India's Zydus Cadila, Dr Reddy's ink pacts to make potential COVID-19 drug Remdesivir

New Delhi: Drug firm Zydus Cadila on Friday said it has signed a non-exclusive licensing agreement with Gilead Sciences Inc for manufacturing and distribution of remdesivir, a potential therapy for Covid-19.

Remdesivir, the investigational drug from Gilead Sciences Inc, has been issued an ‘emergency use authorisation’ (EUA) by the United States Food and Drug Administration (USFDA) to treat patients suffering from severe symptoms of coronavirus, Zydus Cadila said in a statement.

Earlier, in May, three domestic pharmaceutical firms Cipla, Jubilant Life Sciences and Hetero entered into non-exclusive licensing agreements with Gilead Sciences Inc for manufacturing and distribution of remdesivir.

Zydus Chairman 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.” In the last decade, Zydus Cadila has been partnering with Gilead Sciences to address various public healthcare challenges and improve global access to affordable need-based therapies, he added.

“At this critical juncture, we join hands once again to ensure that no efforts are spared in the fight against this pandemic,” Patel said.

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, the statement said.

“Under the agreement, the licence is royalty free until another pharmaceutical product or vaccine is approved for the treatment or prevention of Covid-19 by the USFDA or EMA (European Medicines Agency) or the WHO (World Health Organization) announcing the end of the public health emergency,” it added.

The company will leverage its ability to scale up production to reach patients across India and in 127 countries in Gilead’s global patient solution region, the statement said.

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, it added.