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30 May 2014

Boehringer Ingelheim Announces Comprehens?ive Settlement of US Pradaxa (Dabigatra?n Etexilate Mesylate) Litigation

Boehringer Ingelheim (BI) has reached a comprehensive settlement of state and federal cases in the US litigation regarding Pradaxa (dabigatran etexilate mesylate) in the amount of $650 million.


"Time and again, the benefits and safety of Pradaxa have been confirmed," said Desiree Ralls-Morrison, senior vice president and general counsel, Boehringer Ingelheim USA Corporation. "BI stands resolutely behind Pradaxa and believed from the outset that the plaintiffs' claims lacked merit. Notwithstanding our strong belief that we would prevail in these lawsuits, this settlement allows BI to avoid the distraction and uncertainty of lengthy litigation and focus on our mission of improving patients' lives."


BI is proud of its employees who have worked for years to research, develop and offer to patients such an important medication as Pradaxa. Pradaxa was the first oral anticoagulant approved by FDA in more than 50 years to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF).


"This settlement does not change the facts about Pradaxa or its importance to patients. From the time Pradaxa launched, BI properly advised doctors and patients about its benefits and safety, working closely with FDA, European Medicines Agency (EMA) and other regulators to ensure doctors and patients had the information they needed," said Desiree Ralls-Morrison.


There are approximately 4000 claims that the company seeks to resolve with this settlement. BI expects most, if not all, of the plaintiffs to accept the terms of the settlement and BI will vigorously defend against those who do not.


Pradaxa is the only oral anticoagulant shown to be superior to warfarin in reducing ischemic strokes, with a similar rate of major bleeding events. Ischemic strokes account for nearly nine out of every 10 strokes caused by atrial fibrillation. Pradaxa's efficacy and safety was established in the pivotal RE-LY trial, one of the largest stroke prevention clinical studies ever conducted in patients with NVAF.


FDA has publicly stated that Pradaxa 150 mg twice daily offers a positive benefit-risk profile and provides an important health benefit when used as directed to reduce the risk of stroke and systemic embolism in NVAF patients. On 13 May 2014, FDA once again reaffirmed Pradaxa's positive benefit-risk profile when it issued a Drug Safety Communication that included results from a Medicare study comparing new users of Pradaxa and warfarin who had received a diagnosis of atrial fibrillation. This included more than 134,000 Medicare patients, who were 65 years or older. The new study found that, among new users of blood-thinning drugs, Pradaxa was associated with a lower risk of clot-related strokes, bleeding in the brain and death compared to warfarin. The study also found an increased risk of major gastrointestinal bleeding with use of Pradaxa as compared to warfarin, but unlike in RE-LY, no increased risk of MI compared to warfarin.

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