Gilead Expands Lenacapavir Licensing Agreements to Include Once-Yearly HIV Prevention Formulation

Gilead Sciences (NASDAQ:GILD) has expanded six existing royalty-free voluntary licensing agreements to include an investigational once-yearly formulation of lenacapavir for HIV prevention, the company announced.

The expanded agreements cover 120 countries with high HIV incidence, primarily low- and lower-middle-income nations. They are intended to support manufacturing preparations, technology transfer and supply planning ahead of potential regulatory approval.

The once-yearly formulation remains under investigation in the Phase 3 PURPOSE 365 trial and has not been approved by any regulatory authority.

Six Manufacturers Included in Expanded Agreements

Gilead’s 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.

The company said the six manufacturers were selected based on their experience producing sterile injectable medicines.

The royalty-free agreements are intended to enable the manufacturers to prepare for production and supply of the once-yearly formulation in the countries covered by the licences.

Any commercial availability of the investigational treatment remains subject to clinical trial results and applicable regulatory approvals.

Phase 3 Trial Evaluates Annual Dosing

The ongoing Phase 3 PURPOSE 365 study is evaluating the pharmacokinetics, safety and tolerability of once-yearly intramuscular lenacapavir for HIV prevention.

The open-label trial is designed to assess whether a single annual injection can maintain drug concentrations associated with HIV prevention throughout a 52-week dosing interval.

Lenacapavir is being investigated as pre-exposure prophylaxis, or PrEP, which involves the use of medication to reduce the risk of acquiring HIV.

The once-yearly formulation remains distinct from Gilead’s twice-yearly lenacapavir regimen, which has received approval for PrEP in multiple countries.

Gilead Expands Twice-Yearly Lenacapavir Supply Programme

Gilead also reported a 50% expansion of its no-profit supply programme for twice-yearly lenacapavir.

The programme’s intended reach has increased from 2 million to up to 3 million people through 2028, supported by partnerships with the US President’s Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund.

According to the company, twice-yearly lenacapavir is currently available in 10 countries across sub-Saharan Africa.

Gilead has also announced a separate agreement with the Pan American Health Organization to expand access to the twice-yearly formulation in Latin America and the Caribbean through PAHO’s Regional Revolving Funds.

These access initiatives concern the approved twice-yearly regimen, rather than the investigational once-yearly formulation.

Licensing Expansion Addresses HIV Prevention Access

The licensing announcement comes amid a substantial difference between global PrEP use and international access targets.

According to UNAIDS, fewer than 4 million people worldwide were using PrEP in 2024, compared with a global target of more than 21 million.

Gilead’s expanded licensing arrangements are intended to prepare additional manufacturing capacity for once-yearly lenacapavir while clinical development continues.

The company has not disclosed a commercial launch date for the annual formulation, which remains subject to the outcome of PURPOSE 365 and regulatory review.

Gilead Sciences stock price