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The 11th Annual Ross Prize Symposium will be held June 20 in New York City MANHASSET, N.Y.--(BUSINESS WIRE)-- The Feinstein Institutes for Medical Research has selected Michelle Monje, MD, PhD, from Stanford University, to receive the 11th annual Ross Prize in Molecular Medicine for her outstanding contributions to research relating to the neuroscience of cancer and its implications for therapy. The prize will be presented on June 20, in conjunction with the New York Academy of Sciences (NYAS) at Cure on 345 Park Avenue South in Manhattan and will take place as part of a half-day research symposium. To register for the event (in person or virtual), click here. This press release features multimedia. View the full release here: Michelle Monje, MD, PhD is the recipient of the 11th annual 2024 Ross Prize in Molecular Medicine (Credit: Alison Yip, AP images for HHMI) The Ross Prize is made possible by the generosity of Feinstein Institutes board vice chairman Jack Ross and his wife, Robin, assistant vice president of principal gifts at the Northwell Health Foundation. Established in 2013, the Ross Prize is awarded annually through the Feinstein Institutes' peer-reviewed, open-access journal Molecular Medicine. The prize includes a $50,000 award for the recipient and is given to investigators whose research shows high potential for transforming how we treat and cure disease. Ross Prize recipients continue to make breakthroughs in their respective fields. Helen H. Hobbs, MD, and Jonathan C. Cohen, PhD, received the 2023 Ross Prize – they were the first to discover the genetic cause of fatty liver disease and their work led to a new class of drugs that lower cholesterol. Ross Prize 2022 recipients Katalin Karikó, PhD, and Drew Weissman, MD, PhD, were awarded the 2023 Nobel Prize in Physiology or Medicine for their groundbreaking messenger RNA (mRNA) research that helped develop COVID-19 vaccines. “A pioneer in oncology and neuroscience, Dr. Monje’s work has revealed fundamental new insights into tumors of the central nervous system,” said Kevin J. Tracey, MD, president and CEO of the Feinstein Institutes, Karches Family Distinguished Chair in Medical Research and editor emeritus of Molecular Medicine. “The Ross Prize recognizes the significance and importance of her research in this new field of cancer neuroscience.” Dr. Monje's research focuses on the connections between brain science, immune system function, and brain cancer, specifically how brain cells (neurons) and support cells (glia) interact in healthy and disease conditions. In her lab, she studies how the activity of neurons affects the growth of healthy glial cells and the production of new protective cells (myelin) in the brain. Changes in this myelin can lead to cognitive problems, such as those seen in cancer therapy-related cognitive impairment. Additionally, her lab has found that the activity of neurons can also speed up the growth of malignant brain tumors through chemical signals and direct electrical connections between neurons and tumor cells. "My research dives into the intricate crossroads of neuroscience, immunology and brain cancer biology, highlighting the pivotal role of neuron-glial interactions in both health and oncological conditions," said Dr. Monje, Milan Gambhir Professor of Pediatric Neuro-Oncology in the Department of Neurology and Neurological Sciences at Stanford University and a Howard Hughes Medical Institute Investigator. "I am grateful for the Ross Prize, which will enable me to advance our understanding of the complex cellular interactions important for healthy brain functions and hopefully find new therapies to treat brain cancers and the cognitive impairment that can result from cancer chemotherapy." During the event, after a brief award presentation, Dr. Monje will deliver a keynote address discussing her research. Throughout the day, renowned scientists who will share their research include: David H. Gutmann, MD, PhD, Washington University in St. Louis Shawn Hervey-Jumper, MD, University of California, San Francisco Mario Suva, MD, PhD, Harvard University & Mass General Hospital “Robin and I founded the Ross Prize to advance research towards transformative medical therapies," stated Jack Ross. “We are privileged to have supported the outstanding scientific talent acknowledged by the prize for more than a decade.” To learn more about the Ross Prize celebration and symposium, please visit: Northwell.edu/RossPrize. If you would like to nominate a candidate for the 2025 Ross Prize, please make a submission here. Past recipients of the Ross Prize are: Helen H. Hobbs, MD, Howard Hughes Medical Institute