New Delhi: US drug-maker Gilead Sciences has signed non-exclusive voluntary licensing agreements with three Indian pharmaceutical companies -- Mumbai-headquartered Cipla, Hyderabad-based Hetero Labs and Noida-based Jubilant Life Sciences -- who will manufacture and sell the anti-viral drug to treat severe COVID-19 patients.
Gilead's Remdesivir has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for the treatment of hospitalised patients with severe COVID-19 symptoms.
Two other drug manufacturers -- US-based Mylan which has a strong base in India and a Pakistan-based Ferozsons Laboratories -- have also signed licensing agreements with Gilead, which negotiated long-term voluntary licenses with several generic drugmakers in India and Pakistan to produce Remdesivir for developing countries.
Gilead would provide technology transfers to the five drug manufacturers to facilitate the production.
Hetero which has been working with the ICMR for necessary approvals, said Remdesivir would be manufactured at its formulation facility in Hyderabad.
As part of the agreement, Cipla will be permitted to manufacture the active pharmaceutical ingredient (API) and finished product, and market it in 127 countries, including India and South Africa under Cipla's own brand name.
"At Cipla, it is our continuous endeavour 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," Umang Vohra, MD and Global CEO, Cipla Limited, said in a statement.
"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," Vohra added.
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.