U.K.’s Medicines and Healthcare Products Regulatory Agency Authorizes Molnupiravir 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

Applications Remain Under Review by Other Regulatory Authorities, Including U.S. Food and Drug Administration and the European Medicines Agency

KENILWORTH, N.J. & MIAMI, Nov. 4, 2021 – MSD (NYSE: MRK), a trade name of Merck & Co., Inc, Kenilworth, NJ, USA., and Ridgeback Biotherapeutics today announced that the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has granted authorization in the United Kingdom (U.K.) for molnupiravir (MK-4482, EIDD-2801), the first oral antiviral medicine authorized 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. In the U.K., LAGEVRIO® (lah-GEV-ree-oh) is the planned trademark for molnupiravir; the trademark for molnupiravir in other countries has not been approved. MSD announced its application with the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of molnupiravir is under review and recently announced the European Medicines Agency has initiated a rolling review of the company’s Marketing Authorization Application. MSD is actively working to submit applications to other regulatory agencies around the world.

 “The first global authorization of molnupiravir is a major achievement in MSD’s singular legacy of bringing forward breakthrough medicines and vaccines to address the world’s greatest health challenges. In pursuit of MSD’s unwavering mission to save and improve lives, we will continue to move with both rigor and urgency to bring molnupiravir to patients around the world as quickly as possible,” said Robert M. Davis, chief executive officer and president, MSD.

“As an oral therapeutic, molnupiravir offers an important addition to the vaccines and medicines deployed so far to counter the COVID-19 pandemic,” said Dr. Dean Y. Li, executive vice president and president, MSD Research Laboratories. “We are very grateful to the investigators, patients and their families for their critical contributions to the MOVe-OUT study that made this authorization possible.”

The authorization is based on positive results from a planned interim analysis from the Phase 3 MOVe-OUT clinical trial, which evaluated molnupiravir 800 mg twice-daily in non-hospitalized, unvaccinated adult patients with laboratory-confirmed mild-to-moderate COVID-19, symptom onset within five days of study randomization and at least one risk factor associated with poor disease outcomes (e.g., heart disease, diabetes).

“When we embarked on the journey to take molnupiravir from a hope to a reality, we believed we had a responsibility to move as quickly and safely as possible. We believed each day saved could save lives and limit severe disease and the global hardships of this pandemic,” said Wendy Holman, chief executive officer, Ridgeback Biotherapeutics. “It is gratifying to reach this milestone and show that the extraordinary effort of our collaborators, patients, physicians and team and the personal sacrifices made have now achieved that important goal. It is also gratifying to see the first global authorization occur in the U.K., the very place where we administered molnupiravir to the first brave human volunteer.”

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

MSD is 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; and granting voluntary licenses to generic manufacturers and to the Medicines Patent Pool to make generic molnupiravir available in 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, MSD has been producing molnupiravir at risk and expects to produce 10 million courses of treatment by the end of 2021, with at least 20 million courses to be produced in 2022.

Supply agreements: Earlier this year, MSD entered into a procurement agreement with the U.S. Government under which the company will supply approximately 1.7 million courses of molnupiravir to the U.S. Government, upon EUA or approval from the U.S. FDA. Additionally, MSD has entered into supply and advance purchase agreements for molnupiravir with governments worldwide, including the U.K. Government for 480,000 courses of therapy, pending regulatory authorization, and is currently in discussions with additional governments.MSD plans to implement 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, MSD 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, MSD previously announced that the company has entered into non-exclusive voluntary licensing agreements for molnupiravir with established Indian 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.

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

About Molnupiravir

Molnupiravir (MK-4482, EIDD-2801) is an investigational, orally administered form of a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the causative agent of COVID-19.

Molnupiravir was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University; Emory/DRIVE received some research funding from the U.S. Department of Defense and the National Institutes of Health. Molnupiravir is being developed by MSD in collaboration with Ridgeback Biotherapeutics. Ridgeback received an upfront payment from MSD 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 MSD and by Wayne and Wendy Holman of Ridgeback.

Molnupiravir is also being evaluated for post-exposure prophylaxis in MOVe-AHEAD, a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study, which is evaluating the efficacy and safety of molnupiravir in preventing the spread of COVID-19 within households. For more information, please visit http://msdcovidresearch.com. Please visit the MSD media library for molnupiravir images and b-roll.

About the MOVe-OUT Study

The MOVe-OUT trial (MK-4482-002) (NCT04575597) is a global Phase 3, randomized, placebo-controlled, double-blind, multi-site study of non-hospitalized adult patients with laboratory-confirmed mild-to-moderate COVID-19. Patients enrolled in the study were unvaccinated against SARS-CoV-2, had at least one risk factor associated with poor disease outcomes, and symptom onset within five days prior to randomization. The primary efficacy objective of MOVe-OUT is to evaluate the efficacy of molnupiravir compared to placebo as assessed by the percentage of participants who are hospitalized and/or die from the time of randomization through Day 29.

The Phase 3 portion of the MOVe-OUT trial was conducted globally in countries including Brazil, Canada, Chile, Colombia, France, Germany, Guatemala, Mexico, Philippines, Russia, South Africa, Spain, Taiwan, Ukraine, the United Kingdom and the United States. For further information about the MOVe-OUT trial, please visit clinicaltrials.gov.

The most common risk factors for poor disease outcome included obesity, older age (>60 years), diabetes mellitus and heart disease. Delta, Gamma and Mu variants accounted for nearly 80% of the baseline viral variants that had been sequenced at the time of the interim analysis. Recruitment in Latin America, Europe and Africa accounted for 56%, 23% and 15% of the study population, respectively.

About Ridgeback Biotherapeutics

Headquartered in Miami, Florida, Ridgeback Biotherapeutics LP is a biotechnology company focused on emerging infectious diseases. Ridgeback markets EbangaTM for the treatment of Ebola and has a late-stage development pipeline which includes molnupiravir for the treatment of COVID-19. Development of molnupiravir is entirely funded by Ridgeback Biotherapeutics and MSD. All equity capital in Ridgeback Biotherapeutics, LP originated from Wayne and Wendy Holman, who are committed to investing in and supporting medical technologies that will save lives. The team at Ridgeback is dedicated to working toward finding life-saving and life-changing solutions for patients and diseases that need champions.