investigator, director of the Eugene McDermott Center for Human Growth and Jonathan C. Cohen, PhD, professor of Internal Medicine, Center for Human Nutrition and Eugene McDermott Center for Human Growth and Development; Katalin Karikó, PhD, University of Pennsylvania Perelman School of Medicine adjunct professor and senior vice president at BioNTech and Drew Weissman, MD, PhD, University of Pennsylvania Perelman School of Medicine Roberts Family Professor of Vaccine Research; Adrian R. Krainer, PhD, Cold Spring Harbor Laboratory professor; Daniel Kastner, MD, PhD, the National Institutes of Health’s National Human Genome Research Institute scientific director; Huda Y. Zoghbi, MD, professor, Departments of Pediatrics, Molecular and Human Genetics, Neurology and Neuroscience at Baylor College of Medicine; Jeffrey V. Ravetch, MD, PhD, the Theresa and Eugene M. Lang Professor and head of the Leonard Wagner Laboratory of Molecular Genetics and Immunology at The Rockefeller University; Charles N. Serhan, PhD, DSc, director of the Center for Experimental Therapeutics and Reperfusion Injury at Brigham and Women’s Hospital, the Simon Gelman Professor of Anaesthesia at Harvard Medical School and professor at Harvard School of Dental Medicine; Lewis C. Cantley, PhD, the Meyer Director of the Sandra and Edward Meyer Cancer Center at Weill Cornell Medical College and New York-Presbyterian Hospital; John J. O'Shea, MD, scientific director at the National Institute of Arthritis and Musculoskeletal and Skin Diseases; and Dan R. Littman, MD, PhD, the Helen L. and Martin S. Kimmel Professor of Molecular Immunology in the Skirball Institute of Biomolecular Medicine at New York University School of Medicine. About the Feinstein Institutes The Feinstein Institutes for Medical Research is the home of the research institutes of Northwell Health, the largest health care provider and private employer in New York State. Encompassing 50 research labs, 3,000 clinical research studies and 5,000 researchers and staff, the Feinstein Institutes raises the standard of medical innovation through its five institutes of behavioral science, bioelectronic medicine, cancer, health system science, and molecular medicine. We make breakthroughs in genetics, oncology, brain research, mental health, autoimmunity, and are the global scientific leader in bioelectronic medicine – a new field of science that has the potential to revolutionize medicine. For more information about how we produce knowledge to cure disease, visit and follow us on LinkedIn. About Molecular Medicine Molecular Medicine sits at the forefront of its field, rapidly disseminating discovery in the genetic, molecular, and cellular basis of physiology and disease across a broad range of specialties. With over two decades of experience publishing to a multidisciplinary audience, and continually celebrating innovation through the ‘Ross Prize in Molecular Medicine’ and ‘Anthony Cerami Award in Translational Medicine,’ the journal strives towards the design of better molecular tools for disease diagnosis, treatment, and prevention. Molecular Medicine is published by BMC, part of Springer/Nature, in partnership with The Feinstein Institutes for Medical Research. About the New York Academy of Sciences The New York Academy of Sciences is an independent, not-for-profit organization that since 1817 has been committed to advancing science for the benefit of society. With more than 20,000 Members in 100 countries, the Academy advances scientific and technical knowledge, addresses global challenges with science-based solutions, and sponsors a wide variety of educational initiatives at all levels for STEM and STEM related fields. The Academy hosts programs and publishes content in the life and physical sciences, the social sciences, nutrition, artificial intelligence, computer science, and sustainability. The Academy also provides professional and educational resources for researchers across all phases of their careers. Please visit us online at . View source version on businesswire.com: Contacts Matthew Libassi 631-793-5325 mlibassi@northwell.edu Source: The Feinstein Institutes for Medical Research Smart Multimedia Gallery Photo Michelle Monje, MD, PhD is the recipient of the 11th annual 2024 Ross Prize in Molecular Medicine (Credit: Alison Yip, AP images for HHMI) Logo View this news release and multimedia online at:

