The five companies are collaborating for the clinical trial of the investigational oral anti-viral drug Molnupiravir for the treatment of mild COVID-19 in an outpatient setting in India.
Following the clinical trial protocol approval given by the Drugs Controller General of India, the clinical trial will be conducted for the treatment of mild COVID-19 in an outpatient setting.
A pill to combat COVID-19 and soon the Indian market may be flooded by these. Called Molnupiravir and developed by Merck Sharpe Dohme (or MSD in quickspeak) and Ridgeback Biotherapeutics, there are several Indian companies in the race to launch it – some have a licensing arrangement with MSD and others do not. Molnupiravir is an experimental drug consumed in the form of a pill and last June several Indian companies – Cipla, Dr. Reddy’s, Emcure, Sun Pharma and Torrent announced that they were collaborating for clinical trial of investigational anti-viral drug Molnupiravir for COVID-19. The five companies are collaborating for the clinical trial of the investigational oral anti-viral drug Molnupiravir for the treatment of mild COVID-19 in an outpatient setting in India.
Between March and April, these five pharma companies had individually entered into a non-exclusive voluntary licensing agreement with Merck Sharpe Dohme (MSD) to manufacture and supply Molnupiravir to India and over 100 low and middle-income countries (LMICs). However, the race is not confined to the five companies that have been licenced by MSD. There are several others Indian companies and one of the early ones in this was Hyderabad-based Natco Pharma, which apparently has completed the clinical trials and is waiting marketing and manufacturing approval from the Indian drug regulator.
The five pharma companies that had entered into a collaboration agreement, will jointly sponsor, supervise and monitor the clinical trial in India. One of the company official revealed that the trials were still on but it was just a matter of weeks before they would all be seeking the regulatory approval and said, there will be “lot of Molnupiravir available then.” In a joint note shared by the companies in June, as per the directive of the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization, 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 clinical trial protocol approval given by the Drugs Controller General of India, the clinical trial will be conducted for the treatment of mild COVID-19 in an outpatient setting. The process was planned to conclude by September and involving a recruitment of 1,200 patients. Such collaboration for a clinical trial is being described as “a first-of-its-kind within the Indian pharma industry.” On successful completion of the clinical trial, each company will independently approach the regulatory authorities for approval to manufacture and supply Molnupiravir for the treatment of COVID-19 in India.
Molnupiravir, the note had said, is an oral anti-viral that inhibits the replication of multiple RNA viruses including SARS-CoV-2.
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