Gilead Sciences has granted non-exclusive, royalty-free licenses to six generic manufacturers to produce and distribute lenacapavir in 120 low-income countries. These countries face a high prevalence of HIV and limited resources.
The licenses encompass both the use of lenacapavir for HIV prevention (subject to approval) and its application in the treatment of heavily treatment-experienced adults with multi-drug resistant HIV. Gilead’s strategy aims to expedite the availability of lenacapavir in these underserved communities.
Gilead will implement a two-pronged strategy to ensure affordable access: a voluntary licensing program and providing its own supply of lenacapavir at no profit until generic manufacturers can meet the demand.
Gilead has carefully selected its partners based on their expertise in manufacturing high-quality generic HIV and infectious disease medicines, including sterile injectable formulations. The licensees include Dr. Reddy’s Laboratories Limited, Emcure, Eva Pharma, Ferozsons Laboratories Limited, Hetero, and Mylan.
To address the urgent need for lenacapavir, Gilead is prioritizing registration in 18 high-incidence countries, where it will provide its supply of the drug until generic versions become available. The licensees will simultaneously build manufacturing capacity to ensure a seamless transition once generic versions are approved.
This comprehensive approach reflects Gilead’s commitment to making lenacapavir accessible and affordable worldwide, with the ultimate goal of eradicating HIV.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
