(Image from Gilead Sciences)
Gilead Sciences’ (NSDQ:GILD) said Tuesday that it has signed licensing agreements with five generic pharmaceutical manufacturers based in India and Pakistan to further expand supply of remdesivir, the experimental drug being used in the U.S. to treat COVID-19.
The non-exclusive, voluntary agreements allow the companies — Mylan (NSDQ:MYL), Cipla, Ferozsons Laboratories, Hetero Labs and Jubilant Lifesciences — to manufacture remdesivir for distribution in 127 countries. The countries consist of nearly all low-income and lower-middle income countries, as well as several upper-middle- and high-income countries that face significant obstacles to healthcare access, according to Foster City, Calif.-based Gilead.
The FDA gave remdesivir emergency use authorization May 1. State health departments are distributing it within their states.
Remdesivir is an intravenous drug that normally takes months to produce. Production also requires sterile drug product manufacturing capabilities, which limits the number of organizations capable of manufacturing the medicine.
Under the licensing agreements, the companies in India and Pakistan have a right to receive a technology transfer of the Gilead manufacturing process for remdesivir to enable them to scale up production more quickly, Gilead said on its website. The licensees also set their own prices for the generic product they produce.
The licenses are royalty-free until the World Health Organization 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.
Hetero will make remdesivir in its Hyderabad formulation facility, according to that company.
“Hetero is pleased to partner with Gilead to enable access for this important drug to India and other developing countries at this crucial time,” said Dr. B. Partha Saradhi Reddy, chair of the Hetero Group of Companies, in a news release. “This agreement also illustrates the significance of global collaboration and the need for coming together to fight the health crises impacting humanity. Hetero has developed this product in India and has already been working with the government, (Indian Council of Medical Research) and (Drug Controller General of India) for necessary studies and approvals to bring this product to treat COVID-19 patients in India.”