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Merck and the Bill & Melinda Gates Medical Research Institute Announce Licensing Agreement for Novel Tuberculosis Antibiotic Candidates

RAHWAY, N.J., and Cambridge M.A., October 18, 2022 – Merck, (NYSE: MRK), known as MSD outside of the United States and Canada, and the Bill & Melinda Gates Medical Research Institute (Gates MRI) today announced a licensing agreement for two preclinical antibacterial candidates for evaluation as potential components of combination regimens for the treatment of tuberculosis (TB). These candidates were discovered by Merck scientists as part of the TB Drug Accelerator (TBDA). The TBDA is a collaboration established among biopharmaceutical companies, research organizations and universities to accelerate the discovery and development of novel therapeutic candidates against TB. The initiative was established with support and leadership from the Bill & Melinda Gates Foundation. “Tuberculosis is one of the world’s most significant infectious causes of human disease and death,” said Dr. Emilio Emini, chief executive officer, the Bill & Melinda Gates Medical Research Institute. “The

Merck 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; Merck continues to evaluate other long-acting PrEP candidates Merck (NYSE: MRK), known as MSD outside of the United States and Canada, 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

Merck Advances Phase 3 Trial to Evaluate Investigational Islatravir as Once-Monthly Oral PrEP for Women at High Risk for Acquiring HIV-1

Collaboration with the Bill & Melinda Gates Foundation Seeks to Bring Forward a New HIV Prevention Option to Help Address the HIV Epidemic with Focus on Women in Sub-Saharan Africa Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced a collaboration with the Bill & Melinda Gates Foundation (the foundation) where the foundation is committing to provide funding to support a pivotal Phase 3 study investigating a once-monthly oral pre-exposure prophylaxis (PrEP) 1 option in women and adolescent girls at high risk for acquiring HIV-1 infection in sub-Saharan Africa. The study, IMPOWER 22, will evaluate the efficacy and safety of islatravir - Merck’s novel investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) under evaluation for both treatment and prevention - and is anticipated to begin by early 2021. More than half of new HIV infections globally occur in sub-Saharan Africa, with women accounting for nearly 60 percent

Merck Announces Fourth-Quarter and Full-Year 2020 Financial Results

Fourth-Quarter 2020 Worldwide Sales Were $12.5 Billion, an Increase of 5% Fourth-Quarter 2020 GAAP Loss per Share Was $0.83, Reflecting Charges Related to Acquisitions and Intangible Asset Impairments; Fourth-Quarter Non-GAAP EPS Was $1.32 Full-Year 2020 Worldwide Sales Were $48.0 Billion, an Increase of 2%; Excluding the Impact from Foreign Exchange, Sales Grew 4% KEYTRUDA 2020 Worldwide Sales Grew 30% to $14.4 Billion BRIDION 2020 Worldwide Sales Grew 6% to $1.2 Billion; Excluding the Impact from Foreign Exchange, Sales Grew 7% Animal Health 2020 Worldwide Sales Grew 7% to $4.7 Billion; Excluding the Impact from Foreign Exchange, Sales Grew 10% Full-Year 2020 GAAP EPS Was $2.78, Reflecting Charges Related to Acquisitions, Collaborations and Intangible Asset Impairments; Full-Year Non-GAAP EPS Was $5.94 2021 Financial Outlook Anticipates Full-Year 2021 Worldwide Sales to Be Between $51.8 Billion and $53.8 Billion, Including a Positive Impact from Foreign Exchange of Approximately 2%

Merck and Instituto Butantan Announce Collaboration Agreement to Develop Vaccines to Protect Against Dengue Infections

Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Instituto Butantan, Sao Paulo, Brazil, a non-profit producer of immunobiologic products for Brazil today announced a collaboration agreement to develop vaccines to protect against dengue virus disease, the mosquito-borne infection. Instituto Butantan and Merck have licensed certain rights from National Institute of Allergy and Infectious Diseases (NIAID), part of the United States National Institutes of Health (NIH), for the development of live attenuated tetravalent vaccines (LATV). Instituto Butantan’s dengue vaccine candidate, TV003, is currently being evaluated in a large Phase 3 study in Brazil. “By sharing data from our ongoing vaccine development programs, Instituto Butantan and Merck are better positioned to achieve our goal of reducing the significant human and economic toll of dengue virus in Brazil and around the world,” said Dr. Dimas Covas, director, Instituto Butantan. “We look forward to

