New Delhi: Gilead Sciences Inc has signed non-exclusive voluntary licensing agreements with five generic pharmaceutical manufacturers – Cipla Ltd, Jubilant Life Sciences, Hetero Labs Ltd, Mylan and Ferozsons Laboratories – on a royalty-free basis until a new drug or vaccine is developed against Covid-19, the US-based firm said in a release late Tuesday.
The agreements allow the five companies to manufacture remdesivir for distribution in 127 countries, including India, where all the generic companies except Ferozsons Laboratories have manufacturing facilities. Ferozsons Laboratories is based out of Pakistan.
“The licenses are royalty-free until the World Health Organization declares the end of the Public Health Emergency of International Concern regarding COVID-19, or until a pharmaceutical product other than remdesivir or a vaccine is approved to treat or prevent Covid-19, whichever is earlier," Gilead said.
Under the pact, the companies have a right to receive a technology transfer of the Gilead manufacturing process for remdesivir to enable them to scale up production more quickly, and they also can set their own prices for the generic product they produce.
Jubilant Life Sciences had earlier on Tuesday announced that its subsidiary Jubilant Generics Ltd has entered into a non-exclusive licencing agreement with US-based Gilead Sciences Inc.
The US-based firm’s move to not charge royalty during the period of the covid-19 pandemic and allow free pricing comes on the back of concern over the drug’s pricing, which has come up as a potential treatment against Covid-19.
Gilead in a press release last week said that production of the drug will be challenging as it requires scarce raw materials, with their own lengthy production time, and specialized manufacturing capabilities with limited global capacity.
Any disruption to the supply chain impacting these scarce raw materials and other manufacturing inputs could reduce the amount of remdesivir produced and increase the time it takes to do so, Gilead had said in a release last week.
As per Gilead’s press release, the agreement allows the five companies to produce and sell generic remdesivir in a host of countries like Afghanistan, Bangladesh, Philippines, South Africa, Thailand, Ukraine, among others.
However, large and developed markets like the US, China, the UK, the European Union, Australia and Japan are not included in the list.
The US Food and Drug Administration had on 1 May granted remdesivir, an investigational antiviral therapy developed by Gilead, the Emergency Use Authorization (EUA) to treat Covid-19, helping facilitate broader use of the intravenous injection to treat hospitalized patients with severe Covid-19 disease.
The EUA was based on available data from two global clinical trials, including Gilead’s own global Phase 3 study evaluating remdesivir in patients with severe disease.
More clinical trials are ongoing to generate more data on the safety and efficacy of the drug as a treatment for Covid-19. As the clinical trials are ongoing and all the data that has come out is preliminary, remdesivir continues to remain an investigational drug and has not been given final approval by US FDA.
Remdesivir is also part of the World Health Organization’s Solidarity Trial which is underway across the world including at over half a dozen sites in India.
The promoters of HT Media Ltd, which publishes Mint, and Jubilant Life Sciences are closely related. There are, however, no promoter cross-holdings.