NEW YORK, June 4, 2024 /PRNewswire/ -- Hospital for Special Surgery (HSS), the world's leading academic medical center focused on musculoskeletal health, honored Kenneth C. Griffin, Founder and CEO of Citadel and Founder of Griffin Catalyst, Steven B. Haas, MD, Chief of the Knee Service, and Hollis G. Potter, MD, Chairman of the Department of Radiology and Imaging at the 39th HSS Tribute Dinner on Monday, June 3. HSS announced a $12 million multi-year gift from Mr. Griffin to support a first-of-its-kind research initiative focused on transforming treatment for debilitating knee conditions at the event. Continue Reading HSS Honors Distinguished Physicians and Visionary Philanthropist Kenneth C. Griffin and Announces $12 Million Multi-Year Gift from Griffin to Advance Orthopedic Research and Care. AN EVENING RECOGNIZING EXCELLENCE IN MUSCULOSKELETAL MEDICINE At HSS's premier fundraising event recognizing physicians and philanthropists making an impact in the field of musculoskeletal medicine, Mr. Griffin was presented with the 2024 HSS Tribute Dinner Award by Robert K. Steel, Co-Chair of the HSS Board of Directors. Dr. Haas was presented with the HSS Lifetime Achievement Award by baseball legend Bernie Williams, and Dr. Potter was presented with the HSS Lifetime Achievement Award by Chase Coleman, founder of Tiger Global and an HSS Trustee. The evening, which featured a musical performance by five-time Grammy Award-winner Jon Batiste, was attended by over 750 guests and raised more than $5 million for patient care, research and medical education. "The Lifetime Achievement Award is our highest recognition for an outstanding healthcare leader at HSS," said Douglas E. Padgett, MD, Surgeon-In-Chief and Medical Director. "Both Drs. Haas and Potter exemplify the qualities that make HSS unique: their unwavering dedication to providing the highest quality of care; consistent efforts to advance the science in their respective fields; and their leadership in developing new techniques, technologies and treatment advances that have transformed the lives of patients around the world." An Extraordinary GIFT With the new transformational gift from Mr. Griffin announced at the event, HSS will establish the Kenneth C. Griffin Research Accelerator to accelerate the pace of innovative research to help millions of people regain their mobility and quality of life. Mr. Griffin's donation will advance work to better personalize treatment to the unique clinical needs of each patient and will also support construction of the HSS Kellen Tower, a new headquarters for joint replacement surgery and global destination for the treatment of complex orthopedic problems that is expected to open in 2025. "We are privileged to honor Ken with the Tribute Dinner Award and to have his incredible support," said Bryan T. Kelly, MD, MBA, President and CEO at HSS. "As one of the country's foremost philanthropists, Ken has demonstrated outstanding leadership in his efforts to improve quality and access to healthcare. His support of cutting-edge research drives progress in science and medicine that will have a global impact." Joint pain affects more than 80 million adults in the United States, with nearly 1 in 2 people experiencing chronic pain in the knee. HSS performs more than 12,000 hip and knee replacement surgeries annually, more than any other hospital in the United States. The breadth of expertise and high patient volume uniquely position HSS to drive innovative investigations for joint disease so that patients can achieve the mobility and function they desire, with results that will last a lifetime. "The extraordinary scientists, physicians, and healthcare professionals at the Hospital for Special Surgery lead the world in the research and treatment of orthopedic care," said Mr. Griffin. "I am proud to support HSS in its broad impact that stretches from helping elite athletes get back on the field to enabling seniors to actively engage with their grandchildren. The research and innovation at HSS is changing the lives of people around the world." Mr. Griffin has previously supported vital investigations in knee replacement surgery and precision medicine, as well as the expansion of facilities for care and research at HSS. "We are deeply grateful for Ken's remarkable generosity. This gift will help us establish how to personalize every aspect of knee replacement surgery for maximum benefit," said Dr. Haas. "Ken's generous contribution and partnership will have significant impact in creating the best environment for joint replacement care at HSS and in shaping the standards of care globally," said Mr. Steel. About HSS HSS is the world's leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the 14th consecutive year), No. 2 in rheumatology by U.S. News & World Report (2023-2024), and the best pediatric orthopedic hospital in NY, NJ and CT by U.S. News & World Report "Best Children's Hospitals" list (2023-2024). In a survey of medical professionals in more than 20 countries by Newsweek, HSS is ranked world #1 in orthopedics for a third consecutive year (2023). Founded in 1863, the Hospital has the lowest readmission rates in the nation for orthopedics, and among the lowest infection and complication rates. HSS was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center five consecutive times. