Pharma Majors Collaborate for Clinical Trial of Investigational Oral Anti-Viral Drug Molnupiravir for COVID-19

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Molnupiravir for COVID-19

Clinical Trial of Investigational Oral Anti-Viral Drug Molnupiravir for COVID-19. Cipla Limited (BSE: 500087; NSE: CIPLA EQ, referred to as “Cipla”), Dr.  Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC:  DRREDDY, hereafter referred to as “Dr. Reddy’s”), Emcure Pharmaceuticals Limited (hereafter  referred to as “Emcure”), Sun Pharmaceutical Industries Limited.

(Reuters: SUN.BO,  Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its  subsidiaries and/or associate companies), and Torrent Pharmaceuticals Limited (“Torrent”,  BSE: 500420, NSE: TORNTPHARM), announced today that the 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.  

Between March and April this year, these five 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 (LMICs). 

Molnupiravir for COVID-19

The five pharma companies have entered into a collaboration agreement, wherein the parties will  jointly sponsor, supervise and monitor the clinical trial in India. As per the directive of the Subject  Expert Committee (SEC) of the Central Drugs Standard Control Organization, 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.  

Following the clinical trial protocol approval given by the Drugs Controller General of India, the  clinical trial will be conducted for the treatment of mild COVID-19 in an outpatient setting. It is  expected to take place between June and September this year across India with the recruitment  of 1,200 patients.

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. 

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, through a collaboration with Ridgeback  Biotherapeutics, in a Phase III trial for the treatment of non-hospitalized patients with confirmed  COVID-19 globally. 

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