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HYDERABAD, India — Dr. Reddy’s Laboratories Ltd. has entered into a royalty-free non-exclusive voluntary licensing agreement with Gilead Sciences Ireland UC for the manufacture and commercialization of the drug lenacapavir in India and 120 other countries.
Lenacapavir is a Food and Drug Administration-approved drug indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced (HTE) adults with multi-drug 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 (PrEP) which is yet to be approved globally.
Gilead Sciences launched lenacapavir under the brand name Sunlenca in the United States and Europe in 2022. It is a first-in-class HIV-1 capsid inhibitor.
Dr. Reddy’s has been granted a license to manufacture Lenacapavir and market it for the current approved indication of HIV treatment in HTE adults with multi-drug resistant HIV. Dr. Reddy's will be responsible for technology transfer at its manufacturing site, conducting bioequivalence/clinical studies, product registration and launch in the agreed markets. Additionally, the agreement licenses Dr. Reddy’s to manufacture and commercialize lenacapavir for the PrEP, if approved.
Deepak Sapra, Chief Executive Officer - API and Services for Dr. Reddy’s, said: "Lenacapavir marks an important milestone for Dr. Reddy’s in patient access and affordability for pre and post exposure treatment of HIV. 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.”
The multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes.
Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead's HIV prevention and treatment research program. Lenacapavir is being developed as a foundation for potential future HIV therapies with the goal of offering both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono agent, that help address individual needs and preferences of people and communities affected by HIV1.
