Five pharma companies to collaborate for clinical trial of Molnupiravir for treating mild COVID-19

Molnupiravir is an oral anti-viral that inhibits the replication of multiple RNA viruses including SARS-CoV-2.

Cipla, Dr Reddy’s Laboratories, Emcure Pharmaceuticals, Sun Pharmaceutical Industries and Torrent Pharmaceuticals have announced today that these five companies will collaborate 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. 

The clinical trial process is expected to take place between June and September this year across the country with the recruitment of 1,200 patients. 

Between March and April this year, these five pharma companies had individually entered into a non-exclusive voluntary licensing agreement with Merck Sharp Dohme (MSD) to manufacture & supply Molnupiravir to India as well as to over 100 low & middle-income countries (LMICs). 

These five companies have entered into a collaboration agreement wherein, the parties will jointly sponsor, supervise and monitor the clinical trials in India. As per the directive of the Subject Expert Committee (SEC) of Central Drugs Standard Control Organisation, Dr Reddy’s will conduct the clinical trial using its product while the other four companies would be required to demonstrate equivalence of their product to the product used by Dr Reddy’s in its clinical trial. 

Molnupiravir is an oral anti-viral that inhibits the replication of multiple RNA viruses including SARS-CoV-2. It is presently being studied by MSD via collaboration with Ridgeback Biotherapeutics, in Phase III trial for the treatment of non-hospitalised patients with confirmed COVID-19 globally. 

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 collective fight against the COVID-19 pandemic. On the successful completion of the clinical trial, each company will independently approach the regulatory authorities for approval to manufacture & supply Molnupiravir for the treatment of COVID-19 in India. 

On Tuesday, the stock of Cipla closed 1.7 per cent higher, Dr Reddy’s Lab ended 0.8 per cent higher, and Sun Pharma closed flat while Torrent Pharma ended 0.48 per cent lower.