On Wednesday, half a dozen drug makers including three Indian companies entered into non-exclusive, royalty-free licensing agreements with the drug’s developer, Gilead Sciences, to manufacture generic versions of lenacapavir and market it locally and in 120 low- and middle-income countries.
The companies will have to apply for local clinical trial waiver to be able to supply the generic version of the drug which is touted as a game-changer in ending the HIV epidemic, experts said.
While Gilead has filed patents widely on the drug, the voluntary licence is meant to overcome patent barriers for sale in identified low- and middle-income countries.
“However, its faster accessibility will depend on waiver from local clinical trials. The companies will have to apply for it and only if the drug regulator approves the waiver on local clinical trials, the companies will be able to produce it and export it to other countries,” said an activist working on public health.
Leena Menghaney, head-South Asia for the MSF Access Campaign, said its access will still be an issue to the upper middle-income countries (MICs).
“Nine percent of people at historic risk of HIV infection live in the Upper MICs excluded from the licence. Indian licensees cannot supply active pharmaceutical ingredients (API) outside the territory and must source API from another licensee. Additionally, Argentina and Brazil who have local manufacturing capacity cannot even get the API from the Indian manufacturers who are licensees,” she said.
The six companies that got licence to manufacture and sell a generic version of the twice-yearly HIV shot are Dr Reddy’s Laboratories, Emcure, Eva Pharma, Ferozsons Laboratories, Hetero and Viatris’ Mylan subsidiary.
