By Daniel R. Lucey MD, MPH, FIDSA
On April 27 Merck issued a press release titled, “Amid Humanitarian Crisis in India, Merck Announces 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.”
Merck stated that it “has entered into non-exclusive voluntary licensing agreements for molnupiravir with five established Indian generics manufacturers. 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 Limited, Dr. Reddy’s Laboratories Limited, Emcure Pharmaceuticals Limited, Hetero Labs Limited and Sun Pharmaceutical Industries Limited – five generics manufacturers with World Health Organization (WHO) 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…”
The implications of this agreement could be immense, not only for India but for more than 100 low and middle income countries fighting COVID-19 if “approvals or emergency authorization by local regulatory agencies” are granted.
MERCK has not requested United States Food and Drug Administration emergency use authorization for molnupiravir.
Of note, two weeks ago, on April 15, Merck announced that its studies in outpatients of molnupiravir twice a day for five days were continuing, however, its intravenous formulation for hospitalized patients would be stopped because it “is unlikey to demonstrate a clinical benefit”:
Merck stated on April 15:
“Based on a planned interim analysis of data from the Phase 2, dose-finding portion (Part 1) of two ongoing placebo-controlled Phase 2/3 trials evaluating molnupiravir administered twice a day for five days in outpatients (MOVe-OUT) and hospitalized patients (MOVe-IN) with COVID-19, and from a previously completed Phase 2a dose-ranging study in outpatients, the decision has been made to proceed with the Phase 3 portion (Part 2) of MOVe-OUT in outpatients with COVID-19, evaluating the 800 mg dose of molnupiravir twice daily. Data from MOVe-IN indicate that molnupiravir is unlikely to demonstrate a clinical benefit in hospitalized patients, who generally had a longer duration of symptoms prior to study entry; therefore, the decision has been made not to proceed to Phase 3.”
Daniel Lucey, M.D. MPH, FIDSA, FACP, is a Clinical Professor of Medicine at Dartmouth Geisel School of Medicine, Infectious Disease adjunct Professor at Georgetown Medical Center, senior scholar at Georgetown Law, Anthropology Research Associate at the Smithsonian Museum of Natural History and a member of the Infectious Diseases Society of America Global Health Committee. He served as a volunteer to outbreaks overseas including hands-on Ebola patient care in Sierra Leone and Liberia (Doctors without Borders) 2014, MERS 2013, SARS 2003, as well as HIV, H5N1, Zika, yellow Fever, and pneumonic plague 2017 (with WHO/USAID/CDC). Since Jan. 6, 2020 he has contributed over 75 posts to Science Speaks on COVID-19 and traveled to China in February 2020. He initially proposed, then fundraised and helped design the content for 2018-2022 Smithsonian Exhibition on Epidemics due to zoonotic viruses. From 1982-1988 he trained at University of California San Francisco and Harvard and was an attending physician at the NIH (NIAID) in the 1990s while in the US Public Health Service.