Landmark Phase III Study of Bayer's Xarelto(R) (Rivaroxaban) Initiated for the Secondary Prevention of Myocardial Infarction and Death in Patients wit

PR51354

BERLIN, Nov. 14/PRN=KYODO JBN/ --

     Not intended for U.S. and UK Media

     - 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.

    Our online press service is just a click away: press.healthcare.bayer.com

    Information for editors:

    For full multimedia release, including additional material such as videos

and backgrounders, please visit http://www.multivu.com/mnr/58642-COMPASS-Study

    Find more information at http://www.bayerpharma.com.

    sp (2012-0498E)

    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.

    --------------------------------------------------

    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

    Source: Bayer HealthCare