Hetero-Merck alliance seeks emergency use nod for anti-COVID drug Molnupiravir in India

Hyderabad-based Hetero has entered into a non-exclusive voluntary licensing agreement with the US pharma major MSD for the manufacturing and distribution of investigational oral therapeutic antiviral drug 'molnupiravir' for the treatment of Covid-19.  

Under the licensing deal, Hetero will be allowed to sell Molnupiravir in India and in other low-and middle-income countries (LMICs), following the approvals for emergency use authorization by local regulatory agencies.

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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.

 "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", B. Partha Saradhi Reddy, Chairman, Hetero Group of Companies, said.

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Molnupiravir will be manufactured in Hetero's USFDA and EU-approved formulation facility in Hyderabad.  

Molnupiravir 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.