Hetero, the Hyderabad-based generic pharmaceutical company, to manufacture the anti-viral drug Molnupiravir in India

A test tube containing a patient's sample at a virology research lab in Leuven, Belgium.

 

In what will come as a ray of hope as India battles the growing number of COVID-19 infections, Hyderabad-based generic pharmaceutical company Hetero has entered into a non-exclusive voluntary licensing agreement with Merck Sharp & Dohme (MSD) for the manufacture and distribution of the investigational oral therapeutic antiviral drug candidate Molnupiravir, which is being studied as a possible treatment for COVID-19.

Under this licensing deal, Hetero will be allowed to expand access of Molnupiravir in India and in other low-and middle-income countries, following the approvals for emergency use authorisation by local regulatory agencies. The tie-up is expected to accelerate the availability of Molnupiravir in India and in other low- and middle-income countries.

MSD, which is known as Merck & Co., Inc in the United States and Canada, is developing Molnupiravir in collaboration with Ridgeback Biotherapeutics. The drug is currently being studied in a phase-3 trial for the treatment of non-hospitalised patients with confirmed COVID-19.

Molnupiravir will be manufactured at Hetero’s formulation facility in Hyderabad, which has been approved by regulatory authorities such as the U.S. Food and Drug Administration and the European Medicines Evaluation Agency, or EMEA.

In a statement, Dr B. Partha Saradhi Reddy, chairman, Hetero Group of Companies, said: “Hetero has partnered with MSD to enable access of Molnupiravir for COVID-19 to the Indian population at this much important time to fight the pandemic. We are vertically integrated to manufacture and commercially ready to supply this product to patients swiftly across the country.” He disclosed that Hetero would be “immediately approaching the Drugs Controller General of India to seek regulatory pathway and emergency use authorisation”.

Molnupiravir (EIDD-2801/MK-4482) is an investigational, orally bioavailable form of a potent ribonucleoside analog that inhibits the replication of multiple RNA viruses including SARS-CoV-2, the causative agent of COVID-19. It has been shown to be active in several models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission, as well as SARS-CoV-1 and MERS.

The drug candidate was invented at Drug Innovations at Emory (DRIVE), a not-for-profit biotechnology company wholly owned by Emory University, a private research university in Atlanta, Georgia (United States).

Besides Hetero, MSD has also entered into similar non-exclusive voluntary licensing agreements for Molnupiravir with four other established Indian generic pharmaceutical manufacturers: Cipla, Dr Reddy’s Laboratories, Emcure Pharmaceuticals and Sun Pharmaceutical Industries. All five generic pharmaceutical companies have World Health Organization (WHO) Pre-Qualified Manufacturing facilities and experience as major suppliers to global and key low- and middle-income countries’ procurers.

MSD India, the wholly owned subsidiary of MSD, said in a statement that under the agreements, Merck & Co, Inc U.S. will provide licences to these five manufacturers to supply Molnupiravir to India and more than 100 low- and middle-income countries. The company is also in discussions with the Medicines Patent Pool to explore the potential for additional licenses, the statement added.