Describing their collaboration as a first of its kind in the Indian pharma industry, a release on Tuesday said the companies will jointly sponsor, supervise and monitor the clinical trial that is expected to take place between June and September this year. The trial, for which 1,200 patients are to be recruited, is to be conducted across the country.
The release said as directed by a 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 products to the product used by Dr. Reddy’s. On successful completion of the trial, each company will independently approach the regulatory authorities for approval to manufacture and supply Molnupiravir for the treatment of COVID-19 in the country.
Their move to collaborate follows the non-exclusive voluntary licensing agreement the five companies had individually entered into with Merck Sharpe Dohme (MSD) earlier this year to manufacture and supply Molnupiravir in India and over 100 low and middle-income countries.
Molnupiravir is said to inhibit the replication of multiple RNA viruses, including SARS-CoV-2.
MSD, as part of a collaboration with Ridgeback Biotherapeutics, is conducting Phase III trial of the drug globally for the treatment of non-hospitalised patients with confirmed COVID-19, the release said.
Image Source : PTI Karnataka Chief Minister B S Yediyurappa talks to media before attendin…