1 min read.Updated: 13 Jun 2020, 10:06 AM ISTLeroy Leo
Remdesivir has received emergency use authorisation in the US, India and a few other countries for the treatment of covid-19 after preliminary results showed some promise
NEW DELHI: Gilead Sciences Inc has said that it has signed pacts with four more firms--Dr Reddy’s Laboratories Ltd, Biocon arm Syngene International Ltd, Zydus Cadila Ltd, and Egypt-based Eva Pharma Pvt Ltd—for manufacturing and sale of its novel intravenous drug remdesivir for treatment of covid-19.
Remdesivir has received emergency use authorisation (EUA) in the US, India and a few other countries for the treatment of covid-19 after preliminary results from two trials, including one by US’ National Institute of Allergy and Infectious Diseases, showed some promise.
However, the safety and efficacy of remdesivir to treat covid-19 are still being evaluated in multiple phase 3 clinical trials that are underway. 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.
Gilead's licensing pact with the four companies are in addition to the five signed last month with Cipla Ltd, Jubilant Life Sciences Ltd, Hetero Drugs Ltd, Mylan and Pakistan-based Ferozsons Laboratories.
Zydus Cadila had made an announcement about the pact on Friday.
Gilead’s terms for all nine companies are the same, as per the release. The pact allows the companies to manufacture remdesivir for distribution in 127 countries, which 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.
The licenses are royalty-free until the World Health Organization declares the end of the Public Health Emergency of International Concern status for covid-19, or until an alternative drug or vaccine is approved against the fatal respiratory disease, whichever is earlier.
Under the licensing agreements, the nine companies have a right to receive a technology transfer of the Gilead manufacturing process for remdesivir which will enable them to scale up production more quickly, as well as set their own prices for their products.
As per Zydus Cadila’s release, if a patient requires mechanical ventilation or extracorporeal membrane oxygenation (ECMO), then the dosage suggested is 10 days under the EUA.
A five-day dosage is suggested for patients who do not require invasive mechanical ventilation or ECMO. The treatment can be extended by another five days for patients without ventilator support if the 5-day dosage duration does not demonstrate clinical improvement.
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