Dr. Reddy’s on Wednesday said it has entered into a royalty-free non-exclusive voluntary licensing agreement with Gilead Sciences Ireland for the manufacture and commercialisation of the drug, long-acting HIV drug Lenacapavir, in India and 120 other countries. 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. "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," said Deepak Sapra, Chief Executive Officer- API and Services, Dr. Reddy’s Lenacapavir is approved by USFDA and is 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 consi.
