Molnupiravir
Five Pharma majors to collab for clinical trial of Molnupiravir drug
Hyderabad/UNI: Five Indian pharmaceutical majors joined hands to hold the clinical trial of the investigational and oral anti-viral drug Molnupiravir that inhibits the replication of multiple RNA viruses, including SARS-CoV-2, meant to treat mild COVID-19 outdoor patients in India.
Cipla, Dr Reddy, Emcure, Sun Pharma, and its subsidiaries plus associate companies, including Torrent Pharma announced their collaboration on Tuesday.
Between March and April this year, these pharma companies had individually entered into a non-exclusive voluntary licensing agreement with Merck Sharp Dohme (MSD) to manufacture and supply Molnupiravir to India and over 100 Low and Middle-Income Countries (LMICs).
The five generic drug makers have entered into a collaboration agreement, wherein the parties will jointly sponsor, supervise and monitor the clinical trial in India, Hyderabad-based Dr Reddy labs said in a company release.
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 in the product as used by Dr. Reddy’s in its clinical trial.
Following the clinical trial protocol approval given by the Drugs Controller General of India (DCGI), the clinical validation test 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, they added in a joint statement.
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 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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