Press Release

Aug 27th, 2012 - Munich, Germany – A major subgroup analysis from the ATLAS ACS 2-TIMI 51 study of 7,817 patients with ACS and a recent ST-segment elevation myocardial infarction (STEMI) demonstrated that oral anticoagulant Xarelto^® (rivaroxaban) 2.5 mg twice daily, when added to standard antiplatelet therapy, provides a significant mortality benefit. The analysis showed that adding rivaroxaban to standard antiplatelet therapy significantly reduced the composite primary efficacy endpoint (cardiovascular death, myocardial infarction (MI) or stroke) compared to standard antiplatelet therapy alone. Rates of TIMI major bleeding (not related to coronary artery bypass graft (CABG) surgery) were increased with rivaroxaban. But importantly, rivaroxaban did not increase the rate of fatal bleeding. Overall, the addition of rivaroxaban 2.5 mg twice daily significantly reduced mortality, including cardiovascular death and all cause death, in comparison to standard therapy alone. These results were presented today at the ESC Congress 2012 (European Society of Cardiology), by Dr. Jessica Mega from the TIMI Study Group.

“Approximately 30% of ACS patients have a STEMI diagnosis and the risk of life-
threatening secondary events for STEMI patients is highest at hospitalisation. However, this risk remains high even after the patient has been stabilised and leaves the hospital,” said C. Michael Gibson, M.S., M.D., Senior Investigator of the TIMI Study Group, Harvard Medical School, and the Principal Investigator in the ATLAS ACS studies of rivaroxaban. “These data confirm that adding twice-daily rivaroxaban to standard therapy once patients are stabilised, leads to a significant reduction of this elevated mortality risk.”

Addressing Blood Clots in ACS

ACS is a common and life-threatening condition which occurs when a coronary artery is blocked by a blood clot and reduces blood supply to the heart. This blockage can directly cause heart attack. STEMI is a more serious type of heart attack that is typically caused by a blood clot completely obstructing the coronary artery, leading to damage and death of the heart muscle tissue.

In ACS, blood clots form through two pathways - platelet activation and thrombin generation. During an acute ACS, both platelet activation and thrombin generation are elevated. Patients typically receive a combination of antiplatelets and parenteral anticoagulants in the acute phase only. However, excess thrombin generation persists in stable patients for up to 12 months beyond the acute presentation of ACS, suggesting a persistent hypercoagulable state. Current standard of care for secondary prevention after an ACS is dual antiplatelet therapy. But this only targets one cause of clot formation - platelet activation. Rivaroxaban targets Factor Xa, a key trigger of thrombin generation. Therefore the addition of rivaroxaban to the current standard of care addresses the arterial clot more completely, by targeting both of the causes of clot formation.

“This STEMI analysis presents further evidence from the ATLAS study that rivaroxaban can significantly improve the care of ACS patients, and most importantly, save lives,” said Dr. Kemal Malik, Member of the Bayer HealthCare Executive Committee and Head of Global Development.

About the ATLAS ACS 2-TIMI 51 STEMI Sub-Analysis

The STEMI analysis included 7,817 patients in 44 countries who underwent randomization to twice-daily dosing of either rivaroxaban 2.5 mg, rivaroxaban 5 mg, or placebo. In the analysis, rivaroxaban 2.5 mg twice daily was associated with a significant reduction in the composite primary efficacy endpoint of CV death, MI, or stroke, by comparison to placebo (8.7% vs. 10.6%, P=0.047). Rivaroxaban 2.5 mg twice daily significantly reduced cardiovascular death (2.5% vs. 4.2%, P=0.006) and all-cause death (3.0% vs. 4.7%, P=0.008). Rates of TIMI major bleeding (not related to CABG surgery) were 1.7% vs. 0.6% (P<0.001). Importantly, there was no significant increase in fatal bleeding (0.04% vs. 0.12%, P=0.33).

About the ATLAS ACS 2-TIMI 51 Primary Analysis

In the ATLAS ACS 2-TIMI 51 (Anti-Xa Therapy to Lower cardiovascular events in Addition to aspirin with/without thienopyridine therapy in Subjects with Acute Coronary Syndrome) study rivaroxaban 2.5 mg twice daily, in combination with standard antiplatelet therapy, significantly reduced the composite primary efficacy endpoint of cardiovascular death, myocardial infarction, or stroke in patients with ACS compared to standard antiplatelet alone. Rivaroxaban resulted in higher rates of TIMI major bleeding events not associated with CABG surgery and intracranial haemorrhage compared to standard antiplatelet alone, but there was no increase in the risk of fatal bleeding.

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.

To learn more about VAT, please visit www.VATspace.com

About Xarelto (Rivaroxaban)

Rivaroxaban is the most broadly indicated new oral anticoagulant and is marketed under the brand name Xarelto. To date, Xarelto has been approved for use in the following indications across the venous arterial thromboembolic (VAT) space:

• The prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors in more than 60 countries worldwide
• The treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults in more than 50 countries worldwide
• The prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery in more than 120 countries worldwide

Since the first approval of Xarelto in 2008 in the orthopaedic setting, more than two million patients worldwide have received Xarelto in daily clinical practice in this indication alone.

Rivaroxaban was discovered by Bayer HealthCare, and is being jointly developed with Janssen Research & Development, LLC. Xarelto is marketed outside the U.S. by Bayer HealthCare and in the U.S. by Janssen Pharmaceuticals, Inc. (a Johnson & Johnson Company).

Anticoagulant medicines are potent therapies used to prevent or treat serious illnesses and potentially life threatening conditions. Before initiating therapy with anticoagulant medicines, physicians should carefully assess the benefit and risk for the individual patient.

Responsible use of Xarelto is a very high priority for Bayer, and the company has developed a Prescribers Guide for physicians and a Xarelto Patient Card for patients to support best practice.

To learn more, please visit: www.prescribe.xarelto.com
To learn more about thrombosis, please visit www.thrombosisadviser.com
To learn more about Xarelto, please visit www.xarelto.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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