Business & Finance
Merck Inks Voluntary Licensing Agreements with Five Indian Generics Manufacturers to Accelerate and Expand Global Access to Molnupiravir, an Investigational Oral Therapeutic for the Treatment of COVID-19
27 April 2021 - - US-based pharmaceutical company Merck (NYSE: MRK) has entered into non-exclusive voluntary licensing agreements for molnupiravir with five established Indian generics manufacturers, the company said.

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.

Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics.

Merck has entered into these agreements to accelerate availability of molnupiravir in India and in other low- and middle-income countries (LMICs) following approvals or emergency authorization by local regulatory agencies.

The agreements have been signed with Cipla Ltd., Dr. Reddy's Laboratories Ltd., Emcure Pharmaceuticals Ltd., Hetero Labs Ltd. and Sun Pharmaceutical Industries Ltd. five generics manufacturers with World Health Organization Pre-Qualified Manufacturing facilities and experience as major suppliers to global and key LMIC procurers.

Under the agreements, Merck will provide licenses to these manufacturers to supply molnupiravir to India and more than 100 LMICs.

Merck is also in discussions with the Medicines Patent Pool to explore the potential for additional licenses.

Separately, Merck will also donate more than USD 5m worth of oxygen-production equipment, masks, hand sanitizer and financial aid to support relief efforts in India.

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.

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 Merck.