Hetero Drugs Ltd.

Gilead will provide the drug at a non-profit margin until generics enter the market. Credit: Tada Images via Shutterstock. 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. See Also: FDA lifts clinical hold on Avidity’s lead antibody conjugate therapy trial 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.

Gilead Sciences has announced voluntary licensing agreements with six generic manufacturers to produce low-cost versions of lenacapavir for HIV prevention in 120 resource-limited countries. The agreements aim to improve access to the drug in countries with high HIV incidence, primarily in low- and lower-middle-income regions. The licensing covers both the prevention of HIV and treatment in adults with multi-drug-resistant HIV. To ensure rapid access, Gilead will provide lenacapavir at no profit until the generic manufacturers can fully meet demand.The company has also prioritized registration in 18 countries that account for 70% of the HIV burden, with plans to begin regulatory filings for lenacapavir as HIV pre-exposure prophylaxis (PrEP) by the end of 2024. The agreements are part of Gilead’s broader goal to end the HIV epidemic by supporting sustainable access to long-acting PrEP and working closely with global health advocates. The manufacturers — Dr. Reddy’s Laboratories, Emcure, Eva Pharma, Ferozsons Laboratories, Hetero, and Mylan (a subsidiary of Viatris) — were chosen for having a strong track record of producing generic medicines. Lenacapavir for HIV prevention is still investigational and pending regulatory approval.

iStock, Sundry Photography Gilead Sciences is granting licenses to six companies to produce lenacapavir for pre-exposure prophylaxis, as well as for treating human immunodeficiency virus in heavily pre-treated adults with multidrug-resistant infections. Gilead Sciences on Wednesday announced that it has entered into non-exclusive, royalty free and voluntary licensing deals with developers to manufacture and sell a generic version of its HIV drug lenacapavir in more than 100 resource-limited countries. Under the terms of the agreements, Gilead is granting licenses to six generics developers to produce lenacapavir for pre-exposure prophylaxis (PrEP), as well as for treating HIV in heavily pre-treated adults with multidrug-resistant infections. The six selected partners are Dr. Reddy’s Laboratories, Emcure, Eva Pharma, Ferozsons Laboratories, Hetero and Viatris’ Mylan. Gilead will also provide its products at no profit until its generics partners can fully support demand. The licensing deals will cover 120 low- and middle-income countries where the incidence of HIV is high. The agreements were signed before filing global regulatory applications for lenacapavir “to enable these countries to quickly introduce generic versions” of the drug, according to the company. The deals underscore Gilead’s commitment to make lenacapavir “available as quickly and broadly as possible where the need is greatest,” CEO Daniel O’Day said in a statement, noting that the company has 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.” Lenacapavir is an HIV-1 capsid inhibitor that works by inhibiting various steps of the virus’ life cycle, including the final viral assembly and release into the extracellular space. Unlike other antiviral HIV therapies, lenacapavir targets multiple steps of viral replication. Lenacapavir currently has no documented cross-resistances to other drug classes. Approved under the brand name Sunlenca, lenacapavir won the FDA’s nod in December 2022 as a twice-yearly option treatment for patients with multi-drug-resistant HIV, though its use as PrEP has not yet been cleared. Gilead ran the Phase III PURPOSE program to assess the potential of lenacapavir for HIV prophylaxis. In June 2024, the pharma released data from PURPOSE 1, touting a 100% prevention efficacy in cisgender women . Last month, Gilead followed this up with an interim readout from PURPOSE II, which demonstrated a 96% HIV risk reduction in a broader population including cisgender men, transgender men, transgender women and gender non-binary individuals who have sex with partners assigned male at birth. Gilead is set to start regulatory filings for lenacapavir as PrEP by the end of the year. Wednesday’s licensing deals come as the pharma has faced increasing pressure from various organizations to improve access to its HIV medicine. In July 2024, UNAIDS Executive Director Winnie Byanyima urged Gilead to “move quickly to license lenacapavir to generics producers,” which can “bring the price down and sere all countries where the majority of people who are at risk live.” Byanyima in a statement on Wednesday applauded Gilead, while noting that “much more work is urgently needed to ensure … that Gilead’s commitment to rapid, affordable access is fulfilled.”