May 25, 2017 8:34 PM ET

Pharmaceuticals

Company Overview of Boehringer Ingelheim Pharmaceuticals, Inc.

Company Overview

Boehringer Ingelheim Pharmaceuticals, Inc. provides human prescription medicines 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 cardiovascular causes; and COMBIVENT RESPIMAT, an inhaler for patients with chronic obstructive pulmonary disease. Its products include Flibanserin for the treatment of hypoactive sexual desire disorder in pre-menopausal women; SPIRIVA HandiHaler for the reduction of exacerbations in patients with obstructive pulmonary disease; pramipexole dihydrochloride tablets for Parkinson's disease; Pradaxa for the study on management of deep vein...

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 2016.

Boehringer Ingelheim Pharmaceuticals, Inc. Key Developments

Boehringer Ingelheim Pharmaceuticals, Inc. Announces Phase III Study Enrolling Patients with Progressive Fibrosing Lung Diseases

Boehringer Ingelheim Pharmaceuticals, Inc. announced that the first patient has been enrolled in the PF-ILD trial. This study investigates the efficacy and safety of nintedanib in a range of progressive fibrosing lung conditions other than idiopathic pulmonary fibrosis. There are over 200 conditions that affect the tissue and space around the air sacs of the lungs. These conditions are called interstitial lung diseases or ILDs. Based on clinical observations, there is a group of patients with ILD who, independent from the classification of the ILD, exhibit progressive fibrosis. The proposed terminology for describing this group of patients is PF-ILD. In these patients, the disease appears to follow a course similar to IPF with worsening of respiratory symptoms, lung function, quality of life and ability to perform daily activities, as well as early mortality despite treatment. Nintedanib, which is marketed as Ofev®, is approved for a rare lung disease called IPF, in which it has been shown to slow disease progression as measured by annual rate of decline in lung function. Building on the positive real-world clinical experience in IPF, the Phase III trial is now exploring whether nintedanib can effectively target the scarring in the lungs of patients suffering from other progressive fibrosing ILDs. This double-blind, randomized, placebo-controlled study will evaluate the efficacy and safety of nintedanib 150 mg twice daily over 52 weeks in patients with PF-ILD. The primary endpoint is the annual rate of decline in forced vital capacity (FVC), a measure of disease progression. Other clinical evaluations include the absolute change from baseline in the King's Brief Interstitial Lung Disease Questionnaire, which measures the health-related quality of life of patients with ILDs to assess the impact of treatment. Other main secondary endpoints include time to first ILD exacerbation and overall survival. The study will include patients with PF-ILD with documented lung scarring on imaging, and whose lung function and respiratory symptoms or chest imaging have worsened despite treatment. About PF-ILD Interstitial lung disease encompasses a large group of over 200 lung disorders, but there is no widely accepted single classification. Based on clinical observations, there is a group of patients who, independent of their ILD diagnosis, at some point in time develop a progressive phenotpye. Based on their similar disease characteristics, including decline in lung function and early mortality, it is thought to be appropriate to group these conditions together, regardless of their ILD diagnosis. PF-ILD is the umbrella term for this group of patients. About OFEV®. The U.S. Food and Drug Administration approved OFEV for the treatment of idiopathic pulmonary fibrosis on October 15, 2014. OFEV is one of the first FDA-approved drug treatments for IPF and the only kinase inhibitor approved to treat this disease. The approval was based on findings from a robust clinical trial program involving more than 1,200 patients with IPF worldwide, and included the Phase II TOMORROW® trial and the Phase III INPULSIS® trials. All these studies were randomized, double-blind, placebo-controlled trials comparing OFEV 150 mg twice daily to placebo for 52 weeks. Both INPULSIS® trials were identically designed while the TOMORROW™ study design was similar.

