On October 2, 2024, Dr. Reddy's Laboratories, Hetero, and Viatris subsidiary Mylan, among six global generic drugmakers, entered into non-exclusive, royalty-free voluntary licensing agreements with Gilead to manufacture and market the generic drug lenacapavir. This initiative aims to provide access to HIV prevention in 120 high-incidence, resource-limited countries, pending regulatory approvals.
The agreements were established prior to any global regulatory submissions to facilitate the rapid introduction of lenacapavir in low- and lower-middle-income countries. Currently, lenacapavir is investigational for HIV prevention and has not yet received global approval, with its safety and efficacy for this use still under evaluation.
Lenacapavir, initially launched under the brand name Sunlenca in 2022, is approved by the U.S. FDA for treating HIV-1 in heavily treatment-experienced adults. The agreement allows Dr. Reddy's to manage technology transfer, conduct necessary studies, and oversee product registration and launch in the designated markets.
Hetero's Managing Director, Vamsi Krishna Bandi, emphasized the importance of this agreement in ensuring quick access to lenacapavir in regions like Africa and India, where their company has a significant role in HIV/AIDS care.
Lenacapavir was approved for multi-drug-resistant HIV-1 infections by the European Union in August 2022 and received U.S. FDA approval in December 2022.