About MSD

For over 130 years, MSD has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. MSD is a trade name of Merck & Co., Inc., with headquarters in Kenilworth, N.J., U.S.A. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, MSD continues to be at the forefront of research to prevent and treat diseases that threaten people and animals — including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases — as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.msd.com and connect with us on Twitter, LinkedIn and YouTube.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA.

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2020 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Media Contacts:

Melissa Moody 215-407-3536

Patrick Ryan 973-275-7075

Ridgeback Media Contact:

Chrissy Carvalho Chrissy@goldin.com

Investor Contacts:

Peter Dannenbaum 908-740-1037

Raychel Kruper 908-740-2107

MSD, Ridgeback Biotherapeutics and Emory University will not receive royalties for sales of molnupiravir under this agreement for as long as COVID-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization 

Collaboration continues MSD’s long track record of making its medicines and vaccines accessible and affordable globally

This is the first MPP agreement to provide access for a COVID-19 medical technology

27 October 2021,

Geneva – The Medicines Patent Pool (MPP) and MSD, the tradename of Merck & Co., Inc Kenilworth NJ USA, today announced the signing of a voluntary licencing agreement to facilitate affordable global access for molnupiravir, an investigational oral COVID-19 antiviral medicine. This agreement will help create broad access for molnupiravir use in 105 low- and middle-income countries (LMICs) following appropriate regulatory approvals.  MSD and Ridgeback Biotherapeutics are jointly developing molnupiravir.

Under the terms of the agreement, MPP, through the license granted by MSD, will be permitted to further license non-exclusive sublicences to manufacturers (“MPP Licence”) and diversify the manufacturing base for the supply of quality-assured or WHO-prequalified molnupiravir to countries covered by the MPP Licence, subject to local regulatory authorization. MSD, Ridgeback Biotherapeutics and Emory University will not receive royalties for sales of molnupiravir under this agreement for as long as COVID-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization.

Charles Gore, MPP Executive Director, said, “The interim results for molnupiravir are compelling and we see this oral treatment candidate as a potentially important tool to help address the current health crisis. This transparent, public health-driven agreement is MPP’s first voluntary licence for a COVID-19 medical technology, and we hope that MSD’s agreement with MPP will be a strong encouragement to others.”

Frank Clyburn, Executive Vice President and President of Human Health, MSD, said, “MSD’s mission to save and improve lives is a truly global commitment. This agreement with MPP is another important element in our multi-faceted strategy to accelerate broad, affordable access to molnupiravir, if approved or authorized, for patients no matter where they live, including in countries where governments face greater challenges to finance healthcare.”

Dr Philippe Duneton, Executive Director, Unitaid, co-lead of the ACT-A Therapeutics Pillar said: “Effective, easy to administer, oral treatments that can help to reduce the risk for progression to severe illness may be an important tool to help get the pandemic under control. We encourage further efforts in voluntary licencing to ensure that people in low- and middle-income countries can access COVID-19 treatments once authorized by WHO or a stringent regulatory authority.”

Molnupiravir was invented at Emory University and licensed to Ridgeback Biotherapeutics by Drug Innovation Ventures at Emory (DRIVE), LLC, which was formed by Emory to advance the development of early-stage drug candidates for viral diseases of global concern. Emory received research funding from the U.S. Defense Threat Reduction Agency and the U.S. National Institute of Allergy and Infectious Diseases.

Gregory L. Fenves, President, Emory University said: “The license for molnupiravir to the Medicines Patent Pool will support global public health and address unmet medical needs – reflecting Emory’s mission to serve humanity. Innovative research and collaboration across organizations have been vital in the fight against COVID-19.”

Wendy Holman, Chief Executive Officer, Ridgeback Biotherapeutics said: “We are pleased to collaborate with MPP to ensure that quality-assured generic versions of molnupiravir can be developed and distributed quickly following regulatory authorization. This agreement is another great example of how partnerships and collaboration can do more to address global health challenges than any organization could do on its own.”

MSD and Ridgeback Biotherapeutics recently announced the submission of an Emergency Use Authorization application for molnupiravir to the U.S. Food and Drug Administration and are actively working with additional regulatory agencies worldwide. If authorized, molnupiravir could be the first oral antiviral medicine available for COVID-19 therapy. The submission is based on positive results from a planned interim analysis of the Phase 3 MOVe-OUT study, a global Phase 3, randomized, placebo-controlled, double-blind, multi-site study of non-hospitalized adult patients with laboratory-confirmed mild-to-moderate COVID-19 and at least one risk factor for progression to severe disease or death. Additionally, MSD announced the European Medicines Agency has initiated a rolling review for molnupiravir for the treatment of COVID-19 in adults.

Access the licence agreement.

MPP invites Expressions of Interest (EoI) from potential sublicensees based anywhere in the world for sublicences to manufacture and sell molnupiravir in the licensed territory:

About Molnupiravir

Molnupiravir (MK-4482 and EIDD-2801) is an investigational, orally administered form of a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the causative agent of COVID-19. Molnupiravir has been shown to be active in several preclinical models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission. Additionally, pre-clinical and clinical data have shown molnupiravir to be active against the most common SARS-CoV-2 variants.

Molnupiravir is also being evaluated for post-exposure prophylaxis in MOVe-AHEAD, a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study, which is evaluating the efficacy and safety of molnupiravir in preventing the spread of COVID-19 within households. For more information, please visit http://msdcovidresearch.com.

About MSD

For over 130 years, MSD has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. MSD is a trade name of Merck & Co., Inc., with headquarters in Kenilworth, N.J., U.S.A. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs, and partnerships. Today, MSD continues to be at the forefront of research to prevent and treat diseases that threaten people and animals — including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases — as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.msd.com and connect with us on Twitter, LinkedIn and YouTube.

