BAYER SAYS EU APPROVES XARELTO FOR PE TREATMENT, DVT PREVENTION

     (The following press release from Bayer AG was received by e-mail. It was 
not confirmed by the sender.) 
News-Release 
Not intended for U.S. and UK media
Bayer’s Xarelto® (Rivaroxaban) Approved for the Treatment of Pulmonary
Embolism (PE) and the Prevention of Recurrent Deep Vein Thrombosis (DVT)
and PE in the EU
Blood clots obstructing blood flow in deep veins or in the lungs kill more
than 2,300 people every day worldwide and urgent action is essential to
save lives / Rivaroxaban works as fast as injectable enoxaparin, providing
efficacy when needed for as long as needed / Rivaroxaban offers the only
oral single-drug solution for the treatment of PE and long-term prevention
of DVT and PE, without the need for injections or monitoring / Rivaroxaban
is approved to protect patients from blood clots across more venous and
arterial thromboembolic diseases than any other novel oral anticoagulant 
Berlin, Germany, November 20, 2012 - Bayer HealthCare’s oral anticoagulant
Xarelto® (rivaroxaban) has been approved by the European Commission (EC)
for the treatment of pulmonary embolism (PE) and the prevention of
recurrent deep vein thrombosis (DVT) and PE in adults. This approval makes
rivaroxaban the only novel oral anticoagulant approved in this indication
in the EU. 
"Approximately 1 in 10 patients who suffer a pulmonary embolism dies, and
concerningly, PE remains a leading cause of hospital death," said Dr. Kemal
Malik, Member of the Bayer HealthCare Executive Committee and Head of
Global Development. "This new approval will bring the benefits of Xarelto
to more patients and physicians, where the need for a fast, effective and
convenient therapy against blood clots is essential for both acute and
long-term treatment." 
Pulmonary embolism occurs when a blood clot in the deep veins of the leg or
pelvis detaches and travels to the lung via the heart, where it can block
one of the pulmonary arteries. Without fast treatment, the resulting loss
of lung function can rapidly lead to death. 
Until now, the standard therapy has been the dual drug combination of daily
injections of a low molecular weight heparin, together with an oral vitamin
K antagonist. 
Professor Harry R. Büller, M.D., Academic Medical Center in Amsterdam, The
Netherlands, who led the pivotal EINSTEIN clinical trial programme for
rivaroxaban commented, "Today’s approval marks a turning point for both
doctors and patients in the treatment and prevention of life-threatening
blood clots in patients with pulmonary embolism. As a new treatment option,
rivaroxaban offers a single-drug solution that works as fast as injectable
enoxaparin and can provide protection for as long as needed." 
"A pulmonary embolism is a frightening experience for patients," said Eve
Knight, Co-Founder and CEO of the charity AntiCoagulation Europe (ACE).
"The current standard of care can be complicated which adds to the stress
and burden on the patient so today's news is great for patients. With the
approval of rivaroxaban for the treatment and prevention of PE, patients at
last have the choice of a simple, fast and effective treatment option." 
The approval of rivaroxaban for the treatment of PE and the prevention of
recurrent DVT and PE in adults is based on the important clinical findings
from the pivotal, global Phase III EINSTEIN-PE study. With 4,833 patients
enrolled, EINSTEIN-PE is the largest study ever conducted in the acute
treatment of PE. The study compared the oral single-drug solution of
rivaroxaban 15 mg twice daily for three weeks, followed by 20 mg once
daily, with the current dual drug approach of subcutaneous enoxaparin
followed by a VKA. Patients were treated for three, six or 12 months. 
Rivaroxaban demonstrated efficacy comparable to that of the current
standard therapy in reducing the primary endpoint of recurrent symptomatic
VTE, a composite of symptomatic DVT and non-fatal or fatal PE, without the
need for laboratory monitoring. The overall bleeding rates were similar
between the treatment groups, but importantly rivaroxaban was associated
with significantly lower rates of major bleeding. The results from this
study were published in the New England Journal of Medicine in April this
year. 
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® (Rivaroxaban)
Rivaroxaban is the most broadly indicated new oral anticoagulant and is
marketed under the brand name Xarelto®. 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 80 countries worldwide 
•     The treatment of deep vein thrombosis (DVT) and prevention of
recurrent DVT and pulmonary embolism (PE) in adults in more than 80
countries worldwide 
•     The treatment of PE and prevention of recurrent DVT and PE in adults
in more than 20 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, more than two and a half
million patients worldwide have now received Xarelto in 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 for physicians and a Xarelto Patient Card
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 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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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
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company assumes no liability whatsoever to update these forward-looking
statements or to conform them to future events or developments. 
Contact:
Bayer Pharma AG
Astrid Kranz, Tel. +49 30 468-12057
E-Mail: mailto:astrid.kranz@bayer.com 
Bayer Pharma AG
Stephanie Prate, Tel. +49 30 468 196053
E-Mail: mailto:stephanie.prate@bayer.com 
This press release is available here:
http://www.baynews.bayer.de/baynews/baynews.nsf/id/2012-0533-e 
Yours BayNews Editorial Team 
Bayer AG
Communications
Building W11
51368 Leverkusen, Germany 
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