Merck Canada, Inc.

KIRKLAND, QC , Sept. 4, 2024 /CNW/ - Merck (NYSE: MRK), known as MSD outside of the United States and Canada , announced that WINREVAIR ® (sotatercept) is now authorized for use in Canada in combination with standard pulmonary arterial hypertension (PAH) therapy, for the treatment of adults with World Health Organization [WHO] Group 1 PAH and Functional Class (FC) II or III. Sotatercept is the first activin signaling inhibitor therapy for PAH in Canada . This represents a new class of therapy that works by improving the balance between pro-proliferative and anti-proliferative signaling to modulate vascular proliferation in PAH patients. “We understand the burden that PAH places on patients and caregivers. The approval of WINREVAIR ® represents a step forward for those grappling with this disease. Our commitment to advancing scientific research and developing solutions stands firm to address the unmet needs of Canadians,” said David D. Jones , Managing Director of Merck Canada. About STELLAR The STELLAR study (NCT04576988) was a global, double-blind, placebo-controlled, multicenter, parallel-group clinical trial in which 323 patients with PAH (WHO Group 1 FC II or III) were randomized 1:1 to sotatercept (target dose 0.7 mg/kg) (n=163) or placebo (n=160) plus stable background therapy administered subcutaneously once every 3 weeks. The most common PAH etiologies were idiopathic PAH (59%), heritable PAH (18%), and PAH associated with connective tissue diseases (CTD) (15%). Most participants were receiving either three (61%) or two (35%) background drugs for PAH, and 40% were receiving prostacyclin infusions. The mean time from PAH diagnosis was 8.8 years. Patients had a WHO FC II (49%) or III (51%) at baseline. WINREVAIR ® is the subject of a licensing agreement with Bristol Myers Squibb. About Merck At Merck, known as MSD outside of 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 about our operations in Canada , visit and connect with us on LinkedIn and X @MerckCanada. Forward-Looking Statement of Merck & Co. Inc., Rahway, NJ , 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 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, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( ). ® Merck Sharp & Dohme B.V. Used under license. © 2024 Merck & Co., Inc., Rahway, NJ , USA and its affiliates. All rights reserved. SOURCE Merck Canada Inc.

The MUHC Foundation backs the most innovative cancer researchers in the province. This year’s Le Bal Rouge gala supported the Cancer Research Program of the Research Institute of the McGill University Health Centre and will make a significant impact on the standard of cancer care in Quebec.MONTREAL, June 04, 2024 (GLOBE NEWSWIRE) -- Drawing on the vibrant cultures of Greece and Italy, Windsor Station was converted into a luxurious Mediterranean getaway that encouraged guests to channel their inner Adonis or Aphrodite and give in to the fantasy of the evening. Le Bal Rouge 2024 raised a record-breaking $2,050,000 million for the MUHC Foundation’s Dream Big. End Cancer campaign to support advancements in precision cancer research at the RI-MUHC’s Cancer Research Program. It brings the grand total in the Dream Big. End Cancer campaign to just over $28.3M! Together, we will end cancer as a life-threatening disease. “Tonight, we are one step closer to realizing our big dreams for cancer research and care. This is a historic moment in cancer research, made possible by the brilliant scientists and leaders at the RI-MUHC’s Cancer Research Program who are on the cusp of life-changing breakthroughs in cancer treatment. We are so grateful to our dedicated community of supporters, visionaries, and inspiring philanthropists who united under a common cause: to end cancer as a life-threatening disease.” — Marie-Hélène Laramée, President and CEO, MUHC Foundation The 7th gala since 2016, this year’s Le Bal Rouge recognized the exceptional work of the RI-MUHC’s Cancer Research Program and celebrated physician Dr. Peter Metrakos, Director of the MUHC’s Liver Transplant Program and Leader of the Cancer Research Program at the RI-MUHC. A leader in precision oncology research, he is renowned for identifying pathways to liver metastases and changing the paradigm of care for advanced cancer. Under his leadership, the RI-MUHC’s Cancer Research Program has grown into one of the largest adult cancer research groups in Quebec. “It was a great privilege to be honoured at the MUHC Foundation’s Le Bal Rouge this evening. The RI-MUHC’s Cancer Research Program is revolutionizing care by exploring targeted therapies for various types of cancer and working on non-invasive screening methods like liquid biopsy for early detection, which gives our patients the greatest chance of survival. We