About the Medicines Patent Pool

The Medicines Patent Pool (MPP) is a United Nations-backed public health organisation working to increase access to, and facilitate the development of, life-saving medicines for low- and middle-income countries. Through its innovative business model, MPP partners with civil society, governments, international organisations, industry, patient groups, and other stakeholders, to prioritise and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations. To date, MPP has signed agreements with eleven patent holders for thirteen HIV antiretrovirals, one HIV technology platform, three hepatitis C direct-acting antivirals, a tuberculosis treatment, a long-acting technology and an experimental oral antiviral treatment for COVID-19. MPP was founded by Unitaid, which continues to be MPP’s main funder. MPP’s work on access to essential medicines is also funded by the Swiss Agency for Development and Cooperation (SDC). MPP’s activities in COVID-19 are undertaken with the financial support of the Japanese Government and SDC. More information at https://medicinespatentpool.org/ and follow us on Twitter, LinkedIn and YouTube.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA.

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2020 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Media enquiries

MSD

Sienna Choi

(908) 873-4311

Melissa Moody

(215) 407-3536

Medicines Patent Pool

Gelise McCullough

+41 79 685 64 36

If Granted Marketing Authorization by the European Commission, Molnupiravir Could Be the First Oral Antiviral Medicine for the Treatment of COVID-19 in the European Union

KENILWORTH, N.J. & MIAMI, Oct. 25, 2021 – MSD (NYSE:MRK), a trade name of Merck & Co., Inc, Kenilworth, NJ, USA, today announced that the European Medicines Agency (EMA) has initiated a rolling review for molnupiravir, an investigational oral antiviral medicine, for the treatment of COVID-19 in adults. MSD plans to work with the EMA’s Committee for Medicinal Products for Human Use (CHMP) to complete the rolling review process to facilitate initiating the formal review of the Marketing Authorization Application. As previously announced, MSD has submitted an application for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA), and is actively working to submit applications to other regulatory agencies worldwide.

“This application to the EMA is another step in our efforts to bring molnupiravir forward to patients globally,” said Dr. Dean Y. Li, executive vice president and president, MSD Research Laboratories. “We believe that molnupiravir will be an important addition to the range of public health tools to fight COVID-19 – including the vaccines developed by the research-based pharmaceutical industry, which remain essential and are the first-line of defense against this pandemic.”

The submission is based on positive results from a planned interim analysis from the Phase 3 MOVe-OUT clinical trial, which evaluated molnupiravir in non-hospitalized adult patients with mild-to-moderate COVID-19 who were at increased risk for progressing to severe COVID-19 and/or hospitalization. At the interim analysis, molnupiravir 800 mg twice-daily reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were hospitalized through Day 29 following randomization (28/385), compared with 14.1% of placebo-treated patients (53/377) that were either hospitalized or died; p=0.0012. Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to 8 deaths in patients who received placebo. The incidence of any adverse event was comparable in the molnupiravir and placebo groups (35% and 40%, respectively). The incidence of drug-related adverse events was also comparable (12% and 11%, respectively), and fewer patients in the molnupiravir group discontinued therapy due to an adverse event compared to the placebo group (1.3% and 3.4%, respectively).

“In the nearly two years since COVID-19 emerged, the global scientific community has made extraordinary strides in developing several critical vaccines and treatments, but we still have a need for an oral antiviral medicine that can be taken at home,” said Wendy Holman, chief executive officer, Ridgeback Biotherapeutics. “We believe that molnupiravir, with the exciting finding of reduction in hospitalization and death in the MOVe-OUT study, may help fill that need and look forward to working with the EMA on its review.”

About MSD’s Efforts to Enable Global Access to Molnupiravir, if it is Granted Authorization or Approval

In anticipation of the results from MOVe-OUT and the potential for regulatory authorization or approval, MSD has been producing molnupiravir at risk and expects to produce 10 million courses of treatment by the end of 2021, with more courses expected to be produced in 2022.

On October 11, MSD and Ridgeback announced that MSD had submitted an application for EUA to the U.S. FDA for molnupiravir for the treatment of at-risk adults with mild-to-moderate COVID-19. Additional submissions to global regulatory agencies are underway.

MSD has entered into supply and advance purchase agreements for molnupiravir with other governments worldwide, pending regulatory authorization, and is currently in discussions with additional governments.

MSD is committed to providing timely access to molnupiravir globally, if it is authorized or approved, and plans to implement a tiered pricing approach based on World Bank country income criteria to reflect countries’ relative ability to finance their health response to the pandemic.

As part of its commitment to widespread global access, MSD previously announced that the company has entered into non-exclusive voluntary licensing agreements for molnupiravir with established Indian generic manufacturers to accelerate availability of molnupiravir in more than 100 low- and middle-income countries (LMICs) following approvals or emergency authorization by local regulatory agencies. MSD continues to discuss additional measures and collaborations to accelerate broad, global access to molnupiravir.

About Molnupiravir

Molnupiravir (MK-4482 and EIDD-2801) is an investigational, orally administered form of a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the causative agent of COVID-19. Molnupiravir has been shown to be active in several preclinical models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission. Additionally, pre-clinical and clinical data have shown molnupiravir to be active against the most common SARS-CoV-2 variants.

Molnupiravir was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University; Emory/DRIVE received some research funding from the U.S. Department of Defense and the U.S. National Institutes of Health. Molnupiravir is being developed by MSD in collaboration with Ridgeback Biotherapeutics. Ridgeback received an upfront payment from MSD 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 MSD and by Wayne and Wendy Holman of Ridgeback.

Molnupiravir is also being evaluated for post-exposure prophylaxis in MOVe-AHEAD, a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study, which is evaluating the efficacy and safety of molnupiravir in preventing the spread of COVID-19 within households. For more information, please visit http://msdcovidresearch.com.

