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Bayer Committed to Prevention of Arterial Thrombosis:
ROCKET AF study compares rivaroxaban to warfarin in the prevention of stroke and non-CNS systemic embolism in patients with Atrial Fibrillation / Bayer Schering Pharma supports Thrombosis Research Institute's launch of GARFIELD - a global patient Registry to evaluate 'real life' outcomes in the prevention of stroke in patients with Atrial Fibrillation / Fast Track designation for rivaroxaban development program in the secondary prevention of cardiovascular events in patients with Acute Coronary Syndrome recognizes high unmet medical need.
Barcelona, August 30, 2009 - Bayer Schering Pharma has completed patient
enrollment into the Phase III ROCKET AF study (Rivaroxaban Once daily oral
direct Factor Xa inhibition Compared with vitamin K antagonism for prevention
of stroke and Embolism Trial in Atrial Fibrillation). The ROCKET AF study is
assessing the efficacy and safety of rivaroxaban (Xarelto®) 20 mg once-daily, a
novel oral, direct Factor Xa inhibitor, compared to the current standard of
care, warfarin, a vitamin K antagonist (VKA) dose-adjusted, for the prevention
of stroke and non-CNS systemic embolism in patients with Atrial Fibrillation
(AF).
"We are most encouraged by the excellent progress of the ROCKET AF study in
Atrial Fibrillation and look forward to the study results in 2010," said Kemal
Malik, M.D., member of the Bayer HealthCare Executive Committee and Chief
Medical Officer.
ROCKET AF is a prospective, randomized, double-blind, double-dummy study
including 14,269 patients from more than 1,100 centers across 45 countries,
worldwide. The study design and rationale will be presented at the European
Society of Cardiology (ESC) Congress in Barcelona (1).
GARFIELD Patient Registry
GARFIELD (Global Anticoagulant Registry in the FIELD), a Registry of 50,000
newly diagnosed patients with AF, was also announced at the ESC Congress today
by the Thrombosis Research Institute (TRI) - an independent charitable research
foundation dedicated to improving care in patients with cardiovascular disease.
The Registry will follow patients prospectively for up to six years to assess
the global burden of AF and its launch is being supported by a research grant
from Bayer Schering Pharma.
"The largest study of its kind to date, and involving unselected patients in
randomly identified sites in up to 50 countries around the world, GARFIELD is
unique in focusing on identifying real life outcomes. This includes the
limitations of current interventions to prevent stroke, and how new
opportunities in both AF management and the emerging novel anticoagulant agents
might be used to improve clinical outcomes and reduce the potential burden of
thromboembolic stroke for patients, healthcare systems and society more
generally," said Professor Ajay Kakkar Director of the Thrombosis Research
Institute and Professor of Surgical Sciences at Queen Mary University of London.
"Our substantial research grant to the Thrombosis Research Institute for the
initiation of GARFIELD supports an exceptional project and one which we hope
will generate important new knowledge of great benefit to AF sufferers and
those responsible for their care, helping to improve clinical outcome," added
Kemal Malik.
Unmet Medical Need in SPAF
AF affects over six million people in Europe (2). It causes the two upper
chambers of the heart (the atria) to quiver instead of beating effectively;
resulting in blood not being completely pumped out, which in turn causes
pooling and can lead to clotting in the atria. If a blood clot leaves the
atria, it can become lodged in an artery in the brain causing the patient to
suffer from an ischemic stroke (3). Approximately one in five ischemic strokes
are due to AF (4).
It is particularly important to prevent such events as AF-related strokes are
more severe, cause greater disability and have a worse prognosis than strokes
in patients without AF4. New treatments for SPAF are required as existing
options, such as VKAs, have a narrow therapeutic window and optimal dosing is
difficult to achieve. Therefore, patients taking warfarin must be monitored
frequently to ensure they receive the correct dose.
Fast Track Designation for Rivaroxaban in Acute Coronary Syndrome
The US Food and Drug Administration (FDA) grant of Fast Track designation for
the rivaroxaban development program (ATLAS ACS TIMI 51) in the secondary
prevention of cardiovascular events in patients with Acute Coronary Syndrome
(ACS) recognizes the high unmet medical need. The trial is investigating the
efficacy and safety of rivaroxaban in up to 16,000 patients. Data are expected
in 2011.
About rivaroxaban
Rivaroxaban was invented in Bayer's Wuppertal laboratories in Germany, and is
being jointly developed by Bayer HealthCare and Johnson & Johnson
Pharmaceutical Research & Development, L.L.C. Rivaroxaban is approved in the
European Union for the prevention of VTE in adult patients undergoing elective
hip or knee replacement surgery. Rivaroxaban is marketed under the brand name
Xarelto®. Additional approvals have been granted in other countries, including
Australia, Canada, China, Mexico and Singapore. To date, Xarelto® has been
launched in more than 40 countries around the world by Bayer HealthCare.
The extensive clinical trial program supporting rivaroxaban makes it the most
studied oral, direct Factor Xa inhibitor in the world today. More than 65,000
patients are expected to be enrolled into the rivaroxaban clinical development
program, which will evaluate the product in the prevention and treatment of a
broad range of acute and chronic blood-clotting disorders, including VTE
treatment, stroke prevention in patients with atrial fibrillation, secondary
prevention of acute coronary syndrome, and VTE prevention in hospitalized,
medically ill patients.
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 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, Bayer Schering
Pharma, Consumer Care and Medical Care divisions. 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.
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