Gilead expands lenacapavir licensing to cover once-yearly HIV prevention

Gilead Sciences (Nasdaq: GILD) has expanded its six existing royalty-free voluntary licensing agreements to include an investigational once-yearly formulation of lenacapavir for HIV prevention as pre-exposure prophylaxis (PrEP), according to a company statement.

The expanded agreements cover 120 high-incidence, primarily low- and lower-middle-income countries and are intended to support manufacturing readiness, technology transfer, and supply planning while the Phase 3 PURPOSE 365 trial remains ongoing. Once-yearly lenacapavir has not been approved by any regulatory authority.

The six licensing partners are Dr. Reddy's Laboratories Limited, Emcure Pharmaceuticals Limited, Eva Pharma for Pharmaceutical Industries S.A.E., Ferozsons Laboratories Limited, Hetero, and Mylan Laboratories Limited, a subsidiary of Viatris. Gilead said the manufacturers were selected based on their experience producing sterile injectable medicines.

PURPOSE 365 is an ongoing Phase 3, open-label study evaluating the pharmacokinetics, safety, and tolerability of once-yearly intramuscular lenacapavir for HIV prevention. The study is designed to assess whether a single annual dose can maintain drug concentrations associated with HIV prevention over a 52-week interval.

Gilead's twice-yearly lenacapavir is already approved in multiple countries for PrEP. The company said it has expanded its no-profit supply program by 50%, from 2 million to up to 3 million people through 2028, through partnerships with PEPFAR and the Global Fund. Twice-yearly lenacapavir is currently available in 10 countries across sub-Saharan Africa.

Gilead also recently announced a separate agreement with the Pan American Health Organization to expand access to twice-yearly lenacapavir across Latin America and the Caribbean through PAHO's Regional Revolving Funds.

UNAIDS has reported that fewer than 4 million people were using PrEP globally in 2024, compared with a global target of more than 21 million people.

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