About the MOVe-OUT Study

The MOVe-OUT trial (MK-4482-002) (NCT04575597) is a global Phase 3, randomized, placebo-controlled, double-blind, multi-site study of non-hospitalized adult patients with laboratory-confirmed mild-to-moderate COVID-19. Patients enrolled in the study were unvaccinated against SARS-CoV-2, had at least one risk factor associated with poor disease outcomes, and symptom onset within five days prior to randomization. The primary efficacy objective of MOVe-OUT is to evaluate the efficacy of molnupiravir 800 mg twice daily for five days compared to placebo as assessed by the percentage of participants who are hospitalized and/or die from the time of randomization through Day 29.

The Phase 3 portion of the MOVe-OUT trial was conducted globally, including in more than 170 planned sites in countries including Argentina, Brazil, Canada, Chile, Colombia, Egypt, France, Germany, Guatemala, Israel, Italy, Japan, 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.

The most common risk factors for poor disease outcome included obesity, older age (>60 years), diabetes mellitus and heart disease. Delta, Gamma and Mu variants accounted for nearly 80% of the baseline viral variants that had been sequenced at the time of the interim analysis. Recruitment in Latin America, Europe, and Africa accounted for 56%, 23% and 15% of the study population, respectively.

About Ridgeback Biotherapeutics

Headquartered in Miami, Florida, Ridgeback Biotherapeutics LP is a biotechnology company focused on emerging infectious diseases. Ridgeback markets EbangaTM for the treatment of Ebola and has a late-stage development pipeline which includes molnupiravir for the treatment of COVID-19. Development of molnupiravir is entirely funded by Ridgeback Biotherapeutics and MSD. All equity capital in Ridgeback Biotherapeutics, LP originated from Wayne and Wendy Holman, who are committed to investing in and supporting medical technologies that will save lives. The team at Ridgeback is dedicated to working toward finding life-saving and life-changing solutions for patients and diseases that need champions.

About MSD

For over 130 years, MSD has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, MSD continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.msd.com and connect with us on TwitterLinkedIn and YouTube.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA.

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2020 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Media Contacts:

Melissa Moody 215-407-3536

Patrick Ryan 973-275-7075

Ridgeback Media Contact:

Chrissy Carvalho Chrissy@goldin.com

Investor Contacts:

Peter Dannenbaum 908-740-1037

Raychel Kruper 908-740-2107

If Authorized, Molnupiravir Could Be the First Oral Antiviral Medicine for the Treatment of COVID-19

Submissions to Regulatory Agencies Worldwide Underway

KENILWORTH, N.J., and MIAMI, Oct. 11, 2021 – MSD (NYSE:MRK), a trade name of Merck & Co., Inc, Kenilworth, NJ, USA, today announced that MSD has submitted an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for molnupiravir, an investigational oral antiviral medicine, for the treatment of mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization. The companies are actively working with regulatory agencies worldwide to submit applications for emergency use or marketing authorization in the coming months.

The submission is based on positive results from a planned interim analysis from the Phase 3 MOVe-OUT clinical trial, which evaluated molnupiravir in non-hospitalized adult patients with mild-to-moderate COVID-19 who were at risk for progressing to severe COVID-19 and/or hospitalization. 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 through Day 29 following randomization (28/385), compared with 14.1% of placebo-treated patients (53/377); p=0.0012. Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to 8 deaths in patients who received placebo. The incidence of any adverse event was comparable in the molnupiravir and placebo groups (35% and 40%, respectively). The incidence of drug-related adverse events was also comparable (12% and 11%, respectively), and fewer subjects in the molnupiravir group discontinued therapy due to an adverse event compared to the placebo group (1.3% and 3.4%, respectively).

“The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data,” said Robert M. Davis, chief executive officer and president, MSD. “We are grateful to the patients and investigators in our study, and of course to our own colleagues who have exemplified MSD’s high standards of scientific excellence and our unwavering commitment to patients. I also want to take this moment to applaud our colleagues in the pharmaceutical industry and our collaborators in global health for rising to the challenge of bringing forward medicines and vaccines to fight COVID-19 — medicines and vaccines are both essential to our collective efforts. We look forward to working with the FDA on its review of our application, and to working with other regulatory agencies as we do everything we can to bring molnupiravir to patients around the world as quickly as possible.”

“We are grateful to the clinical investigators and patients who have helped bring us to this important milestone. Without their significant contributions, today’s achievement would not be possible. The submission to the FDA is a critical step towards making molnupiravir available to people who may benefit from an oral antiviral medicine that can be taken at home shortly after diagnosis with COVID-19,” said Wendy Holman, chief executive officer of Ridgeback Biotherapeutics. “We are pleased to partner with MSD and regulatory authorities to help provide molnupiravir to the people who need it here in the U.S. and around the world.”

About MSD’s Efforts to Enable Access to Molnupiravir, if it is Granted EUA or Approval

In anticipation of the results from MOVe-OUT and the potential for regulatory authorization or approval, MSD has been producing molnupiravir at risk and expects to produce 10 million courses of treatment by the end of 2021, with more courses expected to be produced in 2022.

MSD has entered into supply and advance purchase agreements for molnupiravir with other governments worldwide, pending regulatory authorization, and is currently in discussions with additional governments.

MSD is committed to providing timely access to molnupiravir globally, if it is authorized or approved, and plans to implement a tiered pricing approach based on World Bank country income criteria to reflect countries’ relative ability to finance their health response to the pandemic.

As part of its commitment to widespread global access, MSD previously announced that the company has entered into non-exclusive voluntary licensing agreements for molnupiravir with established Indian generic manufacturers to accelerate availability of molnupiravir in more than 100 low- and middle-income countries (LMICs) following approvals or emergency authorization by local regulatory agencies.

About Molnupiravir

Molnupiravir (MK-4482/EIDD-2801) is an investigational, orally administered form of a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the causative agent of COVID-19. Molnupiravir has been shown to be active in several preclinical models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission. Additionally, pre-clinical and clinical data have shown molnupiravir to be active against the most common SARS-CoV-2 variants.

Molnupiravir was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University; Emory/DRIVE received some research funding from the U.S. Department of Defense and the National Institutes of Health. Molnupiravir is being developed by MSD in collaboration with Ridgeback Biotherapeutics. Ridgeback received an upfront payment from MSD 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 MSD and by Wayne and Wendy Holman of Ridgeback.

