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MSD’s MK-0616, an Investigational Oral PCSK9 Inhibitor, Significantly Reduced LDL-C in Patients with Hypercholesterolemia in Phase 2b Study

MK-0616 was generally well tolerated and reduced LDL-C across all dose levels compared to placebo

MSD plans to start Phase 3 pivotal study in the second half of 2023

RAHWAY, N.J., March 6, 2023 – MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA (NYSE: MRK)today announced results from the Phase 2b clinical trial evaluating MK-0616, an investigational, once-daily oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor in adults with hypercholesterolemia. The primary objective of the study was to evaluate the percent change in low density lipoprotein cholesterol (LDL-C) from baseline to week 8 for 4 doses of MK-0616 (6, 12, 18 and 30 mg) versus placebo. At week 8, all doses of MK-0616 significantly reduced LDL-C compared to placebo and the placebo-adjusted reduction from baseline ranged from 41.2% (6 mg, CI 95%, -47.8 to -34.7; p <0.001) to 60.9% (30 mg, 95% CI, -67.6 to -54.3; p<0.001). MK-0616 was generally well-tolerated at all 4 doses studied. These data were presented today at the American College of Cardiology’s 72nd Annual Scientific Session together with World Congress of Cardiology (ACC.23/WCC) and simultaneously published in the Journal of The American College of Cardiology.

Inhibition of PCSK9 increases the removal of LDL-C from the bloodstream. MK-0616 is a macrocyclic peptide and is designed to lower LDL-C via the same biological mechanism as currently approved injectable PCSK9 inhibitors, but in a daily pill form. High LDL-C, if left untreated, can lead to a high risk of atherosclerotic cardiovascular disease (ASCVD) events, such as heart attacks and strokes.

“Despite widely available statin treatments, millions of patients are still not able to lower their cholesterol to the guideline-recommended levels and as a result are at increased risk for serious cardiovascular complications associated with atherosclerosis,” said Dr. Christie M. Ballantyne, principal investigator of the study and Professor of Medicine at Baylor College of Medicine. “Currently available PCSK9 inhibitors are effective tools to treat hypercholesterolemia but must be administered by injection. With these promising data showing that MK-0616 reduced LDL-C levels by up to 60.9%, MK-0616 should be further studied for its potential as a daily oral medicine.”

“These data reinforce our confidence that MK-0616 could become the first oral PCSK9 inhibitor, with the potential to change the way patients with hypercholesterolemia who need additional LDL-C reduction are treated. This may allow many more patients to reach their LDL-C treatment goals,” said Dr. Joerg Koglin, vice president, global clinical development, MSD Research Laboratories. “We look forward to advancing this program into Phase 3 development in the second half of this year.”

Additional data from the Phase 2b Study for MK-0616 (MK-0616-008)

MK-0616-008 (NCT05261126) was a randomized, double-blind, placebo-controlled, multi-center Phase 2b trial designed to evaluate the efficacy and safety of MK-0616 administered daily compared to placebo in adult participants with hypercholesterolemia and a broad spectrum of ASCVD risk. Participants were receiving a range of lipid-lowering therapies from no statin to high-intensity statin. The primary efficacy endpoint was the percent change in LDL-C from baseline to week 8. Supportive secondary endpoints (not multiplicity controlled) were percent change in apolipoprotein B-100 (ApoB) and in non-high-density lipoprotein-C (non-HDL-C) from baseline to week 8, and the proportion of participants who achieved protocol-defined LDL-C goals at week 8.

In total, 381 participants from age 18-80 with hypercholesterolemia with a moderate to high risk of atherosclerotic cardiovascular disease were randomized 1:1:1:1:1 to receive MK-0616 at a dose of 6 mg (n=77), 12 mg (n=76), 18 mg (n=76), or 30 mg (n=76) or placebo (n=76) once daily. The study population consisted of 49% female, 66% White, 17% Asian and 6% Black/African American, and 40% Latino or Hispanic.

At week 8, all doses of MK-0616 significantly reduced LDL-C compared to placebo and the results were generally consistent across the prespecified subgroups. The LDL-C placebo-adjusted reduction from baseline were as follows for each of the four doses studied (p<0.001 for all doses):  6 mg, 41.2% (95% CI, -47.8, -34.7), 12 mg, 55.7% (95% CI, -62.3, -49.1), 18 mg, 59.1% (95% CI, -65.7, -52.5), and 30 mg, 60.9% (95% CI, -67.6, -54.3). Near-complete efficacy was achieved by week 2, with the effect persisting over the eight-week treatment period. At week 8, improvements in secondary endpoints were also observed for all MK-0616 dose arms: ApoB levels were reduced by 32.8% (6 mg) to 51.8% (30 mg), non-HDL-C levels were reduced by 35.9% (6 mg) to 55.8% (30 mg), and protocol-defined LDL-C goals were achieved by 80.5% (6 mg) to 90.8% of participants (30 mg) versus 9.3% on placebo.

MK-0616 was generally well-tolerated with no overall trends across treatment groups in discontinuation rates or adverse events at week 16. No serious adverse events that were considered by the investigator to be related to treatment with MK-0616 were reported.

About PCSK9 and MK-0616

PCSK9 plays a key role in cholesterol homeostasis by regulating levels of LDL receptors, which are responsible for the uptake of cholesterol into cells. Inhibition of PCSK9 prevents the interaction of PCSK9 with LDL receptors. This results in greater numbers of LDL receptors available on the cell surface to remove LDL cholesterol from the blood.

Discovered and developed by MSD, MK-0616 is an investigational, potentially first oral PCSK9 inhibitor designed to lower low density lipoprotein (LDL) cholesterol. MK-0616 is a macrocyclic peptide that binds to PCSK9 and inhibits the interaction of PCSK9 with LDL receptors.

