By Bunmi Yekini
…Non-Exclusive Licensing Agreements Aim to Deliver Low-Cost Generic Lenacapavir to High-Incidence, Resource-Limited Nations
Gilead Sciences, Inc. has entered into non-exclusive, royalty-free licensing agreements with six pharmaceutical manufacturers to produce and distribute generic versions of lenacapavir, a promising drug for HIV prevention and treatment. These agreements will cover 120 high-incidence, resource-limited countries, primarily in low- and lower-middle income regions, pending regulatory approvals.
This bold move is part of Gilead’s strategy to provide broad access to lenacapavir, particularly for pre-exposure prophylaxis (PrEP), in its mission to end the HIV epidemic globally. The agreements were finalized before regulatory submissions, aiming for a rapid rollout of generic lenacapavir for HIV prevention, if approved. The agreements also cover lenacapavir for heavily treatment-experienced (HTE) adults with multi-drug resistant HIV.
Daniel O’Day, Chairman and CEO of Gilead, noted the importance of swift action “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.” He further added that the company has been working urgently with high-volume generic manufacturers to ensure a seamless transition once the drug is approved for PrEP.
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O’Day explained, “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.”
The selected pharmaceutical partners include Dr. Reddy’s Laboratories Limited, Emcure, Eva Pharma, Ferozsons Laboratories Limited, Hetero, and Mylan, a subsidiary of Viatris. These partners were chosen based on their ability to produce high-quality generic medicines and sterile injectable drugs, a crucial factor in manufacturing lenacapavir.
Mitchel Warren, Executive Director of AVAC, welcomed the announcement, while urging for more progress “Today’s announcement by Gilead is good news in moving forward with injectable lenacapavir for PrEP. Voluntary licenses are essential, but not sufficient on their own to translate exciting science into public health impact.” Warren highlighted the significance of the agreements being made before regulatory approval, noting this proactive step as a positive change compared to previous licensing efforts for injectable cabotegravir. However, he urged Gilead to include key priority countries, such as Argentina, Brazil, Mexico, and Peru, which participated in lenacapavir trials but were excluded from the current licensing.
Warren added, “The focus of all stakeholders has to be speed, scale, and equity, and Gilead’s announcement today is a good step forward. But it is critical that all stakeholders ensure that there is a robust and sustainable market so that these companies are able to make large quantities and compete to drive the price down as quickly as possible to reduce new infections.”
To further support low-cost access, Gilead has devised a two-part strategy: first, establishing a strong voluntary licensing program, and second, providing Gilead-supplied lenacapavir at no profit until generic manufacturers can meet demand. This effort will initially focus on 18 countries that account for about 70% of the HIV burden, including Nigeria, South Africa, Kenya, and Uganda.
Gilead is also committed to speeding up national regulatory procedures through frameworks like the European Medicines Agency’s EU Medicines for All. “Delivering long-acting PrEP with speed, at sufficient volume to meet demand, and at prices that enable widespread availability is our priority,” O’Day stated.
These agreements build on Gilead’s 20-year track record of innovation in global health access, where partnerships with generic drug manufacturers have delivered over 30 million treatments for HIV, hepatitis, and COVID-19 in low- and middle-income countries.
The recent success of two Phase 3 trials of lenacapavir for PrEP has reinforced the urgency of its global rollout. The trials, PURPOSE 1 and PURPOSE 2, showed lenacapavir’s superiority over daily oral Truvada for HIV prevention. Based on this data, Gilead plans to begin global regulatory filings by the end of 2024, further advancing the goal of making lenacapavir accessible to those who need it most.