Molnupiravir is also being evaluated for post-exposure prophylaxis in MOVe-AHEAD, a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study, which is evaluating the efficacy and safety of molnupiravir in preventing the spread of COVID-19 within households. For more information, please visit http://msdcovidresearch.com.

About the MOVe-OUT Study

The MOVe-OUT trial (MK-4482-002) (NCT04575597) is a global Phase 3, randomized, placebo-controlled, double-blind, multi-site study of non-hospitalized adult patients with laboratory-confirmed mild-to-moderate COVID-19. Patients enrolled in the study were unvaccinated against SARS-CoV-2, had at least one risk factor associated with poor disease outcomes, and symptom onset within five days prior to randomization. The primary efficacy objective of MOVe-OUT is to evaluate the efficacy of molnupiravir compared to placebo as assessed by the percentage of participants who are hospitalized and/or die from the time of randomization through Day 29.

The Phase 3 portion of the MOVe-OUT trial was conducted globally, including in more than 170 planned sites in countries including Argentina, Brazil, Canada, Chile, Colombia, Egypt, France, Germany, Guatemala, Israel, Italy, Japan, 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.

The most common risk factors for poor disease outcome included obesity, older age (>60 years), diabetes mellitus and heart disease. Delta, Gamma and Mu variants accounted for nearly 80% of the baseline viral variants that had been sequenced at the time of the interim analysis. Recruitment in Latin America, Europe, and Africa accounted for 56%, 23% and 15% of the study population, respectively.

About Ridgeback Biotherapeutics

Headquartered in Miami, Florida, Ridgeback Biotherapeutics LP is a biotechnology company focused on emerging infectious diseases. Ridgeback markets EbangaTM for the treatment of Ebola and has a late-stage development pipeline which includes molnupiravir for the treatment of COVID-19. Development of molnupiravir is entirely funded by Ridgeback Biotherapeutics and MSD. All equity capital in Ridgeback Biotherapeutics, LP originated from Wayne and Wendy Holman, who are committed to investing in and supporting medical technologies that will save lives. The team at Ridgeback is dedicated to working toward finding life-saving and life-changing solutions for patients and diseases that need champions.

About MSD

For over 130 years, MSD has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, MSD continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.msd.com and connect with us on Twitter, LinkedIn and YouTube.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA.

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2020 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

###

Media Contacts:

Melissa Moody 215-407-3536

Patrick Ryan 973-275-7075

Ridgeback Media Contact:

Chrissy Carvalho Chrissy@goldin.com

Investor Contacts:

Peter Dannenbaum 908-740-1037

Raychel Kruper 908-740-2107

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

MSD 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

KENILWORTH, N.J., and MIAMI, Oct. 1, 2021 – MSD (NYSE:MRK), a trade name of Merck & Co., Inc, Kenilworth, NJ, USA, 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 through Day 29 following randomization (28/385), compared with 14.1% of placebo-treated patients (53/377); p=0.0012. Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to 8 deaths in patients who received placebo. At the recommendation of an independent Data Monitoring Committee and in consultation with the U.S. Food and Drug Administration (FDA), recruitment into the study is being stopped early due to these positive results. MSD plans to submit an application for Emergency Use Authorization (EUA) to the U.S. FDA as soon as possible based on these findings and plans to submit marketing applications to other regulatory bodies worldwide.

“More tools and treatments are urgently needed to fight the COVID-19 pandemic, which has become a leading cause of death and continues to profoundly affect patients, families, and societies and strain health care systems all around the world. With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global efforts to fight the pandemic and will add to MSD’s unique legacy of bringing forward breakthroughs in infectious diseases when they are needed most. Consistent with MSD’s unwavering commitment to save and improve lives, we will continue to work with regulatory agencies on our applications and do everything we can to bring molnupiravir to patients as quickly as possible,” said Robert M. Davis, chief executive officer and president, MSD. “On behalf of all of us at MSD, I thank our network of clinical investigators and patients for their essential contributions to the development of molnupiravir.”

“With the virus continuing to circulate widely, and because therapeutic options currently available are infused and/or require access to a healthcare facility, antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed,” said Wendy Holman, chief executive officer of Ridgeback Biotherapeutics. “We are very encouraged by the results from the interim analysis and hope molnupiravir, if authorized for use, can make a profound impact in controlling the pandemic. Our partnership with MSD is critical to ensuring rapid global access if this medicine is approved, and we appreciate the collaborative effort to reach this important stage of development.”

About the Results of the Planned Interim Analysis

The planned interim analysis evaluated data from 775 patients who were initially enrolled in the Phase 3 MOVe-OUT trial on or prior to Aug. 5, 2021. At the time of the decision to stop recruitment based on the compelling interim efficacy results, the trial was approaching full recruitment of the Phase 3 sample size of 1,550 patients, with more than 90% of the intended sample size already enrolled.

Eligibility criteria required that all patients had laboratory-confirmed mild-to-moderate COVID-19, with symptom onset within 5 days of study randomization. All patients were required to have at least one risk factor associated with poor disease outcome at study entry. Molnupiravir reduced the risk of hospitalization and/or death across all key subgroups; efficacy was not affected by timing of symptom onset or underlying risk factor. Additionally, based on the participants with available viral sequencing data (approximately 40% of participants), molnupiravir demonstrated consistent efficacy across viral variants Gamma, Delta, and Mu.

The incidence of any adverse event was comparable in the molnupiravir and placebo groups (35% and 40%, respectively). Similarly, the incidence of drug-related adverse events was also comparable (12% and 11%, respectively). Fewer subjects discontinued study therapy due to an adverse event in the molnupiravir group (1.3%) compared to the placebo group (3.4%).

About MSD Efforts to Enable Access to Molnupiravir, if it is Granted EUA or Approval

In anticipation of the results from MOVe-OUT, MSD has been producing molnupiravir at risk. MSD expects to produce 10 million courses of treatment by the end of 2021, with more doses expected to be produced in 2022.

MSD has entered into supply and purchase agreements for molnupiravir with other governments worldwide, pending regulatory authorization, and is currently in discussions with other governments.

