Landmark Phase III Study of Bayer's Xarelto® (Rivaroxaban) Initiated for the Secondary Prevention of Myocardial Infarction and Death in Patients with Coronary or Peripheral Artery Disease

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- 20,000-patient study will be conducted in collaboration with Population
Health Research Institute
- Composite of cardiovascular death, myocardial infarction and stroke as primary
efficacy endpoint
- Rivaroxaban is the first novel oral anticoagulant under assessment in this
high risk patient population

Bayer HealthCare announced today the initiation of the COMPASS
study, the largest clinical study of its oral anticoagulant
Xarelto(R) (rivaroxaban) to date, investigating the prevention of
major adverse cardiac events (MACE) including cardiovascular death,
myocardial infarction and stroke in patients with coronary artery
disease (CAD) or peripheral artery disease (PAD).

To view the Multimedia News Release, please click:

http://www.multivu.com/mnr/58642-COMPASS-Study

The Phase III study COMPASS will assess the potential of
rivaroxaban to provide important additional protection to patients
when added to aspirin as compared to rivaroxaban and aspirin as
single treatments. The study will be conducted in collaboration with
the Population Health Research Institute (PHRI) and will enroll
approximately 20,000 patients from more than 450 sites across more
than 25 countries worldwide.

"Today, aspirin is the gold standard and provides significant
protection for patients with coronary or peripheral artery disease.
However, a residual risk of cardiac events such as heart attack,
stroke or even death remains in these high-risk patients," said Dr.
Salim Yusuf, Executive Director of the PHRI, Canada, and Principal
Investigator of the COMPASS study. "This is therefore an important
study, designed to provide significant insights on additional,
potentially complementary, cardioprotective benefits of rivaroxaban
for these patients."

In CAD and PAD, the inner wall of the arteries progressively
thickens due to accumulation of lipids, calcification and cell
proliferation. This plaque narrows the arteries and decreases the
amount of blood flow to the heart muscle or the legs. This process is
called atherosclerosis. If plaque from the wall of an artery
ruptures, a blood clot can form at the site of the rupture leading to
serious events including myocardial infarction, stroke or even death.

Currently, the most commonly prescribed treatments for the
prevention of MACE in CAD and PAD patients are antiplatelet agents
such as aspirin - a product with a well documented role in the
prevention of cardiovascular events across a broad range of patients.

"Antiplatelet therapies and rivaroxaban have complementary
mechanisms of action and when combined have been shown to improve
outcomes in patients with acute coronary syndrome. In the same way,
COMPASS will evaluate whether the combination has the potential for
more complete protection against long-term clot formation in patients
with CAD and PAD in comparison to each of the products alone," said
Dr. Kemal Malik, Member of the Bayer HealthCare Executive Committee
and Head of Global Development.

About the Burden of Coronary and Peripheral Artery Disease

Coronary artery disease (CAD) is the most common cause of
cardiovascular disease and is responsible for approximately 7.3
million deaths worldwide every year. One-third to one-half of all
middle-aged men and women in high income countries are at risk of
developing CAD during their lifetime, and the number of people with
CAD is rising globally. By 2020, the burden of coronary artery
disease is projected to reach 82 million disability-adjusted life
years (DALYs) or "healthy years of life lost".

Peripheral artery disease (PAD), while often undiagnosed, affects
over 27 million people in Europe and North America and is a powerful
risk marker of cardiovascular disease. Globally, screening studies
suggest that approximately 20% of adults older than 55 years have
evidence of PAD. The disease prevalence is strongly age-related and,
like CAD, the numbers of affected patients is rising, because of the
aging of the population.

About COMPASS

The Phase III study COMPASS (Cardiovascular OutcoMes for People
using Anticoagulation StrategieS) will include approximately 20,000
patients from more than 450 sites across more than 25 countries
worldwide. Patients with documented atherosclerosis related to CAD or
PAD will be enrolled into the study. The primary efficacy endpoint is
a composite of cardiovascular death, myocardial infarction and
stroke. The primary safety endpoint is major bleeding. In the study,
patients will be randomized to receive either rivaroxaban 2.5 mg
twice-daily in addition to aspirin 100 mg once-daily, rivaroxaban 5
mg twice-daily alone, or aspirin 100 mg once-daily alone. The study
will be conducted by the Population Health Research Institute (PHRI),
a leading academic health science research organization based in
Hamilton, Ontario, Canada.

About the Population Health Research Institute (PHRI)

PHRI is a world-leading academic health science research
institute focused on improving global health outcomes. Based in
Hamilton, Ontario, Canada, its research interests are global and
include a broad spectrum of health-related issues. Originally a
cardiovascular disease research institute, PHRI's programmes have
expanded to include a broad range of medical and societal conditions
in varied populations defined by ethnicity and/or geographic region.
To date, PHRI has conducted more than 50 global trials and
epidemiological studies in more than 1,500 centres in 83 countries,
involving over 500,000 patients. More information can be found at
http://www.phri.ca

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 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 http://www.VATspace.com

About Xarelto(R) (Rivaroxaban)

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

- 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 70
countries worldwide
- The treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT
and pulmonary embolism (PE) in adults in more than 70 countries worldwide
- In the U.S. also for the treatment of pulmonary embolism and prevention of
recurrent PE and DVT in adults
- 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, more than two and a
half million patients worldwide have now received Xareltoin daily
clinical practice.

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 high priority for Bayer, and the
company has developed a Prescribers Guide
[https://prescribe.xarelto.com/scripts/index.php ] for physicians and
a Xarelto Patient Card
[https://prescribe.xarelto.com/scripts/index.php ] for patients to
support best practices.

To learn more, please visit: https://prescribe.xarelto.com

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

To learn more about Xarelto, please visit http://www.xarelto.com

About Aspirin(R)

Acetylsalicylic acid, the active ingredient in Aspirin(R), has
been extensively investigated in more than 200 studies involving more
than 200,000 patients across varying levels of cardiovascular (CV)
risk. Given the existing body of clinical evidence, low-dose aspirin
use in appropriate patients is approved by regulatory authorities
around the world for CV event prevention, and supported by major
evidence-based clinical guidelines, including those of the American
Heart Association and American College of Cardiology, European
Society of Cardiology, and American College of Chest Physicians.

Based on its proven efficacy, safety and cost-effectiveness,
low-dose aspirin continues to be the standard of care for reducing
heart attacks and ischemic strokes in patients with established CV
disease. Additionally, in more than 50 countries around the world,
low-dose aspirin is approved for use in the primary prevention of CV
events in appropriate at risk patients. When used as directed by a
physician, low-dose aspirin is infrequently associated with
clinically significant side effects. Serious bleeding rarely occurs.
Gastro-intestinal bleeding (GI) has been shown to occur in less than
1% of those taking aspirin to prevent a recurrent CV event; serious
GI or extracranial bleeding events are expected in less than 1/10th
of one percent (3 in 10,000 people per year) patients taking low-dose
aspirin for primary prevention[1]. Bayer supports the use of aspirin
for primary prevention only in those markets where the indications
have been approved.

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 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. More information at http://www.healthcare.bayer.com.

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Information for editors:

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

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1. Antithrombotic Trialists' (ATT) Collaboration. Aspirin in the
primary and secondary prevention of vascular disease: collaborative
meta-analysis of individual participant data from randomised clinical
trials. The Lancet 2009; 373:1849-1860

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ots Originaltext: Bayer HealthCare
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Contact:
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