About Hypercholesterolemia

Hypercholesterolemia, a disorder in which there are elevated LDL-C levels in the blood, affects approximately 73 million adults in the U.S. It is a major risk factor associated with ASCVD, which is the leading cause of death in the U.S. and globally. Despite adjusting diet and taking statin therapies, many patients with hypercholesterolemia are still not reaching their LDL-C lowering goals as recommended by guidelines.

MSD’s Focus on Cardiovascular and Pulmonary Disease

MSD has a long history of developing treatments for cardiovascular disease. More than 60 years ago, we introduced our first cardiovascular therapy – and our scientific efforts to understand and treat cardiovascular-related disorders have continued. Cardiovascular disease continues to be one of the most serious health challenges of the 21st century. Approximately 18 million people across the globe die every year, and in the United States, one person dies every 36 seconds from cardiovascular disease.

Advancements in the treatment of cardiovascular disease can make a critical difference for patients around the world. At MSD, we strive for scientific excellence and innovation in all stages of research, from discovery through approval and life cycle management. We work with experts throughout the cardiovascular and pulmonary community to advance research that can help improve the lives of patients globally.

Information for other currently enrolling cardiovascular studies can be found by visiting: https://www.msdclinicaltrials.com/.

About MSD

At MSD, known as Merck & Co., Inc., Rahway, N.J., USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.msd.com and connect with us on Twitter, LinkedIn and YouTube.

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

This news release of Merck & Co., Inc., Rahway, 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 candidates that the candidates 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 Annual Report on Form 10-K for the year ended December 31, 2022 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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MSD’s Investigational Activin Signaling Inhibitor Sotatercept Improved Six-Minute Walk Distance by 40.8 Meters at Week 24 Versus Placebo in Adults with Pulmonary Arterial Hypertension on Background Therapy

Sotatercept demonstrated statistically significant improvements in 8 of 9 secondary measures, including reduction in risk of clinical worsening or death

Results presented today at ACC.23/WCC and published in The New England Journal of Medicine

RAHWAY, N.J., March 6, 2023 – MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA (NYSE: MRK) today announced full results from the Phase 3 STELLAR trial, which evaluated sotatercept, MSD’s novel investigational activin signaling inhibitor biologic, in combination with stable background therapy for the treatment of adult patients with pulmonary arterial hypertension (PAH) (WHO Group 1). Sotatercept significantly improved exercise capacity, increasing 6-minute walk distance (6MWD) by 40.8 meters (95% CI, 27.5-54.1; p<0.001) from baseline at week 24, the study’s primary endpoint.

In addition, sotatercept demonstrated statistically significant and clinically meaningful improvements in eight of nine secondary outcome measures, including improvements in WHO functional class (WHO FC) and pulmonary vascular resistance (PVR). Sotatercept reduced the risk of clinical worsening or death by 84% compared to placebo with a median follow-up of 32.7 weeks (HR=0.16 [95% CI, 0.08-0.35]; p<0.001). The safety profile of sotatercept was generally consistent with that observed in previous studies with sotatercept. These data were presented today at the American College of Cardiology’s 72nd Annual Scientific Session together with World Heart Federation’s World Congress of Cardiology and simultaneously published in The New England Journal of Medicine.

“PAH is a rare, rapidly progressive, debilitating and ultimately life-threatening condition with a five-year mortality rate of 43 percent,” said Dr. Marius Hoeper, Hannover Medical School, Germany, and lead investigator. “Sotatercept demonstrated profound improvements across the primary endpoint of six-minute walk distance and multiple secondary endpoints, including improvements in WHO functional class and pulmonary vascular resistance. These landmark results show the potential of sotatercept and the approach of targeting cellular signaling associated with vascular hyperproliferation and pathological remodeling for the treatment of PAH.”

“The results from the Phase 3 STELLAR trial are immensely important to physicians and patients and highlight the critical role sotatercept may play in improving exercise capacity and other meaningful clinical outcome measures for patients with PAH,” said Dr. Dean Y. Li, president, MSD Research Laboratories. “These findings are compelling given the profound reduction in the risk of clinical worsening or death in patients treated with sotatercept on top of background therapy. We look forward to discussing these pivotal data with health authorities and are working with urgency to bring this potential new treatment option to patients.”

 STELLAR is the first Phase 3 study to evaluate the efficacy of an activin signaling inhibitor added to background therapy in adults with PAH. Key findings from secondary endpoints included:

  • The proportion of patients who achieved multicomponent improvement at week 24 (defined as improvement in 6MWD, improvement in N-terminal pro-B-type natriuretic peptide (NT-proBNP) level, and either improvement in WHO FC or maintenance of WHO FC II) was significantly greater with sotatercept versus placebo (38.9% [n=63/163] versus 10.1% [n=16/160]; p<0.001).
  • Sotatercept demonstrated a statistically significant reduction of -234.6 dyn·sec·cm−5 (95% CI, -288.4 to -180.8; p<0.001) from baseline at week 24 in PVR – a calculation of pulmonary artery pressure, pulmonary artery wedge pressure and cardiac output – versus placebo.
  • Sotatercept demonstrated a statistically significant reduction of -441.6 (95% CI, -573.5 to -309.6; p<0.001) from baseline at week 24 in NT-proBNP levels versus placebo.
  • Patients receiving sotatercept were significantly more likely to improve and maintain WHO FC at week 24 versus placebo. 29.4% (n=48/163) of patients in the sotatercept group improved in WHO FC compared to 13.8% (n=22/160) in the placebo group (p<0.001).
  • Sotatercept significantly reduced events associated with clinical worsening (defined by death of any cause or specified non-fatal clinical worsening events). With a median follow-up of 32.7 weeks, 9 of 163 patients in the sotatercept group died or experienced a clinical worsening event versus 42 of 160 patients in the placebo group (HR=0.16 [95% CI, 0.08 to 0.35]; p<0.001).  
  • A significantly greater proportion of patients treated with sotatercept achieved or maintained a low French risk score (attaining or maintaining all three low-risk criteria: WHO functional class I or II, 6-minute walk distance > 440 meters, and NT-proBNP level < 300 pg per milliliter) versus placebo (39.5% [n=64/163] versus 18.2% [n=29/160]; p<0.001).
  • In patient-reported outcomes using the PAH-SYMPACT® questionnaire, the average scores for Physical Impacts (change from baseline: -0.26 [95% CI, -0.49 to -0.04]; p=0.010) and Cardiopulmonary Symptoms (change from baseline: -0.13 [95% CI, -0.26 to -0.01]; p=0.028) were significantly reduced in patients treated with sotatercept versus placebo. PAH-SYMPACT® is a disease-specific patient-reported outcome instrument. Domain scores range from 0 to 4 with higher scores indicating greater severity of symptoms.
  • The average score for Cognitive/Emotional Impacts using PAH-SYMPACT® was not significantly different between patients treated with sotatercept versus placebo (p=0.156).

