Zydus, which is also involved in developing a vaccine for coronavirus, will now also get to manufacture and distribute Remdesivir. The Indian drug maker will receive the know-how from Gilead Sciences Inc, to manufacture the API for Remdesivir and also to make 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.
On its part, 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.
Commenting on the development, Zydus' Chairman Pankaj Patel said that the agreement with Gilead will help "increase the access" to the 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," said Patel.
Administered intravenously, 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.
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).