Dr. Reddy’s Secures Licensing Deal with Gilead for Lenacapavir in 120 Countries

3 Oct 2024 , 11:12 AM

Dr. Reddy’s has entered into a non-exclusive voluntary licensing agreement with Gilead Sciences Ireland for the production and commercialization of the long-acting HIV drug, Lenacapavir.

The agreement allows Dr. Reddy’s to manufacture and market Lenacapavir in India and 120 other countries, primarily low- and lower-middle-income nations with high HIV prevalence. The drug is currently approved for treating heavily treatment-experienced (HTE) adults with multi-drug resistant HIV.

Dr. Reddy’s will handle technology transfer at its manufacturing site, conduct bioequivalence/clinical studies, and register and launch the product in the agreed markets.

The agreement also includes a provision for Dr. Reddy’s to manufacture and commercialize Lenacapavir for HIV prevention (PrEP) in the same 120 countries, pending approval.

Deepak Sapra, CEO-API and Services at Dr. Reddy’s, stated that this collaboration with Gilead will make a crucial treatment option available to patients in countries with significant HIV disease burden, including India.

Lenacapavir has been approved by the USFDA for the treatment of HIV-1 infection in heavily treatment-experienced adults with limited options due to drug resistance.