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Five drug makers collaborate for clinical trial of Molnupiravir

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Cipla, Dr Reddy's Laboratories, Emcure Pharmaceuticals, Sun Pharmaceutical Industries & Torrent Pharmaceuticals will collaborate for the clinical trial of investigational oral anti-viral drug Molnupiravir for the treatment of mild COVID-19 in India.

Between March 2021 and April 2021, the five pharmaceutical 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).

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 Laboratories 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 Laboratories' 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 2021 and September 2021 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.

Shares of Cipla lost 0.45% to Rs 974.60 on BSE. Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in our home markets of India, South Africa, North America, and key regulated and emerging markets.

Shares of Dr Reddy's Laboratories gained 0.21% to Rs 5,443.40 on BSE. Dr Reddy's Laboratories is an integrated pharmaceutical company. Through its three businesses - pharmaceutical services & active ingredients, global generics and proprietary Products.

Shares of Sun Pharmaceutical Industries rose 0.49% to Rs 680.55 on BSE. Sun Pharmaceutical Industries is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company.

Shares of Torrent Pharmaceuticals slipped 0.24% to Rs 2,914.70 on BSE. Torrent Pharma is the flagship Company of the Torrent Group. It is a specialty-focused company with 76% of its revenue in India from chronic & sub-chronic therapies. It has presence in 40 countries.

Emcure Pharmaceuticals is one of India's leading pharmaceutical player headquartered in Pune with a global presence. The company develops and sells a wide range of branded and generic formulations, API and biotechnology products in over 70 markets. It is ranked as the 12th largest pharma company in India (AIOCD-AWACS MAT March 2021) and the largest Indian pharma company in Canada. Emcure Pharmaceuticals is a market leader in cardiac, gynaecology, blood- related, anti-infective and HIV antiviral therapy areas. The firm is also developing India's first mRNA vaccine for the novel coronavirus using its in-house developed mRNA platform.

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First Published: Jun 30 2021 | 11:27 AM IST

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