Bayer, Inc.

Bayer and Orion’s darolutamide has demonstrated significant survival benefits as part of a combination treatment in patients with metastatic hormone-sensitive prostate cancer (mHSPC), according to new late-stage results shared by the companies. The phase 3 ARANOTE trial randomised more than 660 patients to receive 600mg of darolutamide twice daily or matching placebo, both in addition to androgen deprivation therapy (ADT). The study met its primary endpoint, with the darolutamide combination significantly increasing radiological progression-free survival compared to placebo plus ADT. The darolutamide combination also had a safety profile comparable to that of placebo plus ADT. Prostate cancer is the second most common cancer in men, with an estimated 1.4 million cases diagnosed globally in 2020. ADTs are often used as part of a combination treatment for patients with mHSPC, a stage of the disease in which the cancer has spread outside of the prostate to other parts of the body. However, most of those with mHSPC eventually progress to castration-resistant prostate cancer, at which point survival is limited. Darolutamide, jointly developed by Bayer and Orion, is an oral androgen receptor inhibitor that works to impede the receptor function and the growth of prostate cancer cells. The drug already holds approvals, under the brand name Nubeqa, to treat non-metastatic castration-resistant prostate cancer patients who are at high risk of developing metastatic disease, and in combination with ADT and docetaxel for those with mHSPC. Commenting on the latest results for the therapy, Outi Vaarala, senior vice president of innovative medicines and research and development at Orion, said: “The results of the ARANOTE trial reconfirm that darolutamide… is a viable treatment option for patients with mHSPC. “In these patients, darolutamide has now shown efficacy with and without docetaxel, and thus, pending regulatory approval, can provide choices for the personalised treatment regime.” Bayer is now set to present detailed results from the study at an undisclosed scientific congress and will submit the data to global health authorities to support expanded use of darolutamide in mHSPC. Beyond mHSPC, darolutamide is currently being evaluated across other stages of prostate cancer, including hormone-sensitive high-risk biochemical recurrence disease.

Bayer is working closely with Health Canada and its Canadian retail partners to ensure that all consumers are notified immediately. Lots containing the following codes are impacted: G238402 and G239889. MISSISSAUGA, ON, April 18, 2024 /CNW/ - Bayer is recalling two lots of hydraSense® Baby Nasal Care Easydose® due to a potential contamination. Lots containing the following codes are impacted: G238402 and G239889. No other hydraSense® products are impacted. The safety of Canadians and the quality of our products remains our highest priority. We are working closely with Health Canada and our Canadian retail partners to ensure that all consumers are notified immediately, and that all impacted inventory is removed from shelves and quarantined as soon as possible. What should consumers do? While no adverse events have been reported at this time, consumers who believe that their hydraSense® Baby Nasal Care Easydose® product is from an affected lot are to stop using it immediately and to return it for a full refund by completing a form at or by calling 1-800-265-7382. If you have a medical concern, please speak with your health care provider. How to identify if your product is part of the recall? Lot numbers for hydraSense® Baby Nasal Care Easydose® can be found on the bottom of the box containing the single use vials and on the label of each single use vial. For more information: To report an adverse event, product complaint or have questions about this recall, please contact Bayer at 1-800-265-7382. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, "Health for all, Hunger for none," the company's products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability, and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to Find more information at xx (2024-0XXXE) Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. SOURCE Bayer Inc.