Treatment-emergent adverse events (TEAEs) occurred in 90.8% of patients who received sotatercept versus 91.9% of patients who received placebo, while severe TEAEs were observed in 12.9% versus 18.1% of patients, respectively. Adverse events that occurred more frequently with sotatercept versus placebo were bleeding events, telangiectasia, increased hemoglobin levels, thrombocytopenia, increased blood pressure, and dizziness.

Study design and additional data from the STELLAR trial

STELLAR (NCT04576988) was a pivotal Phase 3, randomized, double-blind, placebo-controlled, multicenter, parallel-group study to evaluate the safety and efficacy of sotatercept in adult patients with PAH (WHO Group 1) being treated with background therapy with WHO Functional Class (FC) II or III. The primary endpoint of the study was exercise capacity, as measured by change from baseline in week 24 6MWD. Nine secondary endpoints, tested hierarchically in the following order, were multicomponent improvement, change in PVR, NT-proBNP level, improvement in WHO FC, time to clinical worsening or death, French risk score, and the PAH-SYMPACT® Physical Impacts, Cardiopulmonary Symptoms and Cognitive/Emotional Impacts domain scores; all assessed at week 24 except clinical worsening, which was assessed when the last patient completed the week 24 visit.

The study enrolled a total of 323 participants who were randomized to receive either sotatercept (n=163) once every 3 weeks at a dose of 0.3 mg/kg at visit 1 and a dose of 0.7 mg/kg thereafter or placebo (n=160) added to stable background PAH therapy. The study population characteristics were: mean [±SD] 47.9 ± 14.8 years of age; 89% white; 79% female; and average length of time since PAH diagnosis of 8.8 years. In total,198 of the randomized patients (61.3%) were receiving triple therapy and 129 patients (39.9%) were receiving prostacyclin infusion therapy. Demographic and baseline characteristics were similar between the sotatercept and placebo groups.

The safety profile of sotatercept was generally consistent with that observed in the Phase 2 PULSAR trial. Seven patients (4.4%) in the placebo group and two patients (1.2%) in the sotatercept group died during the study through the data cutoff date.

About pulmonary arterial hypertension (PAH)

Pulmonary arterial hypertension (PAH) is a rare, progressive and life-threatening blood vessel disorder characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation. Approximately 40,000 people in the U.S. are living with PAH. The disease progresses rapidly for many patients. PAH results in significant strain on the heart, leading to limited physical activity, heart failure and reduced life expectancy. The five-year mortality rate for patients with PAH is approximately 43%.

About sotatercept

Sotatercept is an investigational, potential first-in-class activin signaling inhibitor biologic being studied for the treatment of PAH (WHO Group 1). PAH is a rare disease caused, in part, by hyperproliferation of cells in the arterial walls in the lung, leading to narrowing and abnormal constriction. In pre-clinical models, sotatercept has been shown to modulate vascular cell proliferation, reversing vascular and right ventricle remodeling.

Sotatercept has been granted Breakthrough Therapy Designation and Orphan Drug designation by the U.S. Food and Drug Administration (FDA), as well as Priority Medicines designation and Orphan Drug designation by the European Medicines Agency for the treatment of PAH. MSD acquired exclusive rights to sotatercept in the pulmonary hypertension field through the acquisition of Acceleron Pharma Inc. Sotatercept is the subject of a licensing agreement with Bristol Myers Squibb.

About MSD

At MSD, known as Merck & Co., Inc., Rahway, N.J., USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.msd.com and connect with us on Twitter, LinkedIn and YouTube.

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

This news release of Merck & Co., Inc., Rahway, 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 candidates that the candidates 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 Annual Report on Form 10-K for the year ended December 31, 2022 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Media:

Julie Cunningham (617) 519-6264

Ayn Wisler (917) 691-6218

Investor:

Peter Dannenbaum (908) 740-1037

Damini Chokshi (908) 740-1807

MSD Opens Enrollment in New Phase 3 Clinical Trials with Investigational Once-Daily Islatravir in Combination with Doravirine for Treatment of HIV-1 Infection

Islatravir and other HIV data presented at CROI 2023

RAHWAY, N.J., Feb. 22, 2023 – MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA (NYSE: MRK) announced today that the company has opened enrollment in its new Phase 3 clinical program with investigational once-daily islatravir 0.25 mg in combination with doravirine 100 mg (DOR/ISL) for the treatment of HIV-1 infection.

“Our extensive efficacy and safety analyses from the islatravir clinical program over the past year provided critical information to shape our research going forward,” said Todd Correll, executive director, DOR/ISL product development team lead, MSD Research Laboratories. “We believe islatravir in combination with doravirine has the potential to help make a difference for people living with HIV and are excited to open enrollment in our new Phase 3 clinical trials.”