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New Jersey, Connecticut and in the Long Island and Westchester County regions of New York State, as well as in Florida. In addition to patient care, HSS leads the field in research, innovation, and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair and tissue regeneration. In addition, more than 200 HSS clinical investigators are working to improve patient outcomes through better ways to prevent, diagnosis, and treat orthopedic, rheumatic and musculoskeletal diseases. The HSS Innovation Institute works to realize the potential of new drugs, therapeutics and devices. The HSS Education Institute is a trusted leader in advancing musculoskeletal knowledge and research for physicians, nurses, allied health professionals, academic trainees, and consumers in more than 165 countries. The institution is collaborating with medical centers and other organizations to advance the quality and value of musculoskeletal care and to make world-class HSS care more widely accessible nationally and internationally. . About Kenneth C. Griffin Kenneth C. Griffin is the Founder and CEO of Citadel, one of the world's leading alternative investment firms. Ken is also the Founder and Non-Executive Chairman of Citadel Securities, one of the world's preeminent market makers. Ken's decades of philanthropic involvement reflect the same strategic mindset that has contributed to his business success. A passionate philanthropist, Ken has donated more than $2 billion to advance education, opportunity, and health sciences initiatives that significantly transform people's lives. Now advanced through Griffin Catalyst, Ken's contributions have expanded access to education at all levels for millions of Americans, transformed research and medical institutions with historic gifts, and strengthened our cultural institutions. Ken's insights were instrumental in the launch of Operation Warp Speed's accelerated COVID-19 vaccine development and deployment strategies. About Steven B. Haas, MD Steven B. Haas, MD, joined HSS as an orthopedic resident following his internship at the Harvard Surgical Service. During his residency, Dr. Haas was inspired by the early development of total knee replacement and conducted impactful research, winning the Philip D. Wilson, MD, Award. He completed his fellowship in knee surgery at HSS under the mentorship of Dr. John Insall, who is considered the father of knee replacement surgery. Dr. Haas then joined the HSS medical staff in 1991 and has served as the Chief of the Knee Service for almost two decades. He holds the John N. Insall Chair in Knee Surgery and is a professor of clinical orthopedics at Weill Cornell Medical College. As Co-Chair of the HSS Quality Coordinating Committee for the past 15 years, Dr. Haas has also helped HSS to become the safest place in the nation to have orthopedic surgery. Dr. Haas is one of the top knee surgeons worldwide, having performed more than 15,000 surgeries for patients from around the globe. He speaks extensively nationally and internationally on knee replacement and has authored more than 130 peer-reviewed publications and chapters in orthopedic literature. Dr. Haas has been an innovator throughout his career, obtaining the first of his 10 US patents during his knee fellowship. He has played a key role in designing knee implants that are used in approximately 13% of knee replacement surgeries worldwide. Additionally, he has created a patented technique that makes these procedures less invasive and allows patients to recover faster, and has developed cutting-edge technologies, including patient-specific instrumentation, accelerometer-based computer navigation, and robotic-assisted knee replacement. In recognition of his global leadership in knee surgery, research, and development, Dr. Haas has been elected the incoming President of the Knee Society, the leading academic organization focused on knee reconstruction surgery. About Hollis G. Potter, MD Hollis G. Potter, MD, is Chairman of the Department of Radiology and Imaging and holds the Coleman Chair in MRI Research at HSS. She established the HSS Magnetic Resonance Imaging (MRI) laboratory in 2008 and is professor of radiology at Weill Cornell Medical College. Dr. Potter is the author of more than 300 peer-reviewed articles and 70 chapters. Her prior and current research interests lie in the use of quantitative MR imaging as a biomarker for