Several Indian drugmakers in race to launch Merck's molnupiravir

US pharma giant Merck & Co and Ridgeback Biotherapies’ investigational oral antiviral molnupiravir that reduced the risk of hospitalization or death by approximately 50% compared to a placebo has got five Indian companies rushing to collaborate on the oral antiviral medicine.

Cipla (NSE: CIPLA), Dr Reddy’s Laboratories (BSE: 500124), Emcure, Sun Pharma (NSE: SUNPHARMA) and Torrent (NSE: TORNTPHARM) are collaborating for the clinical trials in India of the investigational, oral, anti-viral drug molnupiravir for the treatment of mild COVID-19. There are several other Indian companies in a race to launch it. Some have a licensing arrangement with Merck and others do not.

Molnupiravir is an experimental drug consumed in the form of a pill. Early this month, Merck announced at the recommendation of an independent Data Monitoring Committee and in consultation with the US Food and Drug Administration, recruitment into the study is being stopped early due to the positive results.

Indian companies got into the act much earlier. Between March and April, five pharma companies had individually entered into a non-exclusive voluntary licensing agreement with Merck to manufacture and supply molnupiravir to India and over 100 low and middle-income countries.

The race, however, is not confined to the five companies that have been licenced by Merck. There are several other Indian companies and one of the early ones in the fray is Hyderabad-based Natco Pharma, which apparently has completed clinical trials and is awaiting marketing and manufacturing approval from the Indian drug regulator.

The five pharma companies that had entered into a collaboration agreement are to jointly sponsor, supervise and monitor the clinical trial in India. As per the directive of the Subject Expert Committee of the Central Drugs Standard Control Organization, Dr Reddy’s is to conduct the clinical trial using its product, and the four pharma companies will be required to demonstrate equivalence of their product to the product used by Dr Reddy’s in its clinical trial.