Value through Innovation17 September 2014
28 May 2014

Boehringer Ingelheim announces comprehensive settlement of U.S. Pradaxa® (dabigatran etexilate) litigation

Ingelheim, Germany, May 28, 2014 – Boehringer Ingelheim announced today that the company has reached a comprehensive settlement of state and federal cases in the U.S. litigation regarding Pradaxa® (dabigatran etexilate). The settlement enables Boehringer Ingelheim to focus solely on its mission of improving patients' lives and allows the company to avoid the distraction and uncertainty of lengthy litigation. The settlement was closed at 650 million US Dollar (appr. 470 million €). It comes after a reaffirmation from the U.S. Food and Drug Administration (FDA) of the positive benefit-risk profile of Pradaxa®, when it published the results of a Medicare study of more than 134,000 patients.1

"Time and again the benefits and safety of Pradaxa® have been confirmed in many clinical trials and in real world data analyses. This settlement does not change the facts about Pradaxa® or its importance to patients," said Andreas Neumann, Head of the Legal Department and General Counsel, Boehringer Ingelheim worldwide. "From the time Pradaxa® launched, Boehringer Ingelheim properly advised healthcare professionals and patients about its benefits and safety, working closely with US, European and many other regulators to ensure healthcare professionals and patients had the information they needed."

Boehringer Ingelheim 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 in more than 50 years to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF).

"We continue to stand resolutely behind Pradaxa® and believed from the outset that the plaintiffs’ claims lacked any merit. Notwithstanding our strong belief that we would prevail in these lawsuits, this settlement allows our company to avoid the distraction and uncertainty of protracted litigation over years and years," said Andreas Neumann. "The US litigation system is unique as it allows advertising to find clients and incentives for large numbers of plaintiffs to bring cases involving pharmaceutical products regardless of the merits of their claims. Furthermore we have to consider that juries composed of lay people have to decide about very difficult scientific matters. All this does not allow reliable predictions for the outcome of a huge number of individual trials and that is why we came to the tough decision to settle," Andreas Neumann added.

There are approximately 4,000 claims that the company seeks to resolve with this settlement. Boehringer Ingelheim expects most, if not all, of the plaintiffs to accept the terms of the settlement and Boehringer Ingelheim will vigorously defend against those who do not.

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.2 On May 13, 2014, FDA once again reaffirmed the positive benefit-risk profile of Pradaxa® when used as directed when it issued a Drug Safety Communication1 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 of age 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.1 The study also found an increased risk of major gastrointestinal bleeding with use of Pradaxa® as compared to warfarin, but unlike in RE-LY®,3,4 no increased risk of MI compared to warfarin.1

Compared to the 50 year-old anticoagulant warfarin, Pradaxa® 150 mg dose taken twice daily is superior at reducing the risk of ischemic and hemorrhagic strokes with a comparable rate of bleeding to the warfarin treatment.3,4 Pradaxa® 110 mg dose taken twice daily, which is indicated for certain patients, was as effective as warfarin at reducing risk of stroke with lower rates of bleeding.3,4 Moreover, Pradaxa® 150 mg is the only novel oral anticoagulant which in its pivotal study versus warfarin (RE-LY® ) showed a superior reduction of ischemic strokes (the most common stroke for NVAF patients5).3,4

As with any anticoagulant, there needs to be a balanced consideration of stroke risk reduction and bleeding risk. Patients should not stop taking their anticoagulant medication without first talking to their health care providers. Discontinuing anticoagulation therapy puts a patient at increased risk of stroke.

NOTES TO THE EDITORS

About Pradaxa® (dabigatran etexilate)
Clinical experience of Pradaxa® (dabigatran etexilate) exceeds that of all other novel oral anticoagulants, equating to over 2.9 million patient-years in all licensed indications worldwide.7 Pradaxa® has already been in the market for more than 6 years and is approved in over 100 countries.7

Currently approved indications for Pradaxa® are:8

  • Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF) and a risk factor for stroke
  • Primary prevention of venous thromboembolic events in patients undergoing elective total hip replacement surgery
  • Primary prevention of venous thromboembolic events in patients undergoing elective total knee replacement surgery

A number of countries including the USA, have already approved Pradaxa® for patients with a deep vein thrombosis or a pulmonary embolism in the following indication:9

  • Treatment of deep vein thrombosis and pulmonary embolism
  • Prevention of recurrent deep vein thrombosis and pulmonary embolism

Pradaxa®, a direct thrombin inhibitor (DTI), was the first widely approved drug in a new generation of direct oral anticoagulants, available to target a high unmet medical need in the prevention and treatment of acute and chronic thromboembolic diseases.8,10 Potent antithrombotic effects are achieved with direct thrombin inhibitors by specifically blocking the activity of thrombin, the central enzyme in the process responsible for clot (thrombus) formation.11 In contrast to vitamin-K antagonists, which variably act via different coagulation factors, Pradaxa® provides effective, predictable and reproducible anticoagulation with a low potential for drug-drug interactions and no drug-food interactions, without the need for routine coagulation monitoring or dose adjustment.10,12

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 142 affiliates and a total of more than 47,400 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.

Taking social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative "Making more Health" and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.

In 2013, Boehringer Ingelheim achieved net sales of about 14.1 billion euros. R&D expenditure corresponds to 19.5% of its net sales.

References
1FDA Drug Safety Communication: FDA study of Medicare patients finds risks lower for stroke and death but higher for gastrointestinal bleeding with Pradaxa (dabigatran) compared to warfarin – 13 May 2014. http://www.fda.gov/Drugs/DrugSafety/ucm396470.htm Last accessed May 2014.
2FDA Drug Safety Communication: Update on the risk for serious bleeding events with the anticoagulant Pradaxa (dabigatran) – 2 November 2012 http://www.fda.gov/Drugs/drugsafety/ucm326580.htm Last accessed May 2014.
3Connolly SJ, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139-51.
4Connolly SJ, et al. Newly identified events in the RE-LY trial. N Engl J Med. 2010;363:1875-6.
5Andersen KK, et al. Hemorrhagic and ischemic strokes compared: stroke severity, mortality, and risk factors. Stroke. 2009;40(6):2068-72.
6Ezekowitz MD, et al. Rationale and design of RE-LY: Randomized evaluation of long-term anticoagulant therapy, warfarin, compared with dabigatran. Am Heart J. 2009;157(5):805-10.
7Boehringer Ingelheim Data on File.
8Pradaxa® European Summary of Product Characteristics 2014.
9PRADAXA® Prescribing Information, 2014. Available at: http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing%20Information/PIs/Pradaxa/Pradaxa.pdf. Last accessed: May 2014
10Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet. 2008;47(5):285–95.
11Di Nisio M, et al. Direct thrombin inhibitors. N Engl J Med. 2005;353:1028–40.
12Stangier J, et al. Pharmacokinetic Profile of the Oral Direct Thrombin Inhibitor Dabagitran Etexilate in Healthy Volunteers and Patients Undergoing Total Hip Replacement. J Clin Pharmacol. 2005;45:555–63.

*RE-LY® was a global, phase III, PROBE (prospective, randomized, open-label with blinded endpoint evaluation) design trial comparing two fixed doses of the oral direct thrombin inhibitor Pradaxa® (110mg and 150mg twice daily) each administered in a blinded manner, with open label warfarin.3,4,6

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    Boehringer Ingelheim

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    Judith von Gordon
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