Indian pharma firms ink deal with U.S. drug maker Gilead to make, market generic HIV drug lenacapavir?

Dr. Reddy’s Laboratories, Hetero and Viatris subsidiary Mylan are among six generic drugmakers globally to enter into non-exclusive, royalty-free voluntary licencing agreements with U.S.-based drug maker Gilead Sciences to manufacture and market its generic lenacapavir, subject to regulatory approvals, in 120 high-incidence, resource-limited countries.

The agreements were signed in advance of any global regulatory submissions to enable these countries, which primarily are low- and lower-middle income countries, to quickly introduce generic versions of lenacapavir for HIV prevention, if approved, Gilead said in a release.

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The use of lenacapavir for the prevention of HIV is investigational, and not approved anywhere globally, and the safety and efficacy for this use have not been established, it said.

Announcing signing of the agreement with Gilead Sciences Ireland UC, Dr. Reddy’s said Lenacapavir is a U.S. FDA (Food and Drug Administration) approved drug indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.

Additionally, Lenacapavir is currently under investigation for the prevention of HIV (pre-exposure prophylaxis or PrEP), but this is yet to be approved globally. Gilead Sciences had first launched Lenacapavir under the brand name Sunlenca in the U.S. and Europe markets in 2022.

Dr. Reddy’s said as part of the agreement it will be responsible for technology transfer at its manufacturing site, conducting bioequivalence/clinical studies, product registration and launches in the agreed markets. The agreement also grants a licence to Dr. Reddy’s to manufacture and commercialise lenacapavir for the indication of prevention of HIV (PrEP) in 120 countries, if approved.

Hetero said Lenacapavir was a breakthrough HIV-1 capsid inhibitor that works with other antiretroviral drugs to treat multi-drug-resistant HIV-1 infections. “We will bring quick access to lenacapavir in Africa, India and other LMICs, where we’ve been a cornerstone of HIV/AIDS care,” Hetero Group of Companies Managing Director, Vamsi Krishna Bandi said.

Lenacapavir was approved for use in HIV-positive adults with multi-drug resistance by the European Union in August 2022 and received U.S. FDA approval in December 2022.