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• Newly commissioned secondary packaging and sterile filling facility will increase production of immunotherapy for cancer patients in Singapore and the Asia Pacific region.
• New manufacturing capabilities with fully automated and semi-automated packaging lines will significantly increase production of MSD’s cancer immunotherapy and vaccines
• Inhaler production facility when ready in 2026 will manufacture next generation inhaler devices for targeted administration of medicines
• Over 100 jobs requiring advanced manufacturing and digitalization skills will be created over the next few years.

SINGAPORE, October 5, 2022 – MSD (trade name of Merck & Co., Inc., Rahway, N.J., USA [NYSE: MRK]) announced the opening of a new secondary packaging facility to support the production of vaccines and biologics, including the company’s cancer immunotherapy products. MSD also broke ground for a new inhaler production facility for the manufacture of new generation inhaler medicines in Singapore.

A continued, multiyear investment in Singapore

The new manufacturing facilities are key components of the company’s up to US$500 million investment over five years that started in 2020. This is in addition to the US$2 billion invested since the start of MSD’s manufacturing operations in Singapore in 1997.

Other components of the total investment include new technology to further the company’s environmental sustainability goals, and modernization of MSD’s information technology (IT) infrastructure in support of digitizing the facilities.

The opening of the new secondary packaging facility and ground-breaking for the inhaler production facility located at Tuas, was witnessed by Singapore’s Minister for Trade & Industry, Mr Gan Kim Yong who was the Guest-of-Honour, and Mr Robert Davis, Chief Executive Officer and President of MSD (known as Merck & Co., in the U.S. and Canada), today.

“MSD is committed to Singapore as a strategic node in our company’s global manufacturing network with a focus on producing innovative medicines to treat chronic diseases and cancer as well as vaccines that prevent infectious diseases for patients living in Singapore and throughout the Asia Pacific region and beyond,” said Fernando Otero, associate vice president, MSD Manufacturing Division, Singapore.

“The talent, research, and technology capabilities that first attracted our company to Singapore has been a key incentive for our continuing investment. We’re delighted to further invest in building technologically advanced facilities and highly skilled manufacturing here,” he added. 

The investment is estimated to create over 100 new jobs over the next few years to support the new facility and multi-year investment plan, with many positions requiring advanced manufacturing and digital skills. This would bring the company’s total employees in Singapore to more than 1,800 over the next few years.  

Goh Wan Yee, Senior Vice President & Head (Healthcare), Singapore Economic Development Board, said: “As the gateway to Asia Pacific, Singapore has the talent, infrastructure, and supply chain network for healthcare companies to innovate, manufacture, and commercialise products and solutions for the region. By tapping on Singapore’s deep capabilities in advanced manufacturing and digital, MSD’s latest expansion will enable it to produce more innovative medicines and vaccines to meet the region’s needs. We look forward to strengthening our long-term partnership with MSD, supporting its continued growth and creating more good job opportunities for Singaporeans.”

Bringing breakthrough pharmaceutical innovations closer to Asia Pacific patients

These new facilities are located within MSD’s existing 72-acre, multi-product manufacturing hub in Tuas.

The secondary packaging facility will house a semi-automated, vial-packaging line to produce KEYTRUDA^® (pembrolizumab), an immunotherapy to treat certain cancers, and three fully automated syringe-packaging lines to produce the company’s GARDASIL^®9 (Human Papillomavirus 9-valent Vaccine, Recombinant), an HPV vaccine.

In 2021, the site commenced the sterile filling process of KEYTRUDA® vials. Secondary packaging, cold storage and a quality control laboratory will be a part of the expanded facility which further adds to the supply chain footprint for this product in Singapore.

The new inhaler medicine facility, when ready in 2026, will manufacture next generation inhaler devices for targeted administration of medicines.

“MSD has been in Singapore since 1993 and continues to invest significantly in Singapore to impact patients worldwide through our innovative medicines and vaccines. The launch of the new secondary packaging facility and ground-breaking for the new inhaler facility today highlights the value that biopharmaceutical innovation brings to Singapore, contributing to the health and wellbeing of the nation and the region,” said David Peacock, President, Asia Pacific, MSD.

“It further demonstrates our commitment to making a difference by bringing our medicines and vaccines to people as quickly as possible, while ensuring that the Asia Pacific region is well-positioned to manage future healthcare challenges,” he added.  

Singapore is home to MSD’s Asia Pacific hub  

MSD has unique entities in Singapore that bring together all of MSD’s business divisions, encompassing Manufacturing, Research & Development (R&D), Human Health, Animal Health, one of its IT Hubs, and our Asia Pacific regional headquarters.