MSD is committed to providing timely access to molnupiravir globally, if it is authorized or approved, and plans to implement a tiered pricing approach based on World Bank country income criteria to reflect countries’ relative ability to finance their health response to the pandemic.

As part of its commitment to widespread global access, MSD 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 (LMICs) following approvals or emergency authorization by local regulatory agencies.

More About the MOVe-OUT Study

The MOVe-OUT trial (MK-4482-002) (NCT04575597) was a global Phase 3, randomized, placebo-controlled, double-blind, multi-site study of non-hospitalized adult patients with laboratory-confirmed mild to moderate COVID-19, at least one risk factor associated with poor disease outcomes, and symptom onset within five days prior to randomization. The primary efficacy objective of MOVe-OUT is to evaluate the efficacy of molnupiravir compared to placebo as assessed by the percentage of participants who are hospitalized and/or die from the time of randomization through Day 29.

The Phase 3 portion of the MOVe-OUT trial was conducted globally, including in more than 170 planned sites in countries including Argentina, Brazil, Canada, Chile, Colombia, Egypt, France, Germany, Guatemala, Israel, Italy, Japan, 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.

The most common risk factors for poor disease outcome included obesity, older age (>60 years), diabetes mellitus, and heart disease. To date, the Delta, Gamma, and Mu variants have accounted for nearly 80% of the evaluable cases in the trial.   Recruitment in Latin America, Europe, and Africa accounted for 55%, 23% and 15% of the study population, respectively.

About Molnupiravir

Molnupiravir (MK-4482/EIDD-2801) is an investigational, orally administered form of a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the causative agent of COVID-19. Molnupiravir has been shown to be active in several preclinical models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission. Additionally, pre-clinical and clinical data have shown molnupiravir to be active against the most common SARS-CoV-2 variants. Molnupiravir was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University, and is being developed by MSD in collaboration with Ridgeback Biotherapeutics. Ridgeback received an upfront payment from MSD 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 MSD and by Wayne and Wendy Holman of Ridgeback.

Molnupiravir is also being evaluated for post-exposure prophylaxis in MOVe-AHEAD, a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study, which is evaluating the efficacy and safety of molnupiravir in preventing the spread of COVID-19 within households. For more information, please visit http://msdcovidresearch.com/.

About Ridgeback Biotherapeutics

Headquartered in Miami, Florida, Ridgeback Biotherapeutics LP is a biotechnology company focused on emerging infectious diseases. Ridgeback markets EbangaTM for the treatment of Ebola and has a late-stage development pipeline which includes molnupiravir for the treatment of COVID-19. Development of molnupiravir is entirely funded by Ridgeback Biotherapeutics and MSD. All equity capital in Ridgeback Biotherapeutics, LP originated from Wayne and Wendy Holman, who are committed to investing in and supporting medical technologies that will save lives. The team at Ridgeback is dedicated to working toward finding life-saving and life-changing solutions for patients and diseases that need champions.

About MSD

For over 130 years, MSD has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. MSD is a trade name of Merck & Co., Inc., with headquarters in Kenilworth, N.J., U.S.A. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, MSD continues to be at the forefront of research to prevent and treat diseases that threaten people and animals — including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases — as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.msd.com and connect with us on Twitter, LinkedIn and YouTube.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

 Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2020 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

###

Media Contacts:

Melissa Moody 215-407-3536

Patrick Ryan 973-275-7075

Ridgeback Media Contact:

Chrissy Carvalho 646-660-8641

Investor Contacts:

Peter Dannenbaum 908-740-1037

Raychel Kruper 908-740-2107

KENILWORTH, N.J., Sept. 21, 2021 – MSD (NYSE:MRK), a trade name of Merck & Co., Inc, Kenilworth, NJ, USA, affirmed its commitment to Environmental, Social, and Governance (ESG) priorities as core to our company and a strong driver of sustainable value for our business and society. In our 2020/2021 ESG Progress Report, we describe our most recent advances toward achieving our ESG priority objectives, as well as our efforts to address the health and economic challenges that the COVID-19 pandemic uncovered and intensified.

We are proud of our work in ESG, which is grounded in and catalyzed by the core values that have guided our mission for more than 130 years: a focus on the health and wellness of people and animals, respect and commitment to our employees and their families, the highest standards of ethics and integrity, and scientific excellence in innovation. Every day, these values guide us as we work to bring hope and help to humanity and animals, through our discovery of important medicines and vaccines, our social responsibility, and the positive impact on health and health equity for all.

Sustaining our high level of ESG performance builds on our company’s legacy of creating long-term value for our business and the communities that surround us. It ensures we apply our global resources and investments to the areas that are most critical. We continue to challenge ourselves to innovate, make ambitious commitments, and engage collaborative partnerships to solve major global issues.

As part of our responsibility to patients, employees, customers, communities, shareholders, and the planet, we strive to:

  • Sustain our long-term business success and investments in the discovery and development of innovative medicines and vaccines that address the most critical health care needs for people and animals around the world;
  • Develop affordable and accessible product solutions that make the strongest contributions to health and health equity;
  • Foster an inclusive workforce that is gender-balanced and embraces employees who reflect diversity in race, ethnicity, sexual orientation, culture, faith, prior military service, ability, and relevant experiences;
  • Accelerate achievement of our climate goals and reduce our environmental impact on the health of people and the planet;
  • Operate with the highest standards of ethics and integrity, holding ourselves accountable to those we serve through our transparent governance and reporting practices.

Our new ESG report outlines the steps we are taking to secure a better future for all.  From expanded patient access to essential therapies, to new Global Diversity & Inclusion goals that will accelerate our success in cultivating a diverse and inclusive workforce, to our recent announcement to achieve carbon neutrality across our operations by 2025, and much more, we are ensuring the company continues to bring value to the world.

We encourage you to learn more about our 2020/2021 efforts and achievements and our broader commitments for the future – in the full ESG Report, available online at MSD.com.

