Zydus Cadila, Gilead ink licensing agreement to manufacture, market Remdesivir

New Delhi: Zydus Cadila, a healthcare company recently announced that it has signed a non-exclusive licensing agreement with Gilead Sciences Inc., for the manufacturing and distribution of Remdesivir, the investigational drug, which has been issued an Emergency Use Authorization by the U.S. Food and Drug Administration (FDA) to treat patients suffering from severe symptoms of Novel Coronavirus. Zydus has been supporting the fight against COVID 19 with therapeutics, vaccines, and diagnostics.

As part of the non-exclusive agreement, Zydus will receive the manufacturing know-how from Gilead Sciences Inc., to manufacture the API for Remdesivir and the finished product and market it in 127 countries, including India. Under the agreement, the license is royalty-free until another pharmaceutical product or vaccine is approved for the treatment or prevention of COVID 19 by the USFDA or EMA or the WHO announcing the end of the public health emergency. Zydus will leverage its ability to scale up production to reach patients across India and across the 127 countries in Gilead's Global Patient Solution region.

Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens, including Ebola, Marburg, MERS, and SARS. In vitro testing conducted by Gilead has demonstrated that Remdesivir is active against the virus that causes COVID-19. The safety and efficacy of remdesivir to treat COVID-19 are being evaluated in multiple ongoing Phase 3 clinical trials.

Remdesivir must be administered intravenously. Under this EUA, the 10-day dosing duration is suggested for patients requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO), and the 5-day dosing duration is suggested for patients not requiring invasive mechanical ventilation and/or ECMO. If a patient on the 5-day dosing duration does not demonstrate clinical improvement after five days, treatment may be extended for up to five additional days (10 days total).

Speaking on the development, Chairman of Zydus, Mr. Pankaj Patel said, "We are happy to collaborate with Gilead Sciences and increase the access to this life-saving drug for patients suffering from COVID 19. Over the last decade, we have been partnering with Gilead Sciences to address various public healthcare challenges and improve global access to affordable need-based therapies. At this critical juncture, we join hands once again to ensure that no efforts are spared in the fight against this pandemic."

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