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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 http://www.msd-singapore.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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Demonstrated efficacy from the MOVe-OUT phase 3 trial in non-hospitalized at-risk adults with COVID-19 indicate that LAGEVRIO® (molnupiravir), initiated within 5 days from the onset of symptoms, reduced the risk of hospitalization or death from the time of randomization through Day 29.

SINGAPORE, April 19, 2022 – MSD (NYSE: MRK), known as Merck & Co., Inc., Kenilworth, NJ, USA in the United States and Canada today announced that LAGEVRIO® (molnupiravir), an oral antiviral treatment for adults with mild to moderate COVID-19 has received interim authorization by the Health Sciences Authority (HSA) under the Pandemic Special Access Route (PSAR).   

In line with the authorization, LAGEVRIO® will be made available as an oral antiviral for the treatment of mild to moderate COVID-19 patients aged 18 years and above who are at high risk for progressing to severe COVID-19 and/or hospitalization, and in whom alternative COVID-19 treatment options are not clinically appropriate.

LAGEVRIO® works by inserting itself into the viral RNA of SARS-CoV2 leading to inhibition of viral replication.

The authorization is based on the positive results from a planned interim analysis of the Phase 3 MOVe-OUT global trial, as well as a recent study update, which evaluated LAGEVRIO® compared to placebo in adult patients who were unvaccinated against SARS-CoV-2, had a confirmed SARS-CoV-2 infection, experienced symptom onset within five days of study randomization, and had at least one risk factor associated with poor disease outcomes including age >60 years, obesity, diabetes, or cardiovascular disease.¹

The study found that early treatment with molnupiravir helped reduce the risk of hospitalizations or death from the time of randomization through Day 29.

LAGEVRIO® is generally well-tolerated, with no serious safety concerns identified. It is the only oral COVID-19 treatment with no known contraindications or expected drug interactions, enabling appropriate use in patients with comorbidities and concomitant medications. It also requires no dosage adjustment for patients with impaired kidney or liver function.

The World Health Organization (WHO) recently added a new recommendation on LAGEVRIO® for COVID-19 patients with non-severe illness. Locally, LAGEVRIO® is included in National Centre for Infectious Disease (NCID) treatment guidelines for COVID-19.

“Based on available efficacy data and the demonstration of a reduction in the risk of death by 89% – molnupiravir, an oral antiviral agent, is an important tool to Singapore’s pandemic response. Combined with vaccines, oral antiviral treatments may help mitigate the risk of disease progression or death in select vulnerable groups who continue to bear the brunt of this pandemic. Oral antivirals can allow healthcare professionals to help high-risk patients with mild to moderate symptoms in community settings as soon as they test positive to help limit disease progression. High-risk patients can remain at home and still be actively treated,” said Dr Asok Kurup, Infectious Disease Specialist at Infectious Diseases Care, Mt Elizabeth Medical Centre.

“LAGEVRIO®, a single oral medicine with demonstrated efficacy and convenient administration, has a role in addressing high-risk patient needs. Molnupiravir has shown to be effective against a range of variants, and new findings demonstrating in vitro activity against the Omicron variant provide additional confidence in the potential of molnupiravir as an important treatment option for those who are at high risk for progression to severe disease,” said Dr. Aileen Dualan, Asia Pacific Head of Medical Affairs, MSD.

In October 2021, MSD announced that the Singapore Government entered into an advanced supply and purchase agreement with MSD to secure courses of LAGEVRIO® for the population once authorized or approved.

“LAGEVRIO® marks another milestone in MSD’s long legacy of industry-leading research in the development of therapeutics and vaccines against infectious diseases, which is consistent with our unwavering commitment to saving and improving lives for over 130 years. We believe that a variety of treatments and vaccines are needed to overcome the pandemic. We are committed towards working closely with the Singapore government to make LAGEVRIO® as widely accessible to eligible Singapore patients as quickly as possible,” said Pang Lai Li, Managing Director of Singapore and Malaysia, MSD.

As of March 28, 2022, MSD has entered into advanced supply and purchase agreements for molnupiravir with governments from over 35 markets worldwide, including The United States, Australia, Canada, South Korea, Japan, Thailand, Singapore, Brunei, and United Kingdom pending regulatory authorizations, and is currently in discussions with other governments. As of March 28, 2022, Molnupiravir has received regulatory authorization or approval in over 10 markets.

LAGEVRIO® Selected Safety Information (SSI)¹

INDICATIONS

LAGEVRIO (molnupiravir) is indicated for the treatment of mild to moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization.

DOSAGE AND METHOD OF USE

Recommended dose of LAGEVRIO in adult patients is 800 mg (four 200 mg capsules) taken orally every 12 hours for 5 days, with or without food.

