MSD announces supply & purchase agreement with Singapore Government for Molnupiravir

October 6, 2021 2:36 am Asia/Singapore

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).