About MSD

 For over 130 years, MSD has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. MSD is a trade name of Merck & Co., Inc., with headquarters in Kenilworth, N.J., U.S.A. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, MSD continues to be at the forefront of research to prevent and treat diseases that threaten people and animals — including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases — as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.msd.com and connect with us on Twitter, LinkedIn and YouTube.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2020 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

###

Media Contacts:

Patrick Ryan 973-275-7075

John Cummins 202-508-4567

Investor Contacts:

Peter Dannenbaum 908-740-1037

Raychel Kruper 908-740-2107

Study Now Enrolling Participants Who Live in the Same Household as Someone With Symptomatic, Laboratory-Confirmed COVID-19

KENILWORTH, N.J. and MIAMI, Sept. 1, 2021 – MSD (NYSE:MRK), a trade name of Merck & Co., Inc, Kenilworth, NJ, USA, and Ridgeback Biotherapeutics announced today the initiation of the Phase 3 MOVe-AHEAD clinical trial to evaluate molnupiravir, an investigational oral antiviral therapeutic, for the prevention of COVID-19 infection. The global study is enrolling individuals who are at least 18 years of age and reside in the same household as someone with laboratory-confirmed SARS-CoV-2 infection with symptoms. For more information on the molnupiravir MOVe-AHEAD clinical trial, visit www.clinicaltrials.gov.

“As the pandemic continues to evolve and surges are being reported in many places around the world, it is important that we investigate new ways to protect individuals exposed to the virus from becoming infected with symptomatic disease,” said Dr. Nick Kartsonis, senior vice president, vaccines and infectious diseases, clinical research, MSD Research Laboratories. “If successful, molnupiravir could provide an important additional option towards reducing the burden of COVID-19 on our communities.”

The safety and efficacy of molnupiravir is also currently being evaluated in Part 2 of the ongoing MOVe-OUT trial, which is a global Phase 3, randomized, placebo-controlled, double-blind, multi-site study of non-hospitalized adult patients with laboratory-confirmed mild to moderate COVID-19 and at least one risk factor associated with poor disease outcomes. Data from the study is expected in the second half of 2021.

MOVe-AHEAD Study

MOVe-AHEAD (MK-4482-013) (NCT04939428) is a Phase 3 multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of orally administered molnupiravir compared to placebo in preventing the spread of SARS-CoV-2, the virus that causes COVID-19, within households. The trial will enroll approximately 1,332 participants who will be randomized to receive either molnupiravir (800 mg) or placebo orally every 12 hours for five days. The study will enroll participants who are at least 18 years of age and currently residing in the same household with someone who received a positive test for SARS-CoV-2, has at least one sign or symptom of COVID-19 and has not had those signs and symptoms for more than five days. Participants are not eligible for the trial if they have received the first dose of a COVID-19 vaccine more than seven days prior to enrollment, have previously had COVID-19 or are showing any signs or symptoms of COVID-19.

The primary endpoints of the trial include percentage of participants with COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms) through Day 14, percentage of participants with an adverse event and percentage of participants who discontinued study intervention due to an adverse event.

The trial is being conducted globally in countries including Argentina, Brazil, Colombia, France, Guatemala, Hungary, Japan, Mexico, Peru, Philippines, Romania, Russia, South Africa, Spain, Turkey, Ukraine, and the United States.

About Molnupiravir

Molnupiravir (MK-4482/EIDD-2801) is an investigational, orally administered form of a potent ribonucleoside analog that inhibits the replication of multiple RNA viruses including SARS-CoV-2, the causative agent of COVID-19. Molnupiravir has been shown to be active in several preclinical models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission, as well as SARS-CoV-1 and MERS. Molnupiravir was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University and is being developed by MSD in collaboration with Ridgeback Biotherapeutics. Since licensed by Ridgeback, all funds used for the development of molnupiravir have been provided by Wayne and Wendy Holman and MSD.

About Ridgeback Biotherapeutics

Headquartered in Miami, Florida, Ridgeback Biotherapeutics LP is a biotechnology company focused on emerging infectious diseases. Ridgeback markets EbangaTM for the treatment of Ebola and has a late-stage development pipeline which includes molnupiravir for the treatment of COVID-19. Development of molnupiravir is entirely funded by Ridgeback Biotherapeutics and MSD. All equity capital in Ridgeback Biotherapeutics, LP originated from Wayne and Wendy Holman, who are committed to investing in and supporting medical technologies that will save lives. The team at Ridgeback is dedicated to working toward finding life-saving and life-changing solutions for patients and diseases that need champions.

About MSD

For over 130 years, MSD has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. MSD is a trade name of Merck & Co., Inc., with headquarters in Kenilworth, N.J., U.S.A. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, MSD continues to be at the forefront of research to prevent and treat diseases that threaten people and animals — including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases — as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.msd.com and connect with us on Twitter, LinkedIn and YouTube.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2020 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

###

Media Contacts:

Melissa Moody 215-407-3536

Courtney Ronaldo 908-740-6132

Ridgeback Media Contact:

Chrissy Carvalho 646-660-8641

Investor Contacts:

Peter Dannenbaum 908-740-1037

Raychel Kruper 908-740-2107

KENILWORTH, N.J., July 29, 2021 – MSD (NYSE:MRK), a trade name of Merck & Co., Inc, Kenilworth, NJ, USA, today announced that Cristal N. Downing has been appointed chief communications & public affairs officer, a newly created role, effective August 16, 2021. Downing will become a member of MSD’s Executive Team and lead the development, advancement and execution of the company’s communications and public affairs strategy.

“Cristal is a transformational leader with a well-established track record of achievement,” said Rob Davis, CEO and president, MSD. “Cristal’s experience, business acumen, leadership capabilities and integrity will be invaluable as we drive productive conversations and strategic impact with a broad range of stakeholders, double down on our promising pipeline and work to accelerate delivery of our vital innovations to the world.”

