Gilead Signs Licensing Deals with Generic Manufacturers for Lenacapavir Production

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Gilead Sciences, Inc. has officially signed non-exclusive, royalty-free voluntary licensing agreements with six pharmaceutical manufacturers in order to assist with the production and sale of generic lenacapavir.¹ Although they are all still subject to the mandatory regulatory approvals, the agreements would provide 120 nations—mainly those that are low or lower-income, and resource-limited—with access to generic versions of lenacapavir for the prevention of human immunodeficiency virus (HIV).

This is done via pre-exposure prophylaxis (PrEP); though lenacapavir is an FDA-approved drug indicated for the treatment of HIV-1 infection in heavily treatment-experienced (HTE) adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations, this indication is yet to be approved globally. Gilead has laid out its efforts of providing access via a two-part plan consisting of launching a voluntary licensing program, along with providing products (at no profit) until generic manufacturers can handle the demand. It’s also important to point out that these aforementioned agreements cover both lenacapavir for HIV prevention, and lenacapavir for HIV treatment in HTE adults with multi-drug resistant HIV.

“Given the transformative potential of lenacapavir for prevention, our focus is on making it available as quickly and broadly as possible where the need is greatest,” commented Daniel O’Day, Gilead’s chairman and CEO. “Gilead teams have been working with urgency to bring on high-volume generic manufacturers now, so that we can ensure a rapid transition to these voluntary license partners after lenacapavir for PrEP is approved.”

The six generic companies that will be producing and supplying lenacapavir to the 120 countries are Dr. Reddy’s Laboratories Limited, Emcure, Eva Pharma, Ferozsons Laboratories Limited, Hetero, and Mylan, a subsidiary of Viatris. The selected partners are reportedly prepared and equipped to manufacture sterile injectable medicines.

"Lenacapavir marks an important milestone for Dr. Reddy’s in patient access and affordability for pre- and post-exposure treatment of HIV,” said Deepak Sapra, CEO, API and services, Dr. Reddy’s Laboratories Ltd.² “The collaboration with Gilead will help us make this latest treatment option available to patients in 120 primarily low- and lower- middle income countries, including in India. Many of these countries have a very high disease burden of HIV. This is an important endeavor in our journey to create impact on 1.5 billion patients by 2030.”

In the meantime, until the generic versions are available, Gilead plans to initially focus on registration in the 18 countries that represent about 70% of the HIV burden in the countries named in the license, including Botswana, Eswatini, Ethiopia, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, Philippines, Rwanda, South Africa, Tanzania, Thailand, Uganda, Vietnam, Zambia, and Zimbabwe.

References

1. 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. Gilead Sciences. October 2, 2024. Accessed October 4, 2024. https://www.gilead.com/news/news-details/2024/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

2. Dr. Reddy’s signs voluntary licensing agreement with Gilead Sciences to manufacture and commercialise Lenacapavir in India and other countries. Dr. Reddy’s. October 2, 2024. Accessed October 4, 2024. https://www.drreddys.com/cms/cms/sites/default/files/2024-10/DRL%20Press%20release-%20VL%20with%20Gilead-%20%20final-%20Oct%202nd%2C%202024.pdf