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

Cipla, Dr. Reddy’s, Emcure, Sun Pharma and Torrent to collaborate for clinical trial of investigational anti-viral drug Molnupiravir for COVID-19

India, June 29, 2021 – Cipla Limited, Dr. Reddy’s  Laboratories  Ltd., Emcure Pharmaceuticals Limited, Sun Pharmaceutical Industries Limited, and Torrent Pharmaceuticals Limited, 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).

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.

About Anti-Viral Drug Molnupiravir:

CAS Number: 2349386-89-4

IUPAC Name: [(2R,3S,4R,5R)-3,4-dihydroxy-5-[4-(hydroxyamino)-2-oxopyrimidin-1-yl]oxolan-2-yl]methyl 2-methylpropanoate

Molnupiravir (development codes MK-4482 and EIDD-2801) is an experimental antiviral drug which is orally active and was developed for the treatment of influenza. It is a prodrug of the synthetic nucleoside derivative N4-hydroxycytidine, and exerts its antiviral action through the introduction of copying errors during viral RNA replication.

The drug was developed at Emory University by the university’s drug innovation company, Drug Innovation Ventures at Emory (DRIVE). It was then acquired by Miami-based company Ridgeback Biotherapeutics, who later partnered with Merck & Co. to develop the drug further.

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.

COVID-19: 

In late July 2020 Merck, which had been partnering with Ridgeback Biotherapeutics on developing the drug, announced its intention to move Molnupiravir to late-stage trials beginning in September 2020. On October 19, 2020, Merck began a one-year Stage 2/3 trial focused on hospitalized patients. In June 2021, the US Department of Health and Human Services committed to buying $1.2 billion worth of Molnupiravir from Merck if it receives FDA approval

About Cipla Limited:

Established in 1935, 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. Our strengths in the respiratory, anti-retroviral, urology, cardiology, anti-infective and CNS segments are well-known. Our 46 manufacturing sites around the world produce 50+ dosage forms and 1,500+ products using cutting- edge technology platforms to cater to our 80+ markets. Cipla is ranked 3rd largest in pharma in India (IQVIA MAT April’ 21), 3rd largest in the pharma private market in South Africa (IQVIA MAT April 21), and is among the most dispensed generic players in the U.S. For over eight decades, making a difference to patients has inspired every aspect of Cipla’s work. Our paradigm-changing offer of a triple anti-retroviral therapy in HIV/AIDS at less than a dollar a day in Africa in 2001 is widely acknowledged as having contributed to bringing inclusiveness, accessibility and affordability to the centre of the HIV movement. A responsible corporate citizen, Cipla’s humanitarian approach to healthcare in pursuit of its purpose of ‘Caring for Life’ and deep-rooted community links wherever it is present make it a partner of choice to global health bodies, peers and all stakeholders. For more, please visit www.cipla.com, or click on Twitter, Facebook, LinkedIn.

About Dr. Reddy’s:

Dr. Reddy’s Laboratories Ltd. is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy’s operates in markets across the globe. Our major markets include – USA, India, Russia & CIS countries, and Europe. For more information, log on to: www.drreddys.com

About Emcure Pharmaceuticals:

Established in 1981, Emcure Pharmaceuticals Ltd. (EPL) is one of India’s leading pharmaceutical player headquartered in Pune with a global presence. Driven by technology and innovation, the company’s mission has been to develop and deliver Effective Medicines to Cure patients, enabling them to lead healthier lives. Emcure develops and sells a wide range of branded and generic formulations, API and biotechnology products in over 70 markets. Emcure is ranked as the12th largest pharma company in India (AIOCD-AWACS MAT Mar ’21) and the largest Indian pharma company in Canada. Emcure is a market leader in cardiac, gynecology, blood-related, anti-infective and HIV antiviral therapy areas. Emcure is also developing India’s first mRNA vaccine for the novel coronavirus using its in-house developed mRNA platform. To know more about Emcure, please visit: https://www.emcure.com

About Sun Pharmaceutical Industries Limited:

Sun Pharma is the world’s fourth largest specialty generic pharmaceutical company and India’s top pharmaceutical company. A vertically integrated business and a skilled team enables it to deliver high-quality products, trusted by customers and patients in over 100 countries across the world, at affordable prices. Its global presence is supported by manufacturing facilities spread across 6 continents and approved by multiple regulatory agencies, coupled with a multi-cultural workforce comprising over 50 nationalities. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities across multiple R&D centers, with investments of approximately 6-7% of annual revenues in R&D. For further information, please visit www.sunpharma.com & follow us on Twitter @SunPharma_Live.

About Torrent Pharma:

Torrent Pharma, with annual revenues of more than Rs 8,000 crores, is the flagship Company of the Torrent Group, with group revenues of Rs 21,500 crores. It is ranked 8th in the Indian Pharmaceuticals Market and is amongst the Top 5 in the therapeutics segments of Cardiovascular (CV), Central Nervous System (CNS), and Vitamins Minerals Nutritionals (VMN). It is a specialty-focused company with 76% of its revenue in India from chronic & sub-chronic therapies. It has presence in 40 countries and is ranked No. 1 amongst the Indian Pharma Companies in Brazil, Germany and Philippines. Torrent has 8 manufacturing facilities (7 in India & 1 in US), of which 5 are USFDA approved. With R&D as the backbone for its growth in domestic & overseas market, it has invested significantly in R&D capabilities with state-of-the-art R&D infrastructure employing around 700+ scientists. Please visit www.torrentpharma.com for more information.