Dr. Reddy’s Laboratories Ltd has recently informed exchanges that the company has signed a royalty-free non-exclusive voluntary licensing deal with Gilead Sciences Ireland UC to manufacture and commercialise the drug Lenacapavir in India and 120 other countries.
Lenacapavir is a drug approved by the United States Food and Drug Administration (USFDA) 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. Furthermore, lenacapavir is now under investigation for HIV prevention (PrEP), which has yet to be approved globally.
In the exchange filing, the company also shared, “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.”
