Merck Has Completed Manufacturing of 10 Million Courses of Therapy and Remains on Track to Produce at Least 20 Million Courses in 2022 to Provide Widespread Access to Molnupiravir Globally

KENILWORTH, N.J. & MIAMI--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that a total of approximately 3.1 million courses of molnupiravir, an investigational oral antiviral COVID-19 medicine, have been provided to the U.S. government for allocation across the country. The U.S. Department of Health and Human Services (HHS) has created a public website to help providers identify locations that have received shipments of government-procured COVID-19 therapeutics available under Emergency Use Authorization. In 2021, Merckentered a procurement agreement with the U.S. government under which the company agreed to supply approximately 3.1 million courses of molnupiravir to the U.S. government upon Emergency Use Authorization or approval from the U.S. Food and Drug Administration.

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“As we start 2022, more than 2,000 COVID-19 deaths are being reported in the U.S. daily, which underscores the need for medicines including molnupiravir that can be taken at home. In line with our commitment to accelerating access to molnupiravir in the U.S., we have now supplied more than 3 million courses to the U.S. government within approximately 7 weeks of receiving Emergency Use Authorization from the U.S. Food and Drug Administration,” said Robert M. Davis, chief executive officer and president, Merck. “I am grateful to our colleagues who have worked tirelessly over the past year to accomplish this goal and to the health care providers who remain on the front lines of caring for patients with COVID-19.”

“We believe that molnupiravir will be a critical addition in helping curb the impact of COVID-19 on patients and health care systems in the U.S., particularly with the medicine’s antiviral activity against many variants of concern. We will continue to work with urgency to bring this important medicine to appropriate patients as quickly as possible,” said Wendy Holman, chief executive officer, Ridgeback Biotherapeutics.

In addition to the U.S. agreement, Merck has entered into advance purchase and supply agreements for molnupiravir in more than 30 markets worldwide, including Australia, Canada, Korea, Japan, Thailand, Ukraine and United Kingdom, pending regulatory authorizations, and is currently in discussions with additional governments. To date, Merck has shipped molnupiravir to more than 25 countries; in countries where it is approved or authorized, patients have begun to receive the medicine.

About Merck’s Global Efforts to Accelerate Access to Molnupiravir Following Regulatory Authorizations or Approvals

Global access has been a priority for Merck and Ridgeback since the inception of their molnupiravir collaboration. The companies are committed to providing timely access to molnupiravir globally through our comprehensive supply and access approach, which includes investing at risk to produce millions of courses of therapy; tiered pricing based on the ability of governments to finance health care; entering into supply agreements with governments; allocating up to 3 million courses of therapy for distribution through UNICEF and the ACT Accelerator Therapeutics Partnership; and granting voluntary licenses to generic manufacturers and to the Medicines Patent Pool to make generic molnupiravir available in more than 100 low- and middle-income countries following local regulatory authorizations or approvals.

Supply: In anticipation of the results from MOVe-OUT and the potential for regulatory authorization or approval, Merck produced molnupiravir at risk, manufacturing 10 million courses of treatment by the end of 2021, with at least 20 million courses expected to be produced in 2022. To date, Merck has shipped molnupiravir to over 25 markets, including approximately 3.1 million patient courses supplied to the U.S. government; in countries where it is approved or authorized, patients have begun to receive the medicine. To supplement the supply from licensed generic manufacturers, Merck has entered an agreement with UNICEF to allocate up to 3 million courses of therapy to low- and middle-income countries through the first half of 2022.

Supply agreements:Merckentered into a procurement agreement with the U.S. government under which the company has supplied approximately 3.1 million courses of molnupiravir to the U.S. government, upon Emergency Use Authorization or approval from the U.S. Food and Drug Administration. The procurement of molnupiravir was supported in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, in collaboration with the DOD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) under contract number W911QY21C0031.

The U.S. Department of Health and Human Services (HHS) has created a public website to help providers locate dispensing sites that have received shipments of government-procured COVID-19 therapeutics available under Emergency Use Authorization. Merck has also entered into advance purchase and supply agreements for molnupiravir with governments for over 30 markets worldwide, including Australia, Canada, Korea, Japan, Thailand, Ukraine and United Kingdom, pending regulatory authorizations, and is currently in discussions with additional governments. Merck is implementing a tiered pricing approach based on World Bank country income criteria to reflect countries’ relative ability to finance their health response to the pandemic.

Voluntary licenses: As part of its commitment to widespread global access, Merck previously announced that it has entered into a licensing agreement with the Medicines Patent Pool to increase broad access for molnupiravir in low- and middle-income countries. Additionally, Merck previously announced that the company has entered into non-exclusive voluntary licensing agreements for molnupiravir with established generic manufacturers to accelerate availability of molnupiravir in more than 100 low- and middle-income countries following approvals or emergency authorization by local regulatory agencies.

Merck continues to discuss additional measures and collaborations to accelerate broad, global access to molnupiravir.

Authorized Use of Molnupiravir in the U.S.

The U.S. 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).

Selected Safety Information for Molnupiravir

Contraindications

No contraindications have been identified based on the limited available data on the emergency use of molnupiravir authorized under this EUA.

Warnings and Precautions

There are limited clinical data available for molnupiravir. Serious and unexpected adverse events may occur that have not been previously reported with molnupiravir use.

Molnupiravir is not recommended for use during pregnancy. Based on findings from animal reproduction studies, molnupiravir may cause fetal harm when administered to pregnant individuals. There are no available human data on the use of molnupiravir in pregnant individuals to evaluate the risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

Molnupiravir is authorized to be prescribed to a pregnant individual only after the healthcare provider has determined that the benefits would outweigh the risks for that individual patient. If the decision is made to use molnupiravir during pregnancy, the prescribing healthcare provider must document that the known and potential benefits and the potential risks of using molnupiravir during pregnancy were communicated to the pregnant individual.

There is a pregnancy surveillance program that monitors pregnancy outcomes in individuals exposed to molnupiravir during pregnancy. The prescribing healthcare provider must document that a pregnant individual was made aware of Merck’s pregnancy surveillance program at 1-877-888-4231 or pregnancyreporting.msd.com. If the pregnant individual agrees to participate in the pregnancy surveillance program and allows the prescribing healthcare provider to disclose patient specific information to Merck, the prescribing healthcare provider must provide the patient’s name and contact information to Merck. Pregnant individuals exposed to molnupiravir can also report the exposure by contacting Merck at 1-877-888-4231 or pregnancyreporting.msd.com.

Advise individuals of childbearing potential of the potential risk to a fetus and to use an effective method of contraception correctly and consistently during treatment with molnupiravir and for 4 days after the final dose.

Prior to initiating treatment with molnupiravir, assess whether an individual of childbearing potential is pregnant or not, if clinically indicated.

Molnupiravir is not authorized for use in patients less than 18 years of age because it may affect bone and cartilage growth. The safety and efficacy of molnupiravir have not been established in pediatric patients.

Adverse Reactions

The most common adverse reactions occurring in ≥1% of subjects in the molnupiravir treatment group in the Phase 3 double-blind MOVe-OUT study were diarrhea (2% versus placebo at 2%), nausea (1% versus placebo at 1%), and dizziness (1% versus placebo at 1%) all of which were Grade 1 (mild) or Grade 2 (moderate).

Serious adverse events occurred in 7% of subjects receiving molnupiravir and 10% receiving placebo; most serious adverse events were COVID-19 related. Adverse events leading to death occurred in 2 (