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Merck Announces Supply Agreement with U.S. Government for Molnupiravir, an Investigational Oral Antiviral Candidate for Treatment of Mild to Moderate COVID-19

U.S. government commits to purchase approximately 1.7 million courses of Molnupiravir upon issuance of Emergency Use Authorization or approval by the U.S. Food and Drug Administration Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced it has entered into a procurement agreement with the United States government for molnupiravir (MK-4482). Molnupiravir is currently being evaluated in a Phase 3 clinical trial, the MOVe-OUT study, for the treatment of non-hospitalized patients with laboratory-confirmed COVID-19 and at least one risk factor associated with poor disease outcomes. Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics. “Merck is pleased to collaborate with the U.S. government on this new agreement that will provide Americans with COVID-19 access to molnupiravir – an investigational oral therapy being studied for outpatient use early in the course of disease – if it is authorized or approved,” said Rob Davis,

Merck Statement on Clinical Data for Molnupiravir Generated by Hetero in India

KENILWORTH, N.J., July 9, 2021 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, affirmed its commitment to enabling global access to molnupiravir through its voluntary license agreements and ongoing clinical program. As previously announced, Merck has entered into voluntary license agreements for molnupiravir with established Indian generics manufacturers. Merck has […]

Merck Announces First-Quarter 2024 Financial Results

Sales Reflect Continued Strong Growth in Oncology and Vaccines Total Worldwide Sales Were $15.8 Billion, an Increase of 9% From First Quarter 2023; Excluding the Impact of Foreign Exchange, Growth Was 12% KEYTRUDA Sales Grew 20% to $6.9 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 24% GARDASIL/GARDASIL 9 Sales Grew 14% to $2.2 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 17% GAAP EPS Was $1.87; Non-GAAP EPS Was $2.07; GAAP and Non-GAAP EPS Include a Charge of $0.26 per Share for Acquisition of Harpoon Received FDA Approval of WINREVAIR, a First-in-Class Treatment for Adults With Pulmonary Arterial Hypertension (WHO Group 1) Made Meaningful Regulatory and Clinical Progress Across Other Therapeutic Areas, Including Oncology, Vaccines and Infectious Diseases Expanded Pipeline and Portfolio Through Business Development, Including Completed Acquisition of Harpoon and Proposed Acquisition of Elanco’s Aqua Business Full-Year 2024 Financial Outlook Raises and

Merck Announces Retirement of Dr. Roy D. Baynes; Dr. Eliav Barr Appointed Head of Global Clinical Development and Chief Medical Officer

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that Dr. Roy D. Baynes, head of Global Clinical Development (GCD) and Chief Medical Officer, Merck Research Laboratories (MRL), will be retiring from Merck in July. Dr. Baynes will be succeeded by Dr. Eliav Barr, effective April 1, 2022. Dr. Baynes will continue to report to Dr. Dean Y. Li, president, Merck Research Laboratories, until his retirement. “Roy is one of the world’s pre-eminent oncologists and clinical development experts, and his masterful spearheading of the development of KEYTRUDA leaves an indelible mark on Merck, on oncology and on the lives of patients and their families. As textbooks are updated to reflect the era of immuno-oncology, Roy’s contributions cannot be overstated, and will persist far beyond his eight years with Merck,” said Dr. Li. “I know there are many who join me in thanking Roy for his efforts and wishing him well in his next chapter.” Dr. Baynes joined Merck in

Merck and Ridgeback Biotherapeutics Provide Update on Progress of Clinical Development Program for Molnupiravir, an Investigational Oral Therapeutic for the Treatment of Mild-to-Moderate COVID-19

Phase 3 MOVe-OUT Study of Molnupiravir in Outpatients to Proceed, Phase 2/3 MOVe-IN Study in Hospitalized Patients Will Not Proceed Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today provided an update on the clinical development program for molnupiravir (MK-4482/ EIDD-2801), an investigational orally available antiviral therapeutic. 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

