Key Highlights:
- Dr. Reddy’s Laboratories has entered a royalty-free, non-exclusive voluntary licensing agreement with Gilead Sciences covering investigational once-yearly lenacapavir for HIV pre-exposure prophylaxis (PrEP). The agreement supports manufacturing readiness, technology transfer, and future supply planning across 120 high-incidence countries, including India.
- The once-yearly formulation is being evaluated in the Phase 3 PURPOSE 365 trial. If approved, it could provide HIV prevention with a single annual dose, while addressing barriers associated with more frequent PrEP dosing.
- The agreement builds on Dr. Reddy’s existing 2024 partnership with Gilead for twice-yearly lenacapavir. Importantly, once-yearly lenacapavir for HIV prevention remains investigational and is not yet approved by any regulatory authority.
Implications:
By preparing manufacturing and technology transfer now, Dr. Reddy’s can help expand long‑acting PrEP options beyond daily pills and six‑monthly injections, potentially improving adherence and access in resource‑limited settings while strengthening its HIV portfolio as Gilead advances the Phase 3 PURPOSE 365 trial.
Source: ET Pharma
