August 01, 2014 12:38 PM 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. The company’s 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 (ipratropium bromide and albuterol), an inhaler for patients with chronic obstructive pulmonary disease. Its products also comprise Flibanserin, a compound for the treatment of hypoactive sexual des...

900 Ridgebury Road

Ridgefield, CT 06877-0368

United States

Founded in 1971

Phone:

203-798-9988

Fax:

203-791-6234

Key Executives for Boehringer Ingelheim Pharmaceuticals, Inc.

Executive Vice President of Sales & Marketing - Prescription Medicines Business
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

Boehringer Ingelheim Pharmaceuticals, Inc. Receives Grant from U.S. Food & Drug Administration for Therapy Designation to nintedanib

Boehringer Ingelheim Pharmaceuticals, Inc. announced that the U.S. Food & Drug Administration (FDA) has granted Breakthrough Therapy designation to nintedanib, an investigational therapy currently under FDA review for the treatment of people with idiopathic pulmonary fibrosis (IPF). The efficacy and safety of nintedanib in the treatment of IPF has not been established. The Breakthrough Therapy designation process was established by the FDA in 2012 and is intended to expedite the development and review of drugs for serious or life-threatening conditions, and preliminary clinical evidence indicates that the therapy may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. IPF is a serious and life-threatening lung disease that causes permanent scarring of the lungs, difficulty breathing and decreases the amount of oxygen the lungs can supply to the body. IPF affects as many as 132,000 Americans. There are currently no FDA-approved treatments. Results from two global Phase 3 studies evaluating the efficacy and safety of nintedanib in the treatment of IPF were presented at the American Thoracic Society (ATS) International Conference and published in the New England Journal of Medicine in May 2014. Nintedanib was granted Priority Review designation in June 2014, Fast Track designation in June 2013 and orphan drug status in June 2011.

U.S. FDA Accepts NDA Filing for Boehringer Ingelheim's Investigational Nintedanib and Grants Priority Review Designation for the Treatment of Idiopathic Pulmonary Fibrosis

Boehringer Ingelheim Pharmaceuticals, Inc. announced that the New Drug Application (NDA) for its investigational compound nintedanib has been accepted for filing by the U.S. Food & Drug Administration (FDA) and granted Priority Review designation. The application for nintedanib is currently under review for the treatment of people with idiopathic pulmonary fibrosis (IPF), a rare, progressive and fatal lung disease that affects as many as 132,000 Americans. There are currently no FDA-approved treatments for IPF. The efficacy and safety of nintedanib in the treatment of IPF has not been established.

Boehringer Ingelheim's Investigational Antidote for Pradaxa(R) (dabigatran etexilate mesylate) Receives FDA Breakthrough Therapy Designation

Boehringer Ingelheim Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to idarucizumab, an investigational fully humanized antibody fragment, or Fab, being studied as a specific antidote for Pradaxa (dabigatran etexilate mesylate). The FDA established the Breakthrough Therapy Designation as a means to help accelerate the development and review of drugs for serious or life-threatening conditions if preliminary clinical evidence indicates the therapy may demonstrate a substantial improvement over existing therapies on one or more clinically significant endpoints. A global phase III study, RE-VERSE AD(TM), is underway in patients taking PRADAXA who have uncontrolled bleeding or require emergency surgery or procedures (NCT02104947). Currently, no U.S. sites have been initiated; however, European sites are actively enrolling.

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