assessment of early depletion of matrix from cartilage and fibrocartilage, as well as the reduction of susceptibility artifact around orthopedic hardware. She has been the co-recipient of the American Orthopaedic Association Research Award, the Cabaud Award for Excellence in Basic Science Research from the American Orthopaedic Society for Sports Medicine, the Robert E. Fairer Award from the ASTM, the Heritage Research Investigator in Translational Medicine Award from Crain's, and the Nicholas Andry Award from the Association of Bone and Joint Surgeons. Most recently, Dr. Potter was a recipient of the 2022 Gold Medal Award from the International Society of Magnetic Resonance in Medicine. Her laboratory has been continuously funded by the National Institutes of Health (NIH) on an RO1 level since 2008. She has continuously served on several NIH/National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Study Sections since 2007. Many of her current basic science imaging projects have been successfully transported into clinical use and implementation. Additionally, Dr. Potter is a co-founder of Imagen Technologies, a start-up company that uses artificial intelligence to interpret diagnostic images. SOURCE Hospital for Special Surgery

Ad hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules Sandoz reaches agreement with Amgen resolving all patent litigation related to its US denosumab biosimilars Agreement clears path for launch of Jubbonti® and Wyost® on May 31, 2025 or earlier under certain circumstancesJubbonti® and Wyost® are first and only FDA-approved biosimilars to and interchangeable with Prolia*® and Xgeva*®Anticipated launch further strengthens Sandoz biosimilar portfolio and advances growth strategy Basel, April 30, 2024 – Sandoz, the global leader in generic and biosimilar medicines, today announced that it has reached agreement with Amgen to resolve all patent disputes between the two companies relating to the US Food and Drug Administration (FDA)-approved Sandoz denosumab biosimilars. Patent infringement proceedings were initially filed by Amgen in the US Federal District Court for the District of New Jersey in May of 2023 pursuant to the Biologics Price Competition and Innovation Act (BPCIA). Resolution of the BPCIA litigation followed months of vigorous defense by Sandoz against claims by Amgen that the company infringed up to 21 patents expiring as late as 2037, protecting reference medicines Prolia® and Xgeva®. Under the terms of the agreement, Sandoz may enter the US market with a biosimilar version of Prolia® and Xgeva® on May 31, 2025, or earlier under certain circumstances if customary acceleration provisions are triggered. Sandoz received FDA approval for the first and only denosumab biosimilars, Jubbonti® and Wyost®, on March 5, 2024. Jubbonti® and Wyost® are interchangeable with and approved by FDA for all indications of reference medicines Prolia® and Xgeva®. They have the same dosage form, route of administration, dosing regimen and presentation as the respective reference medicines. The settlement clears the path to bring both Jubbonti® and Wyost® to the US market on May 31, 2025, or earlier under certain circumstances. Bringing denosumab to market allows us to further our Purpose of pioneering access for patients, by providing them with affordable high-quality medicines. The terms of the agreement will not impact our previously disclosed 2024 guidance. About Wyost® (denosumab-bbdz)Wyost® is approved to prevent skeletal-related events (SREs) in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.1 Bone is the third most frequent site for metastatic tumors.2 Nearly all types of cancer can spread to the bone and cause pain and fractures, though cancers that often metastasize in bones include breast and prostate.3 Wyost® 120 mg/1.7 mL (70 mg/mL) injection has been approved by the FDA as interchangeable with the reference medicine, a human monoclonal antibody designed to bind to the RANKL protein, an activator of osteoclasts (cells involved in breaking down bone tissue).8,9 Wyost® is indicated in the US to prevent SREs in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.1 SELECT IMPORTANT SAFETY INFORMATION CONTRAINDICATIONSHypocalcemia and known clinically significant hypersensitivity to denosumab products. WARNINGS AND PRECAUTIONSSame Active Ingredient: Patients receiving Wyost should not receive other denosumab products concomitantly. Hypersensitivity reactions including anaphylaxis may occur. Discontinue permanently if a clinically significant reaction occurs. Hypocalcemia: Denosumab products can cause severe symptomatic hypocalcemia. Fatal cases have been reported with denosumab products use. Correct hypocalcemia