Dr. Reddy’s Laboratories on Saturday said it has signed a non-exclusive licensing agreement with Gilead Sciences to register, manufacture and sell the U.S. biopharmaceutical firm’s antiviral drug remdesivir that has emerged as a potential treatment for COVID-19.
Biocon firm Syngene and Zydus Cadila Healthcare have also entered into similar agreements with Gilead, under which they get to manufacture the product for distribution in 127 countries.
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They join Hetero Labs, Jubilant Lifesciences and Mylan, who had signed the agreement last month with Gilead.
An investigational antiviral therapy, remdesivir has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (USFDA) to treat COVID-19. Phase 3 clinical studies to evaluate the safety and efficacy of the drug are underway. In India, the Union Health Ministry had recently cleared remdesivir for treatment of COVID-19 patients under emergency use.
As part of the agreementsthey have signed, the drugmakers receive technology transfer of the manufacturing process for remdesivir and get to set their own prices for the generic product they produce, Gilead said.
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The licenses are royalty-free until the World Health Organization (WHO) declares the end of the Public Health Emergency of International Concern regarding COVID-19 or until a pharmaceutical product other than remdesivir or a vaccine is approved to treat or prevent COVID-19, whichever is earlier, Gilead said.
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Stating that it will receive technology transfer for manufacturing remdesivir, Dr. Reddy's said it needs to do the manufacturing scale up as well as obtain regulatory approval for marketing the product in respective countries.
