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9 May 2013

Boehringer Ingelheim to Expand Body of Evidence with Novel Cardiovasc?ular Research Supporting Pradaxa (Dabigatra?n Etexilate Mesylate)

Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) has confirmed research currently underway for Pradaxa (dabigatran etexilate mesylate) in new cardiovascular patient populations, as well as robust plans to gather real-world evidence in patients with non-valvular atrial fibrillation (NVAF). These plans are the cornerstone of an initiative to expand the scientific knowledge of stroke prevention and interventional cardiology with Pradaxa and demonstrate BIPI's leadership and commitment to innovative solutions for patients and healthcare providers.

Initiating new research will help strengthen understanding of the safety and efficacy profile of dabigatran, the longest studied new oral anticoagulant (NOAC). Since its discovery 20 years ago, dabigatran has been evaluated through the extensive RE-VOLUTION clinical trial programme, which includes 10 clinical trials involving approximately 40,000 patients in more than 44 countries globally.

"We are proud of Pradaxa's strong foundation of clinical research and market experience. BI is committed to evaluating PRADAXA in new areas of cardiovascular treatment," said Sabine Luik, MD, Senior Vice President, Medicine & Regulatory Affairs, US Regional Medical Director, BIPI. "Our collaborations with experts and regulators to build and launch new clinical programmes, and our innovative complementary research on real-world data, will help to deepen our understanding of Pradaxa's benefit/risk profile, address evolving patient needs and benefit the cardiovascular community as a whole."

The efficacy and safety of Pradaxa to reduce the risk of stroke and systemic embolism in patients with NVAF was established in the pivotal RE-LY trial, one of the largest stroke prevention clinical studies ever conducted with NVAF patients.

To date, dabigatran research has also been conducted in the following areas:

- Prevention of venous thromboembolism (VTE) in patients undergoing elective total hip and knee replacement surgery

- Acute treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE)

- Prevention of recurrent DVT or PE.

The company recently announced it submitted applications to US and EU regulatory authorities to review dabigatran for its use in patients with DVT and PE.

In the US, Pradaxa is indicated to reduce the risk of stroke and systemic embolism in patients with NVAF.

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