Gilead inks pacts with generic makers on Remdesivir

U.S. drugmaker Gilead has signed non-exclusive voluntary licensing agreements with five generic pharmaceutical manufacturers based in India and Pakistan to further expand the supply of Remdesivir, its investigational antiviral product to treat COVID-19.

The agreements allow the companies – Cipla, Hetero Labs, Jubilant Lifesciences, Mylan and Ferozsons Laboratories – to manufacture Remdesivir for distribution in 127 countries.

Under the agreements, the companies have a right to receive a technology transfer of the Gilead manufacturing process for Remdesivir to enable them to scale up production more quickly. The licensees also set their own prices for the generic product they produce, Gilead said.

A statement from the company said 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.

The 127 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.

The USFDA had recently granted emergency use authorization (EUA) for Remdesivir to treat COVID-19. Remdesivir is authorized for the treatment of hospitalised patients with severe COVID-19 disease. The optimal duration of treatment is still being studied in ongoing clinical trials.

Gilead Chairman and CEO Daniel O’Day, in an open letter recently, said Remdesivir is the result of more than a decade of research, experimentation and iteration by Gilead scientists. “In recent years, we have been studying its impact in hemorrhagic fever viruses such as Ebola, Marburg and Nipah viruses as well as other coronaviruses such as SARS and MERS. We had built up sufficient knowledge so that when the novel coronavirus emerged, we could move very quickly into clinical trials,” he said.

On the supply side, he had said: “We are working to build a global consortium of pharmaceutical and chemical manufacturers to expand global capacity and production.”

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