New Data Provides Further Evidence of Lung Function Improvements in Severe Asthma with Tiotropium Delivered via the Respimat^® Inhaler

Ridgefield, CT, October 28, 2013 – Boehringer Ingelheim today presented the latest data for tiotropium in asthma at the 2013 American College of Chest Physicians (ACCP) annual meeting (CHEST 2013) in Chicago. The CHEST session “Tiotropium and Asthma” features a total of four oral presentations from Phase 2 and 3 studies of tiotropium delivered via the Respimat^® inhaler in severe asthma patients. Tiotropium is currently being evaluated to determine the efficacy and safety in treating asthma patients and is not currently approved for this indication.

Pooled Phase 3 data being presented from the replicate PrimoTinA-asthma^® studies (NCT00772538 and NCT00776984) provide further evidence for tiotropium delivered via the Respimat^® inhaler as a possible add-on treatment for severe persistent asthma. Data presented at CHEST show that in adult asthma patients who remain symptomatic despite treatment with at least inhaled corticosteroids (ICS)/long-acting beta-2 agonists (LABA), tiotropium delivered via the Respimat^® inhaler reduced the risk of severe asthma exacerbations and any asthma exacerbation. These results add to data from the ongoing Phase 3 trial program that has previously shown positive results for tiotropium in severe asthma patients who remained symptomatic despite treatment with at least ICS/LABA.

"There is a serious unmet need for additional therapies for severe asthma patients who remain symptomatic and experience exacerbations despite current treatment," said Donald P. Tashkin, MD, emeritus professor of medicine, David Geffen School of Medicine at UCLA, Los Angeles, and lead author on one of the presentations. “The data being presented at CHEST add further evidence of the potential of tiotropium in treating severe symptomatic asthma.”

Asthma exacerbations (or attacks) occur in patients across all degrees of asthma severity and are an important cause of asthma-related morbidity and mortality.

“The CHEST session featuring four oral presentations communicating the clinical trial results of tiotropium, is a testament to the breadth and depth of our UniTinA-asthma^® program and the company’s leadership position in developing new therapies for lung diseases,” said Tunde Otulana, MD, senior vice president, Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “We at Boehringer Ingelheim are committed to developing new treatments for the growing number of asthma patients who remain symptomatic despite current therapy and are encouraged by these additional findings.”

24-hour Spirometry Data Presented at CHEST 2013
Spirometry pulmonary function tests were conducted to evaluate whether once-daily dosing resulted in sustained improvements in lung function over 24 hours. Data from these spirometry tests demonstrated that tiotropium delivered once daily via the Respimat^® inhaler showed statistically significant improvements in lung function versus placebo and were sustained over the 24 hour timeframe:

Additional Data Presented at CHEST 2013
A pooled analysis of adverse event (AE) data from the PrimoTinA-asthma^® studies was also presented. A lower percentage of patients in the tiotropium-treated group (73.5 percent, n=335) reported AEs versus placebo (80.3 percent, n=336) patients. The most commonly reported AEs by patients were asthma (tiotropium group: 39.9 percent, n=182; placebo group: 50.9 percent, n=232), peak expiratory flow (PEF) rate decrease (tiotropium group: 20.4 percent, n=93; placebo group: 26.8 percent, n=122) and nasopharyngitis (tiotropium group: 11.2 percent, n=51; placebo group: 12.3 percent, n=56).

In addition, Phase 3 data from the PrimoTinA-asthma^® studies and Phase 2 data (NCT00365560) of tiotropium delivered via the Respimat^® inhaler as add-on to ICS+LABA in severe symptomatic asthma patients were presented during the session at CHEST.

About the PrimoTinA-Asthma^® Phase 3 Studies
The PrimoTinA-asthma^® Phase 3 studies were two replicate double-blind, parallel group trials, which evaluated symptomatic adult patients with a confirmed diagnosis of severe persistent asthma of at least five-years duration, diagnosed before the age of 40 years, and either life-long non-smokers or ex-smokers (10 pack-years or less) who had quit smoking one or more years before study enrollment.

A total of 912 patients were randomized to receive tiotropium 5 µg once daily delivered via the Respimat^® inhaler (n=456) or placebo (n=456) for 48 weeks as add-on therapy to maintenance treatment with at least high dose ICS/LABA. In addition, patients in the trials were permitted to receive additional background therapy, including antihistamines, anti-allergic agents, nasal steroids and omalizumab.

The primary endpoints included peak and trough FEV₁ and time to first severe exacerbation (from the pooled study population). The frequency and profile of AEs reported by the tiotropium-treated group were similar to that of placebo. The most commonly reported AEs were asthma, PEF rate decrease, nasopharyngitis and headache.

About the UniTinA-Asthma^® Clinical Trial Program
The PrimoTinA-asthma^® studies are a part of the comprehensive Phase 3 trial program, UniTinA-asthma^®, which includes a number of clinical trials in adults, adolescents and pediatric patients across different asthma severities who remain symptomatic on current treatment with ICS. The program includes over 4,000 patients in more than 150 sites globally. Results from the PrimoTinA-asthma^® studies in severe asthma patients were presented at the 2012 European Respiratory Society (ERS) Annual Congress in Vienna, Austria, with additional sub-analyses presented at the 2013 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting, the 2013 American Thoracic Society (ATS) International Conference and the ERS Annual Congress 2013.

About Asthma
Asthma is a chronic disease characterized by airway inflammation and bronchoconstriction. When a person with asthma comes into contact with an asthma trigger (e.g. infections, pollen, smoke), their airways can become inflamed, swollen and constricted and excess mucus is produced. These reactions can cause the airways to become narrower and irritated, making it difficult to breathe. People suffering from asthma experience recurrent episodes of wheezing, breathlessness, chest tightness and coughing. Asthma attacks occur when symptoms become more intense or frequent.

As of December 2012, an estimated 300 million people worldwide suffer from asthma. Estimates have shown that the number of people with asthma could grow by an additional 100 million people worldwide by 2025.

By avoiding asthma triggers, one can help to reduce the severity of asthma. Although asthma cannot be cured, appropriate management can control the disease in many patients. Despite current treatment options, approximately 40 percent of patients with asthma remain symptomatic.

Leading Respiratory Forward
Through research, treatments and patient-centric support services, the Boehringer Ingelheim (BI) lung health portfolio is designed to help address the challenges people living with a lung disease face every day. Leveraging the company’s cutting edge science and leadership in chronic obstructive pulmonary disease (COPD), BI is researching new treatment approaches where needs persist. It is the company’s goal to make a difference in the lives of patients with COPD, 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 140 affiliates and more than 46,000 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 2012, Boehringer Ingelheim achieved net sales of about $19.1 billion (14.7 billion euro). R&D expenditure in the business area Prescription Medicines corresponds to 22.5% of its net sales.

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

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