Once-daily oral anticoagulant receives positive Common Drug Review recommendation for stroke prevention in atrial fibrillation

Bayer Inc. welcomes support for public reimbursement of new treatment

TORONTO, April 23, 2012 /PRNewswire/ - Hundreds of thousands of Canadians living with atrial fibrillation (AF) are now one step closer to getting public reimbursement for a new stroke prevention therapy - news that was welcomed today by Bayer Inc.

The Canadian Agency for Drugs and Technologies in Health (CADTH) through the Common Drug Review (CDR), has positively recommended to Canada's provincial and other publicly funded drug plans that they reimburse the Bayer Inc. once-daily oral anticoagulant Xarelto^® (rivaroxaban tablet), for the prevention of stroke and systemic embolism in patients with non-valvular AF, in whom warfarin is indicated, and who meet all of the following criteria: are unable to achieve adequate anticoagulation with warfarin and have a CHADS₂ score of ≥ 2.

This recommendation is based on a review of cost-effectiveness and clinical evidence supported by ROCKET AF, a randomized, double-blind global Phase III study that compared once-daily Xarelto^® with warfarin in more than 14,000 patients, including 750 from Canada. Xarelto^® is indicated for the prevention of stroke and systemic embolism in patients with AF, in whom anticoagulation is appropriate.

"This positive recommendation is great news for patients with AF," said Doug Grant, Head, Corporate Affairs, Bayer Inc. "As a company with a significant and long-standing focus on anticoagulation, we are pleased to see CADTH's recommendation that provinces reimburse a once-daily treatment that does not require routine blood tests or dose adjustments for AF patients at risk of stroke."

AF, the most common form of cardiac arrhythmia in clinical practice, affects approximately 350,000 Canadians and is an established risk factor for stroke and premature death. It is estimated that after age 60, one-third of all strokes are caused by AF. ⁽¹⁾

About Atrial Fibrillation (AF)

In patients with atrial fibrillation (AF), an irregular heartbeat makes them vulnerable to the formation of a blood clot in the atria, which can travel to the brain, potentially resulting in a stroke. Strokes cause damage to the brain, and can lead to physical and behavioural impairment, significant disability, or even death. About a third of people with AF have no symptoms whatsoever. The danger of AF being undetected is that it puts people at risk of serious complications, including stroke.

About Xarelto^®

Xarelto^® (rivaroxaban tablet) is a fixed-dose oral anticoagulant that has a rapid onset of action with a predictable dose response, does not require routine coagulation monitoring and dose adjustments, and has limited potential for food* and drug interactions.⁽²⁾

In addition to the approval of Xarelto^® for the prevention of stroke and systemic embolism in patients with AF, in whom anticoagulation is appropriate, Xarelto^® is also approved in Canada for the treatment of deep vein thrombosis (DVT) without symptomatic pulmonary embolism (PE), and for the prevention of venous thromboembolic events (VTE) in patients who have undergone elective total hip or total knee replacement surgery. To date, Xarelto^® is approved in more than 110 countries worldwide and has been successfully launched in more than 85 countries by Bayer for the VTE indication.

The extensive clinical trial program investigating Xarelto^® makes it one of the most studied and widely published oral, direct Factor-Xa inhibitors. The studies, reported and ongoing, involve over 75,000 patients for the prevention and treatment of venous and arterial thromboembolic disorders across a broad range of acute and chronic conditions, including those for which market authorization has not yet been obtained, such as the secondary prevention of acute coronary syndrome and treatment of pulmonary embolism.

Xarelto^® like other anticoagulants, should be used with caution in patients with an increased risk of bleeding. Bleeding can occur at any site during therapy with Xarelto^®. The possibility of a hemorrhage should be considered in evaluating the condition of any anticoagulated patient. Any unexplained fall in hemoglobin or blood pressure should lead to a search for a bleeding site.

Patients at high risk of bleeding should not be prescribed Xarelto^®. Should severe bleeding occur, treatment with Xarelto^® must be discontinued and the source of bleeding investigated promptly. The use of Xarelto^® is not recommended in patients with severe renal impairment.

Physicians should refer to the Xarelto^® Product Monograph for complete information.

*Xarelto^® 15 mg and 20 mg tablets should be taken with food

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 innovative materials. Headquartered in Toronto, Ontario, Bayer Inc. operates the Bayer Group's HealthCare and MaterialScience businesses in Canada. Bayer CropScience 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 Montréal and Calgary.

Bayer Inc. has approximately 800 employees across Canada and had sales of $808 million CDN in 2011. Globally, the Bayer Group had sales of over 36 billion Euro in 2011. Bayer Inc. invested approximately $13 million CDN in research and development in 2011. Worldwide, the Bayer Group spent the equivalent of over 2.9 billion Euro in 2011 in R&D. For more information, go to www.bayer.ca.

References

(1) Heart and Stroke Foundation of Canada. http://www.heartandstroke.on.ca/site/c.pvI3IeNWJwE/b.5052981/k.17A/Atrial_fibrillation.htm?src=report (Accessed August 2011)
(2) Xarelto® Product Monograph (pg. 21) February 13, 2012.

SOURCE Bayer Inc.