couldn’t have done it without the support of the MUHC Foundation and without the generosity of our donors.” — Dr. Peter Metrakos, Director of the MUHC’s Liver Transplant Program and Leader of the Cancer Research Program at the RI-MUHC Guests were treated to an unforgettable Mediterranean-inspired meal by renowned Montreal-based chef Armando Arruda, and danced to the upbeat, sultry musical notes of Paul Chacra and 1945 The Band. Along with guests and supporters, the MUHC Foundation’s Le Bal Rouge co-chairs, Rosa Trunzo and Kheng Ly, celebrated the achievements of Dr. Metrakos and the RI-MUHC’s Cancer Research Program. Their outstanding leadership was instrumental in the evening’s success. “The MUHC Foundation’s Le Bal Rouge is a testament to the impact our community can have when we come together and dream big. We’re building a world where our loved ones and future generations will have a chance against cancer and supporting our talented health care professionals is a part of our mandate as community leaders. I am very proud to have been part of Le Bal Rouge, and to support the outstanding achievements of the RI-MUHC’s Cancer Research Program.” — Rosa Trunzo, Senior Vice President and Region Head, Eastern Canada, CIBC “It has been a great privilege and pleasure to be a part of the MUHC Foundation’s Le Bal Rouge, I am so grateful for all the support and trust I have received over the years which allow me to further contribute to the well-being of our community and causes that are dear to my heart such as cancer research.” — Kheng Ly, Founder, President & Chief Executive Officer of Brivia Group The RI-MUHC’s Cancer Research Program is renowned for its collaborative, multidisciplinary team of experts who are leading the way in precision cancer medicine. Already, the program is harnessing the power of two promising new methods of cancer detection: liquid biopsy, or using a patient’s blood to detect cancer cells, and organoids, patient tumours grown in a lab that will allow treatments to be tested before administering them to a patient. Both are on the cusp of being a standard of cancer care and will lead to new ways to diagnose and treat cancers, from ovarian and breast to liver cancer. “The MUHC Foundation is an incredibly special group of people who are determined to provide some of the world’s best cancer researchers and leaders with the resources they need to do life-changing work. The community support at tonight’s Le Bal Rouge was moving, and all funds raised will support compassionate patient care and breakthrough cancer treatments.” — Marc P. Tellier, Chair of the MUHC Foundation and Senior Partner, Novacap “The support of the MUHC Foundation has been transformative for the MUHC. Seeing Montreal’s business community come together at Le Bal Rouge to support cancer research, care and teaching at our institution is incredibly inspiring. Thank you to everyone who contributed to this extraordinary event and for making a difference in the lives of our patients and their families.” — Dr. Lucie Opatrny, President and Executive Director, MUHC Since 2016, the MUHC Foundation’s Le Bal Rouge has raised over $8,750,000 million to support innovative research and exceptional care at the MUHC, underscoring the MUHC Foundation’s ability to drive impactful change in Quebec. Thank you to our sponsors Brivia Management Inc., CIBC, Air Canada, Merck Canada, Rio Tinto, Matrox, Jack Victor, Canso Investment Counsel Ltd., PBY Capital Limited, AtkinsRéalis, Power Corporation du Canada About the McGill University Health Centre Foundation The McGill University Health Centre (MUHC) Foundation raises funds to support excellence in patient care, research and teaching at the McGill University Health Centre, one of the top university hospitals in Canada. Our Dream Big Campaign to change the course of lives and medicine is raising millions of dollars to solve humanity’s deadliest puzzles: infectious diseases; end cancer as a life-threatening illness; fix broken hearts through innovative cardiac care; detect the silent killers—ovarian and endometrial cancers—early; create the best skilled health care teams in Canada; and much more. We are rallying our entire community to solve the world’s most complex health care challenges. https://muhcfoundation.com Tarah SchwartzVice-President, Communications & MarketingMcGill University Health Centre Foundationtarah.schwartz@muhc.mcgill.ca A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/8031dac5-a042-4e49-96f6-c179b48e3d34

