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May 05, 2015 4:24 AM ET

Pharmaceuticals

Company Overview of Boehringer Ingelheim Pharmaceuticals, Inc.

Company Overview

Boehringer Ingelheim Pharmaceuticals, Inc. provides human prescription medicines. It offers pharmaceutical products for the treatment of lung health, cardiovascular diseases, men's prostate health, and anti-viral therapy. Its products include angiotensin II receptor blocker Micardis tablets for the reduction of the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients who are unable to take angiotensin-converting enzyme inhibitors; and COMBIVENT RESPIMAT, an inhaler for patients with chronic obstructive pulmonary disease. The company’s products also comprise Flibanserin for the treatment of hypoactive sexual desire disorder in pre-menopausal women; SPIRIVA Ha...

900 Ridgebury Road

P.O. Box 368

Ridgefield, CT 06877-0368

United States

Founded in 1971

Phone:

203-798-9988

Fax:

203-791-6234

Key Executives for Boehringer Ingelheim Pharmaceuticals, Inc.

Director of Office of Diversity and Inclusion
Manager of Communications and Public Relations
Compensation as of Fiscal Year 2014.

Boehringer Ingelheim Pharmaceuticals, Inc. Key Developments

FDA Files Supplemental New Drug Application for Boehringer Ingelheim's Pradaxa (Dabigatran Etexilate Mesylate) for the Prophylaxis of Deep Venous Thrombosis and Pulmonary Embolism After Hip Replacement Surgery

Boehringer Ingelheim Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration filed a supplemental New Drug Application (sNDA) for Pradaxa (dabigatran etexilate mesylate) for the prophylaxis of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have had primary elective total hip replacement surgery. If approved, this will become the fourth indication for PRADAXA. It is estimated that nearly 300,000 total hip replacement surgeries are performed each year in the United States. Without prophylaxis (anticoagulation treatment to prevent blood clots), the incidence of DVT detected by venography (x-ray visualization of the veins after administering injectable contrast dye) ranges from 40% to 60% of primary elective hip surgery patients, and fatal PE occurs in approximately one of 500 patients. The submission to the FDA is based on the results of two randomized, double-blind, phase III trials, RE-NOVATE and RE-NOVATE II. The studies compared the efficacy and safety of PRADAXA to enoxaparin in preventing venous thromboembolism (VTE) and death in patients undergoing total hip replacement surgery. In RE-NOVATE, 3,494 patients having primary elective total hip replacement were randomized to three groups receiving prophylactic treatment with one of two doses of PRADAXA (220 mg or 150 mg) once daily or enoxaparin 40 mg once daily for 28 to 35 days. The first PRADAXA group was given a dose of 110 mg on the day of surgery and 220 mg daily thereafter; the second PRADAXA group received a dose of 75 mg on the day of surgery and 150 mg daily thereafter. The enoxaparin group was given a dose of 40 mg the day before surgery and daily thereafter. The results showed patients taking PRADAXA 220 mg had a lower composite total of VTE (VTE comprises DVT and PE) and all-cause death (6.0%) than those on PRADAXA 150 mg (8.6%) and on enoxaparin 40 mg (6.7%). There was no significant difference in the rates of major bleeding among all treatment groups: 2.0% for PRADAXA 220 mg, 1.3% for PRADAXA 150 mg and 1.6% for enoxaparin 40 mg. The most common adverse events were gastrointestinal disorders, with similar frequencies in all treatment groups (PRADAXA 220 mg, 44.2%; PRADAXA 150 mg, 44.0%; enoxaparin 40 mg, 44.8%). Treatment with PRADAXA resulted in higher rates of wound secretion than enoxaparin (8.9% with PRADAXA 220 mg and 8.3% with PRADAXA 150 mg vs. 5.5% with enoxaparin). In RE-NOVATE II, 2,055 patients undergoing primary elective total hip replacement were randomly assigned prophylactic treatment for 28 to 35 days with PRADAXA 220 mg once daily or enoxaparin 40 mg once daily. Patients receiving PRADAXA were treated with a dose of 110 mg on the day of surgery and 220 mg daily thereafter. The enoxaparin group was given a dose of 40 mg the day before surgery and daily thereafter. The results showed the composite total of VTE and all-cause death occurred in 7.7% of patients in the PRADAXA group vs. 8.8% of patients in the enoxaparin group. There was no difference in major bleeding rates between the two treatments (1.4% for patients on PRADAXA and 0.9% for patients on enoxaparin). Gastrointestinal disorders were the most frequent adverse events in the study, and were similar in both treatment groups (35.8% of PRADAXA patients vs. 35.7% of enoxaparin patients). The incidence of wound secretion was slightly higher for patients on PRADAXA (2.7%) than on enoxaparin (1.2%). PRADAXA was initially approved by FDA in 2010 to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF). In 2014 FDA approved two additional indications for PRADAXA for the treatment of DVT and PE in patients who have been treated with a parenteral anticoagulant for five to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated. About Pradaxa® (dabigatran etexilate mesylate) Capsules. Indications and Usage Pradaxa (dabigatran etexilate mesylate) capsules is indicated: to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation; for the treatment of deep venous thrombosis and pulmonary embolism in patients who have been treated with a parenteral anticoagulant for 5-10 days; to reduce the risk of recurrence of deep venous thrombosis and pulmonary embolism in patients who have been previously treated.

Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company Announce Availability of First-In-Class Type 2 Diabetes Treatment Glyxambi (Empagliflozin/Linagliptin) Tablets for Adults in U.S. Pharmacies

Glyxambi (empagliflozin/linagliptin) tablets are now available by prescription in many chain and independent pharmacies across the U.S., including Walgreens and Rite Aid. GLYXAMBI, part of the Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company. Diabetes alliance portfolio, is the first and only dual inhibitor combination therapy approved in the U.S. to combine the mechanisms of action of a sodium glucose co-transporter-2 (SGLT2) inhibitor and a dipeptidyl peptidase-4 (DPP-4) inhibitor in a once-daily tablet. GLYXAMBI is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D) when both empagliflozin and linagliptin are appropriate treatments. GLYXAMBI is a once-daily tablet taken in the morning that combines 10 mg or 25 mg of empagliflozin, an SGLT2 inhibitor, with 5 mg of linagliptin, a DPP-4 inhibitor. GLYXAMBI is not for people with type 1 diabetes or for diabetic ketoacidosis (increased ketones in the blood or urine).

Boehringer Ingelheim Pharmaceuticals, Inc. to Present Results from Two Analyses of the GLORIA-AF Registry Program

Boehringer Ingelheim Pharmaceuticals, Inc. will present results from two analyses of the GLORIA-AF Registry Program examining the use of antithrombotic treatment to reduce the risk of stroke for patients with non-valvular atrial fibrillation (NVAF). The new findings are the first reported prescribing patterns data from Phase II of the GLORIA-AF Registry Program and were included in poster presentation sessions at the American College of Cardiology 64th Annual Scientific Session. Results from one analysis demonstrated 21.9% of patients with paroxysmal (occasional) NVAF and a CHA2DS2-VASc score of 2 or higher were not given an oral anticoagulant medication, compared to 12.4% and 11.2% t of those diagnosed with persistent or permanent NVAF, respectively, and a CHA2DS2-VASc score of 2 or higher. Current NVAF guidelines call for a choice of antithrombotic therapy based on patients' risk of stroke or thromboembolism and bleeding, rather than the type of NVAF. A second analysis showed that a considerable number of new-onset NVAF patients with a CHA2DS2-VASc score of 2 or higher received aspirin alone or went untreated (age 64 or younger, 20.6%; age 65-74, 19.7%; age 75-79, 15.6%; age 80 or older, 17.6%). Newer drugs known as novel oral anticoagulants (NOACs) accounted for 52.1% of anticoagulants prescribed (25.0% dabigatran, 20.5% rivaroxaban, and 6.6% apixaban). The most frequently prescribed oral anticoagulants in patients with a CHA2DS2-VASc score of 2 or higher were vitamin K antagonists (VKAs, e.g., warfarin), especially among elderly and very elderly patients (age 64 or younger, 27.9%; age 65-74, 24.7%; age 75-79, 27.9%; age 80 or older, 31.7%).

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