Gilead Sciences has expanded six royalty-free voluntary licensing agreements to include investigational once-yearly lenacapavir for HIV prevention as pre-exposure prophylaxis, or PrEP.
The agreements cover 120 high-incidence countries, primarily low- and lower-middle-income countries. They are intended to support manufacturing readiness, technology transfer and future supply planning while Gilead’s Phase III PURPOSE 365 study is ongoing.
PURPOSE 365 is evaluating the pharmacokinetics, safety and tolerability of once-yearly intramuscular lenacapavir for HIV prevention.
The agreements were signed with Dr. Reddy’s Laboratories, Emcure Pharmaceuticals, Eva Pharma for Pharmaceutical Industries, Ferozsons Laboratories, Hetero and Mylan Laboratories, a Viatris subsidiary. The same companies are manufacturing twice-yearly lenacapavir for HIV prevention under existing voluntary licensing agreements with Gilead.
Gilead said the manufacturers were selected based on their experience producing complex sterile injectable medicines and their history as voluntary licensing partners with the company.
Once-yearly lenacapavir remains investigational and has not been approved for HIV prevention. Gilead said that, if approved, a single annual dose could provide HIV prevention for one year.
The licensing expansion follows Phase III PURPOSE 1 and PURPOSE 2 trials of twice-yearly lenacapavir for HIV prevention. Gilead said twice-yearly lenacapavir showed superiority to a daily oral PrEP comparator in those studies.
The company said it is extending its access model for twice-yearly lenacapavir to include potential future generic long-acting HIV-prevention options.
The agreements are intended to allow licensing partners to prepare manufacturing and supply activities before the completion of the Phase III trial and potential regulatory approvals.
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