2009-08-30 ESC Congress 2009

The Bayer Cardiology Success Story continues: A new chapter in Cardiovascular and Cardio-Pulmonary Care

Barcelona, Spain, August 30, 2009 – Bayer Schering Pharma presents its cardiology franchise at the ESC Congress 2009, bringing together the company’s comprehensive portfolio of marketed and pipeline products designed to prevent or treat both acute and chronic diseases for cardiovascular and cardio-pulmonary health. This dedicated approach aims to address the unmet medical need in cardiovascular disease, the number one cause of death worldwide. An estimated 17.5 million people died from cardiovascular disease in 2005 and this number is expected to rise to 20 million by 2015. (1)

“Cardiovascular and cardio-pulmonary health is an area of high medical need, and one where Bayer is determined to deliver benefits to both patients and physicians,” said Frank Misselwitz, MD, Vice President of Global Clinical Development and Head of the Therapeutic Area Cardiovascular and Coagulation, Bayer Schering Pharma AG. “Building on more than a century of heritage in pioneering therapeutic breakthroughs in cardiovascular risk factors, Bayer Schering Pharma is now expanding into other fields of cardiology by identifying and developing compounds with the potential to overcome the limitations of current medicines.”

Bayer Schering Pharma is investing in research and development in cardiovascular and cardio-pulmonary health, focusing on promising compounds such as riociguat for pulmonary hypertension (PH) and Xarelto® (rivaroxaban) in several cardiovascular indications. With this portfolio, Bayer prepares for the life style challenges of an aging population in the industrialized world of the future.

In particular Bayer Schering Pharma aims to address the unmet needs of sizeable populations not receiving optimal therapy in cardiovascular indications as well as investigate novel treatment approaches for smaller populations, where only limited treatment options are available, such as in PH and acute decompensated heart failure (ADHF).

Current products in the Bayer portfolio include Adalat® (nifedipine) and AspirinCardio® (low-dose acetylsalicylic acid), with a combined turn over close to 1 billion Euros annually; Xarelto® (rivaroxaban), which has recently begun its success story with its first indication; and Glucobay® (acarbose), which continues its success especially in the emerging markets.

Since its invention, more then 35 years ago, Adalat® (nifedipine) has been developed to a first-choice calcium channel blocker for the management of hypertension (high blood pressure) and coronary heart disease (CHD). AspirinCardio® (low-dose acetylsalicylic acid) is a key growth driver of the marketed products to prevent thrombosis and it is regarded as the gold standard in the prevention of myocardial (re-) infarction, stroke, and angina pectoris worldwide. With 5.4 billion tablets sold (2), AspirinCardio was the leading cardiovascular brand in 2008.

Pritor®/Kinzal® (telmisartan) is the only angiotensin II receptor blocker that has demonstrated the same level of cardio and vascular protection as the current gold standard angiotensin-converting enzyme inhibitor in high CV risk patients. The active ingredient telmisartan is co-marketed with its originator Boehringer Ingelheim and promoted by Bayer Schering Pharma in most European countries. Glucobay® (acarbose) is the first-in-class alpha-glucosidase-inhibitor, used to treat and to prevent type 2 diabetes (3) with the potential to offer additional cardiovascular benefits.

One of the latest achievements was the launch of Xarelto® (rivaroxaban), the first in class oral, direct factor Xa inhibitor to prevent venous thromboembolism (VTE) after elective hip or knee replacement surgery. Today, Xarelto® is appoved in more than 60 countries and is under investigation in a broad range of indications, including VTE treatment, stroke prevention in atrial fibrillation (SPAF), secondary prevention of acute coronary syndromes (ACS), and the prevention of VTE in medically ill patients.

Bayer Schering Pharma is investigating novel approaches for conditions where current treatment options are limited. One area of high unmet medical need is PH where there is an urgent need for more efficient therapies. PH encompasses multiple disease subtypes, but currently existing drug treatments are indicated solely for pulmonary arterial hypertension (PAH), which represents only a small proportion of the PH patients in need of therapies. (4)

Bayer already markets Ventavis® (inhaled iloprost), the first and only EMEA approved lung-selective inhaled form of prostacyclin for the treatment of idiopathic/ heritable PAH. To further expand in this disease area, there is a new compound under development in the cardiology franchise pipeline: riociguat. This unique soluble guanylate cyclase (sGC) stimulator is currently in phase III trials being studied for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH), PAH as well as in phase II trials for other types of PH.

ADHF is a disease area where no significant treatment breakthroughs have been made for more than 30 years. Bayer Schering Pharma is focused on identifying a robust solution for patients with ADHF and is investigating an sGC activator treatment: cinaciguat is currently in phase II trials.

About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of healthcare, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, 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. The pharmaceuticals business operates under the name Bayer Schering Pharma. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.

Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at www.bayerscheringpharma.de.

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 www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

REFERENCE
(1) World Health Organisation (WHO), Cardiovascular Diseases. 2008. http://www.who.int/topics/cardiovascular_diseases/en/
(2) IMS Health, IMS MIDAS, Q1/2009, sales data international products, segment "Cardiovascular Risk Management"  (Europe, Canada, Asia Pacific, Japan)
(3) Acarbose is indicated for diabetes and in selected countries also for the prevention of type 2 diabetes
(4) Qualitative market research. Easton Associates, 2008.