevention. If the drug is approved, a single annual dose would protect against HIV for a full year, which Gilead says could widen prevention choices and ease the barriers that limit PrEP uptake and persistence.

The expansion builds on Gilead’s access model for the twice yearly version of lenacapavir, which the company is extending to support multiple generic long acting prevention options. That version showed superiority over a daily oral PrEP comparator across diverse populations in the Phase 3 PURPOSE 1 and PURPOSE 2 trials. Gilead describes the new agreements as one of the earliest HIV PrEP access planning efforts to take place during Phase 3 development, drawing on about two decades of experience building global access pathways for its HIV medicines.

Johanna Mercier, Gilead’s chief commercial and corporate affairs officer, said a discreet, extended duration option could matter most in high incidence, resource limited settings, where people often struggle to obtain PrEP and stay on it. She said signing licensing agreements this early gives manufacturers, health systems and communities more time to prepare, with the aim of shortening and broadening the path from innovation to impact if the drug is approved.

The agreements were signed with the six companies already manufacturing twice yearly lenacapavir for PrEP under license: Dr. Reddy’s Laboratories, Emcure Pharmaceuticals, Eva Pharma for Pharmaceutical Industries, Ferozsons Laboratories, Hetero and Mylan Laboratories, a Viatris subsidiary. Gilead chose them for their track record in producing complex sterile injectable medicines and their history as licensing partners.

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Related Topics and Keywords

#GlobalHealth, #HIVPrevention, #PrEP, #PURPOSE365, #VoluntaryLicensing, Biopharma, gilead, lenacapavir