When the world needs us, together we rise to the challenge

Dear Colleagues, Today, we announced the emergency use authorization of molnupiravir, our investigational oral antiviral COVID-19 medicine, by the U.S. Food and Drug Administration (FDA). The action today taken by the FDA to authorize a pill for COVID-19 treatment that can be taken at home marks an important milestone in the pandemic. With this news, […]

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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 will also donate more than $5 million in supplies and equipment to aid relief efforts in India Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the company 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 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

Merck Announces Third-Quarter 2023 Financial Results

Sales Reflect Sustained Growth, Particularly in Oncology and Vaccines Total Worldwide Sales Were $16.0 Billion, an Increase of 7% From Third Quarter 2022; Excluding LAGEVRIO, Growth Was 6%; Excluding LAGEVRIO and the Impact of Foreign Exchange, Growth Was 8% KEYTRUDA Sales Grew 17% to $6.3 Billion; Excluding the Impact of Foreign Exchange, Sales Also Grew 17% GARDASIL/GARDASIL 9 Sales Grew 13% to $2.6 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 16% LAGEVRIO Sales Grew 47% to $640 Million; Excluding the Impact of Foreign Exchange, Sales Grew 51% GAAP EPS Was $1.86; Non-GAAP EPS Was $2.13 Announced Collaboration Agreement With Daiichi Sankyo for Three Clinical-Stage ADC Candidates Received FDA Approval of KEYTRUDA for Perioperative Treatment of Certain Patients With NSCLC in Combination With Chemotherapy, Based on KEYNOTE-671 Trial Obtained FDA Priority Review of Biologics License Application for Sotatercept Presented Compelling Data at ESMO 2023 Congress, Including:

Merck Announces Second-Quarter 2023 Financial Results

Sales Reflect Sustained Underlying Growth, Particularly in Oncology and Vaccines Total Worldwide Sales Were $15.0 Billion, an Increase of 3% From Second Quarter 2022; Excluding LAGEVRIO, Growth Was 11%; Excluding LAGEVRIO and the Impact of Foreign Exchange, Growth Was 14% KEYTRUDA Sales Grew 19% to $6.3 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 21% GARDASIL/GARDASIL 9 Sales Grew 47% to $2.5 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 53% LAGEVRIO Sales Declined 83% to $203 Million; Excluding the Impact of Foreign Exchange, Sales Declined 82% GAAP Loss per Share Was $2.35; Non-GAAP Loss per Share Was $2.06; GAAP and Non-GAAP Loss per Share Include a Charge of $4.02 per Share for the Acquisition of Prometheus Presented Compelling Data in Earlier Stages of Cancer at 2023 ASCO Annual Meeting, Including: Positive Phase 3 Results From KEYNOTE-671 Trial Promising New Data From Phase 2b KEYNOTE-942/mRNA-4157-P201 Trial in Collaboration With Moderna

Merck Announces First-Quarter 2023 Financial Results

First Quarter 2023 Reflected Continued Strong Underlying Performance Across Key Growth Drivers, Particularly in Oncology and Vaccines Total Worldwide Sales Were $14.5 Billion, a Decrease of 9% From First Quarter 2022; Excluding LAGEVRIO, Growth Was 11%; Excluding LAGEVRIO and the Impact of Foreign Exchange, Growth Was 15% KEYTRUDA Sales Grew 20% to $5.8 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 24% GARDASIL/GARDASIL 9 Sales Grew 35% to $2.0 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 43% LAGEVRIO Sales Declined 88% to $392 Million; Excluding the Impact of Foreign Exchange, Sales Declined 87% GAAP EPS Was $1.11; Non-GAAP EPS Was $1.40; GAAP and Non-GAAP EPS Include $0.52 of Charges Related to Acquisition of Imago and Collaboration and Licensing Agreement With Kelun-Biotech Announced Proposed Acquisition of Prometheus Biosciences to Strengthen Immunology Pipeline Presented Compelling Data From Innovative Cardiovascular Pipeline With: Positive Phase

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