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Healthcare major Zydus Cadila on Friday informed that it has inked a non-exclusive licensing agreement with global healthcare major Gilead Sciences Inc, to manufacture and distribute Remdesivir- an investigational drug to be used for Covid-19 patients.
Remdesivir has been given an Emergency Use Authorization by the US drug regulator, US Food and Drug Administration (USFDA) to treat patients suffering from severe symptoms of Novel Coronavirus.
The agreement allows Zydus to receive manufacturing know-how of the drug from Gilead Sciences to make the API for Remdesivir and the finished product.
The non-exclusive agreement also enables Zydus to market Remdesivir product in 127 countries, including India.
As per 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 informed in a statement here.
Zydus has been supporting the fight against Covid-19 with therapeutics, vaccines and diagnostics.
Speaking on the development, Pankaj Patel, Chairman of Zydus Group, 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."
Zydus will leverage its ability to scale up production to reach patients across India and 127 countries in Gilead’s Global Patient Solution region, it said.
Drug Usage
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.
The drug - 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).
Zydus (Cadila Healthcare) shares ended one per cent higher on the BSE to close at ₹374 Friday.
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