New Study Published in New England Journal of Medicine Shows Investigational BIBF 1120 Demonstrated Positive Trend in Reducing Lung Function Loss in Idiopathic Pulmonary Fibrosis

RIDGEFIELD, CT, Sept. 21, 2011 /PRNewswire/ -- Boehringer Ingelheim's investigational tyrosine kinase inhibitor (TKI) BIBF 1120 demonstrated a positive trend in reducing lung function decline in patients with idiopathic pulmonary fibrosis (IPF), according to phase II clinical trial results published today online in the New England Journal of Medicine (NEJM). IPF is a progressive and severely debilitating lung disease with a high mortality rate, for which there are no approved treatments in the United States.

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In the study, known as TOMORROW (To Improve Pulmonary Fibrosis with BIBF 1120), patients treated with 150 mg of BIBF 1120 twice daily demonstrated a 68 percent reduction in the rate of forced vital capacity (FVC) decline compared to placebo. FVC is the volume of air that is expelled into a spirometer following maximum inhalation. FVC, which is a test that measures lung function, is a part of the examinations conducted in IPF patients and is scientifically accepted for assessment of IPF treatment effects. Patients treated with 150 mg of BIBF 1120 twice daily also had a lower incidence of acute exacerbations, defined as sudden deterioration of clinical status, compared with placebo. Acute exacerbations are associated with rapid disease progression, severe abrupt decline in FVC and high mortality.

In addition, treatment with 150 mg of BIBF 1120 twice daily resulted in a small decrease in impairment of quality of life, as measured by the St. George's Respiratory Questionnaire (SGRQ). SGRQ scores measure the impact of quality of life, with higher scores – as well as increasing scores – signaling greater impairment. In contrast, increased impairment was reported among patients receiving placebo.

Gastrointestinal symptoms and liver transaminase increases were more frequent in patients receiving 150 mg of BIBF 1120 twice daily than placebo and adverse events leading to discontinuation were mostly diarrhea, nausea and vomiting.

"People who suffer from IPF are in great need of a safe and effective treatment to preserve lung function so they can maintain physical activity and reduce the impact on their independence for as long as possible," said Luca Richeldi, MD, PhD, lead study author and director of the Research Centre for Rare Lung Diseases, University of Modena and Reggio Emilia, Modena, Italy. "The positive trends in slowing the decline in lung function over time, reducing the incidence of acute exacerbations and improving the quality of life with BIBF 1120 are a promising proof of concept."

BIBF 1120 received orphan-drug designation from the U.S. Food and Drug Administration in June 2011. Two pivotal phase III clinical trials are currently underway enrolling a total of 970 patients in 20 countries. The first patients entered the trials in April and May 2011, respectively. For more information about the phase III trials or to learn how to enroll, please visit clinicaltrials.gov (identifiers NCT01335464 and NCT01335477).

"The results of the phase II clinical trial for BIBF 1120 in IPF give us the confidence to continue assessing the compound's potential in phase III clinical trials," said Christopher Corsico, MD, MPH, senior vice president, Medicine and Regulatory, North America, Boehringer Ingelheim Pharmaceuticals, Inc. "Boehringer Ingelheim remains committed to identifying an effective treatment for IPF to help bridge the unmet therapeutic need for the thousands of people suffering from this fatal disease."

TOMORROW Data at ERS 2011 Annual Congress

The NEJM paper will be presented at the European Respiratory Society (ERS) 2011 Annual Congress on Monday, Sept. 26, 2011. Additional results of the TOMORROW trial will be presented during oral sessions at ERS on Sunday, Sept. 25, 2011 and at a BI-sponsored symposium on Monday, Sept. 26, 2011. Key presentations include:

• Efficacy of BIBF 1120 in patients with IPF is dose-dependent: results from the TOMORROW trial (Sunday, Sept. 25, 2011, 8:30-8:45 a.m. CEST)
• Effect of baseline FVC on preservation of lung function with BIBF 1120: results from the TOMORROW trial (Sunday, Sept. 25, 2011, 8:45-9 a.m. CEST)
• Presentation of the NEJM TOMORROW paper; Efficacy of a tyrosine kinase inhibitor in idiopathic pulmonary fibrosis at the ERS/NEJM "Late Breaking Research Session" (Monday, Sept. 26, 2011, 1:18-1:36 p.m. CEST)
• Satellite symposium: Idiopathic Pulmonary Fibrosis: Evolutions in Diagnosis and Treatment  (Monday, Sept. 26, 2011, 5:15-7:15 p.m. CEST)

About the TOMORROW Trial

The phase II TOMORROW trial was a 12-month, randomized, double-blind, placebo-controlled trial conducted at 92 sites in 25 countries. The trial evaluated the safety and efficacy of oral BIBF 1120 at four dosage levels in reducing decline in lung function measured by FVC among 432 patients diagnosed with IPF, as defined by the American Thoracic Society (ATS) and ERS.

The primary endpoint for the TOMORROW trial was annual rate of decline in FVC. Secondary endpoints included acute exacerbations, quality of life using the SGRQ and total lung capacity.

About BIBF 1120

BIBF 1120 is an investigational small molecule tyrosine kinase inhibitor (TKI) in development by Boehringer Ingelheim for idiopathic pulmonary fibrosis (IPF). It targets three growth factors: the vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR) and platelet-derived growth factor receptor (PDGFR). These receptors have been shown to be potentially involved in pathomechanisms of pulmonary fibrosis. By blocking these signaling pathways that are involved in fibrotic processes, it is believed that BIBF 1120 has the potential to reduce disease progression, namely slowing the decline of lung function. BIBF 1120 is also in clinical development as a treatment option for cancer, including non-small cell lung cancer, ovarian cancer, colorectal cancer and hepatocellular carcinoma.

About Idiopathic Pulmonary Fibrosis

Idiopathic pulmonary fibrosis (IPF) is a progressive and severely debilitating lung disease with a high mortality rate, for which there are no approved treatments in the U.S. Research indicates that IPF affects approximately 100,000 Americans. IPF is characterized by inflammation and 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 and often have difficulty participating in everyday physical activities.

Leading Respiratory Forward

Boehringer Ingelheim has been a leader in developing therapies for chronic obstructive pulmonary disease for more than 20 years. Treatment of airway diseases has long been a major area of focus for Boehringer Ingelheim and significant resources are dedicated to research in this field. More recently, the Company has also branched out into developing treatment options for asthma, lung cancer, idiopathic pulmonary fibrosis and other respiratory diseases.

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.

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