Merck, known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced the signing of a long-term supply agreement with the United Nations Children’s Fund (UNICEF) to facilitate broad global access for molnupiravir, an investigational oral antiviral Covid-19 medicine.

Under the agreement, Merck will allocate up to 3 million courses of molnupiravir to UNICEF throughout the first half of 2022 for distribution in more than 100 low- and middle-income countries following regulatory authorizations. Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics and it has been authorized for use in more than 10 countries, including in the United States, United Kingdom, Japan and Taiwan.

“Merck is delivering on our commitment to make molnupiravir available – widely, quickly and equitably. Through this groundbreaking agreement with UNICEF, millions of patients in more than 100 low- and middle-income countries will gain access to molnupiravir through UNICEF and the ACT Accelerator Therapeutics Partnership in the first half of 2022,” said Robert M. Davis, chief executive officer and president, Merck. “I am proud of the fact that patients in these low- and middle-income countries will gain access at the same time as patients in countries with higher incomes.”

To accelerate broad global access for molnupiravir upon authorization or approval, Merck’s comprehensive supply and access approach includes investing at risk to produce millions of courses of therapy, granting voluntary licenses to generic manufacturers and to the Medicines Patent Pool to help increase affordable, quality-assured supply in the developing world, and entering into supply agreements with governments and other organizations, including this agreement with UNICEF.

“As part of our commitment to ensuring access to critical medicines, we picked Merck as our partner for molnupiravir because of our shared commitment to ensuring global, affordable availability. Molnupiravir, which can be efficiently delivered to low- and middle-income countries, can play a significant role in global efforts to address the pandemic,” said Wendy Holman, chief executive officer, Ridgeback Biotherapeutics. “We are proud of this agreement with UNICEF to help address global health challenges and inequities by making molnupiravir accessible to patients around the world.”

The US Food and Drug Administration (FDA) has issued an EUA for the emergency use of the unapproved molnupiravir, a nucleoside analogue that inhibits SARS-CoV-2 replication by viral mutagenesis, for the treatment of mild to moderate coronavirus disease 2019 (Covid-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe Covid-19, including hospitalization or death, and for whom alternative Covid-19 treatment options authorized by FDA are not accessible or clinically appropriate. Molnupiravir is not FDA-approved for any use including for use for the treatment of Covid-19. Prior to initiating treatment with molnupiravir, carefully consider the known and potential risks and benefits.

Molnupiravir is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of molnupiravir under section 564(b)(1) of the Federal, Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Molnupiravir is not authorized for use in patients less than 18 years of age or who are hospitalized due to Covid-19. Benefit of treatment with molnupiravir has not been observed in subjects when treatment was initiated after hospitalization due to Covid-19. Molnupiravir is not authorized for use for longer than five consecutive days. Molnupiravir is not authorized for pre-exposure or post-exposure prophylaxis for prevention of Covid-19. Molnupiravir may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs in the therapeutic class to which molnupiravir belongs (i.e., anti-infectives).

Molnupiravir (MK-4482) is an investigational, orally administered nucleoside analog that inhibits the replication of SARS-CoV-2, the causative agent of Covid-19. Merck and Ridgeback’s “orange Covid-19 pill” is a Swedish Orange opaque capsule with the Merck corporate logo and “82” printed in white ink, available in certain markets outside of the U.S. as Lagevrio.

Results from the phase 3 MOVe-OUT study demonstrated the efficacy benefit of molnupiravir treatment was generally consistent across patients infected with SARS-CoV-2 variants of concern, Delta, Gamma and Mu. Preliminary preclinical data has shown that molnupiravir has antiviral activity against the newly identified variant, Omicron (B1.1.529). Molnupiravir has yet to be evaluated against Omicron in clinical studies.

Molnupiravir was invented at Emory University. Drug Innovation Ventures at Emory (DRIVE), LLC, which was formed by Emory to develop early-stage drug candidates for viral diseases of global concern, advanced molnupiravir through IND submission. Emory/DRIVE received some research funding from the US Department of Defense and the U.S. National Institutes of Health. Molnupiravir is being developed by Merck in collaboration with Ridgeback Biotherapeutics. Ridgeback received an upfront payment from Merck and also is eligible to receive contingent payments dependent upon the achievement of certain developmental and regulatory approval milestones. Any profits from the collaboration will be split between the partners equally. Since licensed by Ridgeback, all funds used for the development of molnupiravir have been provided by Merck and Ridgeback.

Molnupiravir was evaluated in MOVe-OUT, a global phase 3, randomized, placebo-controlled, double-blind, multi-site study of non-hospitalized adult patients with symptomatic, laboratory-confirmed mild to moderate Covid-19 and at least one risk factor associated with poor disease outcomes. The phase 3 portion of the MOVe-OUT trial was conducted globally in more than 170 sites in locations including Argentina, Brazil, Canada, Chile, Colombia, Egypt, France, Germany, Guatemala, Israel, Italy, Mexico, Philippines, Poland, Russia, South Africa, Spain, Sweden, Taiwan, Ukraine, the United Kingdom and the United States. For further information about the MOVe-OUT trial, please visit clinicaltrials.gov. Molnupiravir is also being evaluated for post-exposure prophylaxis in MOVe-AHEAD, a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study evaluating the efficacy and safety of molnupiravir in preventing the spread of Covid-19 within households. \

Headquartered in Miami, Florida, Ridgeback Biotherapeutics LP is a biotechnology company focused on emerging infectious diseases.