Finerenone is the first non-steroidal, selective mineralocorticoid receptor (MR) antagonist to demonstrate positive kidney and cardiovascular outcomes in patients with chronic kidney disease associated with type 2 diabetes1 The approval is based on the results of the Phase III FIDELIO-DKD and FIGARO-DKD studies investigating the efficacy and safety of finerenone on kidney and cardiovascular (CV) outcomes in patients with CKD associated with T2D Despite guideline-directed therapies, many patients with chronic kidney disease associated with type 2 diabetes still progress to loss of kidney function and are at high risk for cardiovascular events2,3,4 MISSISSAUGA, ON, Oct. 26, 2022 /CNW/ - Bayer Inc. announced today that Health Canada approved finerenone, under the brand name KERENDIA®, as an adjunct to standard of care therapy in adults with chronic kidney disease (CKD) and type 2 diabetes (T2D) to reduce the risk of end-stage kidney disease and a sustained decrease in estimated glomerular filtration rate, cardiovascular death, non-fatal myocardial infarction and hospitalization for heart failure5. Finerenone is available in two tablet strengths – 10 mg and 20 mg. The approval of finerenone by Health Canada is based on the positive results of the pivotal Phase III FIDELIO-DKD and FIGARO-DKD studies. FIDELIO-DKD was presented at the American Society of Nephrology's (ASN) Kidney Week Reimagined 2020 and simultaneously published in the New England Journal of Medicine in October 20201. FIGARO-DKD was presented at the European Society of Cardiology (ESC) Congress on August 28, 2021 and published in the New England Journal of Medicine in December 20216. "There is an unmet need for patients with kidney disease from diabetes, it remains the number one cause of end stage kidney disease requiring dialysis in Canada and triples the risk of dying from cardiovascular disease over type 2 diabetes alone," said Dr. Sheldon Tobe, University of Toronto Postgraduate Fellowship Director – Nephrology and Professor of Medicine, University of Toronto and Northern Ontario School of Medicine. "For patients with diabetic kidney disease across a wide range of severity, the addition of finerenone to standard of care produced a dramatic improvement in the risk of heart disease and the risk of loss of kidney function and the need for dialysis. For patients who develop diabetes today, I believe that finerenone together with our best therapies, has the potential to improve cardiovascular outcomes and prevent the need for dialysis over their lifetime." Chronic kidney disease is a common and potentially deadly condition that is generally underrecognized. CKD can shorten life expectancy of patients with type 2 diabetes by up to 16 years relative to the general population living without either disease. Up to 40% of all patients with type 2 diabetes develop chronic kidney disease. In T2D, mineralocorticoid receptor (MR) overactivation is thought to contribute to CKD progression which can be driven by metabolic, haemodynamic or inflammation and fibrosis factors1,4,7,8,9. "FIDELIO-DKD is the first large contemporary Phase III positive outcomes study in patients with chronic kidney disease and type 2 diabetes with a primary composite endpoint consisting exclusively of kidney-specific outcomes, while FIGARO-DKD is the first contemporary Phase III CV outcomes trial with the majority of patients with earlier stage (1-2) CKD with albuminuria to show CV benefit in patients with CKD associated with T2D. These two trials are a part of the largest global Phase III clinical trial program to date in CKD and T2D," said Dr. Shurjeel Choudhri, Senior Vice President and Head of Medical and Scientific Affairs for Bayer Canada. "With our longstanding expertise in innovative science in the cardiovascular space, today's approval of finerenone marks an important milestone in Bayer's commitment to improving the lives of patients with kidney and cardiovascular diseases." About Finerenone Finerenone (BAY 94-8862) is a non-steroidal, selective antagonist of the mineralocorticoid receptor that has been shown to block harmful effects of mineralocorticoid receptor overactivation. In T2D, MR overactivation is thought to contribute to CKD progression and cardiovascular damage, which can be driven by metabolic, haemodynamic or inflammation and fibrosis factors1,4,7,8,9. Having randomized more than 13,000 patients with CKD and T2D around the world, the Phase III programme with finerenone in CKD and T2D comprises two studies, evaluating the effect of finerenone versus placebo on top of standard of care on both renal and cardiovascular outcomes. FIDELIO-DKD (FInerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease) investigated the efficacy and safety of finerenone in comparison to placebo in addition to standard of care on the reduction of kidney failure and kidney disease progression in approximately 5,700 patients with CKD and T2D5. FIGARO-DKD (FInerenone in reducinG cArdiovascular moRtality and mOrbidity in Diabetic Kidney Disease) investigated the efficacy and safety of finerenone versus placebo in addition to standard of care on the reduction of cardiovascular morbidity and mortality in approximately 7,400 patients with CKD and T2D across 47 countries including sites in Europe, Japan, China and the U.S. Both FIDELIO-DKD and FIGARO-DKD studies met their primary endpoints. Finerenone was generally well-tolerated with similar overall rates of adverse events in the finerenone and placebo arms of both clinical trials. The most common adverse reaction associated with finerenone was hyperkalemia. This was expected based on the mechanism of action. Hyperkalemia events were generally manageable by temporary interruption of finerenone with few permanent treatment discontinuations. There were no observed deaths due to hyperkalemia in either study1,6. KERENDIA® has already been approved by a number of health authorities, including the U.S. Food and Drug Administration (FDA) in July 2021 and by the European Commission for marketing authorization in the European Union (EU) in February 2022. About Chronic Kidney Disease in Type 2 Diabetes Chronic kidney disease (CKD) is a potentially deadly condition that is generally underrecognized – one in 10 Canadians has kidney disease10. CKD is one of the most frequent complications arising from diabetes and is also an independent risk factor of cardiovascular disease. Up to 40% of all patients with type 2 diabetes develop CKD. Despite guideline-directed therapies, patients with CKD and T2D remain at high risk of CKD progression and cardiovascular events. It is estimated that CKD affects more than 160 million people with T2D worldwide. CKD in T2D is the main cause of end stage kidney disease11, which requires dialysis or a kidney transplant to stay alive12. About Bayer's Commitment in Cardiovascular and Kidney Diseases Bayer is an innovation leader in the area of cardiovascular diseases, with a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. The heart and the kidneys are closely linked in health and disease, and Bayer is working in a wide range of therapeutic areas on new treatment approaches for cardiovascular and kidney diseases with high unmet medical needs. The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development. Together, these products reflect the company's approach to research, which prioritizes targets and pathways with the potential to impact the way that cardiovascular diseases are treated. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2021, the Group employed around 100,000 people and had sales of 44.1 billion euros. R&D expenses before special items amounted to 5.3 billion euros. For more information, go to . Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. SOURCE Bayer Inc.