Pharmacovigilance Aspects of Licensing Agreements Training Course: Ensuring Compliance and Quality Management in Global Partnerships.

This training course will review global pharmacovigilance requirements in licensing agreements, emphasizing compliance with legal obligations and good pharmacovigilance practice. The course will cover global regulatory frameworks, best practices in licensing agreements, legal aspects, and audit and compliance aspects of third-party agreements. It will be of interest to all personnel involved in business development, licensing agreements, drug safety, regulatory affairs, and drug registration.

Gilead Sciences, Inc. (Nasdaq: GILD) has taken a significant step towards expanding access to its investigational HIV prevention drug, lenacapavir, by signing non-exclusive, royalty-free voluntary licensing agreements with six pharmaceutical manufacturers. These agreements, announced on October 1, 2024, aim to increase access to lenacapavir in 120 high-incidence, resource-limited countries, primarily low- and lower-middle income nations [1].

The agreements allow the six manufacturers—Dr. Reddy’s Laboratories Limited, Emcure, Eva Pharma, Ferozsons Laboratories Limited, Hetero, and Mylan, a subsidiary of Viatris—to produce and supply generic versions of lenacapavir. Gilead plans to price the product at no profit to the company and will supply lenacapavir until generic manufacturers can fully support demand [1].

Gilead's strategy aligns with its broader vision of ending the HIV epidemic globally. The company is prioritizing registration in 18 countries that represent about 70% of the HIV burden in the named countries. These countries are Botswana, Eswatini, Ethiopia, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, Philippines, Rwanda, South Africa, Tanzania, Thailand, Uganda, Vietnam, Zambia, and Zimbabwe [1].

The agreements also cover lenacapavir for HIV treatment in heavily treatment-experienced adults with multi-drug resistant HIV. Daniel O’Day, Chairman and Chief Executive Officer of Gilead, emphasized the importance of making lenacapavir available quickly and broadly where the need is greatest [1].

Gilead's efforts to expand access to lenacapavir reflect extensive consultations with more than 100 global health stakeholders. The company's partnerships with generic drug manufacturers have already helped make high-quality, low-cost therapies available to millions of people in low- and middle-income countries [1].

Gilead is committed to ensuring that individuals who participated in the PURPOSE studies have access to lenacapavir for PrEP post-trial. The company will begin a series of global regulatory filings for lenacapavir for PrEP by the end of 2024. Updates on these filings will be shared as discussions with regulatory bodies progress [1].

References:
[1] https://www.businesswire.com/news/home/20241001289353/en/Gilead-Signs-Royalty-Free-Voluntary-Licensing-Agreements-With-Six-Generic-Manufacturers-to-Increase-Access-to-Lenacapavir-for-HIV-Prevention-in-High-Incidence-Resource-Limited-Countries