3 Indian drugmakers sign agreement with Gilead Sciences, US to produce and sell Remdesivir

indica News Bureau-

Gilead Sciences, the US drug maker has signed a non-exclusive voluntary licensing agreements with three Indian pharmaceutical companies — Hyderabad-based Hetero Labs, Mumbai-headquartered Cipla, and Noida-based Jubilant Life Sciences to manufacture and sell the anti-viral drug to people who have severe COVID-19 infection. US-based Mylan which has a strong base in India and a Pakistan-based Ferozsons Laboratories have also signed such agreements with Gilead Sciences.

Gilead will provide the technology transfer to these 5 drug manufacturers to facilitate production of Remdesivir.

Gilead’s Remdesivir has received emergency use authorisation (EUA) for treatment of  hospitalised COVID-19 patients. 

Hetero said Remdesivir will be produced at its formulation facility in Hyderabad. At the moment the company is working to take all the necessary approvals for manufacturing the drug.

CIPLA will manufacture and market the drug in 127 countries, including India and South Africa under Cipla’s own brand name. 

In a statement the company said: “At Cipla, it is our continuous endeavor to ensure that no patient is denied access to life-saving treatments. Our partnership with Gilead represents this unwavering commitment and is a significant step towards saving millions of lives impacted by the pandemic.” 

It added: “As the world is faced with the COVID-19 crisis, it is imperative that we collaborate and fight this virus together. We are pleased to partner with Gilead for this cause and take this treatment to patients across countries after the required regulatory approvals.” 

Cipla will receive the manufacturing know-how from Gilead Sciences to manufacture the drug at a commercial scale.

The Health Ministry recently said that it is examining Remdesivir, which was used during the Ebola outbreak, as one protocol in the treatment for Covid-19 in the country.

In a statement, Jubilant whose subsidiary Jubilant Generics Ltd inked a pact with Gilead Sciences, said they are very happy to strengthen its partnership with the US giant to license Remdesivir, “which, based on initial data, shows promise to be a potential therapy for COVID-19, a pandemic creating unprecedented health and economic crisis globally”.

“We will be monitoring the clinical trials and regulatory approvals very closely and would be ready to launch the drug shortly after the required regulatory approvals. We also plan to produce the drug’s Active Pharmaceutical Ingredient (API) in-house helping its cost effectiveness and consistent availability,” said Jubilant Life Sciences in a stock exchange filing on Tuesday.

Remdesivir is given to patients intraveinous one time each day for up to 10 days depending on recommendations of healthcare providers, according to the FDA.

The drug may help decrease the amount of the coronavirus in bodies and help patients get better faster, said the agency.

Possible side effects of Remdesivir include infusion-related reactions and increases in levels of liver enzymes.

“These are not all the possible side effects of Remdesivir. Remdesivir is still being studied so it is possible that all of the risks are not known at this time,” said the FDA.

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