March 11, 2015

Not intended for U.S. and UK Media - World Congress of Nephrology 2015:

Bayer to Present Latest Clinical Data in the Area of Kidney Diseases

ARTS-DN-Phase IIb-study results of finerenone in diabetic nephropathy and early clinical data on molidustat
Leverkusen, March 11, 2015 - Bayer HealthCare will present latest clinical data on development candidates in the area of kidney diseases at the World Congress of Nephrology (WCN), March 13-17, 2015, in Cape Town, South Africa. An oral and poster presentation will describe the results from the Phase IIb ARTS-DN study with finerenone for the treatment of patients with diabetic nephropathy. Early clinical results on molidustat in patients with anemia and chronic kidney disease will also be presented. A Bayer sponsored lunch symposium will give insight into unmet needs in renal therapies with a focus on ways forward in diabetic kidney disease and renal anemia.

Presentations on Bayer development candidates at WCN 2015:

Oral presentation: Results of ARTS-DN: A randomized study to assess the safety and efficacy of finerenone in patients with Type 2 diabetes and diabetic nephropathy - Theme symposium: CKD and its consequences; Session 9: Clinical trials - Monday, March 16, 2015: 6:25 PM-6:40 PM; Auditorium 1, Cape Town International Convention Centre (CTICC).

Poster presentations: Results of ARTS-DN: A randomized study to assess the safety and efficacy of finerenone in patients with Type 2 diabetes and diabetic nephropathy - Poster# SUN-488, Session: CKD and its consequences - Miscellaneous - Sunday, March 15, 2015, 11:00 AM-12.30 PM; Exhibition Hall, Cape Town International Convention Centre (CTICC).

Safety, tolerability, pharmacokinetics and pharmacodynamics of the oral HIF stabilizer molidustat in pre-dialysis patients with renal anemia - Poster# MON-348, Session: Anaemia (CKD 3-5) - Monday, March 16, 2015, 11:00 AM-12:30 PM; Exhibition Hall, Cape Town International Convention Centre (CTICC).

Lunch Symposium: Unmet needs in renal therapies: Way forward in renal anaemia and diabetic kidney disease - Sunday, March 15, 2015, 12:30 PM-1:45 PM, Meeting room 1.41 - 1.44, Cape Town International Convention Center (CTICC). - Program: What is known and unknown about current and future anemia treatments: Expectations for new HIF-PH inhibitors, Iain C. MacDougall, King's College Hospital NHS Foundation Trust, London, UK

Evidence based medicine, real world evidence and emerging concepts in diabetic kidney disease, Luis M. Ruilope, Complutense University, Madrid, Spain

About Finerenone
Finerenone (BAY 94-8862) is a novel potent and selective oral non-steroidal mineralo-corticoid receptor (MR) antagonist blocking deleterious effects of aldosterone. Increased activation of the MR leads to pathological changes in the heart and kidneys, which can be prevented by effective MR antagonism. Current steroidal MR antagonists on the market have proven to be effective in reducing cardiovascular mortality in patients with heart failure (HF). However, they are underutilized due to the incidence of hyperkalemia, renal dysfunction, and anti-androgenic / progestonal side effects. Finerenone has demonstrated a promising efficacy and safety profile in preclinical studies as well as in Phase IIa (ARTS study). The MR antagonist is currently in clinical Phase IIb development for the treatment of worsening chronic heart failure and diabetic nephropathy and is currently expected to enter clinical Phase III end of 2015.

About Molidustat
Molidustat (BAY 85-3934) is a novel inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase (PH), an enzyme which stimulates erythropoietin (EPO) production and the formation of red blood cells. Phase I data have shown that inhibition of HIF-PH by Molidustat results in an increase in endogenous production of EPO. A Phase IIb program with Molidustat is currently ongoing in patients with anemia associated with chronic kidney disease and/or end-stage renal disease.

About Diabetic Nephropathy
Continuously increased sugar levels in the blood of diabetic patients can damage the kidneys. Kidney performance (the so-called glomerular filtration rate or GFR) is reduced, and in addition the damaged kidney loses increased amounts of protein in the urine (albuminuria). Over time, the kidneys may fail completely. Without either regular dialysis or a kidney transplant, kidney failure is always fatal. Diabetic nephropathy is the most common cause of kidney failure world-wide.

About Anemia in Chronic Kidney Disease
Anemia associated with chronic kidney disease and/or end-stage renal disease is a major cause of anemia in industrialized countries. The diseased kidneys do not produce sufficient levels of the hormone erythropoietin (EPO) resulting in insufficient production of red blood cells and anemia. Molidustat stabilizes HIF (hypoxia inducible factor), a protein associated with EPO production, which leads to an increase of endogenous EPO production.

About Cardiology at Bayer
Bayer is committed to delivering Science For A Better Life by advancing a portfolio of innovative treatments. Cardiovascular diseases have become a severe problem in our society. Bayer is working in a wide range of therapeutic areas on new treatment approaches for cardiovascular, lung and kidney diseases. 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 HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of around EUR 20.0 billion (2014), is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare's aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 60,700 employees (Dec 31, 2014) and is represented in more than 100 countries. More information is available at

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Forward-looking statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup 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.
Last updated: December 04, 2013 Copyright © Bayer AG