Pradaxa® (dabigatran etexilate mesylate) Capsules Now on Formulary at Nation's Top Heart Hospitals

Widespread Access Significant Given High Admission Rates for Patients with Non-Valvular Atrial Fibrillation

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Boehringer Ingelheim Pharmaceuticals, Inc.

Jul 21, 2011, 08:00 ET

RIDGEFIELD, Conn., July 21, 2011 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) today announced that Pradaxa® (dabigatran etexilate mesylate) capsules has been added to hospital formularies at 49 of the top 50 cardiology and heart surgery hospitals, as ranked by U.S. News & World Report's Best Hospitals 2011-2012, published online on July 19. PRADAXA is approved by the U.S. Food and Drug Administration (FDA) to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF).(1)

Atrial fibrillation (AFib), characterized by an irregular heartbeat,(2) increases the risk of stroke nearly five times.(3) Approximately 80 percent of U.S. adults living with AFib are age 65 or older,(4) and many have other conditions, such as diabetes or hypertension, that further increase the risk of stroke.(2) A Medicare claims database analysis showed that approximately 70 percent of NVAF patients are hospitalized each year.(5) Overall, annual hospital admissions for NVAF, as a primary or secondary diagnosis, total nearly 2.7 million or approximately seven percent of all hospital admissions in the U.S.(6)

"At Boehringer Ingelheim, patients are our first priority and we've worked with hospitals across the country to support the addition of PRADAXA to formularies," said Wa'el Hashad, vice president, cardiovascular and metabolic disorders marketing, Boehringer Ingelheim Pharmaceuticals, Inc. "In the first seven months after approval, more than 250,000 patients were prescribed PRADAXA, suggesting this important treatment has been well received in the everyday clinical setting to reduce the risk of stroke in patients with non-valvular atrial fibrillation."

PRADAXA is now included on formularies that insure about 90 percent of covered lives in the U.S.(7) For those patients who may not otherwise be able to afford treatment, BIPI offers patient assistance programs to help provide coverage for the costs of their medications.

Findings from the pivotal, Phase III RE-LY® trial showed that PRADAXA 150mg taken twice daily significantly reduced stroke and systemic embolism by 35 percent beyond the reduction achieved with warfarin in patients with NVAF.(1) Effects of PRADAXA were more apparent in patients with lower levels of INR (international normalized ratio) control.(1) Dabigatran was recently recommended in an update to atrial fibrillation treatment guidelines. PRADAXA is approved to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation in Canada, Japan, New Zealand and several other countries across four continents.

About Atrial Fibrillation and Stroke

Atrial fibrillation can cause blood clots to form in the heart that can travel to the brain and cause a stroke.(2) Atrial fibrillation is associated with up to 15 percent of all strokes in the U.S.(3) An estimated 2.3 million Americans are living with AFib,(4) and the prevalence is expected to increase to 5.6 million by 2050.(4) A large managed care database study showed that NVAF represents roughly 95 percent of all AFib cases in the U.S.(4) Non-valvular atrial fibrillation refers to patients that do not have a prosthetic heart valve requiring anticoagulation, or patients with valvular disease that does not require surgical repair. Atrial fibrillation imposes a substantial economic burden to the healthcare system,(6) specifically the high costs associated with stroke.(8)

About Pradaxa® (dabigatran etexilate) Capsules

Indications and Usage

PRADAXA is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

IMPORTANT SAFETY INFORMATION ABOUT PRADAXA

CONTRAINDICATIONS

PRADAXA is contraindicated in patients with active pathological bleeding and patients with a known serious hypersensitivity reaction (e.g., anaphylactic reaction or anaphylactic shock) to PRADAXA.

WARNINGS AND PRECAUTIONS

Risk of Bleeding

PRADAXA increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding.

Risk factors for bleeding include:

- Medications that increase the risk of bleeding in general (e.g., anti-platelet agents, heparin, fibrinolytic therapy, and chronic use of NSAIDs).

-Labor and delivery

Promptly evaluate any signs or symptoms of blood loss, such as a drop in hemoglobin and/or hematocrit or hypotension. Discontinue PRADAXA in patients with active pathological bleeding.