prior to initiating Wyost. Monitor calcium levels during therapy, especially in the first weeks of initiating therapy, and adequately supplement all patients with calcium and vitamin D. Osteonecrosis of the jaw (ONJ) has been reported in patients receiving denosumab products. Perform an oral examination prior to starting Wyost. Monitor for symptoms. Avoid invasive dental procedures during treatment with Wyost. Atypical femoral fracture: Evaluate patients with thigh or groin pain to rule out a femoral fracture. Hypercalcemia Following Treatment Discontinuation in Patients with Giant Cell Tumor of Bone and in Patients with Growing Skeletons: Monitor patients for signs and symptoms of hypercalcemia, and manage as clinically appropriate. Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation: When Wyost treatment is discontinued, evaluate the individual patient’s risk for vertebral fractures. Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of potential risk to the fetus and to use effective contraception. ADVERSE REACTIONSBone Metastasis from Solid Tumors: Most common adverse reactions (≥ 25%) were fatigue/asthenia, hypophosphatemia, and nausea. Multiple Myeloma: Most common adverse reactions (≥ 10%) were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache. Giant Cell Tumor of Bone: Most common adverse reactions (≥ 10%) were arthralgia, headache, nausea, back pain, fatigue, and pain in extremity. Hypercalcemia of Malignancy: Most common adverse reactions (> 20%) were nausea, dyspnea, decreased appetite, headache, peripheral edema, vomiting, anemia, constipation, and diarrhea. USE IN SPECIFIC POPULATIONSPediatric patients: Recommended only for treatment of skeletally mature adolescents with giant cell tumor of bone. Renal impairment: Patients with creatinine clearance less than 30 mL/min or receiving dialysis are at risk for hypocalcemia. Adequately supplement with calcium and vitamin D. This is not the complete list of all the safety information for Wyost. Please click to see full Prescribing Information for Wyost. About Jubbonti® (denosumab-bbdz)Jubbonti® is approved to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.4 Osteoporosis is a bone disease that develops when bone mineral density and bone mass decrease or when bone strength and structure change. People living with osteoporosis typically do not have symptoms and might not know they have the disease until they experience a fracture. More than 10 million US adults aged 50 and over live with osteoporosis, a major cause of fractures in postmenopausal women and in older men.5,6 Half of all women over the age of 50 will experience an osteoporotic fracture during their lifetime.7 Jubbonti® 60 mg/1 mL injection has been approved by the FDA as interchangeable with the reference medicine, a human monoclonal antibody designed to bind to the RANKL protein, an activator of osteoclasts (cells involved in breaking down bone tissue).8,9 Jubbonti® is indicated in the US to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.4 SELECT IMPORTANT SAFETY INFORMATION WARNING: SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASESee full prescribing information for complete boxed warning. Patients with advanced chronic kidney disease are at risk of severe hypocalcemia following denosumab products administration. Severe hypocalcemia requiring hospitalization, life-threatening events and fatal cases have been reported.The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia.Prior to initiating Jubbonti in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with Jubbonti in these patients should be supervised by a healthcare provider with expertise in the diagnosis and management of CKD-MBD. CONTRAINDICATIONSHypocalcemia; pregnancy; and known hypersensitivity to denosumab products. WARNINGS AND PRECAUTIONSHypocalcemia: Pre-existing hypocalcemia must be corrected before initiating Jubbonti. Adequately supplement all patients with calcium and vitamin D. Concomitant use of calcimimetic drugs may also worsen hypocalcemia risk. Evaluate for presence of chronic kidney disease mineral-bone disorder. Monitor serum calcium. Same Active Ingredient: Patients receiving Jubbonti should not receive other denosumab products concomitantly. Hypersensitivity including anaphylactic reactions may occur. Discontinue permanently if a clinically significant reaction occurs. Osteonecrosis of the jaw (ONJ): Has been reported with denosumab products. Monitor for symptoms. Atypical femoral fractures: Have been reported. Evaluate patients with thigh or groin pain to rule out a femoral fracture. Multiple vertebral fractures have been reported following treatment discontinuation. Patients should be transitioned to another