Hetero and Gilead License Agreement Expands Lenacapavir Access to 120 HIV High-Incidence Countries

Hetero, a leading pharmaceutical company based in Hyderabad, India, has announced a new partnership with Gilead Sciences Ireland UC to manufacture and distribute lenacapavir, an innovative HIV treatment. This collaboration is set to extend the availability of lenacapavir to 120 primarily low- and lower-middle-income countries (LMICs). The agreement, which is non-exclusive and royalty-free, represents a significant advance in global HIV care, particularly for heavily treatment-experienced patients with multi-drug-resistant HIV.

Lenacapavir, a breakthrough HIV-1 capsid inhibitor, is used in combination with other antiretrovirals to treat multi-drug-resistant HIV-1 infections. It uniquely targets multiple stages of the HIV lifecycle, offering a highly effective treatment option for patients with limited alternatives. Additionally, lenacapavir is being explored for HIV prevention through pre-exposure prophylaxis (PrEP).

Dr. Vamsi Krishna Bandi, Managing Director of Hetero Group of Companies, highlighted the importance of this partnership in enhancing HIV prevention and treatment. He noted Hetero's longstanding commitment to combating HIV/AIDS globally, with the company having developed over 30 combinations of treatment that address nearly 40% of the global HIV/AIDS population. Dr. Bandi emphasized that this agreement would accelerate access to lenacapavir in Africa, India, and other LMICs where Hetero has been a pivotal provider of HIV/AIDS care.

Leveraging its strong research capabilities and extensive manufacturing and distribution networks, Hetero aims to quickly expand the availability of lenacapavir across the agreed-upon 120 countries. The company's goal is to ensure that even the most underserved and remote areas can benefit from effective and affordable HIV prevention and treatment.

This partnership follows promising results from a pivotal Phase 3 clinical trial conducted by Gilead. An interim analysis revealed that lenacapavir reduced HIV infections by 96% compared to background incidence rates. This underlines the transformative potential of lenacapavir as a long-acting option for both treatment and prevention of HIV.

Currently, lenacapavir is being studied as a long-acting HIV prevention drug in ongoing clinical trials. The drug can be administered every six months via a subcutaneous injection after an initial oral loading dose. Lenacapavir received approval for use in HIV-positive adults with multi-drug resistance from the European Union in August 2022 and from the U.S. FDA in December 2022. However, its use for HIV prevention is still investigational and has not been approved globally.

Hetero is renowned for its vertically integrated pharmaceutical operations, which encompass research and development, manufacturing, and marketing of high-quality chemical and biologic medicines across various therapeutic areas. With over 30 years of industry experience, Hetero is one of the largest producers of Active Pharmaceutical Ingredients (APIs) worldwide. The company's strategic business areas include APIs, Global Generics, Biosimilars, and Custom Pharmaceutical Services.