LAGEVRIO should be administered as soon as possible after a diagnosis of COVID-19 has been made and within 5 days of symptom onset in adults who are at risk for progression to severe COVID-19.

Safety and efficacy of LAGEVRIO have not been established in pediatric patients less than 18 years of age.

No dose adjustment of LAGEVRIO is recommended for geriatric patients, patients with renal impairment and hepatic impairment.

LAGEVRIO is not recommended to be taken during pregnancy.

CONTRAINDICATIONS

None.

WARNING AND PRECAUTIONS

None.

ADVERSE EVENTS

Clinical Trials Experience

Interim analysis of a Phase 3 double-blind trial (MOVe-OUT) was carried out to evaluate safety of LAGEVRIO in which 765 non-hospitalized subjects with COVID-19 were randomized and treated with LAGEVRIO (N=386) or placebo (N=379) for up to 5 days and followed through Day 29. Adverse events were those reported while subjects were on study intervention or within 14 days of study intervention completion/discontinuation.

Occurrence of adverse events in 1% of subjects receiving molnupiravir and 3% of subjects receiving placebo resulted in discontinuation of study intervention. Serious adverse events occurred in 7% of subjects receiving molnupiravir and 14% receiving placebo; none was considered drug- related by the investigator and most were COVID-19 related. Adverse events leading to death occurred in none of the subjects receiving molnupiravir and 2.3% of subjects receiving placebo.

Most common adverse reactions in molnupiravir treatment group in MOVe-OUT are diarrhea, nausea, dizziness and headache.

Full prescribing information is available upon request.

About Molnupiravir

Molnupiravir (MK-4482) is an investigational, orally administered nucleoside analog that inhibits the replication of SARS-CoV-2, the causative agent of COVID-19. MSD and Ridgeback’s “orange COVID-19 pill” is a Swedish Orange opaque capsule with the MSD corporate logo and “82” printed in white ink, available in certain markets outside of the U.S. as LAGEVRIO®.

Results from the Phase 3 MOVe-OUT study demonstrated the efficacy benefit of molnupiravir treatment was generally consistent across patients infected with SARS-CoV-2 variants of concern, Delta, Gamma and Mu. Preliminary preclinical data has shown that molnupiravir has antiviral activity against the newly identified variant, Omicron (B1.1.529). Molnupiravir has yet to be evaluated against Omicron in clinical studies.

Molnupiravir was invented at Emory University. Drug Innovation Ventures at Emory (DRIVE), LLC, which was formed by Emory to develop early-stage drug candidates for viral diseases of global concern, advanced molnupiravir through IND submission. 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 Ridgeback.

Molnupiravir was evaluated in MOVe-OUT, a global Phase 3, randomized, placebo-controlled, double-blind, multi-site study of non-hospitalized adult patients with symptomatic, laboratory-confirmed mild to moderate COVID-19 and at least one risk factor associated with poor disease outcomes. The Phase 3 portion of the MOVe-OUT trial was conducted globally in more than 170 sites in locations including Argentina, Brazil, Canada, Chile, Colombia, Egypt, France, Germany, Guatemala, Israel, Italy, 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. Molnupiravir is also being evaluated for post-exposure prophylaxis in MOVe-AHEAD, a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study evaluating the efficacy and safety of molnupiravir in preventing the spread of COVID-19 within households. For more information, please visit http://msdcovidresearch.com.

B-roll and photography relating to molnupiravir and the arrival of molnupiravir shipment are available here

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. 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 in more than 170 sites, in locations including Argentina, Brazil, Canada, Chile, Colombia, Egypt, France, Germany, Guatemala, Israel, Italy, 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 the vast majority of the baseline viral variants that had been sequenced at the time of the interim analysis.

About Ridgeback Biotherapeutics

Headquartered in Miami, Florida, Ridgeback Biotherapeutics LP is a biotechnology company focused on emerging infectious diseases. Ridgeback markets Ebanga^TM for the treatment of Ebola and has a late-stage development pipeline which includes molnupiravir for the treatment of COVID-19. The team at Ridgeback is dedicated to developing life-saving and life-changing solutions for patients and diseases that need champions as well as providing global access to these medicines. In line with Ridgeback’s mission for equitable global access, all Ridgeback services and treatment for Ebola patients in Africa are delivered free of charge.