Two new Phase 3 studies began enrolling participants this month:

  • MK-8591A-051 – A Phase 3, Randomized, Active-Controlled, Open-Label Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in Participants With HIV-1 Who Are Virologically Suppressed on Antiretroviral Therapy
  • MK-8591A-052 – A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in Participants With HIV-1 Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF)

The following new Phase 3 studies are expected to begin enrollment in March:

  • MK-8591A-P053 – A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in HIV-1 Infected Treatment-Naïve Participants
  • MK-8591A-P054 – A Phase 3 Open-label Clinical Study of Doravirine/Islatravir (DOR/ISL [100 mg/0.25 mg]) Once-Daily for the Treatment of HIV-1 Infection in Participants Who Previously Received DOR/ISL (100 mg/0.75 mg) Once-Daily in a Phase 3 Clinical Study
    • Certain study participants currently enrolled in prior DOR/ISL studies (Protocols 018, 020 and 033), which evaluated once-daily DOR/ISL 100/0.75 mg in treatment-naïve and virologically suppressed participants, will have the option of transitioning to study P054 evaluating once-daily DOR/ISL 100/0.25 mg as a potential fixed-dose combination, two-drug regimen.

Select MSD abstracts for islatravir at the Conference on Retroviruses and Opportunistic Infections (CROI) 2023 include:

  • Switch to DOR/ISL (100/0.75MG) QD From B/F/TAF: Week 48 Results From a Phase 3 Trial. Late-breaker oral presentation: 197. Mills, A, et al.
  • Switch to DOR/ISL (100/0.75MG) QD: Week 48 Results From An Open-label Phase 3 Trial. Late-breaker oral presentation: 196. Molina, J-M, et al.
  • Effect of Islatravir on Total Lymphocyte and Lymphocyte Subset Counts. Oral presentation: 192. Squires, K, et al.
  • Modeling To Optimize Islatravir QW Dose in HIV Virologically Suppressed PWH. Late-breaker poster: 497. Vargo, R, et al.

For more information, including details around the virtual programming, please visit the CROI 2023 website.

MSD’s Commitment to HIV

For more than 35 years, MSD has been committed to scientific research and discovery (R&D) in HIV. Today, we are developing a series of antiviral options designed to help people manage HIV and protect people from HIV, with the goal of reducing the growing burden of infection worldwide. We remain committed to working hand-in-hand with our partners in the global HIV community to address the complex challenges that impede progress toward ending the epidemic.

About MSD

At MSD, known as Merck & Co., Inc., Rahway, N.J., USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.msd.com and connect with us on Twitter, LinkedIn and YouTube.

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

This news release of Merck & Co., Inc., Rahway, 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 candidates that the candidates 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 Annual Report on Form 10-K for the year ended December 31, 2021 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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(617) 519-6264

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Steven Graziano
(908) 740-6582

MSD Collaborator Instituto Butantan Announces Results from Its Phase 3 Vaccine Candidate Trial for the Prevention of Dengue Disease

RAHWAY, N.J., Dec. 16, 2022 – At MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA (NYSE: MRK), we are highly encouraged by the tremendous progress scientists and clinicians at the Instituto Butantan have made in developing their single dose dengue disease vaccine candidate. We are working with Instituto Butantan to conduct a detailed analysis of these results in order to determine next steps for our own dengue vaccine candidate (V181).

Instituto Butantan’s announcement represents an important clinical research milestone for the global health community. Both MSD and Instituto Butantan’s investigational vaccines are derived from materials licensed from the U.S. National Institutes of Health (NIH) and both institutions are evaluating formulations analogous to the NIH TV003 formulation. Under the collaboration agreement announced in December 2018, MSD and Instituto Butantan are sharing clinical data and other learnings from their respective dengue vaccine development programs.

This collaboration is an example of how MSD is engaging the global public health community to develop vaccines for important diseases primarily affecting tropical and subtropical regions of the world.

About dengue

Dengue is one of the fastest growing mosquito-borne diseases that affects not just the health but often the economic stability of people across the globe. It is a leading cause of serious and sometimes debilitating illness in tropical and subtropical countries.1 With approximately half of the world’s population, or four billion people, at risk for dengue disease, dengue is a critical public health challenge. Globally, 400 million dengue infections occur annually, according to the WHO2, with 50-100 million infections being symptomatic.3,4 While the majority of infections are uncomplicated, serious illness caused by dengue can be severe and lead to death5 (~500,000 cases per year are severe enough to require hospitalization and ~2.5% of severely affected individuals may die6). Mild dengue fever is characterized by a high fever, rash, and muscle and joint pain. A severe form of dengue fever, (dengue hemorrhagic fever) can cause severe bleeding, a sudden drop in blood pressure and death.7

About MSD

At MSD, known as Merck & Co., Inc., Rahway, N.J., USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.msd.com and connect with us on Twitter, LinkedIn and YouTube.

