India, Hyderabad, 27th April 2021: Hetero, one of India’s leading generic pharmaceutical companies and the world’s largest producer of anti-retroviral drugs, announced today that it has entered into a non-exclusive voluntary licensing agreement with MSD for the manufacturing and distribution of investigational oral therapeutic antiviral drug ‘Molnupiravir’ for the treatment of 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 (LMICs), following the approvals for emergency use authorization by local regulatory agencies.
Molnupiravir is an investigational oral antiviral agent currently being studied in a Phase 3 trial for the treatment of non-hospitalized patients with confirmed Covid-19. MSD is developing Molnupiravir in collaboration with Ridgeback Biotherapeutics.
Dr. B. Partha Saradhi Reddy, Chairman, Hetero Group of Companies,commented: “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. We will be immediately approaching the DCGI to seek regulatory pathway and emergency use authorization. We remain committed to the global fight against the pandemic and will continue to provide access to potential therapies for Covid-19 treatment.”
Molnupiravir will be manufactured in our world-class formulation facility in Hyderabad, India, which has been approved by stringent global regulatory authorities such as USFDA and EU, among others.
About Molnupiravir
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-CoV2, the causative agent of COVID-19. Molnupiravir 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. EIDD-2801 was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University. Since licensed by Ridgeback, all funds used for the development of EIDD-2801 by Ridgeback have been provided by Wayne and Wendy Holman and MSD.
Hetero entered into a non-exclusive voluntary licensing agreement with MSD for the manufacturing and distribution of investigational oral therapeutic antiviral drug ‘Molnupiravir’ for the treatment of 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 (LMICs), following the approvals for emergency use authorization by local regulatory agencies.
Hetero completed a phase 3 clinical trial (approved by CDSCO) in about 1218 COVID-19 patients, the data of which was approved by subject expert committee (SEC) and recommended for marketing authorisation. Subsequently, CDSCO provided the approval for manufacturing and marketing (M&M).