antiresorptive agent if Jubbonti is discontinued. Serious infections including skin infections: May occur, including those leading to hospitalization. Advise patients to seek prompt medical attention if they develop signs or symptoms of infection, including cellulitis. Dermatologic reactions: Dermatitis, rashes, and eczema have been reported. Consider discontinuing Jubbonti if severe symptoms develop. Severe bone, joint, muscle pain may occur. Discontinue use if severe symptoms develop. Suppression of bone turnover: Significant suppression has been demonstrated. Monitor for consequences of bone over-suppression. ADVERSE REACTIONSPostmenopausal osteoporosis: Most common adverse reactions (> 5% and more common than placebo) were: back pain, pain in extremity, hypercholesterolemia, musculoskeletal pain, and cystitis. Pancreatitis has been reported in clinical trials. Male osteoporosis: Most common adverse reactions (> 5% and more common than placebo) were: back pain, arthralgia, and nasopharyngitis. Glucocorticoid-induced osteoporosis: Most common adverse reactions (> 3% and more common than active-control group) were: back pain, hypertension, bronchitis, and headache. Bone loss due to hormone ablation for cancer: Most common adverse reactions (≥ 10% and more common than placebo) were: arthralgia and back pain. Pain in extremity and musculoskeletal pain have also been reported in clinical trials. USE IN SPECIFIC POPULATIONSPregnant women and females of reproductive potential: Denosumab products may cause fetal harm when administered to pregnant women. Advise females of reproductive potential to use effective contraception during therapy, and for at least 5 months after the last dose of Jubbonti. Pediatric patients: Denosumab products are not approved for use in pediatric patients. Renal impairment: No dose adjustment is necessary in patients with renal impairment. Patients with advanced chronic kidney disease (eGFR <30 mL/min/1.73 m2), including dialysis-dependent patients, are at greater risk of severe hypocalcemia. The presence of underlying chronic kidney disease-mineral bone disorder markedly increases the risk of hypocalcemia. This is not the complete list of all the safety information for Jubbonti. Please click to see full Prescribing Information for Jubbonti.References1. Wyost®. Prescribing Information. Available at: Prescribing Information [Last accessed: March 2024]2. Bone Metastasis. Apoorva Jayarangaiah; Alysia K. Kemp; Pramod Theetha Kariyann, Oct 25 2022. Available at https://www.ncbi.nlm.nih.gov/books/NBK507911/#:~:text=The%20skeleton%20is%20the%20third,metastasize%20to%20bone%20as%20well. [Last accessed: March 2024]3. American Cancer Society. Bone Metastases. Available at: https://www.cancer.org/treatment/understanding-your-diagnosis/advanced-cancer/bone-metastases.html [Last accessed: March 2024]4. Jubbonti®. Prescribing Information. Available at: Prescribing Information [Last accessed: March 2024]5. National Institute of Arthritis and Musculoskeletal and Skin Diseases. Osteoporosis. 2022. Available at: https://www.niams.nih.gov/health-topics/osteoporosis [Last accessed: March 2024]6. National Center for Health Statistics. Osteoporosis or Low Bone Mass in Older Adults: United States, 2017–2018. 2021. Available at: https://www.cdc.gov/nchs/products/databriefs/db405.htm [Last accessed: March 2024]7. Bone Health and Osteoporosis Foundation. Osteoporosis Fast Facts. Available at: https://www.bonehealthandosteoporosis.org/wp-content/uploads/Osteoporosis-Fast-Facts-2.pdf [Last accessed: March 2024]8. Amgen Inc. Prolia® (Denosumab): Prescribing Information. Available at: https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/Prolia/prolia_pi.pdf [Last accessed: March 2024]9. Amgen Inc. Xgeva® (Denosumab): Prescribing Information. Available at: https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/xgeva/xgeva_pi.pdf [Last accessed: March 2024] *Xgeva® and Prolia® are registered trademarks of Amgen Inc. DisclaimerThis Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law. About SandozSandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 800 million patient treatments are provided annually by Sandoz, generating substantial global healthcare savings and even larger social impact. Its leading portfolio of approximately 1,500 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the first biosimilar in 2006. In 2023, Sandoz recoded sales of 9.6 billion. Global Media Relations contacts Investor Relations contacts Global.MediaRelations@sandoz.com Investor.Relations@sandoz.com Joerg E. Allgaeuer+49 171 838 4838 Karen M. King+1 609 722 0982 Chris Lewis+49 174 244 9501 Laurent de Weck+41 79 795 7364 Attachment Media Release Deno Agreement 24-04-30