Earlier this month, Gilead Sciences announced that it had signed non-exclusive, royalty-free voluntary licensing agreements with six pharmaceutical companies to manufacture and supply high-quality, low-cost versions of lenacapavir for 120 primarily low- and lower-middle income nations.
The plans, driven by the exceptionally positive results of the PURPOSE 1 and PURPOSE 2 studies, will incorporate lenacapavir for pre-exposure prophylaxis (PrEP) to prevent HIV as well as for treating HIV.
Gilead has also committed to providing lenacapavir globally until the six generic manufacturers (Dr. Reddy’s Laboratories Limited, Emcure, Eva Pharma, Ferozsons Laboratories Limited, Hetero and Mylan) can meet global demand.
“The PURPOSE clinical trial program continues to set new standards for innovative science, trial design, community input and intentional recruitment, all coming together to yield stellar results,” said Jared Baeten, MD, PhD, Senior Vice President, Clinical Development and Virology Therapeutic Area Head, Gilead Sciences. “Gilead is committed to employing the same kind of rigorous, thoughtful and collaborative approach to ensure that lenacapavir for PrEP has the most transformative impact possible if approved.”
The PURPOSE 1 and PURPOSE 2 studies showed lenacapavir, injected every six months, was 99.9% effective at preventing HIV acquisition, higher than existing oral PrEP – in the form of TDF/FTC (marketed as Truvada).
Activists have been urging Gilead Sciences to provide this groundbreaking formulation for global use, citing its exceptional efficacy, high safety profile, and potential for changing the global fight against HIV.
Eighteen countries have been identified as priorities for initial registration and access: Botswana, Eswatini, Ethiopia, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, the Philippines, Rwanda, South Africa, Tanzania, Thailand, Uganda, Vietnam, Zambia, and Zimbabwe.
At the time of this writing, Gilead Sciences has not specified any concrete timelines for the licensing and production of generic lenacapavir.
You can read Gilead’s press release here: https://www.gilead.com/news/news-details/2024/gilead-presents-additional-efficacy-safety-and-demographic-data-from-purpose-2-trial-at-5th-hiv-research-for-prevention-conference