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

This news release of Merck & Co., Inc., Rahway, 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 candidates that the candidates 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 Annual Report on Form 10-K for the year ended December 31, 2021 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:

Julie Cunningham (+1 617-519-6264)

Kimberly Petrillo (+1 247-742-2813)

Investor Contacts:

Alexis Constantine (+1 908-740-1051)

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1WHO | Dengue and severe dengue. Published online 2022. Accessed November 28, 2022. https://www.who.int/news-room/fact-sheets/detail/dengue-and-severe-dengue

2WHO | Dengue and severe dengue. Published online 2022. Accessed November 28, 2022. https://www.who.int/news-room/fact-sheets/detail/dengue-and-severe-dengue

3Russell KL, Rupp RE, Morales-Ramirez JO, et al. A phase I randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of a live-attenuated quadrivalent dengue vaccine in flavivirus-naïve and flavivirus-experienced healthy adults. Hum Vaccin Immunother. Published online 2022:1-12. doi:10.1080/21645515.2022.2046960

4Messina JP, Brady OJ, Golding N, et al. The current and future global distribution and population at risk of dengue. Nat Microbiol. 2019;4(9):1508-1515. doi:10.1038/s41564-019-0476-8

5WHO | Dengue and severe dengue. Published online 2022. Accessed November 28, 2022. https://www.who.int/news-room/fact-sheets/detail/dengue-and-severe-dengue

6WHO | Dengue and severe dengue. Published online 2021. Accessed June 6, 2022. https://apps.who.int/mediacentre/factsheets/fs117/en/index.html

7Mayo Clinic | Dengue fever. Published online 2022. Accessed November 28, 2022. https://www.mayoclinic.org/diseases-conditions/dengue-fever/symptoms-causes/syc-20353078#:~:text=The%20severe%20form%20of%20dengue,pressure%20(shock)%20and%20death.

MSD Responds to Sudan Ebolavirus Outbreak in Uganda with Plans to Produce and Donate Investigational Vaccine Doses for IAVI’s Vaccine Development Program

RAHWAY, N.J., Oct. 25, 2022 – MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA (NYSE: MRK)announced today that in response to the health and humanitarian crisis of the Sudan ebolavirus outbreak in Uganda, the company plans to produce and donate vials of investigational candidate Sudan ebolavirus vaccine to IAVI, a global nonprofit scientific research organization, for further clinical research use. IAVI plans to use these vials for its ongoing Sudan ebolavirus vaccine development program. The vials will be produced from existing investigational bulk drug substance previously manufactured by MSD and are intended to be used as part of the World Health Organization’s (WHO’s) efforts to fight the outbreak in Uganda. MSD and IAVI are working toward a formal agreement and are collaborating now to accelerate this effort.

“We are proud to work together with IAVI in support of the World Health Organization’s response to address the Sudan Ebola outbreak in Uganda,” said Beth-Ann Coller, executive director, Global Clinical Development Vaccines, MSD Research Laboratories. “We are moving with urgency to prepare these vials and donate them to IAVI as quickly as possible to help support the efforts of the WHO and the people of Uganda as they grapple with this outbreak.”

MSD anticipates that it will fill approximately 50,000 doses for IAVI from the existing bulk drug substance by the end of 2022. Further use in the response to the outbreak will be subject to authorization by applicable health authorities.

Dr. Mark Feinberg, president and CEO of IAVI, said, “We are very grateful to MSD for supplying the investigational vaccine for IAVI, which will help accelerate IAVI’s program. IAVI looks forward to working with partners responding to the ongoing Sudan Ebola outbreak to evaluate vaccine effectiveness and safety. We hope that our efforts may contribute to the response in Uganda should the outbreak persist, and also enable the world to be better prepared for future Sudan Ebola outbreaks.”

About MSD

At MSD, known as Merck & Co., Inc., Rahway, N.J., USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.msd.com and connect with us on Twitter, LinkedIn and YouTube.

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

This news release of Merck & Co., Inc., Rahway, 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 candidates that the candidates 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 Annual Report on Form 10-K for the year ended December 31, 2021 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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MSD Announces Positive Top-line Results from Pivotal Phase 3 STELLAR Trial Evaluating Sotatercept for the Treatment of Adults with Pulmonary Arterial Hypertension (PAH)

Sotatercept demonstrated significant improvement in exercise capacity and key secondary outcome measures compared to placebo when added to background therapy

RAHWAY, N.J., Oct. 10, 2022 – MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA (NYSE: MRK) announced today positive top-line results from the pivotal Phase 3 STELLAR trial evaluating the safety and efficacy of sotatercept, an investigational activin receptor type IIA-Fc (ActRIIA-Fc) fusion protein being evaluated as an add-on to stable background therapy for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1). The trial met its primary efficacy outcome measure, demonstrating a statistically significant and clinically meaningful improvement in 6-minute walk distance (6MWD, which measures how far patients can walk in 6 minutes) from baseline at 24 weeks. Eight of nine secondary efficacy outcome measures achieved statistical significance, including the outcome measure of proportion of participants achieving multicomponent improvement (defined as improvement in 6MWD, improvement in N-terminal pro-B-type natriuretic peptide (NT-proBNP) level, and either improvement in WHO FC or maintenance of WHO FC II), and the outcome measure of time to death or the first occurrence of a clinical worsening event (TTCW). The Cognitive/Emotional Impacts domain score of PAH-SYMPACT®, which was assessed as the ninth and final secondary outcome measure, did not achieve statistical significance. The overall safety profile of sotatercept in STELLAR was in general consistent with what has been observed in Phase 2. Results from the study will be presented at an upcoming scientific congress.

 “In the Phase 3 STELLAR study, sotatercept added to currently approved background therapy showed a profound effect on the primary efficacy outcome measure of improvement from baseline to 24 weeks in six-minute walk distance. The results from the secondary efficacy outcomes, including a favorable benefit seen in patients’ time to a clinical-worsening event, are especially noteworthy,” said Dr. Dean Y. Li, president, MSD Research Laboratories. “We believe that in totality, the results observed in the STELLAR study suggest that sotatercept has the potential to transform the treatment of patients with PAH. We are moving with urgency on our regulatory applications to bring this investigational therapy to these patients.”

