Boehringer Ingelheim Presents Phase 3 Sub-Analyses for Tiotropium Across a Range of Symptomatic Asthma Patients at ATS 2013

Ridgefield, CT, May 21, 2013 – Boehringer Ingelheim today announced data from Phase 2 and Phase 3 studies from the Company’s ongoing clinical trial program investigating the efficacy and safety of tiotropium in asthma. These data were presented at the American Thoracic Society International Conference (ATS 2013) in Philadelphia, Pennsylvania.

To determine whether the effect on bronchodilation and time to first severe exacerbation seen in severe asthma patients in the two Phase 3 PrimoTinA-asthma^™ studies was limited to definable subgroups of patients, pre-planned subgroup analyses of the data were carried out. The PrimoTinA-asthma^™ studies were replicate trials evaluating once-daily tiotropium delivered via the Respimat^® inhaler in patients with severe persistent asthma.

The pre-planned subgroup analyses demonstrated that tiotropium delivered once daily via the Respimat^® inhaler showed promising results across a broad spectrum of patients with severe persistent asthma who remained symptomatic and experienced exacerbations despite current treatment with at least high-dose inhaled corticosteroids (ICS) and/or long-acting beta2 agonists (LABA).

"These analyses show that the results for time to first severe exacerbation and first episode of asthma worsening found with the addition of tiotropium may not be limited to specific subgroups of patients," said Professor Huib A. M. Kerstjens of the University Medical Centre, Groningen, The Netherlands, and one of the main authors on the presented studies. “Asthma affects patients with all kinds of medical histories and backgrounds. These results suggest tiotropium’s promise independent of patients’ baseline characteristics, providing an important clinical insight into tiotropium’s potential in asthma treatment.”

Neither the time to first severe exacerbation nor the time to first episode of asthma worsening was dependent on baseline characteristics, some of which are usually found in patients with chronic obstructive pulmonary disease (COPD), such as former smoking, non-allergic status or minimal bronchodilator response.

It was also important to investigate whether patients included in the PrimoTinA-asthma^™ Phase 3 studies were identified to have asthma alone and not comorbid COPD.

In a separate study presented at ATS, further analysis of the PrimoTinA-asthma^™ data suggested that improvements in lung function seen in the Phase 3 studies were related to tiotropium’s potential role in asthma and not due to comorbid COPD diagnosis, as strict criteria were used to ensure patients enrolled in the studies had a confirmed diagnosis of asthma and that patients with COPD were excluded.

“Despite current treatment options, approximately 40 percent of people with asthma remain symptomatic and may experience life-threatening asthma exacerbations,” said Tunde Otulana, MD, acting head, Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “Finding new advancements for the growing number of people affected by asthma remains one of Boehringer Ingelheim’s priorities, and we are encouraged to see additional data reinforcing tiotropium’s potential as an additional treatment option for asthma patients who remain symptomatic on current therapies.”

About the PrimoTinA-Asthma^TM Phase 3 Studies
The PrimoTinA-asthma^™ Phase 3 studies were two replicate double-blind, parallel group trials including asthma patients aged 18-75 years, with at least a five-year history of asthma, diagnosed before the age of 40 years, and life-long non-smokers or ex-smokers (10 pack-years or less) who quit smoking one or more years before study enrollment.

A total of 912 patients were randomized to receive tiotropium 5 µg delivered via the Respimat^® inhaler (n=256) or placebo (n=256) for 48 weeks. In addition to ICS/LABA, 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 forced expiratory volume (FEV₁) and time to first severe exacerbation. In these studies, the rate of adverse events (AEs) reported in the tiotropium add-on and placebo add-on groups was similar. The most commonly reported AEs were asthma, peak expiratory flow (PEF) rate decrease, nasopharyngitis and headache.

Additional Data Presented at ATS 2013
In addition to the PrimoTinA-asthma^™ data, Boehringer Ingeheim presented data investigating tiotropium in adult patients with moderate persistent asthma. Results from a Phase 2 double-blind, randomized, placebo-controlled, four-way crossover study with no washout periods revealed all three doses of tiotropium (1.25, 2.5 and 5 µg) as an add-on therapy to ICS in symptomatic patients with moderate persistent asthma were statistically different (P < 0.0001) from placebo for the primary endpoint FEV₁peak_(0-3h). The most promising once-daily tiotropium dose was 5 µg delivered via the Respimat^® inhaler. The overall incidence of AEs was comparable between placebo and the three tiotropium doses, and serious adverse events were rare and considered unrelated to treatment. The most commonly reported AEs were asthma and nasopharyngitis.

Tiotropium is being investigated to determine its efficacy and safety in treating asthma patients and is not currently approved for this indication.

About the UniTinA-Asthma^TM Clinical Trial Program
The PrimoTinA-asthma^™ studies are a part of the comprehensive Phase 3 trial program UniTinA-asthma^™, which includes 18 clinical trials in adults, adolescents and pediatric patients across different asthma severities who remain symptomatic on current treatment with inhaled corticosteroids. The program includes more than 4,000 patients in 150+ sites globally.

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. However, many patients still suffer from uncontrolled asthma despite the available treatment options. They can continue to have symptoms and lifestyle restrictions and might even require emergency care. 

Leading Respiratory Forward
Through research, treatments and patient-centric support services, the Boehringer Ingelheim 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), Boehringer Ingelheim 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.

As a central element of its culture, Boehringer Ingelheim has a demonstrated commitment to corporate social responsibility. 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 www.us.boehringer-ingelheim.com