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Jubilant, Gilead ink pact for Remdesivir

Multiple additional clinical trials are underway to generate more data on the safety and efficacy of Remdesivir

Multiple additional clinical trials are underway to generate more data on the safety and efficacy of Remdesivir  

Drug can be sold in India, 126 nations

Jubilant Life Sciences, through a subsidiary, has entered into a non-exclusive licensing agreement with Gilead Sciences Inc. to register, manufacture and sell Gilead’s Remdesivir, a potential therapy for COVID-19 in 127 countries, including India.

Under the agreement, Jubilant Generics, the subsidiary, will have the right to receive a technology transfer of the Gilead manufacturing process to scale up production to enable expedited access of the medicine to COVID-19 patients upon approvals by regulatory authorities in the respective countries.

The list of 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, a Jubilant Life Sciences statement said. Jubilant Life Sciences chairman Shyam S.Bhartia and co-chairman and MD Hari S. Bhartia said Remdesivir, based on initial data, showed promise as a potential therapy for COVID-19. “We will be monitoring the clinical trials and regulatory approvals very closely and would be ready to launch the drug shortly after the required regulatory approvals. We also plan to produce the drug’s active pharmaceutical ingredient (API) in-house helping its cost effectiveness and consistent availability.”

An investigational anti-viral therapy developed by Gilead, Remdesivir received Emergency Use Authorisation (EUA) by the US Food and Drug Administration to treat COVID-19. The Authorisation will facilitate broader use of Remdesivir to treat hospitalised patients with severe COVID-19 disease.

The EUA was based on available data from two global clinical trials – U.S. National Institute for Allergy and Infectious Diseases’ placebo-controlled Phase 3 study in patients with moderate to severe symptoms of COVID-19 and Gilead’s global Phase 3 study evaluating Remdesivir in patients with severe disease.

Multiple additional clinical trials are underway to generate more data on the safety and efficacy of Remdesivir as a treatment for COVID-19. Remdesivir remains an investigational drug and has not been approved by USFDA, the release said.

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Printable version | Jul 9, 2020 8:25:37 AM | https://www.thehindu.com/business/jubilant-gilead-ink-pact-for-remdesivir/article31568415.ece

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