- Canada first country to approve novel anticoagulant -
TORONTO, Sept. 16 /CNW/ - Today, Canada became the first country to
approve Xarelto(R) (rivaroxaban), the first in a new class of anticoagulants,
for the prevention of venous thromboembolic events (VTE), or blood clots, in
patients who have undergone elective total hip or total knee replacement
surgery. As a direct factor Xa inhibitor, Xarelto targets an enzyme that acts
as a 'switch' to control clotting, reducing the risk of potentially deadly
blood clots that can form post hip or knee replacement surgery.
VTE is a serious life-threatening condition which kills more people each
year than breast cancer, AIDS, prostate cancer and motor vehicle accidents
combined. Overall, it is estimated that there are 15,000 to 20,000 VTE cases
in Canada annually.
"Xarelto has the potential to revolutionize how we prevent dangerous
blood clots after total hip or total knee replacement surgery in Canada," said
Dr. A.G.G. Turpie, Professor of Medicine, McMaster University, Canada, and
Principal Investigator for the RECORD program. "The existing treatment
standards have limitations, so new therapies such as Xarelto can help doctors
to prevent potentially lethal effects of venous blood clots."
For patients undergoing major orthopaedic surgery such as hip or knee
replacements the risk of VTE increases significantly. In fact, venous blood
clots occur in 40-60% of patients undergoing major orthopedic surgery and not
receiving preventative care. In 2005-2006, there were nearly 69,000
hospitalizations for hip and knee replacements in Canada.
"I nearly died from a blood clot following my knee replacement surgery
last year," says Mario Zecchini. "Fortunately, my doctor was just down the
hall when I collapsed two days after surgery and reacted quickly to save my
life. I never knew how dangerous a blood clot could be before this happened to
me. People having a knee or a hip replaced need to speak to their doctor
before surgery to make sure they are properly protected."
Health Canada's approval of Xarelto was based on data from the RECORD 1,
2 and 3 clinical program, in which nearly 10,000 orthopedic patients have been
investigated - the largest ever conducted in the prevention of VTE in patients
undergoing knee or hip replacement surgery. Xarelto demonstrated superior
efficacy over enoxaparin in head-to-head comparisons (RECORD1 and 3), and a
comparison of extended-duration (5 weeks) Xarelto with short-duration
(2 weeks) enoxaparin (RECORD2). In all of the trials, Xarelto and enoxaparin
demonstrated similar safety profiles including low rates of major bleeding.
"Bayer HealthCare has achieved a major step forward in establishing a new
era in antithrombosis therapy and we are excited that we immediately provide
Xarelto to patients in Canada," said Philip Blake, President and CEO, Bayer
Inc. "The direct Factor Xa-inhibitor Xarelto is the most extensively studied
compound of its class and this first approval validates the unprecedented
results in this remarkable development program."
About Xarelto(R) (rivaroxaban)
The extensive clinical trial program supporting Xarelto makes it the most
studied oral direct Factor Xa inhibitor in the world today. Almost 50,000
patients are expected to be enrolled into the Xarelto clinical development
program which will evaluate the product in the prevention and treatment of a
broad range of acute and chronic disorders associated with venous or arterial
blood clots. This includes VTE treatment, stroke prevention in patients with
atrial fibrillation, VTE prevention in hospitalized, medically ill patients
and secondary prevention of acute coronary syndrome.
Xarelto 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.
About Bayer Inc.
Bayer Inc. (Bayer) is a Canadian subsidiary of Bayer AG, an international
research-based group with core businesses in health care, crop science, and
Headquartered in Toronto, Ontario, Bayer Inc. operates the Bayer Group's
HealthCare and MaterialScience businesses in Canada. Bayer Crop Science Inc.,
headquartered in Calgary, Alberta operates as a separate legal entity in
Canada. Together, the companies play a vital role in improving the quality of
life for Canadians - producing products that fight diseases, protecting crops
and animals, and developing high-performance materials for applications in
numerous areas of daily life. Canadian Bayer facilities include the Toronto
headquarters and offices in Ottawa and Calgary.
Bayer Inc. has approximately 1,000 employees across Canada and had sales
of over $986 million CDN in 2007. Globally, the Bayer Group had sales of over
32 billion Euro in 2007. Bayer Inc. invested approximately $45 million CDN in
research and development in 2007. Worldwide, the Bayer Group spends the
equivalent of over 2.5 billion Euro in 2007 in R&D.
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 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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16, 2008 at:
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