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Merck and Ridgeback Announce That 3.1 Million Courses of Molnupiravir, an Investigational Oral Antiviral COVID-19 Medicine, Have Been Supplied to the U.S. Government for Use in the United States

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 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, Merck entered 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

https://www.merck.com/news/merck-and-ridgeback-announce-that-3-1-million-courses-of-molnupiravir-an-investigational-oral-antiviral-covid-19-medicine-have-been-supplied-to-the-u-s-government-for-use-in-the-united-states/

Merck and Ridgeback’s Molnupiravir, an Investigational Oral Antiviral COVID-19 Medicine, Demonstrated Activity Against Omicron Variant in In Vitro Studies

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced data from six preclinical studies demonstrating that molnupiravir, an investigational oral antiviral COVID-19 medicine, was active against the SARS-CoV-2 variant Omicron (B1.1.529) in vitro. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220128005096/en/ “These findings from multiple independent in vitro studies showing that molnupiravir has consistent antiviral activity against Omicron, the primary variant circulating globally, provide additional confidence in the potential of molnupiravir as an important treatment option for certain adults with mild to moderate COVID-19 who are at high risk for progressing to severe disease,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “We are grateful to these investigators for these important insights, and to our own colleagues who are working with global

https://www.merck.com/news/merck-and-ridgebacks-molnupiravir-an-investigational-oral-antiviral-covid-19-medicine-demonstrated-activity-against-omicron-variant-in-in-vitro-studies/

Merck and Ridgeback Announce Publication of Phase 3 Study of Molnupiravir, an Investigational Oral Antiviral COVID-19 Treatment, in the New England Journal of Medicine

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced the  New England Journal of Medicine has published findings from the Phase 3 MOVe-OUT trial evaluating molnupiravir, an investigational oral antiviral medicine, in non-hospitalized high risk adults with mild to moderate COVID-19. Data from MOVe-OUT demonstrated that early treatment with molnupiravir significantly reduced the risk of hospitalization or death in high risk, unvaccinated adults with COVID-19. Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211216006079/en/ Molnupiravir is authorized in the United Kingdom as the first oral antiviral for the treatment of mild to moderate COVID-19 in adults with a positive SARS-CoV-2 diagnostic test and who have at least one risk factor for developing severe illness. The European

https://www.merck.com/news/merck-and-ridgeback-announce-publication-of-phase-3-study-of-molnupiravir-an-investigational-oral-antiviral-covid-19-treatment-in-the-new-england-journal-of-medicine/

Merck and Ridgeback Biotherapeutics Provide Update on Results from MOVe-OUT Study of Molnupiravir, an Investigational Oral Antiviral Medicine, in At Risk Adults With Mild-to-Moderate COVID-19

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today provided an update on the MOVe-OUT study of molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine for COVID-19. Data are now available from all enrolled participants (n=1433). In this study population, molnupiravir reduced the risk of hospitalization or death from 9.7% in the placebo group (68/699) to 6.8% (48/709) in the molnupiravir group, for an absolute risk reduction of 3.0% (95% confidence interval [CI]: 0.1, 5.9; nominal p-value=0.0218) and a relative risk reduction of 30% (relative risk 0.70; 95% CI: 0.49, 0.99). Nine deaths were reported in the placebo group, and one in the molnupiravir group. The adverse event profile for molnupiravir remained consistent with the profile reported at the planned interim analysis. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211126005279/en/ Based on

https://www.merck.com/news/merck-and-ridgeback-biotherapeutics-provide-update-on-results-from-move-out-study-of-molnupiravir-an-investigational-oral-antiviral-medicine-in-at-risk-adults-with-mild-to-moderate-covid-19/

Merck and Ridgeback Announce Japanese Government to Purchase 1.6 Million Courses of Molnupiravir, an Investigational Oral COVID-19 Antiviral Medicine, Upon Authorization or Approval

