New Pradaxa^® safety and efficacy data to be featured at ‘Best of ASH’ session

Ingelheim, Germany, 05 December 2012 – The management of bleeding associated with the novel oral anticoagulants is one of the topics of interest at this year's annual meeting of the American Society of Hematology. Important new data from the RE-LY trial and pooled results from five Phase III studies will be presented, which compare the management and outcomes for Pradaxa (dabigatran etexilate) and warfarin treatment.¹ The data will provide insights into the prognosis of anticoagulated patients in case a major bleed should occur. The new data will be presented on December 8th at the ASH Annual Meeting and Exposition in Atlanta, Georgia, USA and are additionally featured in 'The Best of ASH' session, making them one highlight among numerous clinical reports presented at the scientific meeting.

The results from a second study with Pradaxa, the one-year post-treatment follow-up from the RE-SONATETM trial, will also be presented in the ‘The Best of ASH’ session. This data will shed light on the long-term risk of recurrence of deep vein thrombosis or pulmonary embolism after an extended maintenance therapy.² The treatment of deep vein thrombosis or pulmonary embolism with Pradaxa is part of an ongoing clinical development program and is not yet approved.

'BEST of ASH' oral presentation information:

Additional studies on Pradaxa being presented at the ASH Annual Meeting and Exposition

Furthermore, data evaluating the clinical experience with Pradaxa and preclinical studies of dabigatran will be presented during the congress. Of particular note will be results from a real-world practice analysis examining the safety and efficacy of Pradaxa for the primary prevention of deep vein thrombosis or pulmonary embolism after total knee or hip replacement, as well as the latest updates from the Boehringer Ingelheim Research & Development Programme, regarding the potential of an highly specific antibody fragment antidote for rapid reversal of the anticoagulant effect of Pradaxa during critical care situations.

Details of the Pradaxa data presentations:

ATRIAL FIBRILLATION

• Persistence Among Patients with Non-Valvular Atrial Fibrillation Beginning Dabigatran or Warfarin (Lead Author: K. M Francis, presented by K. Siu) [Abstract No. 365, Monday 10 December, Health Services and Outcomes Research Session, 8:00 a.m.]

Primary prevention of VENOUS THROMBOEMBOLISM in patients after total knee or hip replacement surgery:

• Real-World Study of Dabigatran Etexilate for Thromboprophylaxis in Over 5000 Hip or Knee Replacement Patients: Favourable Safety Profile in Subgroups with Different BMI, Renal Function and Age (Lead Author: N. Rosencher) [Abstract No. 1160, Saturday 8 December, Session 332 Antithrombotic Therapy: Poster I, 5:30 p.m. – 7:30 p.m.]
• Epidemiological Data On the Incidence of Co-Morbidities and Co-Medications in Patients Undergoing Total Hip or Knee Replacement Surgery: Real-World Study and Phase III Clinical Trials (Lead Author: N. Rosencher) [Abstract No. 2269, Sunday 9 December, Session 332 Antithrombotic Therapy: Poster II, 6:00 p.m. – 8:00 p.m.]

PRE-CLINICAL STUDIES:

• Reversal of Dabigatran's Anticoagulant Activity in the Monkey by a Specific Antidote and Pharmacokinetic and Pharmacodynamic Modeling (Lead Author: J. Toth) [Abstract No. 22, Saturday 8 December, Session332 Antithrombotic Therapy I, 12:45 p.m.]
• Acceleration of Dabigatran Elimination by Activated Charcoal Perfusion and Hemodialysis in a Pig Model (Lead Author: J. Lange) [Abstract No. 2272, Sunday 9 December, Session 332 Antithrombotic Therapy: Poster II, 6:00 p.m. – 8:00 p.m.]
• In Vitro Characterization, Pharmacokinetics and Reversal of Supratherapeutic Doses of Dabigatran-Induced Bleeding in Rats by a Specific Antibody Fragment Antidote to Dabigatran (Lead Author: J. van Ryn) [Abstract No. 3418, Monday 10 December, Session 332 Antithrombotic Therapy: Poster III, 6:00 p.m. – 8:00 p.m.]

Full details of the abstracts can be accessed via ASH Annual Meeting and Exposition website at https://ash.confex.com/ash/2012/webprogram/start.html

For more information on Pradaxa, please visit www.newshome.com and follow the company on Twitter www.twitter.com/boehringer.

NOTES TO THE EDITORS

About dabigatran etexilate
Dabigatran etexilate is at the forefront of a new generation of oral anticoagulants/direct thrombin inhibitors (DTIs)³ targeting a high unmet medical need in the prevention and treatment of acute and chronic thromboembolic diseases.

Potent antithrombotic effects are achieved with direct thrombin inhibitors by specifically blocking the activity of thrombin (both free and clot-bound), the central enzyme in the process responsible for clot (thrombus) formation. In contrast to vitamin-K antagonists, which variably act via different coagulation factors, dabigatran etexilate provides effective, predictable and consistent anticoagulation with a low potential for drug-drug interactions and no drug-food interactions, without the need for routine coagulation monitoring or dose adjustment.

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 44,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.

In 2011, Boehringer Ingelheim achieved net sales of about 13.2 billion euro. R&D expenditure in the business area Prescription Medicines corresponds to 23.5% of its net sales.

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