Generic Remdesivir To Be Produced For 127 Countries
Gilead Sciences, Inc. said it has signed non-exclusive voluntary licensing agreements with several generic pharmaceutical manufacturers based in India and Pakistan to further expand access to remdesivir, an experimental antiviral treating hospitalized COVID-19 disease patients.
Announced on May 12, 2020, the agreements allow the companies – Cipla Ltd., Ferozsons Laboratories, Hetero Labs Ltd., Jubilant Lifesciences, and Mylan – to manufacture remdesivir for distribution in 127 countries.
The selected countries consist of nearly all low-income and lower-middle-income countries, as well as several upper-middle- and high-income countries that face significant obstacles to healthcare access around the world.
Under the licensing agreements, 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.
The licensees also set their own prices for the generic product they produce.
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.
The agreements permit distribution in the following countries found at this link.
Remdesivir (GS-5734) is an investigational nucleotide analog with broad-spectrum antiviral activity – it is not approved anywhere for any use.
However, as of May 1, 2020, remdesivir has been issued an Emergency Use Authorization (EUA) in the USA for those hospitalized with severe disease. New data from clinical studies indicate it may shorten the time it takes to recover from the infection.
Remdesivir has demonstrated in vitro and in vivo activity in animal models against the viral pathogens MERS and SARS, which are also coronaviruses and are structurally similar to COVID-19 disease.
The limited preclinical data on remdesivir in MERS and SARS indicate that remdesivir may have potential activity against COVID-19.
Remdesivir was originally developed to treat the Ebola and Marburg virus diseases but was ineffective for these viral infections.
In an open letter published on April 29, 2020, Gilead’s CEO Daniel O’Day said: ‘Thank you to everyone who has helped to bring us this far with remdesivir – from the patients involved in clinical trials to healthcare workers, study investigators, and many other groups.’
‘We know that there is still a lot of work to be done and a long way to go in finding medical solutions to stop the pandemic.’
‘At the same time, today’s news on remdesivir represents important progress and offers hope at a time when it is badly needed.’
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