Boehringer Ingelheim's Anticoagulant PRADAX® Awarded Prestigious Prix Galien Canada for Most Innovative Product in 2011

BURLINGTON, ON, Nov. 17, 2011 /CNW/ - Boehringer Ingelheim (Canada) Ltd. announced today that its treatment for stroke prevention in patients with atrial fibrillation, PRADAX® (dabigatran etexilate), was awarded the Prix Galien Canada 2011, Innovative Product Award last night. The Prix Galien is the most prestigious award in Canadian pharmaceutical research and innovation.  It is presented annually to a pharmaceutical product whose efficacy, safety and innovation contributes to enhance the quality of life of Canadians.

Approved by Health Canada in 2010, PRADAX® is an oral anticoagulant for the prevention of stroke and systemic embolism in adults with atrial fibrillation or AF.  PRADAX® was anxiously anticipated by the medical community and patients because it was the first drug approved in Canada in more than two decades to reduce the risk of stroke in this patient population.1  In the past year, over 65,000 Canadian patients with atrial fibrillation started PRADAX® as a treatment for stroke prevention.

"The approval of Pradax was critical for AF patients in Canada as it meant that they had another treatment option besides warfarin which imposed significant effects on their quality of life, including having to undergo regular blood tests, constant dose adjustments or potential interactions with foods or other drugs," says Dr. Stuart Connolly, Director, Division of Cardiology at The Population Health Research Institute at McMaster University in Hamilton.

The approval of PRADAX® was based on data from the landmark RE-LY® Trial (Randomized Evaluation of Long term anticoagulant therapY), a global, Phase III, randomized trial of 18,113 patients, enrolled in over 950 centres in 44 countries, including 52 centres in Canada and 1,150 Canadian patients.2 In the study, PRADAX® 150 mg twice-daily dose was proven to be more effective than the standard of care, warfarin, at preventing strokes, with comparable safety.3

"The development of PRADAX® represents an important milestone in Canadian pharmaceutical history, and we are proud that the Prix Galien Jury has recognized our work with this special award," says Dr. Theodore Witek, President and CEO of Boehringer Ingelheim (Canada) Ltd.   "Key to Health Canada's decision was the groundbreaking results of the RE-LY® trial, and we are proud to say this global program was coordinated out of McMaster University in Hamilton. This level of innovation is fundamental for Canadian patients and we believe our innovation will transform the way patients with atrial fibrillation are managed in Canada."

Atrial fibrillation (AF) is the most common type of arrhythmia or irregular heart beat.  It affects approximately 250,000 Canadians.  A person's risk of AF doubles with each decade of life after the age of 55.  Most importantly, AF increases an individual's risk of stroke.  In fact, after the age of 60, one-third of all strokes are caused by AF and people with AF have a three to five times greater risk of stroke due to a blood clot, also known as ischemic stroke.4

PRADAX® was recognized as the most Innovative Canadian Product in 2011at a Gala Ceremony last evening during the Tenth Annual Canadian Health Research Awards Ceremony in Ottawa.  For more information, visit http://eng.prix-galien-canada.com/prix_galien_canada.html.

NOTES TO EDITORS

About dabigatran etexilate (PRADAX®)

PRADAX® is a novel, reversible oral direct thrombin inhibitor. It provides its anticoagulant effect by selectively blocking the activity of thrombin, the central enzyme in clot formation.5,6

The Canadian approval of PRADAX® for stroke prevention in atrial fibrillation is based on data from the landmark RE-LY® Trial published in the New England Journal of Medicine.7  The study population included patients with high, moderate, and low risk of stroke.  PRADAX® 150 mg twice-daily dose was proven to be more effective than warfarin at preventing strokes, with comparable safety.3

Specifically, PRADAX® 150 mg twice daily significantly reduced the risk of stroke and systemic embolism by 35 per cent versus warfarin, (p=0.0001) without increasing the risk of major bleeding, and reducing the risk of intracranial bleeding by 59 per cent (p<0.0001).7  The efficacy and safety benefits of PRADAX® occurred without any evidence of hepatotoxicity.7 The adverse event reported in the RE-LY® trial that was significantly more common with dabigatran etexilate than with warfarin were gastrointestinal (GI) disorders, such as abdominal pain, diarrhea, dyspepsia and nausea. 8 There was a comparable rate of major GI bleeding with dabigatran etexilate 110 mg bid and warfarin, though the rate of major GI bleeds was significantly higher with dabigatran etexilate 150 mg bid than warfarin [dabigatran etexilate 110 mg bid (1.1%/yr; p=0.6); warfarin (1.1%/yr) and dabigatran etexilate 150 mg bid (1.6%/yr; p= 0.001)]. In patients with atrial fibrillation treated for the prevention of stroke and systemic embolism, the co-administration of oral anti-platelet (including aspirin and clopidogrel) and NSAID therapies increases the risk of bleeding, by about two-fold.8 This higher rate of bleeding events by ASA or clopidogrel co-medication was, however, also observed for warfarin. Close clinical surveillance (looking for signs of bleeding or anaemia) is recommended throughout the treatment. 8

Health Canada approved the 150 mg dose of PRADAX® to be taken twice-daily for prevention of stroke and systemic embolism in patients with atrial fibrillation in whom anti-coagulation is appropriate. The 110mg dose is recommended for use in patients 80 years of age or older and may be considered for patients at higher risk of bleeding.8 PRADAX® is also indicated for the prevention of venous thromboembolism (VTE) in adult patients who have undergone elective total hip or total knee replacement surgery.8

About Boehringer Ingelheim (Canada) Ltd.

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 42,000 employees.

Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.

In 2010, Boehringer Ingelheim posted net sales of 11.7 billion euro while spending almost 24% of net sales in its largest business segment Prescription Medicines on research and development.

The Canadian headquarters of Boehringer Ingelheim was established in 1972 and the Research and Development Centre located in Laval, Québec, Canada since 1988. Boehringer Ingelheim (Canada) Ltd. is home to more than 700 employees including 160 scientists across the country.

For more information please visit www.boehringer-ingelheim.ca.

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1 Schwartz, N, Albers, G.  Dabigatran challenges warfarin's superiority in stroke prevention in atrial fibrillation.  Stroke. 2010;41;1307-1309.

2 Data on file. Boehringer Ingelheim, Ridgefield, CT. Clinical Trial Report 1160.26.

3 Oldgren J, et al. Dabigatran etexilate versus warfarin in atrial fibrillation patients with low, moderate and high CHADS2 score - a RE-LY®  subgroup analysis. Presented at the 59th Annual Scientific Session of the American College of Cardiology, 15th March 2010.

4 Atrial Fibrillation: The Heart of the Matter. Heart and Stroke Foundation of Canada, 2010.

5 Van Ryn J, Hauel, N, Waldmann L. et al.  Dabigatran inhibits both clot-bound and fluid-phase thrombin in vitro: comparison to heparin and hirudin.  2008 ATVB Oral Presentations (P570). Arterioscler Thromb Vasc Biol 2008; 28:el36-7.

6 Di Nision M, Meddeldorps S, Buller HR, et al. Direct Thrombin inhibitors. N Eng J Med 2005; 353: 1028-40.

7 Connolly SJ, et al. Dabigatran versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med 2009; 361:1139-51.

8 Health Canada - PRADAX® Product Monograph. June 13, 2011

SOURCE Boehringer Ingelheim

For further information:

Sara McClelland
Boehringer Ingelheim Canada Ltd.
(905) 631-4713
sara.mcclelland@boehringer-ingelheim.com

Jeanelle Frampton
Environics Communications
(416) 969-2670
jframpton@environicspr.com

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