New Delhi [India], June 13 — Healthcare majors Dr Reddy’s Laboratories and Zydus Cadila said on Saturday they have signed non-exclusive licensing agreements with Gilead Sciences Inc for the manufacturing and distribution of Remdesivir.
The investigational drug has been issued an emergency use authorisation by the US Food and Drug Administration (FDA) to treat patients suffering from severe symptoms of novel coronavirus.
Gilead Sciences has signed similar non-exclusive voluntary licensing agreements with Cipla, Hetero Labs, Jubilant Lifesciences and Mylan. All these licences are royalty-free until the World Health Organisation declares the world free from coronavirus pandemic, or a drug or vaccine is approved against the deadly virus.
Zydus said it 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.
“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,” said Zydus Chairman Pankaj Patel.
“At this critical juncture, we join hands once again to ensure that no efforts are spared in the fight against this pandemic,” he said in a statement. The pharma company has been supporting the fight against Covid-19 with therapeutics, vaccines and diagnostics.
Dr Reddy’s said it will receive technology transfer from Gilead for manufacturing of Remdesivir. It will need to do the manufacturing scale up and obtain regulatory approval for marketing of this drug in respective countries.
On June 1, the Drug Controller General of India (DCGI) granted the marketing authorisation to Gilead Sciences’ anti-viral drug remdesivir injection 5 mg/mL and Remdesivir lyophilised powder for injection 100 mg for the treatment of suspected or laboratory-confirmed coronavirus disease 2019 (Covid-19) in adults and children hospitalised with severe disease.
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.
The 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 three clinical trials.
