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Boehringer Ingelheim Announces Enrollment is Complete for the Largest Atrial Fibrillation Outcomes Trial - The RE-LY(TM) Study

RIDGEFIELD, Conn., Jan. 17 /PRNewswire/ -- Boehringer Ingelheim announced today that enrollment is complete for the landmark RE-LY trial to evaluate the long-term efficacy and safety of investigational oral direct thrombin inhibitor dabigatran etexilate for the prevention of stroke and systemic embolism in patients with atrial fibrillation. RE-LY (Randomized Evaluation of Long Term Anticoagulant Therapy) is the largest stroke prevention in atrial fibrillation trial conducted to date, with 18,114 patients, in 1,000 centers in 44 countries worldwide enrolled between December 2005 and December 2007. Currently, more than 10,000 patients have been treated for at least 6 months with final study results expected to be reported in early 2009.

The RE-LY trial is comparing two blinded doses of oral dabigatran etexilate with warfarin sodium (target INR 2.0-3.0) in patients with non-valvular atrial fibrillation who are at moderate-to-high risk of stroke. Currently, the standard treatment to prevent stroke in these patients is the vitamin K antagonist, warfarin. It is estimated that warfarin is currently prescribed for only half of all eligible patients.

Dr. Salim Yusuf, Professor of Epidemiology and Cardiology and head of the study coordinating center at McMaster University in Hamilton, Canada, stated that: "Patient enrollment in RE-LY has exceeded our original expectations by far."

Atrial fibrillation is the most common sustained cardiac rhythm disturbance affecting six percent of individuals over the age of 65 and 10 percent of people over the age of 80. Atrial fibrillation is a leading risk factor for stroke and, despite warfarin sodium being available as an effective treatment option, atrial fibrillation still accounts for approximately 15 percent of all strokes.

Approximately 750,000 Americans suffer a stroke each year. More than 150,000 of these strokes are fatal, making it the third leading cause of death in the United States. Approximately 500,000 Americans survive a stroke each year; there are almost six million stroke survivors in the United States. Stroke is the leading cause of chronic adult disability in the United States and the primary reason why people end up in assisted-living homes. Stroke is associated with a heavy cost burden: treating and preventing stroke costs the U.S. healthcare system almost $63 billion each year.

Total annual costs (2005 US dollars) for treatment of atrial fibrillation were estimated at $6.65 billion, including $2.93 billion (44 percent) for hospitalizations, $1.95 billion (29 percent) for the incremental inpatient cost of atrial fibrillation as a co-morbid diagnosis, $1.53 billion (23 percent) for outpatient treatment of atrial fibrillation, and $235 million (4 percent) for prescription medications.

The results of clinical trials evaluating the use of dabigatran etexilate in the prevention of venous thromboembolism following total knee replacement and hip replacement surgery have already been published and an application for registration in Europe was submitted in February 2007. More than 10,000 patients have completed Phase II and III trials to date. Completion of enrollment for RE-LY is the latest milestone in the extensive Phase III clinical trial program investigating dabigatran etexilate in more than 34,000 patients for the prevention and treatment of a range of thromboembolic conditions and stroke.

Dr. Andreas Barner, Member of the Board of Boehringer Ingelheim and responsible for Research, Development and Medicine said: "Our investment in landmark trials such as RE-LY demonstrates Boehringer Ingelheim's ongoing commitment to improving future treatment options for patients with cardiovascular conditions."

RE-LY methodology:

RE-LY is a global, multi-center, non-inferiority, randomized trial comparing two blinded doses (150mg twice daily or 110mg twice daily) of dabigatran etexilate with open label warfarin sodium in patients with non-valvular atrial fibrillation and at least one other major risk factor for stroke. The median treatment duration is anticipated to be two years.

Primary outcomes of the trial will measure the incidence of stroke (including hemorrhagic) and systemic embolism. Secondary outcome measures include all death, incidence of stroke (including hemorrhagic), systemic embolism, pulmonary embolism, acute myocardial infarction, or vascular deaths (including deaths from bleeding).

About dabigatran etexilate

Dabigatran etexilate is a reversible binding oral direct thrombin inhibitor, an oral anticoagulant in late stage clinical development. It specifically and reversibly inhibits thrombin, the central and essential enzyme in the coagulation cascade responsible for thrombus (blood clot) formation. Dabigatran etexilate, developed by Boehringer Ingelheim, is currently being evaluated in a number of thrombo-embolic disease indications in an extensive, global Phase III clinical trial program.

Dabigatran etexilate is an investigational compound. It has been submitted to European authorities for approval in a first intended indication; primary VTE prevention following elective total hip or knee replacement surgery. The safety and efficacy of dabigatran etexilate has not been evaluated by the U.S. Food and Drug Administration for any indication.

The Phase III trial program

The Phase III trial program is designed to investigate the oral direct thrombin inhibitor dabigatran etexilate as a potential treatment, prevention and prophylaxis for several thromboembolic disease conditions. It is expected to involve more than 34,000 patients from Asia, Australia, Europe, the Americas, and South Africa. Patients will be divided into different treatment arms involving dabigatran etexilate compared with current standard therapy.

In addition to stroke prevention in atrial fibrillation, ongoing trials are evaluating the efficacy and safety of dabigatran etexilate in the treatment of acute VTE, secondary prevention of VTE, and in acute coronary syndrome following a myocardial infarction with the aim of reducing the risk of further cardiovascular events.

About 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 137 affiliates in 47 countries and approximately 38,400 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 2006, Boehringer Ingelheim posted net sales of US $13.3 billion (10.6 billion euro) while spending approximately one-fifth of net sales in its largest business segment, Prescription Medicines, on research and development.

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