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New Analysis of Phase III Trials Examines the Impact of Boehringer Ingelheim's IPF Therapy Nintedanib on Lung Function Decline Based on Patients' Baseline Severity.

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RIDGEFIELD, Conn., Sept. 9, 2014 /PRNewswire/ -- A pre-specified, pooled subgroup sensitivity analysis from the two identically designed Phase III INPULSIS(TM) trials, presented today at the European Respiratory Society International Congress(ERS) evaluated the impact of the investigational drug nintedanib on reducing the decline in lung function, as measured by annual rate of decline in forced vital capacity (FVC), in patients with idiopathic pulmonary fibrosis (IPF) based on the severity of lung function impairment at baseline. The efficacy and safety of nintedanib in the treatment of IPF has not been established.

In this analysis, nintedanib produced a similar reduction in lung function decline across two pre-specified groups after 52 weeks of treatment:

* Baseline FVC >70% predicted: -111.3mL (nintedanib) vs. -220.3mL (placebo)

* Baseline FVC <70% predicted: -119.7mL (nintedanib) vs. -233.2mL (placebo)

"These results provide important insight on the effect of nintedanib across the patients studied in the Phase III clinical trials, regardless of baseline lung function," said Professor Ulrich Costabel, Ruhrlandklinik University Hospital, Germany.

In addition, researchers introduced three multiple imputation sensitivity analyses to account for missing data for patients who prematurely withdrew from INPULSIS(TM)-1 or INPULSIS(TM)-2 before week 52. The findings of these three analyses look to add to the primary and key secondary endpoint results achieved in the two Phase III trials.

"These new sensitivity analyses of the INPULSIS(TM) trials provide additional data around the potential efficacy of nintedanib," said Tunde Otulana, M.D., senior vice president, Clinical Development & Medical Affairs at Boehringer Ingelheim. "We are continuing to work closely with the FDA to make nintedanib available to people with IPF."

In the pre-specified, pooled subgroup analysis, 95.5% of patients who received nintedanib and 89.6% of those who received placebo experienced an adverse event. In total, these events were severe in 27.3% in the nintedanib arm and 23.4% in the placebo arm. Adverse events led to treatment discontinuation in 19.3% and 13.0% of patients receiving nintedanib and placebo, respectively.

About the Phase III INPULSIS(TM) trials (INPULSIS(TM)-1 and INPULSIS(TM)-2) The double-blind, randomized and placebo-controlled trials evaluated the effect of oral nintedanib, 150 mg twice daily, on annual rate of decline in forced vital capacity FVC, in people with IPF over 52 weeks. A total of 1,061 (n=638, nintedanib vs. 423, placebo) people with IPF were enrolled in the two trials, including 513 people in INPULSIS(TM)-1 (n=309, nintedanib vs. 204, placebo) and 548 in INPULSIS(TM)-2 (n=329, nintedanib vs. n=219, placebo). The trials had an identical design, dosing, inclusion criteria, and endpoints.

The primary endpoint was the annual rate of decline in FVC (expressed in mL over 52 weeks). There were two key secondary endpoints: change from baseline in health-related quality of life, as assessed by the SGRQ total score, and time to first acute exacerbation (days).

Included were people over 40 years of age with a diagnosis of IPF within five years before enrollment based on the most recent American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS) and Latin American Thoracic Association (ALAT) IPF guidelines for diagnosis and management.

Diagnosis required central review and confirmation of a combination of high resolution computerized tomography pattern and surgical lung biopsy if available.

About nintedanib

Nintedanib is an investigational small molecule tyrosine kinase inhibitor (TKI) in development by Boehringer Ingelheim for idiopathic pulmonary fibrosis (IPF). It targets growth factors, which have been implicated in pulmonary fibrosis C the vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), and platelet-derived growth factor receptor (PDGFR).

About idiopathic pulmonary fibrosis

Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, severely debilitating and ultimately fatal lung disease. It is characterized by progressive scarring of lung tissue and loss of lung function over time. Development of scarred tissue is called fibrosis. Over time, as the tissue thickens and stiffens with scarring, the lungs lose their ability to take in and transfer oxygen into the bloodstream, and vital organs do not get enough oxygen. As a result, individuals with IPF experience shortness of breath, cough and often have difficulty participating in everyday physical activities.

IPF affects as many as 132,000 Americans, though the incidence can vary considerably and there is some evidence that the population is increasing. There are currently no FDA-approved treatments. Although lung transplantation has been shown to improve survival, the procedure is uncommon because of the limited availability of lungs for transplantation, or people are either too ill or don't survive long enough to undergo the transplant.

About Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, Conn., 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 142 affiliates and more than 47,400 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.

Social responsibility is a central element of Boehringer Ingelheim's culture. 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 2013, Boehringer Ingelheim achieved net sales of about $18.7 billion (14.1 billion euro). R&D expenditure in the Prescription Medicines business corresponds to 19.5% of its net sales.

For more information please visit http://www.us.boehringer-ingelheim.com

Contact: Boehringer Ingelheim Pharmaceuticals, Inc. Name: Jennifer Forsyth Public Relations Phone: 203-791-5889 Email: jennifer.forsyth@boehringer-ingelheim.com

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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