GILD Grants Right for HIV PrEP Candidate to Six Generic Companies

Core Insights - Gilead Sciences has entered licensing agreements with six pharmaceutical companies to produce a low-cost version of lenacapavir for HIV prevention in 120 low-and lower-middle-income countries [1][3] - Lenacapavir has shown promising results in late-stage studies, achieving primary efficacy goals and demonstrating superior efficacy compared to Truvada [2] - Gilead aims to support access to lenacapavir through a royalty-free licensing program and will supply the drug at no profit until generic manufacturers can meet demand [3][5] Licensing Agreements - The selected companies for manufacturing lenacapavir include Dr. Reddy's Laboratories, Emcure, Eva Pharma, Ferozsons Laboratories, Hetero, and Mylan [1] - The agreements cover lenacapavir for both prevention and treatment of multi-drug-resistant HIV [3] - Gilead's choice of partners was based on their experience in producing high-quality generics and sterile injectable medicines [3] Market Strategy - Gilead plans to register lenacapavir in 18 countries that account for approximately 70% of the HIV burden in the licensed regions [5] - The countries targeted for registration include Botswana, Kenya, Nigeria, South Africa, and others [5] - Gilead has previously enabled access to affordable treatments for HIV and other diseases through partnerships, distributing over 30 million treatments in low-and middle-income countries [5] Clinical Development - Two pivotal studies, PURPOSE 1 and PURPOSE 2, have shown that lenacapavir, administered twice a year, is more effective than the daily oral dose of Truvada [2] - Gilead plans to submit global regulatory filings for lenacapavir by the end of 2024 [2] - Year-to-date, Gilead's shares have increased by 4.6%, outperforming the industry average decline of 1.5% [2]