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that the Japanese government will purchase, upon authorization or approval, approximately 1.6 million courses of molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine. Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics. Merck’s applications for the potential authorized use of molnupiravir are under review by Japan’s Pharmaceuticals and Medical Devices Agency, the U.S. Food and Drug Administration , and the European Medicines Agency . Molnupiravir is authorized in the United Kingdom for the treatment of mild-to-moderate COVID-19 in adults with a positive SARS-CoV-2 diagnostic test and who have at least one risk factor for developing severe illness. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211110005792/en/ “We are proud to partner with the Japanese

https://www.merck.com/news/merck-and-ridgeback-announce-japanese-government-to-purchase-1-6-million-courses-of-molnupiravir-an-investigational-oral-covid-19-antiviral-medicine-upon-authorization-or-approval/

Merck and Ridgeback’s Investigational Oral Antiviral Molnupiravir Reduced the Risk of Hospitalization or Death by Approximately 50 Percent Compared to Placebo for Patients with Mild or Moderate COVID-19 in Positive Interim Analysis of Phase 3 Study

At the Interim Analysis, 7.3 Percent of Patients Who Received Molnupiravir Were Hospitalized Through Day 29, Compared With 14.1 Percent of Placebo-Treated Patients Who were Hospitalized or Died Merck Plans to Seek Emergency Use Authorization in the U.S. as Soon as Possible and to Submit Applications to Regulatory Agencies Worldwide If Authorized, Molnupiravir Could be the First Oral Antiviral Medicine for COVID-19 Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine, significantly reduced the risk of hospitalization or death at a planned interim analysis of the Phase 3 MOVe-OUT trial in at risk, non-hospitalized adult patients with mild-to-moderate COVID-19. At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were either hospitalized or died

https://www.merck.com/news/merck-and-ridgebacks-investigational-oral-antiviral-molnupiravir-reduced-the-risk-of-hospitalization-or-death-by-approximately-50-percent-compared-to-placebo-for-patients-with-mild-or-moderat/

Merck and Ridgeback Statement on Positive FDA Advisory Committee Vote for Investigational Oral Antiviral Molnupiravir for Treatment of Mild to Moderate COVID-19 in High Risk Adults

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today provided the following statement at the conclusion of the U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) regarding the Emergency Use Authorization (EUA) application for molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine, for the treatment of mild to moderate COVID-19 in adults with positive results of direct SARS-CoV-2 viral testing who are at high risk for progressing to severe COVID-19 and/or hospitalization. The Advisory Committee voted 13-10 that the known and potential benefits of molnupiravir outweigh its known and potential risks for the treatment of mild to moderate COVID-19 in high risk adult patients who are within five days of symptom onset. The FDA is not bound by the committee’s guidance but takes its advice into consideration. This press release features multimedia. View the full release here:

https://www.merck.com/news/merck-and-ridgeback-statement-on-positive-fda-advisory-committee-vote-for-investigational-oral-antiviral-molnupiravir-for-treatment-of-mild-to-moderate-covid-19-in-high-risk-adults/

Merck and Ridgeback Announce U.S. Government to Purchase 1.4 Million Additional Courses of Molnupiravir, an Investigational Oral Antiviral Medicine, for the Treatment of Mild-to-Moderate COVID-19 in At Risk Adults

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that the United States government will exercise two of its options to purchase a total of 1.4 million additional courses of molnupiravir, an investigational oral antiviral medicine, if the medicine is granted Emergency Use Authorization (EUA) or approval by the U.S. Food and Drug Administration (FDA), for approximately $1 billion. With these exercised options, the U.S. government has now committed to purchase a total of approximately 3.1 million courses of molnupiravir, for approximately $2.2 billion, between authorization and early 2022. The U.S. government also has the ability to purchase more than 2 million additional courses through further options that remain in the contract. Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics. This press release features multimedia. View the full release here:

https://www.merck.com/news/merck-and-ridgeback-announce-u-s-government-to-purchase-1-4-million-additional-courses-of-molnupiravir-an-investigational-oral-antiviral-medicine-for-the-treatment-of-mild-to-moderate-covid-19-in-a/