About STELLAR

STELLAR (NCT04576988) is a pivotal Phase 3, randomized, double-blind, placebo-controlled, multicenter, parallel-group study designed to evaluate the safety and efficacy of sotatercept compared to placebo, as an add-on to background therapy for the treatment of adults with pulmonary arterial hypertension (WHO Group 1). The primary endpoint is exercise capacity, as measured by 6-minute walk distance (6MWD) 24 weeks following initiation of treatment. Nine secondary outcome measures were assessed: proportion of participants achieving multicomponent improvement (consisting of improvement in 6MWD, improvement in N-terminal pro-B-type natriuretic peptide (NT-proBNP) level, and either improvement in WHO FC or maintenance of WHO FC II); change from baseline in pulmonary vascular resistance (PVR); change from baseline in NT-proBNP levels; proportion of participants who improved in WHO FC; time to death or the first occurrence of a clinical worsening event (TTCW); proportion of participants who maintained or achieved a low risk score using the simplified French Risk score calculator; change from baseline in the Physical Impacts domain score of PAH; change from baseline in the Cardiopulmonary Symptoms domain score of PAH-SYMPACT®; and change from baseline in the Cognitive/Emotional Impacts domain score of PAH-SYMPACT®.

About pulmonary arterial hypertension (PAH)

Pulmonary arterial hypertension (PAH) is a rare, progressive and life-threatening blood vessel disorder characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation. Currently, an estimated 40,000 people in the U.S. and 30,000 people in the European Union are living with PAH and the disease progresses rapidly for many patients despite current standard of care treatment. PAH results in significant strain on the heart, leading to limited physical activity, heart failure and reduced life expectancy. The 5-year mortality rate for patients with PAH is approximately 43 percent.

About sotatercept

Sotatercept is an investigational, potential first-in-class activin receptor type IIA-Fc (ActRIIA-Fc) fusion protein in development for the treatment of adult patients with pulmonary arterial hypertension (WHO Group 1). Sotatercept was designed to rebalance pro-proliferative (ActRIIA/Smad2/3-mediated) and anti- proliferative (BMPRII/Smad1/5/8-mediated) signaling associated with pulmonary arterial wall and right ventricular remodeling.

Sotatercept has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA), as well as Priority Medicines designation by the European Medicines Agency for the treatment of PAH.

MSD acquired exclusive rights to sotatercept in the pulmonary hypertension field through the acquisition of Acceleron Pharma Inc. Sotatercept is the subject of a licensing agreement with Bristol Myers Squibb.

About MSD

At MSD, known as Merck & Co., Inc., Rahway, N.J., USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.msd.com and connect with us on Twitter, LinkedIn and YouTube.

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

This news release of Merck & Co., Inc., Rahway, 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 candidates that the candidates 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 Annual Report on Form 10-K for the year ended December 31, 2021 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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MSD to Initiate New Phase 3 Clinical Program with Lower Dose of Daily Oral Islatravir in Combination with Doravirine for Treatment of People with HIV-1 Infection

Phase 2 study evaluating an investigational weekly oral combination treatment regimen of islatravir and Gilead Sciences’ lenacapavir to resume with lower dose of islatravir

Monthly oral islatravir development for pre-exposure prophylaxis (PrEP) to be discontinued; MSD continues to evaluate other long-acting PrEP candidates

RAHWAY, N.J., Sept. 20, 2022 – MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA (NYSE: MRK) announced today that the company will initiate a new Phase 3 clinical program with once-daily islatravir for the treatment of people with HIV-1 infection. These new Phase 3 studies will evaluate a once-daily oral combination of doravirine 100 mg and a lower dose of islatravir (DOR/ISL). One study will evaluate DOR/ISL in previously untreated adults with HIV-1 infection and two studies will evaluate DOR/ISL as a switch in antiretroviral therapy (ART) in adults with HIV-1 infection who are virologically suppressed. Certain study participants currently enrolled in once-daily treatment studies with DOR 100 mg/ISL 0.75 mg will have the option of transitioning to a new study with the lower islatravir dose. The U.S. Food and Drug Administration (FDA) has reviewed and agreed with this plan. The investigational new drug application (IND) for the once-daily oral DOR/ISL treatment program remains under a partial clinical hold for any studies that would use doses higher than the dose to be studied in the new Phase 3 program. Refer to the company’s news release issued December 13, 2021,for more information on the islatravir clinical hold.

The Phase 2 clinical trial (NCT05052996) evaluating an investigational oral once-weekly combination treatment regimen of islatravir and Gilead’s lenacapavir in adults with HIV-1 infection who are virologically suppressed will resume under an amended protocol with a lower dose of islatravir. The IND under which the islatravir + lenacapavir once-weekly treatment regimen is being investigated remains under a partial clinical hold for any studies that would use weekly oral islatravir doses higher than the doses considered for the revised clinical program. Islatravir and lenacapavir, in combination, are investigational and not approved for use. The safety and efficacy of this combination has not yet been established.

Additionally, after careful evaluation and analysis, MSD will discontinue the development of once-monthly oral islatravir for PrEP. Participants in the ongoing Phase 3 PrEP once-monthly oral studies will continue to be monitored. The company remains committed to developing compounds for long-acting HIV prevention and believes in the potential of the nucleoside reverse transcriptase translocation inhibitor (NRTTI) mechanism. A Phase 1b study in adults with HIV-1 infection assessing MK-8527, a novel NRTTI candidate, will commence shortly (NCT05494736). MSD will continue to engage with key stakeholders as it works to help address the unmet need in HIV prevention.

“We are grateful to the study investigators and the many participants in the trials of islatravir. Following extensive evaluations and consultation with FDA, we are pleased to be able to initiate our new Phase 3 clinical program to evaluate islatravir for the treatment of HIV-1 infection,” said Dr. Eliav Barr, senior vice president and head of global clinical development, chief medical officer, MSD Research Laboratories. “We continue to believe in the potential of the NRTTI mechanism and we are evaluating additional candidates with the goal of helping to address unmet needs in HIV prevention. As part of this, we are pleased to continue our partnership with the Bill & Melinda Gates Foundation as we continue to evaluate potential long-acting PrEP opportunities.”

