Generic pharmaceutical firm and leading producer of anti-retroviral drugs Hetero has entered into a licensing agreement with Gilead Sciences Inc. for the manufacture and distribution of Remdesivir in 127 countries, including India.
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An investigational drug, Gilead’s Remdesivir had received emergency use authorisation (EUA) from the U.S. Food and Drug Administration (USFDA) for treatment of hospitalised patients with severe COVID-19 .
Announcing the deal, Hetero said Remdesivir will be manufactured at its formulation facility in Hyderabad. The facility has been approved by regulators such as the USFDA and EU, among others.
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Chairman of Hetero Group of Companies B.Partha Saradhi Reddy said Hetero has developed this product in India. A fully vertically integrated supply chain for the product has been developed.
The company was working with the government, ICMR and DCGI for necessary studies and approvals to bring this product to treat COVID-19 patients in India.
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The agreement with Gilead illustrates the significance of global collaboration and the need for coming together to fight the health crises impacting humanity, he said in a statement.
Wednesday’s announcement by Hetero about the licensing agreement with Gilead follows another such on Tuesday by Jubilant Life Sciences about Jubilant Generics, a subsidiary, forging a non-exclusive licensing agreement with Gilead for Remdesivir manufacturing and distribution.
The EUA is temporary and does not take the place of the formal new drug application submission, review and approval process. The EUA allows for distribution and emergency use of Remdesivir only for the treatment of COVID-19.
Besides Remdesivir, other anti-viral drugs being considered for treatment of COVID-19 globally are Favipiravir and anti-malarial drug Hydroxychloroquine. Glenmark Pharmaceuticals had recently announced approval from the Drug Controller General of India to conduct clinical trials of Favipiravir on COVID-19 patients.
Strides Pharma had also recently said it has developed, commercialised and exporting the antiviral Favipiravir tablets. For the India market, the company said it will apply to Indian drug authorities to commence necessary studies.