Dr Reddy’s enters pact with Gilead Sciences to manufacture, sell HIV drug Lenacapavir in India and 120 countries

Dr Reddy’s Laboratories said it has entered into a royalty-free non-exclusive voluntary licensing agreement with Gilead Sciences Ireland UC for the manufacture and commercialisation of Lenacapavir, in India and 120 other countries.

Lenacapavir is a USFDA approved drug used for 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," Dr Reddy’s said in a press release.

The Hyderabad-based firm has been granted the 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. It 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.