Cipla, Dr. Reddy’s, and others to collaborate on Molnupiravir Covid trial
Five Indian pharma companies – Cipla, Dr. Reddy’s Laboratories, Emcure Pharmaceuticals, Sun Pharmaceutical Industries, and Torrent Pharmaceuticals will join forces to undertake a clinical trial of Molnupiravir, an investigational oral anti-viral drug for the treatment of mild Covid-19 in India.
The clinical trial of Molnupiravir will be in an outpatient setting. Molnupiravir is being developed by MSD (known as Merck in the US and Canada) in collaboration with Ridgeback Biotherapeutics.
Recently, all the five Indian pharma companies had signed separate non-exclusive voluntary licensing agreements with MSD for manufacturing and supplying Molnupiravir to India and to more than a hundred low and middle-income countries (LMICs).
Under a collaboration agreement, Cipla, Dr. Reddy’s Laboratories, Emcure Pharmaceuticals, Sun Pharmaceutical Industries, and Torrent Pharmaceuticals will jointly sponsor, supervise, and monitor the clinical trial of Molnupiravir in India.
According to the directive of the subject expert committee (SEC) of the Central Drugs Standard Control Organization, Dr. Reddy’s Laboratories will hold the clinical trial using its product, while the other four pharma firms will have to prove equivalence of their Molnupiravir product to the product used by the former in its study.
The clinical trial is anticipated to be held between June and September 2021 across India involving 1,200 patients.
The five Indian pharma companies, in a joint statement, said: “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 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.”