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Final Patient Completes Treatment In Boehringer Ingelheim’s RE-LY^® Study, the Largest Atrial Fibrillation Outcomes Trial To Date

Ridgefield, CT, March 20, 2009 —Boehringer Ingelheim today announced that the last patient has completed treatment in the Phase III Randomized Evaluation of Long term Anticoagulant therapy (RE-LY^® ) study. This study compared the long-term efficacy and safety of the oral direct thrombin inhibitor dabigatran etexilate with the current standard therapy, warfarin (target international normalized ratio, INR, 2-3) for the prevention of stroke and non-CNS systemic embolism in patients with atrial fibrillation (AF). Dabigatran etexilate is an oral anticoagulant in Phase III development for stroke prevention in AF, as well as several other therapeutic areas.  Dabigatran etexilate is not approved by the FDA.  RE-LY^® is the largest AF stroke prevention trial to date. The study enrolled 18,113 patients in more than 900 centers in 44 countries worldwide between December 2005 and December 2007. Data will now be analyzed and results are expected to be presented later this year at the European Society of Cardiology (ESC) Congress, taking place in Barcelona, Spain, from August 29th until September 2^nd .

“We are delighted with the completion of treatment in the RE-LY study as it marks an important milestone in the ongoing development of dabigatran etexilate,” said Paul Reilly, Clinical Program Director, Boehringer Ingelheim. “We are grateful to the patients and investigators who participated in the study and look forward to further evaluating the safety and efficacy of dabigatran through the analysis of the data.”

Atrial fibrillation affects more than 2.2 million Americans, making it the most common heart rhythm disorder in the U.S.¹ People with AF are at increased risk for forming blood clots in their hearts² which can raise their risk of stroke five-fold.³ However, clinical studies show that up to 60 percent of AF related strokes can be prevented with appropriate anticoagulant therapy.⁴  Vitamin K antagonists are the current standard therapy for stroke prevention in patients with atrial fibrillation.⁴

About Atrial Fibrillation
Atrial fibrillation is a disorder in which the normally regular and coordinated contraction pattern of the heart's two small upper chambers (the atria) becomes irregular and uncoordinated. The chaotic contraction pattern associated with atrial fibrillation causes blood to pool up in the atria predisposing to formation of clots, which may escape from the heart and become lodged in the arteries leading to the brain and other organs, blocking necessary blood flow.  Many people with the disorder do not have any symptoms but some may feel heart palpitations, shortness of breath, dizziness or fatigue.⁵

About the RE-LY^® study
RE-LY^® investigated whether dabigatran etexilate (two blinded doses) is effective for stroke prevention in patients with non-valvular AF and at least one other major risk factor for stroke (i.e., previous stroke, transient ischemic attack, heart failure, diabetes, high blood pressure or age ≥ 75). Patients enrolled in the study were followed for a minimum of one year.

The primary outcome of the trial is the combined incidence of stroke (including hemorrhagic) and non-CNS systemic embolism. Secondary outcomes include all death, incidence of stroke (including hemorrhagic), systemic embolism, pulmonary embolism, acute myocardial infarction and vascular death (including death from bleeding). Additional safety endpoints include major and minor bleeding events (including intracerebral hemorrhage).

About the Dabigatran Clinical Trial Program
RE-LY^® is part of Boehringer Ingelheim’s large clinical development program to evaluate the efficacy and safety of dabigatran etexilate against current standard therapies in over 38,000 patients. In addition to RE-LY^® , the development program encompasses studies in:

• Primary prevention of venous thromboembolism (VTE)
• Treatment of acute VTE
• Secondary prevention of VTE
• Prevention of cardiac events in patients with acute coronary syndrome

About Dabigatran Etexilate
Dabigatran etexilate is a direct reversible thrombin inhibitor (DTI), in a new class of oral anticoagulants being studied in the prevention and treatment of acute and chronic thromboembolic diseases. DTIs provide an anticoagulant effect by specifically and selectively blocking the activity of thrombin (both free and clot-bound), the central enzyme in the process responsible for clot (thrombus) formation – conversion of fibrinogen to fibrin.

Dabigatran etexilate is not approved by the FDA.  Dabigatran etexilate is approved as Pradaxa^® in over 28 countries for the primary prevention of venous thromboembolic events (blood clots) in adults who have undergone elective total hip or elective total knee replacement surgery.

Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies.  Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and approximately 39,800 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.

In 2007, Boehringer Ingelheim posted net sales of US $15.0 billion (10.9 billion euro) while spending approximately one-fifth of net sales in its largest business segment, Prescription Medicines, on research and development.

For more information, please visit http://us.boehringer-ingelheim.com.

 

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References

1. Fuster V, Rydén LE, Asinger RW et al. ACC/AHA/ESC Guidelines for the Management of Patients with Atrial Fibrillation: Executive Summary A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines and Policy Conferences (Committee to Develop Guidelines for the Management of Patients With Atrial Fibrillation) Developed in Collaboration with the North American Society of Pacing and Electrophysiology. Circulation 2001;104:2118-2150
2. Lip GHY. Does atrial fibrillation confer a hypercoagulable state? Lancet 1995;346:1313-4
3. American Heart Association. “2008 Heart Disease and Stroke Statistics.”
4. Hart RG, Pearce LA, Aguilar MI, et al. Meta-Analysis: antithrombotic therapy to prevent stroke in patients who have non-valvular atrial fibrillation. Ann Intern Med 2007;146:857-67
5. National, Heart Blood and Institute Web site. What is Atrial Fibrillation? Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/af/af_what.html. Accessed on: March 11, 2009

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