MSD’s Commitment to HIV

For more than 35 years, MSD has been committed to scientific research and discovery (R&D) in HIV. Today, we are developing a series of antiviral options designed to help people manage HIV and protect people from HIV, with the goal of reducing the growing burden of infection worldwide. We remain committed to working hand-in-hand with our partners in the global HIV community to address the complex challenges that impede progress toward ending the epidemic.

About MSD

At MSD, known as Merck & Co., Inc., Rahway, N.J., USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.msd.com and connect with us on Twitter, LinkedIn and YouTube.

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

This news release of Merck & Co., Inc., Rahway, 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 candidates that the candidates 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 Annual Report on Form 10-K for the year ended December 31, 2021 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

Deb Wambold 215-779-2234

Brian Plummer bplummer@gilead.com

Investor Contacts:

Peter Dannenbaum 908-740-1037

Steven Graziano 908-740-6582

Jacquie Ross investor_relations@gilead.com

MSD Reports Strong Progress in ESG Focus Areas

  • MSD Committed 91.5 Million Doses of Human Papillomavirus (HPV) Vaccine for Use in Gavi-Supported Countries
  • Developed and Executed Ground-Breaking Access Strategy to Accelerate the Timely Distribution of the Company’s Investigational COVID-19 Therapeutic to Governments Globally
  • In 2021, >99% Pay Equity Achieved in the U.S. for Female and Male Employees, as well as for Non-White and White Employees in Equivalent Positions
  • On Track to Achieve Carbon Neutrality Across Company Operations by 2025 (Scope 1 & 2 emissions)
  • Issued Inaugural $1 Billion Sustainability Bond

RAHWAY, N.J., August 30, 2022 – MSD (NYSE: MRK), known as MSD outside the United States and Canada, today issued its 2021/2022 Environmental, Social and Governance (ESG) Progress Report. The report highlights the company’s performance and progress in its four ESG focus areas: Access to Health, Employees, Environmental Sustainability and Ethics & Values.

“For more than 130 years, our global team has pursued ESG excellence. Today, our ESG approach helps propel and enable our business strategy in ways that make us a better company — and a better corporate citizen. To that end, ESG underpins our Corporate Strategic Framework and every decision we make,” said Robert M. Davis, chief executive officer and president, MSD. “We recognize that ESG is not a destination, but instead a journey. We’re excited and energized about the road ahead as we continue to operate on behalf of society, shareholders and all our stakeholders to enable a safe, sustainable and healthy future for people and communities everywhere.”

The report reflects that MSD’s longstanding ESG commitment is fully integrated in the company’s Corporate Strategic Framework, which is anchored in the company’s purpose of using the power of leading-edge science to save and improve lives around the world.

The report also reflects such milestones as the company’s December 2021 launch of its Sustainability Financing Framework to raise and direct funds to critical ESG projects and support our overall ESG strategy. The company’s first offering was an inaugural $1 billion sustainability bond intended to support projects and partnerships in our four ESG priority areas.

To further accelerate MSD’s ESG efforts, the company will also continue its membership in the Billion Dollar Roundtable (BDR), a leading industry organization that recognizes and celebrates companies that achieve spending of at least $1 billion with minority-, women-, veteran-, LGBT- and disability-owned enterprises. MSD also hosted the most recent BDR Summit, which provided an opportunity for companies to optimize their positive economic impact.  

Other key highlights from this year’s report include:

Access to Health:

  • The company committed 91.5 million doses of its human papillomavirus (HPV) vaccines for use in Gavi-supported countries from 2021 to 2025 and completed expansions to its Elkton, VA, manufacturing facility to increase capacity and supply. With plans for additional expansions to existing and new facilities, MSD expects supply of HPV vaccines to double between 2020 and 2023.
  • In alignment with its approach to ensuring broad, equitable access to health, the company began executing on a comprehensive supply and access strategy early in the COVID-19 pandemic to accelerate equitable global access to the company’s investigational oral antiviral COVID-19 medicine.
  • The company pursues programs to provide access to its medicines and vaccines when market-based solutions are inadequate or unavailable. For example, as the war in Ukraine continues, we’re committed to getting life-saving support, medicines, vaccines and supplies to those who need them most. In the first half of 2022, MSD committed more than $93 million in essential products and funds to ensure that refugees of Ukraine and those who remain inside the country have access to health care.
  • In addition to the billions of people MSD has reached with innovative medicines, vaccines and access strategies throughout its history, the company’s goal is to enable 100 million more people to access its innovative portfolio globally through access strategies, solutions, and partnerships by 2025.

Employees:

  • In 2021, the company achieved >99% pay equity in the U.S. for female and male employees, as well as for non-white and white employees in equivalent positions.
  • The company has set goals to increase representation in senior management roles by 2024 and reported strong progress in 2021:
    • The company increased representation of women globally to 36%, up from 31% in 2020. By 2024, the company aims to increase representation to 40%.
    • The company increased representation of Black/African Americans in the U.S. to 7%, up from 3% in 2020. By 2024, the company aims to increase representation to 10%.
    • The company increased representation of Hispanics/Latinos in the U.S. to 6%, up from 5% in 2020. By 2024, the company aims to increase representation to 10%.

Environmental Sustainability:

  • MSD is on track to achieve carbon neutrality across our operations by 2025. In 2021, with a goal of reducing its operational greenhouse gas (GHG) emissions (Scopes 1 & 2) 46% by 2030 from a 2019 baseline, the company achieved a 9% reduction in Scope 1 & 2 emissions from a 2019 baseline.
  • With a goal of sourcing 100% of its purchased electricity from renewables by 2025, MSD sourced 41% of its purchased electricity from renewables in 2021. The company continues to work toward transitioning to renewable sources of energy to meet its 2025 renewable energy target.  