Moderna and Merck Expand mRNA Cancer Vaccines Collaboration

Expansion Includes the Joint Development of Moderna’s KRAS Oncogene Program and Other Potential mRNA Cancer Vaccines; Merck to Make Equity Investment in Moderna CAMBRIDGE, Mass. and KENILWORTH N.J. May 3, 2018 — Moderna Therapeutics and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced an expansion of their 2016 collaboration to develop and commercialize novel personalized messenger RNA (mRNA) cancer vaccines to now include shared antigen mRNA cancer vaccines including mRNA-5671, Moderna’s mRNA KRAS cancer vaccine. Moderna developed mRNA-5671 starting in 2017.  The two companies will now advance jointly mRNA-5671 in human studies, and plan to conduct combination studies with additional immuno-oncology therapies. “Augmentation of immune responses offers great promise in cancer therapy, as our work with the PD-1-specific antibody KEYTRUDA has shown,” said Dr. Roger M. Perlmutter, President, Merck Research Laboratories.  “We now look

Merck Commemorates 30 Years of MECTIZAN® Donation Program Progress

Program Expanded to Reach Additional 100 Million People Annually for Lymphatic Filariasis in Support of New, Evidence-Based WHO Guidelines Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced an expansion of the MECTIZAN® Donation Program (MDP) to reach up to an additional 100 million people per year through 2025 as part of the global effort to eliminate lymphatic filariasis (LF). Through the MDP, established by Merck in 1987, Merck donates MECTIZAN ® (ivermectin) for onchocerciasis (river blindness) in all affected areas (Latin America, Africa, Yemen) and for LF in African countries where it co-exists with river blindness. LF, also known as elephantiasis, is a parasitic disease transmitted to humans through the bites of mosquitoes. Over time, infection can impair the lymphatic system leading to severe swelling of the limbs and genitals resulting in severe disability and social stigma. One of the neglected tropical diseases (NTDs), it is present in 72

MSD for Mothers Commits $10 Million and Business Expertise to the Global Financing Facility to Help End Preventable Deaths of Mothers

Represents a Critical Step toward Meeting the Sustainable Development Goals for Women, Children and Adolescent Health MSD, known as Merck & Co., Inc., Kenilworth, N.J., U.S.A., inside the United States and Canada, announced today its $10 million commitment to the Global Financing Facility (GFF) in support of Every Woman Every Child to improve maternal and child health in low- and lower-middle-income countries worldwide through its MSD for Mothers initiative. Through the GFF – a multi-stakeholder partnership hosted by the World Bank Group – countries are aiming to make a much greater impact on the lives of their most vulnerable citizens, with the goal of preventing an estimated 3.8 million maternal deaths, 101 million child deaths and 21 million stillbirths by 2030. “Women are the cornerstone of a healthy and prosperous world. When a woman survives pregnancy and childbirth, her family, community and nation thrive,” said Kenneth C. Frazier, chairman and chief executive officer, MSD.

Merck Announces Collaboration to Improve Maternal Health through Expanded Access to Family Planning

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and the Bill & Melinda Gates Foundation today announced that they will work together to expand access to family planning, a critical step in improving the health of women around the world. Merck intends to pledge up to $25 million over eight years as part of Merck for Mothers – the company’s 10-year initiative to reduce maternal mortality around the world. This pledge will be matched by the Gates Foundation as part of its commitment to family planning. These contributions will advance efforts to help reach United Nations Millennium Development Goal 5, which calls for a 75 percent reduction in maternal mortality and universal access to reproductive health by 2015. The announcement, made today at the London Summit on Family Planning, is part of a new, coordinated effort to ensure that voluntary family planning services reach an additional 120 million women and girls in the world’s poorest countries by 2020. More than

Merck and Partners Make Progress In Long-Term Commitment to End River Blindness

Colombia to Request Certification by the World Health Organization of Historic Elimination of River Blindness Public health officials at the 21st Inter-American Conference on Onchocerciasis in Bogota, Colombia announced that Colombia has eliminated onchocerciasis (river blindness) within its borders, making it the first country suffering from river blindness in the Americas to reach this goal. It also was announced that Guatemala and Mexico have now broken the cycle of transmission of river blindness. Both countries will halt their drug treatment programs for the disease in 2012 and begin the three-year post treatment monitoring process, already completed by Colombia, and required by the World Health Organization (WHO) to certify elimination of the disease. Officials attribute the successes in Latin America to a sustained public-private partnership led by The Carter Center that offers health education and drug treatment donated by Merck. The Carter Center – through its Onchocerciasis

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