Dr. Reddy's Laboratories and Hetero have entered into non-exclusive, royalty-free voluntary licensing agreements with Gilead Sciences to manufacture and commercialize generic versions of lenacapavir in 120 high-incidence, resource-limited countries. This agreement aims to expand access to this crucial HIV medication in regions where it is most needed.
Lenacapavir: A Breakthrough HIV-1 Capsid Inhibitor
Lenacapavir, a first-in-class capsid inhibitor, is approved by the U.S. FDA and the European Union for treating HIV-1 infection in heavily treatment-experienced adults with multi-drug resistant HIV-1. These are individuals who have failed their current antiretroviral regimen due to resistance, intolerance, or safety considerations. Gilead Sciences launched lenacapavir under the brand name Sunlenca in the U.S. and Europe in 2022. The drug works in conjunction with other antiretroviral medications to combat multi-drug-resistant HIV-1 infections.
Focus on HIV Prevention (PrEP)
In addition to its therapeutic use, lenacapavir is under investigation for the prevention of HIV (pre-exposure prophylaxis or PrEP). While not yet approved globally for PrEP, studies are underway to evaluate its efficacy in this context. The licensing agreement grants Dr. Reddy's the rights to manufacture and commercialize lenacapavir for HIV prevention in the 120 specified countries, pending regulatory approval.
Dr. Reddy's Role and Responsibilities
Under the agreement, Dr. Reddy's will manage technology transfer at its manufacturing site, conduct bioequivalence and clinical studies, and handle product registration and launches in the agreed-upon markets. This comprehensive approach ensures that the generic version of lenacapavir meets the necessary quality and regulatory standards for distribution in these regions.
Impact on Global HIV Treatment
Deepak Sapra, CEO API and Services, Dr. Reddy's Laboratories, emphasized that the collaboration with Gilead will facilitate the availability of this latest treatment option to patients in 120 primarily low- and lower-middle-income countries, including India. Many of these countries face a significant burden of HIV, making access to effective treatments like lenacapavir crucial for improving public health outcomes.
Hetero Group of Companies Managing Director, Vamsi Krishna Bandi, stated that Hetero will bring quick access to lenacapavir in Africa, India and other LMICs, where they’ve been a cornerstone of HIV/AIDS care.
