Gilead Sciences has announced the signing of voluntary licencing agreements with six generic pharmaceutical manufacturers to facilitate access to lenacapavir, a potential human immunodeficiency virus (HIV) prevention drug, in 120 resource-limited and high-incidence nations.
The company signed agreements with Dr. Reddy’s Laboratories, Eva Pharma, Emcure, Ferozsons Laboratories, Mylan, a subsidiary of Viatris, and Hetero.
These agreements, which are royalty-free and nonexclusive, will allow the production and sale of generic lenacapavir, pending regulatory approvals.
The initiative is part of Gilead's strategy to ensure broad, sustainable access to lenacapavir globally for preexposure prophylaxis (PrEP), aligning with its goal to end the HIV epidemic.
Initially, the drug will be supplied at no profit until generic versions are available, and the agreements also encompasses lenacapavir for HIV treatment in adults with multi-drug resistant HIV.
The companies are expected to build manufacturing capacity for lenacapavir. Gilead is prioritising registration in 18 countries, which carry about 70% of the HIV burden within the licensed territories.
Gilead chair and CEO Daniel O’Day said: “Given the transformative potential of lenacapavir for prevention, our focus is on making it available as quickly and broadly as possible where the need is greatest.
“Gilead teams have been working with urgency to bring on high-volume generic manufacturers now, so that we can ensure a rapid transition to these voluntary license partners after lenacapavir for PrEP is approved.”
Two Phase III trials, PURPOSE 1 and PURPOSE 2, evaluated lenacapavir for PrEP, leading to their early unblinding.
These trials included diverse populations across several countries. Gilead said it is committed to providing post-trial access to lenacapavir for participants and plans to begin global regulatory filings by the end of 2024.
Gilead is also exploring expedited regulatory frameworks, such as the European Medicines Agency’s EU Medicines for All, to hasten the approval process in high-incidence, resource-limited countries.
The company will update on the progress of regulatory discussions for lenacapavir as a PrEP method.
Lenacapavir is still investigational for HIV prevention and has not yet received approval in any country.
In May this year, Cartography Biosciences entered into a strategic partnership with Gilead Sciences, focusing on the discovery and development of new oncology therapies.
