Updated: June 30, 2021 2:10:41 am
Five pharmaceutical companies will collaborate for the clinical trial of the investigational oral antiviral drug Molnupiravir for treatment of mild Covid-19 in an outpatient setting in India. These include Cipla Limited, Dr Reddy’s Laboratories Ltd, Emcure Pharmaceuticals Limited, Sun Pharmaceutical Industries Limited and Torrent Pharmaceuticals Limited.
Molnupiravir is an oral antiviral that inhibits the replication of multiple RNA viruses including SARS-CoV-2. It is presently being studied by Merck Sharpe Dohme (MSD), through a collaboration with Ridgeback Biotherapeutics, in a Phase III trial for the treatment of non-hospitalised patients with confirmed Covid-19 globally.
Between March and April this year, these five pharma companies had individually entered into a non-exclusive voluntary licensing agreement with MSD to manufacture and supply Molnupiravir to India and to over 100 low and middle-income countries.
The five pharma companies have entered into a collaboration agreement, where the parties will jointly sponsor, supervise and monitor the clinical trial in India. As per the directive of the Subject Expert Committee of the Central Drugs Standard Control Organisation, Dr Reddy’s will conduct the clinical trial using its product, and the other four pharma companies will be required to demonstrate equivalence of their product to the product used by Dr Reddy’s in its clinical trial.
Following the protocol approval given by the Drugs Controller General of India, the clinical trial will be conducted for treatment of mild Covid-19 in an outpatient setting. It is expected to take place between June and September this year across India with the recruitment of 1,200 patients. Such collaboration for a clinical trial is a first of its kind within the Indian pharma industry, and will aim to investigate yet another line of treatment in the fight against the pandemic.
On successful completion of the clinical trial, each company will independently approach the regulatory authorities for approval to manufacture and supply Molnupiravir.
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