Boehringer Ingelheim Pharmaceuticals, Inc. Announces Pradaxa® Shows Less Bleeding Than Warfarin in Atrial Fibrillation Patients Undergoing Catheter Ablation

Boehringer Ingelheim Pharmaceuticals, Inc. announced that important new data from the RE-CIRCUIT® study show a better safety profile for Pradaxa® (dabigatran etexilate mesylate) compared to warfarin in atrial fibrillation (AFib) patients undergoing catheter ablation. AFib patients who underwent catheter ablation while being treated with uninterrupted PRADAXA experienced less major bleeding and fewer serious adverse events compared to those treated with uninterrupted warfarin. The results were presented in a late-breaking session at the American College of Cardiology 66th Annual Scientific Session in Washington, D.C. and simultaneously published in the New England Journal of Medicine. In the RE-CIRCUIT trial, uninterrupted PRADAXA significantly reduced the risk of major bleeding complications compared with uninterrupted warfarin. The trial showed a 5.3% absolute risk reduction in its primary endpoint, with major bleeds occurring in 5/317 of patients receiving PRADAXA versus 22/318 of patients receiving warfarin (77.2% relative risk reduction). PRADAXA showed a similar incidence of minor bleeding complications compared to warfarin (59/317 versus 54/318). There were no thromboembolic events in patients taking PRADAXA and one in patients taking warfarin. Six hundred and thirty-five patients with paroxysmal or persistent AFib undergoing catheter ablation were included in the RE-CIRCUIT trial. These patients were reflective of the types of patients undergoing the procedure in routine clinical practice, providing relevant new data to treating physicians. The RE-CIRCUIT study (Randomised Evaluation of dabigatran etexilate Compared to warfarIn in pulmonaRy vein ablation: assessment of different peri-proCedUral antIcoagulation sTrategies) is an exploratory prospective, randomized, open-label, blinded endpoint, multicenter, active controlled trial. Patients with paroxysmal or persistent NVAF scheduled for catheter ablation and eligible for dabigatran 150 mg twice daily were included in the trial. Patients were randomly assigned to dabigatran etexilate mesylate 150 mg twice daily or warfarin (target INR 2.0–3.0) in a 1:1 ratio and remained on this treatment for the duration of the trial. The study enrolled 704 patients across 104 sites, with 635 patients undergoing ablation with uninterrupted anticoagulation treatment. All patients were screened with a transesophageal echocardiogram before their ablation procedure to determine whether any blood clots were present in the upper left heart chamber (left atrium). The safety and efficacy of the therapies were assessed during the three to four month treatment period and follow-up visit one week after treatment end. The primary endpoint of the RE-CIRCUIT study was the incidence of major bleeding events, as defined by the International Society on Thrombosis and Hemostasis (ISTH), during the ablation procedure and up to two months post-ablation. Secondary endpoints included thromboembolic events (stroke/systemic embolism/transient ischemic attack), minor bleeding events or a composite of both the efficacy and safety endpoints during ablation and up to two months after the procedure.

FDA Grants Orphan Drug Designation to Boehringer Ingelheim's Investigational Anti-CD33 Monoclonal Antibody Bi 836858 for Treatment of Myelodysplastic Syndromes

Boehringer Ingelheim announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its anti-CD33 monoclonal antibody BI 836858 for the treatment of myelodysplastic syndromes (MDS). Orphan drug designation is granted by the FDA to investigational compounds intended for the safe and effective treatment, diagnosis, or prevention of rare diseases or disorders that affect fewer than 200,000 people. MDS are a group of bone marrow disorders. The bone marrow produces blood cells. In MDS, the bone marrow is characterized by cell abnormalities and ineffective blood cell production. Various subtypes of the disease exist with variable prognoses and treatment options. In some cases, MDS can progress to acute myeloid leukemia (AML), an aggressive and devastating blood cancer. According to data from the National Cancer Institute, an estimated 15,000 new cases of MDS are identified each year. A Phase I/II multi-center, open-label, dose escalation and randomized trial (NCT02240706 [1]) evaluating BI 836858 in patients with MDS is ongoing. BI 836858 previously received orphan drug designation for the treatment of patients with AML and is currently being evaluated as part of the Leukemia & Lymphoma Society's (LLS) groundbreaking, first-of-its-kind Beat AML Master trial program [2] to advance treatment for patients with AML. Using the latest genomic technology, the trial finds and matches specific AML mutations in newly-diagnosed patients over the age of 60 with an investigational drug or drugs best suited to attack the specific genetic mutations found within the cancer.

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