Quest to investigate antiviral drug Molnupiravir for the treatment of mild Covid-19 has led five pharma giants Dr Reddy’s Laboratories, Cipla, Emcure Pharmaceuticals, Sun Pharmaceutical Industries and Torrent Pharmaceuticals to collaborate for clinical trials of the drug.
As per the collaboration, the five pharma companies will jointly sponsor, supervise and monitor the clinical trials in the country, according to regulatory filings by Dr Reddy’s and Cipla. Molnupiravir is an oral antiviral drug that inhibits the replication of multiple RNA viruses including SARS-CoV-2.
As per the directive of the Subject Expert Committee (SEC) 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, the filings noted.
The clinical trial will be conducted for the treatment of mild Covid-19 in an outpatient setting and is expected to take place between June and September across India with the recruitment of 1,200 patients, they added.
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, the companies noted.
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, it added.
Between March and April this year, the five Indian 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.
Molnupiravir is currently being studied by MSD, through a collaboration with Ridgeback Biotherapeutics, in a Phase Ill trial for the treatment of non-hospitalised patients with confirmed Covid-19 globally.