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-singapore.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 candidates that the candidates wi

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)

SINGAPORE, February 7, 2022 – MSD (NYSE: MRK), a trade name of Merck & Co., Inc, Kenilworth, NJ, USA., announced that David Peacock has been appointed President of its Human Health Division in Asia Pacific from February 1, 2022. Combining all business divisions, MSD in Asia Pacific has approximately 6,000 employees across 12 key markets.¹

David brings a broad range of experience and perspectives from senior roles in the United Kingdom, United States, and across Asia. Most recently, David was the Managing Director for MSD in the United Kingdom and Ireland. Prior to that, he was the Chief of Staff to Kenneth C. Frazier, former Chairman of the board and Chief Executive Officer, Merck & Co., Inc., Kenilworth, N.J. (known as MSD outside the U.S. and Canada). David has also held other significant roles such as Managing Director for MSD in Hong Kong and Macau, and Chief Financial Officer for MSD in Japan.

David said, “I am excited to return to Asia, a diverse and vibrant region. Asia also presents some of the world’s toughest healthcare challenges, and I am looking forward to working with our teams to build on existing partnerships and establishing new ones so that our innovative medicines and vaccines reach as many patients as possible.”   

As we work through the COVID-19 pandemic, MSD will remain focused on discovering and developing innovative medicines and vaccines and working to enable access to these medical inventions to improve population health and save and improve lives.

MSD has a wide footprint in Singapore, bringing together all of MSD’s business divisions ranging from Manufacturing, R&D, Human Health’s commercial operations, Animal Health, an IT Hub and our Asia Pacific Regional Headquarters — a unique microcosm of our global business that enshrines Singapore’s ambitions as a node for technology, innovation, and enterprise.

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 healthcare access 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 COVID-19, 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-singapore.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).

SINGAPORE, October 6, 2021 – MSD (NYSE: MRK), known as Merck & Co., Inc., Kenilworth, NJ, USA in the United States and Canada, is pleased to collaborate with the Singapore government on a supply & purchase agreement that will provide Singapore with access to molnupiravir – an investigational oral antiviral therapeutic for COVID-19 – if authorized or approved.

Molnupiravir is being evaluated in two Phase 3 clinical trials. The MOVe-OUT study is evaluating molnupiravir for the treatment of non-hospitalized patients with laboratory-confirmed COVID-19 and at least one risk factor associated with poor disease outcomes. The MOVe-AHEAD study is evaluating molnupiravir for post-exposure prophylaxis. MSD is developing molnupiravir in collaboration with Ridgeback Biotherapeutics.  

Through the agreement, Singapore will gain access to molnupiravir once certain regulatory milestones are achieved. 

            “We are pleased to enter into this agreement with the Singapore government and to partner with them on bringing supply of molnupiravir, an investigational oral antiviral therapeutic, to Singapore once authorized or approved,” said Pang Lai Li, Managing Director for MSD in Singapore & Malaysia. “MSD believes a range of medicines and vaccines will be needed to make an impact on the pandemic. This agreement is another example of Singapore’s forward-looking strategy of pandemic management and the government’s commitment to investing in innovative medicines and vaccines to combat the pandemic.”

“As the pandemic continues to evolve and surges are being reported in many places around the world, we are hopeful that we can make a meaningful impact on the pandemic through development of an effective oral antiviral that can be taken in earlier stages of disease, outside of hospitalized settings to limit disease progression,” said Dr. Nick Kartsonis, senior vice president, vaccines and infectious diseases, clinical research, MSD Research Laboratories.

            “Early treatment of patients with mild-to-moderate COVID-19 is going to be a game-changer. It is going to limit disease progression to more severe illness especially in high-risk patients. It is a useful adjunct to the high vaccine coverage in Singapore. Very significantly, we can arm our frontline doctors with oral medications that may make a difference at the point of diagnosis. This may shift treatment from hospitals to general practitioners and polyclinics as Singapore pivots towards endemic living with COVID-19,” said Dr Leong Hoe Nam, infectious disease specialist, Rophi Clinic, Mount Elizabeth Novena Hospital.

In addition to developing molnupiravir, MSD is contributing to the pandemic response through its collaboration with Johnson & Johnson to support the manufacturing and supply of Johnson & Johnson’s COVID-19 vaccine.

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More About the MOVe-OUT Study

The MOVe-OUT trial (MK-4482-002) (NCT04575597) is an ongoing 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 on the molnupiravir clinical trial please visit https://www.msd.com/research/covid-19/ 

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.

About Ridgeback Biotherapeutics

Headquartered in Miami, Florida, Ridgeback Biotherapeutics LP is a biotechnology company focused on emerging infectious diseases. Ridgeback markets Ebanga^TM 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-singapore.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).

KENILWORTH, N.J., Sept. 21, 2021 – MSD (NYSE: MRK), known as Merck in the United States and Canada, 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).

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