Ethics & Values:

  • In 2021, MSD maintained 100% compliance to regulatory requirements for active incident monitoring, risk/harm analysis and on-time notification of data breaches.
  • The company fosters a “speak up” culture with a goal of maintaining or exceeding its current percentage of employees responding favorably to the “Willingness to Report” question in its employee survey as an annual average.

Learn more about MSD’s approach to ESG, the company’s commitment to creating value for society and all its stakeholders and its progress on key goals in MSD’s 2021/2022 ESG Progress Report.

About MSD

At MSD, known as Merck & Co., Inc., Rahway, N.J., USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.msd.com and connect with us on Twitter, LinkedIn and YouTube.

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

This news release of Merck & Co., Inc., Rahway, 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 candidates that the candidates 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 Annual Report on Form 10-K for the year ended December 31, 2021 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

Leland Laury 610-659-8856

Investor Contacts:

Peter Dannenbaum 908-740-1037

Steven Graziano 908-740-6582

MSD Announces that Chirfi Guindo will Lead Marketing for MSD Human Health

RAHWAY, N.J., June 21, 2022 – MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA (NYSE: MRK)) today announced that Chirfi Guindo will lead Human Health Marketing as chief marketing officer for MSD Human Health, and will join MSD’s Executive Team, effective July 1, 2022. Guindo will report directly to Robert M. Davis, chief executive officer and president, MSD. As previously announced, Jannie Oosthuizen leads MSD Human Health U.S., and Joe Romanelli will lead MSD Human Health International effective Aug. 1, both also reporting to Davis. Deepak Khanna, interim leader of Human Health International, will retire at the end of this year.

“Chirfi is a purpose-driven leader, dedicated to saving and improving lives around the world. He has deep experience and a proven track record in strategy, marketing and commercialization across primary care, specialty care and rare diseases, in both developed and developing markets,” said Mr. Davis. “I am confident that our Human Health leaders, along with our entire Executive Team, will build on the strong momentum of our business as we deliver value to all our stakeholders, continue to address some of the most pressing medical challenges and make a positive and lasting impact on global health.”

As chief marketing officer for Human Health, Guindo will be responsible for leading the development and implementation of the company’s long-term strategy for the Human Health portfolio spanning oncology, vaccines, pharmaceutical and pipeline products.

Since 2017, Guindo has been executive vice president and head of global product strategy and commercialization at Biogen and served on Biogen’s executive leadership team. In this role, Guindo led global strategy, marketing and commercialization for Biogen’s neurology business. He also led the late-stage Product Development and Commercialization Teams, and oversaw corporate strategy and alliances, value and access, communications, policy, advocacy and corporate responsibility.

Before joining Biogen, Guindo began his MSD career in 1990 and spent more than 25 years in finance, sales, commercial and marketing roles of increasing responsibility in the U.S. and globally. He led global marketing for MSD’s HIV portfolio, and also led MSD’s Human Health businesses in Canada, the Netherlands and South Africa. Guindo has been recognized for developing strong talent and forging innovative public-private partnerships and elevating the profile of MSD as a patient-focused company. A graduate of Ecole Centrale de Paris with a degree in engineering, he also holds a Master of Business Administration from New York University’s Stern School of Management.

About MSD

At MSD, known as Merck & Co., Inc., Rahway, NJ, USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.msd.com and connect with us on Twitter, LinkedIn and YouTube.

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

This news release of Merck & Co., Inc., Rahway, 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 Annual Report on Form 10-K for the year ended December 31, 2021 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: Johanna Herrmann (617) 216-6019

Investor Contacts: Peter Dannenbaum (908) 740-1037

Damini Chokshi (908) 740-1807

MSD Announces That Joseph Romanelli Will Lead MSD Human Health International, Effective August 1, 2022

KENILWORTH, N.J.– MSD (tradename of Merck & Co., Inc., Kenilworth, N.J., USA (NYSE: MRK)) today announced that Joseph Romanelli will lead Human Health International, and join MSD’s Executive Team, effective August 1, 2022. He will report directly to Robert M. Davis, chief executive officer and president, MSD. As previously announced, Arpa Garay leads Human Health Global Marketing, and Jannie Oosthuizen leads Human Health U.S., both also reporting to Davis.

“Joe’s remarkable track record of driving growth, unwavering commitment to keep patients at the center, deep knowledge of the global competitive landscape and passion for MSD’s purpose to save and improve lives make him the ideal leader for our growing and expansive international Human Health business,” said Mr. Davis. “I’m excited to welcome Joe back to MSD, and I am confident that our company and stakeholders will greatly benefit from his leadership, delivery and contributions.”

In this role, Romanelli will have P&L responsibility for MSD’s $22 billion international human health business and lead a team of 14,000 colleagues in more than 75 markets outside of the U.S.

Romanelli returns to MSD after serving as chief executive officer of JiXing Pharmaceuticals, a China-based biopharmaceutical company, since 2021. From 2016 through 2021, Romanelli led MSD’s business in China, based in Shanghai. During his tenure, MSD was one of the fastest growing multinational pharmaceutical businesses in China and China became MSD’s second-largest market. Romanelli joined MSD in 1996 and served in a variety of strategic and operational roles with increasing responsibility and scope. Romanelli received his undergraduate degree from the University of Delaware and his Master’s in Business Administration from Fordham University’s Gabelli School of Management.

About MSD

At MSD, known as Merck & Co., Inc., Kenilworth, NJ, USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. 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 Annual Report on Form 10-K for the year ended December 31, 2021 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

Johanna Herrmann 617-216-6029

Investor Contacts:

Peter Dannenbaum 908-740-1037

Steve Graziano 908-740-6582