Press Release

Apr 17th, 2012 - Berlin, Germany - Bayer HealthCare today released the results from a Xarelto (rivaroxaban) study that reaffirm the benefits of the oral, once-daily anticoagulant in everyday clinical practice. The real-world XAMOS study examined the safety and efficacy of rivaroxaban in preventing potentially deadly venous blood clots (venous thromboembolism or VTE) in adults, following elective total hip or knee replacement surgery.

XAMOS supports the excellent clinical findings of the RECORD trial programme, which showed oral, once-daily rivaroxaban to have consistently superior efficacy as well as a comparable and good safety profile to injectable enoxaparin. Results from XAMOS were presented today at the Annual Scientific Meeting of the British Society for Haematology, in Glasgow, Scotland.

“XAMOS confirms to us that the strong RECORD trial results are reflected in everyday clinical practice,” said Dr. A.G.G. Turpie, Professor of Medicine, McMaster University, Canada and Chairman of the XAMOS Executive Steering Committee. “As the largest analysis of everyday clinical experience with a new oral anticoagulant, XAMOS offers real-world evidence and confidence that oral, once-daily rivaroxaban is safe and effective in protecting against dangerous blood clots in the orthopaedic setting – and importantly without the inconvenience and discomfort of current standard injectable treatments.”

The non-interventional XAMOS study compared outcomes observed in everyday clinical practice across 17,413 orthopaedic patients receiving rivaroxaban or conventional pharmacological treatments for blood clot prevention. The main outcomes included symptomatic thromboembolic events and bleeding events reported as adverse events. The incidence of symptomatic thromboembolic events was lower in patients treated with rivaroxaban compared with conventional therapy (0.89% vs. 1.35%, respectively). Importantly, low and similar rates of major bleeding were observed in both study groups (0.40% vs. 0.34%, respectively).

Dr. Flemming Ornskov, Head of General Medicine, Bayer HealthCare added, “Almost two million patients worldwide have received rivaroxaban in the orthopaedic setting to date, making it the most prescribed new oral anticoagulant in this indication. The XAMOS results also reinforce the clinical promise of rivaroxaban to protect against potentially deadly blood clots across a broad range of venous and arterial thromboembolic conditions, overcoming limitations of traditional anticoagulants.”

About the XAMOS Study

XAMOS (XArelto in the prophylaxis of post-surgical venous thromboembolism after elective Major Orthopaedic Surgery of hip or knee) was an international, non-interventional, open-label cohort study assessing rivaroxaban for thromboprophylaxis in patients after elective orthopaedic surgery of the hip or knee. The study assessed the safety and efficacy of oral rivaroxaban or conventional pharmacological thromboprophylaxis regimens in everyday clinical practice.

Approximately 250 centres across 37 countries enrolled adult patients (aged 18 or over) undergoing elective hip or knee replacement surgery. The attending physician determined the type, duration and dose of thromboprophylaxis. All adverse events, including symptomatic thromboembolic and bleeding events, were documented by the investigators. Serious adverse events were followed-up until a final outcome was available.

About the RECORD Programme

The pooled analysis of RECORD 1-4 trials, which evaluated rivaroxaban (10mg given as one tablet, once-daily) in the prevention of VTE following elective total knee or total hip replacement surgery and involved more than 12,500 patients, demonstrated a statistically significant relative risk reduction of over 50% in those treated with rivaroxaban by comparison to enoxaparin.

The pooled results confirm findings from the four individual RECORD studies, which demonstrated the superior efficacy of rivaroxaban in preventing total VTE in both head-to-head comparisons with enoxaparin, as well as when comparing extended-duration (5 weeks) treatment with rivaroxaban with short-duration (2 weeks) enoxaparin followed by placebo. In all four studies, rivaroxaban and enoxaparin showed similar good safety profiles.

