Boehringer Ingelheim submits applications in Europe to extend the indication for the use of tiotropium Respimat® to the treatment of asthma in adults aged 18 years and over

• Data show that tiotropium Respimat® increased time to first severe exacerbation and first episode of asthma worsening in asthma patients who remain symptomatic despite at least ICS*/LABA^† therapy¹
• Despite current treatment options, at least 40% of patients with asthma remain symptomatic and may experience frightening and life-threatening asthma exacerbations (attacks)²
• The applications are supported by pivotal data from UniTinA-asthma® Phase III clinical trial programme, which involves more than 4,000 patients in over 150 study sites globally, and is addressing the unmet medical need of patients who remain symptomatic despite today’s therapies
• Tiotropium is already approved for the treatment of COPD, with comprehensive clinical trial data from more than 190 tiotropium COPD trials³

INGELHEIM, Germany, November 13, 2013 I Boehringer Ingelheim today announced submission of applications to extend the indication for the use of tiotropium (Spiriva®) Respimat® to the treatment of asthma in adults aged 18 years and over.

“Our extensive studies have demonstrated that tiotropium Respimat® has the potential to be an effective new treatment option which can provide benefits to, and improve outcomes for, adult patients with asthma.  Furthermore, we look forward to results from the paediatric UniTinA-asthma® Phase III studies which are anticipated to become available in 2014,⁴” said Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim.”At least 40% of patients with asthma remain symptomatic and may experience frightening and life-threatening asthma exacerbations (attacks), despite using the available therapeutic options, and we believe that tiotropium, once approved, can help address this clear unmet medical need,” Professor Dugi continued.The European Marketing Authorisation (MA) applications for tiotropium Respimat® are based on results from the UniTinA-asthma® Phase III clinical trial programme which involves more than 4,000 patients in over 150 sites globally.The UniTinA-asthma® clinical trial programme was designed to evaluate the efficacy and safety of tiotropium Respimat® in patients with asthma. UniTinA-asthma® programme includes a total of 11 Phase III studies investigating tiotropium Respimat® added to standard treatment in adults, adolescents and children (age 1+) with persistent asthma across the spectrum of asthma severity.⁵

The first data to come from the UniTinA-asthma® Phase III clinical trial programme were the PrimoTinA-asthma® studies, which demonstrated the efficacy and safety of tiotropium in asthma patients who remained symptomatic despite treatment with at least ICS/LABA therapy.¹ Data from the PrimoTinA-asthma® studies, which have since been published in the New England Journal of Medicine, showed that the addition of tiotropium Respimat® significantly increased time to first severe asthma exacerbation, as well as time to first episode of asthma worsening compared with placebo (standard treatment).¹Data from the MezzoTinA-asthma® Phase III twin studies, which were presented for the first time at the European Respiratory Society (ERS) Annual Congress (7-11 September 2013), were also included in the European MA applications for tiotropium Respimat® in asthma.^6,7 The MezzoTinA-asthma® Phase III twin studies showed that, in asthma patients who remain symptomatic despite moderate-dose maintenance ICS therapy, the addition of tiotropium Respimat® significantly improves lung function, provides sustained bronchodilation over 24 hours and provides a statistically significant and clinically relevant improvement in asthma control.^6,7Tiotropium is already approved for the treatment of COPD, with comprehensive clinical trial data from more than 190 tiotropium COPD trials.³ In-market experience with tiotropium since its introduction via HandiHaler® 10 years ago includes more than 31 million patient-years of real life experience‡ to support its efficacy and safety profile.⁹

Notes to editorsImportant Notice: Tiotropium Respimat® is currently NOT APPROVED for use in asthma. Tiotropium’s safety and efficacy have not yet been fully established in asthma.About UniTinA-Asthma®
UniTinA-asthma®, which includes the PrimoTinA-asthma® and MezzoTinA-asthma® studies, is a large international Phase III clinical trial programme designed to establish the efficacy and safety of tiotropium Respimat® in patients with asthma.The UniTinA-asthma® programme consists of a total of 11 studies investigating tiotropium Respimat® added to usual care in adults, adolescents and and children (age 1+) with persistent asthma across the spectrum of asthma severities. The UniTinA-asthma® programme, which involves more than 4,000 patients in over 150 sites globally, is addressing the unmet medical need of patients who remain symptomatic despite today’s therapies.About Asthma
Asthma is a chronic disorder of the airways characterised by airway inflammation and bronchoconstriction, leading to limited airflow into and out of the lungs and an increased production of mucus.¹⁰When a person with asthma comes into contact with an asthma trigger (e.g. viral infection, pollen, smoke), their airways can become more inflamed, swollen and constricted and produce excess mucus. These reactions cause the airways to become narrower and irritated, making it difficult to breathe.¹⁰People suffering from asthma experience recurrent episodes of wheezing, breathlessness, chest tightness and coughing.¹⁰ These episodes may be punctuated by periods of more severe and sustained deterioration in the management of symptoms, termed an asthma exacerbation or asthma attack.¹⁰Estimates of the numbers of people affected by asthma worldwide vary from 100 to 300 million.^11-13 The prevalence of asthma is highest in industrialised countries. Worldwide, approximately 180,000 deaths are attributable to asthma each year,¹¹ although there is considerable regional variation in mortality rates.¹⁴The economic costs associated with asthma are estimated to rank as one of the highest among chronic diseases. Globally, the economic costs associated with asthma exceed those of tuberculosis and HIV/AIDS combined.¹¹ Developed economies can expect to spend up to 2% of their healthcare budget on asthma.¹⁵Avoiding asthma triggers can help to reduce the severity of asthma. Although asthma cannot be cured, appropriate management can control the disease and enable people to enjoy a good quality of life. However, epidemiological data have shown that, despite treatment, at least 40% of adults with asthma remain symptomatic, which could result in lifestyle restrictions, and might even require emergency care.² These patients could benefit from new treatment options.´About tiotropium (Spiriva^®)
Tiotropium is a long-acting inhaled anticholinergic bronchodilator and was the first inhaled maintenance treatment to provide significant and sustained improvements in lung function in COPD patients with once-daily dosing. Tiotropium works by opening narrowed airways and helping to keep them open for 24 hours.The tiotropium in asthma clinical development programme is being jointly developed by Boehringer Ingelheim and Pfizer with Boehringer Ingelheim managing the operations for all clinical development activities. The existing alliance contract between Boehringer Ingelheim and Pfizer allows for commercialisation by both companies.About Respimat® Soft Mist^TM Inhaler
Developed by Boehringer Ingelheim, Respimat® Soft Mist^TM Inhaler (SMI) is a new generation inhaler delivering a unique Soft Mist^TM16,17 that is easy to inhale,¹⁸ and is preferred by patients compared to other currently available inhalers.^19-20