Dr. Reddy’s Laboratories Ltd. announced that it has entered into a royalty-free non-exclusive voluntary licensing agreement with Gilead Sciences Ireland UC for the manufacture and commercialisation of the drug, Lenacapavir, in India and 120 other countries.
Lenacapavir is a United States Food and Drug Administration (USFDA) 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 (PrEP) which is yet to be approved globally. Gilead Sciences first launched Lenacapavir under the brand name Sunlenca® in the United States and Europe markets in the year 2022. It is a first-in-class HIV-1 capsid inhibitor.
Dr. Reddy’s has been granted a non-exclusive voluntary licence to manufacture Lenacapavir and market it in 120 countries, for the current approved indication of HIV treatment in heavily treatment-experienced (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 grants licence to Dr. Reddy’s to manufacture and commercialise lenacapavir for the indication of prevention of HIV (PrEP) in 120 countries, if approved.
Deepak Sapra, Chief Executive Officer- API and Services, Dr. Reddy’s Laboratories Ltd., 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 endeavour in our journey to create impact on 1.5 billion patients by 2030.”
Lenacapavir is approved in multiple countries for the treatment of adults with multi-drug resistant HIV in combination with other antiretrovirals. The use of lenacapavir for HIV prevention is investigational and the safety and efficacy of lenacapavir for this use have not been established.
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 HIV.
