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Merck To License COVID-19 Treatment Molnupiravir To Five Indian Generics Makers

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Drug major Merck said it entered into non-exclusive voluntary licensing agreements with five Indian generics manufacturers for COVID-19 treatment molnupiravir amid the surging coronavirus cases in India.

Molnupiravir (EIDD-2801/MK-4482) 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 signed deals with Cipla Ltd., Dr. Reddy's Laboratories Ltd., Emcure Pharmaceuticals Ltd., Hetero Labs Ltd. and Sun Pharmaceutical Industries Ltd. These generics makers hold World Health Organization or WHO Pre-Qualified Manufacturing facilities and experience as major suppliers to global and key LMIC procurers.

These agreements are expected to accelerate availability of molnupiravir in India and in other LMICs following approvals or emergency authorization by local regulatory agencies.

Under the deals, Merck will provide licenses to these manufacturers to supply molnupiravir in India and to more than 100 low- and middle-income countries or LMICs. Merck is also in discussions with the Medicines Patent Pool to explore the potential for additional licenses.

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.

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

Kenneth Frazier, chairman and CEO, Merck, said, "The scale of human suffering in India at this moment is devastating, and it is clear that more must be done to help alleviate it. These agreements, toward which we have been working as we have been studying molnupiravir, will help to accelerate access to molnupiravir in India and around the world."

In the wake of the tragic COVID situation in India, U.S. President Joe Biden has pledged America's support with a range of emergency assistance, including oxygen-related supplies, vaccine materials, and therapeutics.

The Defense Department is also working closely with other U.S. agencies to rapidly deploy oxygen-related equipment, rapid COVID-19 test kits, personal protective equipment and other essential materials to India.

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