Temporary Discontinuation of PRADAXA

Discontinuing PRADAXA for active bleeding, elective surgery, or invasive procedures places patients at an increased risk of stroke. Lapses in therapy should be avoided, and if PRADAXA must be temporarily discontinued for any reason, therapy should be restarted as soon as possible.

Effect of P-gp Inducers and Inhibitors on PRADAXA Exposure

The concomitant use of PRADAXA with P-gp inducers (e.g., rifampin) reduces dabigatran exposure and should generally be avoided. P-gp inhibitors ketoconazole, verapamil, amiodarone, quinidine, and clarithromycin, do not require dose adjustments. These results should not be extrapolated to other P-gp inhibitors.

ADVERSE REACTIONS

In the pivotal trial comparing PRADAXA to warfarin, the most frequent adverse reactions leading to discontinuation of PRADAXA were bleeding and gastrointestinal (GI) events. PRADAXA 150 mg resulted in a higher rate of major GI bleeds and any GI bleeds compared to warfarin. In patients greater than or equal to 75 years of age, the risk of major bleeding may be greater with PRADAXA than with warfarin. Patients on PRADAXA 150 mg had an increased incidence of GI adverse reactions. These were commonly dyspepsia (including abdominal pain upper, abdominal pain, abdominal discomfort, and epigastric discomfort) and gastritis-like symptoms (including GERD, esophagitis, erosive gastritis, gastric hemorrhage, hemorrhagic gastritis, hemorrhagic erosive gastritis, and GI ulcer). Drug hypersensitivity reactions were reported in <0.1% of patients receiving PRADAXA.

Other Measures Evaluated

The risk of myocardial infarction was numerically greater in patients who received PRADAXA 150 mg than in those who received warfarin.

For full PRADAXA prescribing information and medication guide, please visit www.pradaxa.com or contact Boehringer Ingelheim's Drug Information Unit at 1-800-542-6257.

About the Boehringer Ingelheim Cares Foundation Patient Assistance Programs

For more than 125 years, Boehringer Ingelheim has been focused on improving the lives of patients. In keeping with the company commitment to do the most good for the most people, Boehringer Ingelheim works hard to ensure its medicines are accessible to everyone who needs them, including senior citizens and families on limited incomes. The Boehringer Ingelheim Cares Foundation Patient Assistance Programs (BI-PAP) make Boehringer Ingelheim medicines available free of charge to patients who are without pharmaceutical insurance coverage, and who meet certain household income levels.

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 145 affiliates and more than 42,000 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.

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 2010, Boehringer Ingelheim posted net sales of about 12.6 billion euro while spending almost 24% of net sales in its largest business segment Prescription Medicines on research and development.

For more information, please visit http://us.boehringer-ingelheim.com and follow us on Twitter at http://twitter.com/boehringerus.

(1) Pradaxa Prescribing Information. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; March 2011.

(2) NHLBI website. "What is AFib?" Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/af/af_what.html. Accessed on: May 2, 2011.

(3) Fuster, V., et al. "ACC/AHA/ESC 2006 Guidelines for the Management of Patients With Atrial Fibrillation – Executive Summary: A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation): Developed in Collaboration With the European Heart Rhythm Association and the Heart Rhythm Society." Circulation. 2006; 114:700-752.

(4) Go, A.S., et al. "Prevalence of Diagnosed Atrial Fibrillation in Adults: National Implications for Rhythm Management and Stroke Prevention: the AnTicoagulation and Risk Factors In Atrial Fibrillation (ATRIA) Study." JAMA. 2001; 285(18):2370-2375.

(5) Mercaldi C.J., et al. "Cost Efficiency of Anticoagulation With Warfarin to Prevent Stroke in Medicare Beneficiaries With Nonvalvular Atrial Fibrillation." Stroke. 2011;42:112-118.

(6) Coyne, K.S., et al. "Assessing the direct costs of treating nonvalvular atrial fibrillation in the United States" Value in Health 2006; 9(5):348-356.

(7) Data on file. Boehringer Ingelheim Pharmaceuticals, Inc.

(8) Harley, C., et al. "Direct Costs And Health Care Utilization Associated With Stroke in the Presence of Atrial Fibrillation in the United States." Poster Presentation at ASAIS Conference 2009.

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.