Approval is based on the Phase 3 KEYNOTE-966 Trial KIRKLAND, QC, May 9, 2024 /CNW/ - Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced that Health Canada has granted approval of KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with gemcitabine-based chemotherapy, for the treatment of adult patients with locally advanced unresectable or metastatic biliary tract carcinoma (BTC). This approval is based on the results from the Phase 3 KEYNOTE-966 trial, which demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus chemotherapy alone. "Biliary tract cancer is usually diagnosed at an advanced stage, where patient survival rates are poor," says André Galarneau, PhD, Executive Director & Vice President, Oncology Business Unit at Merck Canada. "The addition of this indication shows promising overall survival results, which means more potential treatment options for biliary cancer patients in urgent need." About KEYNOTE-966 KEYNOTE-966 was a multicentre, randomized, double-blind, placebo-controlled Phase 3 trial (ClinicalTrials.gov NCT04003636) evaluating pembrolizumab in combination with gemcitabine and cisplatin compared to placebo plus gemcitabine and cisplatin for the first-line treatment of advanced and/or unresectable BTC. The primary endpoint was OS, and the secondary endpoints included progression-free survival (PFS), objective response rate (ORR), as assessed by BICR according to RECIST v1.1. The trial enrolled 1,069 patients with locally advanced unresectable or metastatic BTC, who had not received prior systemic therapy in the advanced disease setting. Patients were randomized (1:1) to receive pembrolizumab (200 mg every three weeks for up to approximately two years) plus gemcitabine and cisplatin, or placebo plus gemcitabine and cisplatin. Treatment continued until unacceptable toxicity or disease progression. For pembrolizumab, treatment continued for a maximum of 35 cycles, or approximately 24 months. For cisplatin, treatment could be administered for a maximum of 8 cycles and for gemcitabine, treatment could be continued beyond 8 cycles. Pembrolizumab with the gemcitabine/cisplatin arm demonstrated a clinically meaningful and statistically significant improvement versus the placebo with gemcitabine/cisplatin arm in OS. In the study, there was a 17% reduction in the risk of death with pembrolizumab plus gemcitabine/cisplatin (HR=0.83 [95% CI, 0.72-0.95]; p=0.0034) versus gemcitabine/cisplatin alone. The median PFS was 6.5 months (95% CI, 5.7-6.9) for the pembrolizumab plus chemotherapy arm versus 5.6 months (95% CI, 5.1,6.6) for the placebo plus chemotherapy arm. The objective response rate at the pre-specified interim analysis was 28.7% (24.9, 32.8) versus 28.5% (24.8, 32.6) respectively. The most common treatment-related adverse events (reported in at least 20% of patients) were neutrophil count decreased, anemia, platelet count decreased, nausea, fatigue, and white blood cell count decreased. For complete information, refer to the KEYTRUDA® product monograph. About Biliary Tract Cancer Biliary tract cancer is a group of rare and highly aggressive cancers in the gallbladder and bile ducts. Biliary tract cancer is the second most common type of primary liver cancer after hepatocellular carcinoma, accounting for 15% of all liver cancers. It is estimated there are approximately 211,000 new cases of BTC diagnosed and 174,000 deaths from the disease each year globally. Biliary tract cancer is most frequently diagnosed in patients between 50 to 70 years old, and 60-70% of BTC patients are diagnosed at an advanced stage. Patients diagnosed with BTC face a very poor prognosis, as the five-year survival rate is estimated to be between 5% and 15%. About KEYTRUDA® KEYTRUDA® is an anti-programmed death receptor-1 (PD-1) therapy that works by helping increase the ability of the body's immune system to help detect and fight tumour cells. KEYTRUDA® is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumour cells and healthy cells. KEYTRUDA® was first approved in Canada in 2015 and currently has indications in several disease areas, including advanced renal cell carcinoma, bladder cancer, non-small cell lung carcinoma, primary mediastinal B-cell lymphoma, classical Hodgkin lymphoma, colorectal cancer, endometrial carcinoma, cervical cancer, esophageal cancer, triple-negative breast cancer, melanoma, and head and neck squamous cell carcinoma. About Merck At Merck, known as MSD outside of 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 about our operations in Canada, visit and connect with us on LinkedIn and X @MerckCanada. Forward-Looking Statement of Merck & Co. Inc., Rahway, NJ, 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 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, 2023 and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ( ). Please see the product monograph for KEYTRUDA® (pembrolizumab) at Merck.ca. ® Merck Sharp & Dohme LLC. Used under license. © 2024 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved. SOURCE Merck Canada Inc. Company Codes: NYSE:MRK