Dr. Reddy’s and Gilead Sciences Expand Voluntary Licensing Agreement to Cover Investigational Once-Yearly Lenacapavir for PrEP Across 120 Countries

Dr. Reddy’s Laboratories has entered into an expanded, non-exclusive, royalty-free voluntary licensing agreement with Gilead Sciences to include an investigational once-yearly formulation of lenacapavir intended for HIV pre-exposure prophylaxis (PrEP). The deal builds directly upon the companies’ initial October 2024 licensing framework, broadening the scope to accelerate technical transfers, process development, and future commercial readiness across resource-limited global health markets.

Scope of the Expanded Agreement

Global Access Territory: Covers 120 high-incidence, low- and lower-middle-income countries (primarily across sub-Saharan Africa, South Asia, and parts of Latin America).
Licensing Consortium: Dr. Reddy’s is one of six generic pharmaceutical manufacturers selected by Gilead under this voluntary access network.
Commercial Terms: Royalty-free licensing framework designed to lower production barriers and support public-sector health programs upon drug authorization.

Molecule Profile and Clinical Pipeline

Mechanism of Action: Lenacapavir functions as a first-in-class, multi-stage, long-acting HIV-1 capsid inhibitor, interfering with viral replication at multiple lifecycle points.
Phase 3 PURPOSE 365 Study: Gilead is currently evaluating the once-yearly injectable formulation in the global Phase 3 PURPOSE 365 clinical trial to assess its efficacy and tolerability for PrEP.
Investigational Status: The once-yearly regimen is strictly investigational, with regulatory approvals, therapeutic safety profiles, and final dosing regimens still pending completion of pivotal trials.

Strategic & Manufacturing Implications

Early Technology Transfer: The licensing initiative allows Dr. Reddy’s to commence active pharmaceutical ingredient (API) synthesis, complex sterile injectable process engineering, and scale-up activities well before formal regulatory decisions.
Supply-Chain Preparedness: Addressing the traditional lag between innovative HIV drug approvals in high-income regions and broad access in high-burden markets by pre-building global distribution networks and manufacturing capacity.