Gilead signs agreements to improve access to HIV prevention medicines

Gilead will offer the drug without a profit margin until generics come to market. Photo credit: Tada Images via Shutterstock.

Gilead Sciences has announced the signing of voluntary licensing agreements with six generic drug manufacturers to facilitate access to lenacapavir, a potential drug for the prevention of human immunodeficiency virus (HIV), in 120 resource-limited and high-incidence countries.

The company signed agreements with Dr. Reddy's Laboratories, Eva Pharma, Emcure, Ferozsons Laboratories, Mylan, a subsidiary of Viatris, and Hetero.

These royalty-free and non-exclusive agreements enable the production and sale of generic lenacapavir, subject to regulatory approvals.

The initiative is part of Gilead's strategy to ensure widespread, sustainable access to lenacapavir for pre-exposure prophylaxis (PrEP) worldwide, consistent with its goal of ending the HIV epidemic.

The drug will initially be supplied at no profit until generic versions are available. The agreements also cover lenacapavir for HIV treatment in adults with multidrug-resistant HIV.

The companies are expected to build production capacity for lenacapavir. Gilead is prioritizing enrollment in 18 countries with approximately 70% of the HIV burden within licensed territories.

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Daniel O'Day, Chairman and CEO of Gilead, said: “Given the transformative potential of lenacapavir for prevention, our focus is on making it available as quickly and widely as possible where the need is greatest.”

“The Gilead teams have worked diligently to secure high-volume generic manufacturers now so that we can ensure a rapid transition to these voluntary licensing partners upon approval of lenacapavir for PrEP.”

Two phase III trials, PURPOSE 1 and PURPOSE 2, evaluated lenacapavir for PrEP, resulting in early unblinding.

These studies included diverse populations in multiple countries. Gilead said it is committed to providing participants with access to lenacapavir after the trial and plans to begin regulatory submissions worldwide by the end of 2024.

Gilead is also exploring accelerated regulatory frameworks, such as the European Medicines Agency's EU Medicines for All, to speed up the approval process in countries with high incidence and limited resources.

The company will report on the progress of regulatory discussions for lenacapavir as a PrEP method.

Lenacapavir is still in research for HIV prevention and has not yet been approved in any country.

In May of this year, Cartography Biosciences entered into a strategic partnership with Gilead Sciences focused on the discovery and development of new oncology therapies.