Pradaxa® Awarded Prix Galien for Most Innovative Product in Canada

INGELHEIM, Germany - Wednesday, November 23rd 2011 [ME NewsWire]

(BUSINESS WIRE)-- For NON-US, Non-Canada and NON-UK Healthcare Media Only

Boehringer Ingelheim’s breakthrough novel oral anticoagulant Pradaxa® (dabigatran etexilate) was awarded the prestigious Prix Galien in Canada. At a Gala Ceremony during the Tenth Annual Canadian Health Research Awards Ceremony in Ottawa, Pradaxa® (Pradax® in Canada) was recognised as the most innovative Canadian product in 2011. Pradaxa® has now received this award for the second time, after winning the German Prix Galien in 2010, in the Primary Care category. The Prix Galien is awarded for new drugs representing a significant advance in pharmaceutical research.

“We are proud that Pradaxa® has been awarded the Canadian Prix Galien,” says Prof. Dr. Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim. “The decision by the jury underlines the outstanding innovation Pradaxa® brings for patients and doctors, providing a much needed advance in stroke prevention in atrial fibrillation, an area of high therapeutic need.”

The approval of Pradaxa® in prevention of stroke and systemic embolism in adults with non-valvular atrial fibrillation (SPAF) was based on data from the landmark RE-LY® trial (Randomized Evaluation of Long term anticoagulant therapY), a global, Phase III trial of 18,113 patients, enrolled in over 950 centres in 44 countries.1 Compared to well-controlled warfarin (median time in therapeutic range (TTR) 67.3%2), the following results were seen with Pradaxa® in the landmark RE-LY® trial:1,2,3

Pradaxa® 150mg bid significantly reduced the risk of stroke and systemic embolism by 35%, providing clinically important stroke prevention in non-valvular atrial fibrillation (AF)

Pradaxa® 150mg bid significantly reduced both ischaemic (RRR 25%) and haemorrhagic stroke (RRR 74%)

Pradaxa® 110mg bid (indicated for certain patients) showed similar rates of stroke and systemic embolism as well-controlled warfarin

Both doses of Pradaxa® significantly reduced intracranial and life threatening bleeding compared to warfarin

Pradaxa® 110mg bid also significantly reduced major bleeds.

The RE-LY® trial was a PROBE trial (prospective, randomized, open-label with blinded endpoint evaluation), comparing two fixed doses of the oral direct thrombin inhibitor dabigatran etexilate (110mg and 150mg bid) each administered in a blinded manner, with open label warfarin.1

“Pradaxa® is a significant advance in medicine. We have been waiting a long time for an alternative to warfarin. Pradaxa® provides superior and clinically significant stroke prevention in the high dose while maintaining an equal level of safety when compared to warfarin,” says Dr. Stuart Connolly, Director, Division of Cardiology at The Population Health Research Institute, McMaster University in Hamilton, Canada. “In addition, it does not require regular blood tests, constant dose adjustments or food restrictions, which makes it very convenient for patients.”

Pradaxa® is an oral anticoagulant for the prevention of stroke and systemic embolism in adults with non-valvular atrial fibrillation (SPAF) and the primary prevention of venous thromboembolism (VTE) in patients undergoing elective total hip and knee replacement surgery. The approval of Pradaxa® was welcomed by the medical community and patients because it was the first new oral anticoagulant approved in decades in countries all over the world.

AF is the most common type of arrhythmia or irregular heartbeat, affecting around 1% of the total population with one in four adults over 40 developing the condition in their lifetime.4,5 People with AF are more likely to experience blood clots, which increases the risk of stroke by five-fold.5,6 Up to three million people worldwide suffer strokes related to AF each year.7,8,9

For more information, visit http://eng.prix-galien-canada.com/prix_galien_canada.html.

~ENDS~

Please click on the link below for ‘Notes to Editors’ and ‘References’:

http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2011/23_november_2011dabigatran.html

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