About Venous Arterial Thromboembolism (VAT)

Thrombosis is the formation of a blood clot inside a blood vessel, blocking a vein (venous thrombosis) or artery (arterial thrombosis). Venous Arterial Thromboembolism (VAT) is caused when some or all of a clot detaches and is moved within the blood stream until it obstructs a smaller vessel. This can result in damage to vital organs, because the tissue beyond the blockage no longer receives nutrients and oxygen.

VAT is responsible for a number of serious and life threatening conditions:

• Venous Thromboembolism (VTE) occurs when part of a clot formed in a deep vein, for example in the leg (known as deep vein thrombosis, or DVT), is carried to the lung, via the heart, preventing the uptake of oxygen. This is known as a pulmonary embolism (PE), an event which can be rapidly fatal
  
• Arterial Thromboembolism (ATE) occurs when oxygenated blood flow from the heart to another part of the body (via an artery) is interrupted by a blood clot. If this occurs in a vessel supplying blood to the brain, it can lead to a stroke, an event that can be severely debilitating or fatal. If it occurs in a coronary artery, it can lead to acute coronary syndrome (ACS), a complication of coronary heart disease which includes conditions such as myocardial infarction (heart attack), and unstable angina

VAT is responsible for significant morbidity and mortality, and requires active or preventative treatment to avoid potentially serious or fatal patient outcomes.

About Rivaroxaban (Xarelto)

Rivaroxaban is an oral anticoagulant that was discovered in Bayer HealthCare’s Wuppertal laboratories in Germany, and is being jointly developed by Bayer HealthCare and Janssen Research & Development, LLC. It has a rapid onset of action with a predictable dose response and high bioavailability, no requirement for routine coagulation monitoring, and a limited potential for food and drug interactions.

Rivaroxaban is marketed under the brand name Xarelto for VTE prevention in adult patients following total elective hip or knee replacement surgery, and it is the only oral anticoagulant that has consistently demonstrated superior efficacy over enoxaparin in this indication. Rivaroxaban is approved in more than 110 countries worldwide and is marketed outside the U.S. by Bayer HealthCare in this indication. On December 9, 2011, Xarelto received further marketing approval in the EU for the prevention of stroke and systemic embolism in patients with Atrial Fibrillation, as well as for the treatment of deep vein thrombosis (DVT) and the prevention of recurrent DVT and pulmonary embolism following an acute DVT in adult patients.

In the U.S., where rivaroxaban has been available since July 2011 for VTE prevention in adult patients following elective hip or knee replacement surgery, Janssen Pharmaceuticals, Inc. (a Johnson & Johnson Company) holds marketing rights. The Bayer HealthCare sales force is supporting Janssen Pharmaceuticals, Inc. in designated hospital accounts. On November 4, 2011, Xarelto received further marketing approval in the U.S. to reduce the risk of stroke and systemic embolism in patients with nonvalvular Atrial Fibrillation.

The extensive clinical trial programme supporting rivaroxaban makes it the most studied and widely published oral, direct Factor Xa inhibitor. The studies involve over 75,000 patients for the prevention and treatment of venous arterial thromboembolic (VAT) disorders across a broad range of acute and chronic conditions, including VTE prevention in adult patients following elective hip or knee replacement surgery, stroke prevention in patients with Atrial Fibrillation, VTE treatment and the prevention of recurrent DVT or PE, and for secondary prevention after an Acute Coronary Syndrome.

To learn more about thrombosis, please visit www.thrombosisadviser.com.

About Bayer HealthCare

The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 17.2 billion (2011), 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 55,700 employees (Dec 31, 2011) and is represented in more than 100 countries. Find more information at www.bayerhealthcare.com.

Contact

Astrid Kranz, Tel. +49 30 468-12057

E-Mail: astrid.kranz@bayer.com

Stephanie Prate, Tel. +49 30 468-196053

E-Mail: stephanie.prate@bayer.com

Find more information at www.bayerpharma.com.

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