“I am honored to become MSD’s chief communications & public affairs officer, and I look forward to collaborating with Rob and all our colleagues to foster relevant, impactful and equitable engagement both within the company and externally across broader environments,” Downing said. “Over the last 18 months, the world has especially come to understand and better appreciate the importance of biopharmaceutical innovation and the promise and power of cutting-edge science. I am deeply proud to help lead a company that is relentlessly committed to delivering on that promise by addressing some of the most significant global health needs.” 

Most recently, Downing was vice president, Communications & Public Affairs, Medical Devices, at Johnson & Johnson. Prior to that, Downing held the role of vice president, Global Finance Communications at Johnson & Johnson, where she partnered with the chief financial officer to develop, integrate and implement a broad range of public affairs and communications strategies that supported the CFO and CEO strategic platforms.

Downing also co-led the development and implementation of the company’s “Our Race to Health Equity” platform – Johnson & Johnson’s Racial & Social Justice strategy. Downing has more than 20 years of leadership capabilities and expertise working in dynamic and complex organizations, including American Express, JP Morgan Chase, and Wells Fargo.

About MSD

For 130 years, MSD has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. MSD is a trade name of Merck & Co., Inc., with headquarters in Kenilworth, N.J., U.S.A. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, MSD continues to be at the forefront of research to prevent and treat diseases that threaten people and animals — including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases — as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.msd.com and connect with us on Twitter, LinkedIn and YouTube.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2020 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

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Media Contacts:

Patrick Ryan 973-275-7075

John Cummins 202-508-4567

Investor Contacts:

Peter Dannenbaum 908-740-1037

Raychel Kruper 908-740-2107

KENILWORTH, N.J., July 9, 2021 – MSD (NYSE:MRK), a trade name of Merck & Co., Inc, Kenilworth, NJ, USA, affirmed its commitment to enabling global access to molnupiravir through its voluntary license agreements and ongoing clinical program.

As previously announced, MSD has entered into voluntary license agreements for molnupiravir with established Indian generics manufacturers. MSD 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.  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. MSD is developing molnupiravir in collaboration with Ridgeback Biotherapeutics.

 One of these generics manufacturers, Hetero, has announced that it has accumulated positive data from an open label clinical study of molnupiravir and has submitted these data to the Drug Controller General of India (DCGI).  MSD is encouraged by these promising data and looks forward to continuing to work with Hetero and other generics manufacturers that MSD has agreements with as they conduct studies of generic versions of investigational molnupiravir.

 MSD, in collaboration with Ridgeback Biotherapeutics, is conducting an ongoing randomized placebo-controlled phase 2/3 clinical trial of molnupiravir in non-hospitalized patients with confirmed COVID-19 at more than 100 sites worldwide. For more information on this clinical trial visit https://msdcovidresearch.com.

MSD has a long track record of making our medicines and vaccines accessible and affordable globally, and we remain committed to doing the same for molnupiravir. These voluntary license agreements are part of this commitment.

About Molnupiravir

Molnupiravir (EIDD-2801/MK-4482) is an investigational, orally bioavailable form of a potent ribonucleoside analog that inhibits the replication of multiple RNA viruses including SARS-CoV-2, the causative agent of COVID-19. Molnupiravir has been shown to be active in several models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission, as well as SARS-CoV-1 and MERS. EIDD-2801 was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University and is being developed by MSD in collaboration with Ridgeback Biotherapeutics. Since licensed by Ridgeback, all funds used for the development of EIDD-2801/MK-4482 have been provided by Wayne and Wendy Holman and MSD.

About MSD

For 130 years, MSD has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. MSD is a trade name of Merck & Co., Inc., with headquarters in Kenilworth, N.J., U.S.A. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, MSD continues to be at the forefront of research to prevent and treat diseases that threaten people and animals — including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases — as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.msd.com and connect with us on Twitter, LinkedIn and YouTube.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2020 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

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Media Contacts:

Melissa Moody 215-407-3536

Investor Contacts:

Peter Dannenbaum 908-740-1037

KENILWORTH, N.J., June 24, 2021 – MSD (NYSE:MRK), a trade name of Merck & Co., Inc, Kenilworth, NJ, USA, today announced that Michael Klobuchar has been appointed executive vice president and chief strategy officer, a newly created role, effective July 5, 2021. As chief strategy officer, Klobuchar will become a member of MSD’s Executive Committee and lead the advancement and execution of the company’s strategy.

“Our company’s strength lies in the insight and expertise of our team and our unrelenting commitment to creating and deploying new medicines and vaccines that address important human and animal health needs,” said Rob Davis, president, MSD. “Mike’s insights, experience in key strategic, operational and financial roles, and deep commitment to scientific innovation will help drive our company’s evolution, and I look forward to collaborating with him in this important new role.”

“I am honored to become MSD’s chief strategy officer, and I look forward to working closely with Rob and the Executive Committee to advance our company’s strategy and amplify the impact of our company’s remarkable scientific capabilities in an evolving industry,” Klobuchar said. “I am continually inspired by our company’s 130-year legacy of scientific innovation that saves and improves lives, and I am humbled to have the opportunity to help sustain that legacy long into the future.”

Klobuchar is currently senior vice president, MSD Research Laboratories Finance and Global Project and Alliance Management. Prior to that he was the company’s senior vice president, Corporate Strategy and Financial Planning, and president, MSD Global Health Innovation Fund. Mike joined MSD in 1998 as a synthetic process development engineer supporting new pipeline candidates within MRL and has since held key technical, operational and financial roles across several areas of the company.  

Klobuchar has a Bachelor of Science degree in Chemical Engineering from Purdue University, a Master of Science degree in Chemical Engineering from Rutgers University and a Master of Business Administration degree from Villanova University.

About MSD

For 130 years, MSD has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. MSD is a trade name of Merck & Co., Inc., with headquarters in Kenilworth, N.J., U.S.A. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, MSD continues to be at the forefront of research to prevent and treat diseases that threaten people and animals — including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases — as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.msd.com and connect with us on Twitter, LinkedIn and YouTube.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2020 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Media Contacts:

Patrick Ryan 973-275-7075

Melissa Moody 215-407-3536

Investor Contacts:

Peter Dannenbaum 908-740-1037

Raychel Kruper 908-740-2107