Boehringer Ingelheim to present comprehensive data supporting broad respiratory portfolio in COPD, asthma and IPF at ERS 2014

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  • First presentation of positive results from pivotal, Phase III TONADO™ studies that supported recent regulatory submissions in Europe and US for tiotropium + olodaterol Respimat®* in COPD - the only fixed-dose combination (FDC) containing tiotropium
  • Data further confirming role of Spiriva® in delivering long-term benefits to COPD patients and in helping to establish COPD management strategy
  • Pooled Phase III data from large UniTinA-asthma® clinical trial programme showing improvement in both symptom control and risk of exacerbations across asthma severities by adding tiotropium Respimat® to at least maintenance inhaled corticosteroid (ICS) therapy
  • Further analyses of the INPULSISTM Phase III trials confirming the robustness of the primary and key secondary endpoint results for nintedanib in IPF. An additional pre-specified subgroup analysis showing similar effects of nintedanib in slowing disease progression, independent of severity of lung function impairment at baseline will also be presented
  • A total of 18 abstracts with key data across COPD, asthma and IPF will be presented

Ingelheim, Germany, 1 September 2014 – The European Respiratory Society (ERS) International Congress, in Munich, Germany, September 6-10, 2014 sets the scene for important announcements across the substantial Boehringer Ingelheim respiratory portfolio. Data to be presented cover new advances in chronic obstructive pulmonary disease (COPD) treatment approaches, further supporting data for tiotropium Respimat® in asthma and rare disease insights for idiopathic pulmonary fibrosis (IPF).

With a total of 18 abstracts presented during ERS 2014, the data will highlight the importance of the company’s focus on respiratory research and advances in addressing unmet needs for patients living with certain lung diseases. Further detailed presentations and information will be provided in two media briefings during the congress.

COPD:Tiotropium + olodaterol Respimat® FDCand Spiriva® (tiotropium)
For the first time, data from the pivotal, 52-week TONADO™ Phase III studies§ involving more than 5,000 patients with COPD will be presented. The TONADO™ studies compared clinical outcomes in patients receiving tiotropium + olodaterol FDC delivered via the Respimat® Soft Mist Inhaler with those on tiotropium or olodaterol (Striverdi®) alone. The data from the TONADO™ studies formed a major part of Boehringer Ingelheim’s recent regulatory submissions in Europe and the US for tiotropium + olodaterol Respimat® FDC in COPD.

These important advances are underpinned by in-depth analyses of Spiriva® clinical trials that demonstrate an extensive wealth of experience since its introduction over 10 years ago** and over 40 million patient-years of real life experience supporting its safety and efficacy.1-7

Further analysis of one of the largest COPD trials, TIOSPIR™, highlights the predictors of debilitating COPD exacerbations and reinforces the need to treat COPD patients early. Spiriva® has shown a positive impact on reducing the risk of these lung attacks across a broad range of severities of COPD patients.††,3,6,8

Tiotropium Respimat®in asthma
Further highlights from the accepted ERS abstracts include studies looking at the impact of adding tiotropium Respimat® to at least ICS maintenance therapy on improving symptom control and reducing the risk of exacerbations across asthma severities. Using results pooled from the large UniTinA-asthma® international Phase III clinical trial programme including the PrimoTinA-asthma®, MezzoTinA-asthma® and GraziaTinA-asthma® trials, these new data will add to existing evidence that has shown the efficacy and safety of tiotropium Respimat® in patients with asthma who continue to experience symptoms despite treatment with at least ICS with or without LABA therapy. Despite current treatment options, almost one in two patients with asthma still have asthma symptoms9,10,11 and may experience frightening and life-threatening asthma exacerbations.

Idiopathic Pulmonary Fibrosis (IPF)
Abstracts to be presented at ERS show further data from the two Phase III INPULSISTM trials, investigating nintedanib 150 mg twice daily in the treatment of IPF.12 The primary endpoint was the annual rate of decline in forced vital capacity (FVC).12 Key secondary endpoints were: change from baseline in health-related quality of life, as assessed by the Saint-George’s Respiratory Questionnaire (SGRQ) and time to first acute exacerbation.12 The robustness of the primary and key secondary endpoint results is supported by sensitivity analyses.13

A pre-specified subgroup analysis of pooled data from the INPULSIS™ trials showed that nintedanib 150 mg twice daily slowed the decline in lung function in patients with IPF, independent of severity of lung function impairment at baseline.14 In addition, nintedanib reduced the proportion of patients with IPF who experienced disease progression as measured by categorical FVC decline.15

About the European Respiratory Society International Congress
The European Respiratory Society International Congress is the largest respiratory meeting in the world and is an important platform for professional exchange. Abstracts submitted to ERS can be accessed through the ERS website, http://www.erscongress.org/. Key sessions are highlighted below. If you would like to know more about planned Boehringer Ingelheim media activities at ERS, please contact Kristin Jakobs, Boehringer Ingelheim, Corporate Communications, Media + PR: press@boehringer-ingelheim.com or visit the online resource for journalists www.newshome.com


Tiotropium + olodaterol Respimat® FDC
The FDC of tiotropium + olodaterol is being investigated to determine its efficacy and safety in treating patients with COPD and has not been approved for clinical use.


Title Lead Author Presentation Details
Once-daily tiotropium and olodaterol fixed-dose combination via the Respimat® improves outcomes vs mono-components in COPD in two 1-year studies R Buhl Session: Oral presentation: Bronchodilators for asthma and COPD
Location: Room A2-2
Session time: 10:45-12:45
Date: Monday 8 September 2014


Safety of once-daily tiotropium and olodaterol fixed-dose combination via the Respimat® in chronic obstructive pulmonary disease in two 1-year studies R Buhl Session: Thematic poster presentation: Asthma and COPD devices and treatments
Location: Hall B2-22
Session time: 12:50-14:40
Date: Sunday 7 September 2014


Effects of 12 weeks of once-daily tiotropium and olodaterol fixed-dose combination on exercise endurance in patients with COPD F Mailtais            

Session: Poster discussion: Clinical trials of drugs and biomarkers for respiratory diseases
Location: Room A2-3
Session time: 08:30-10:30
Date:
Sunday 7 September 2014

Spiriva® (tiotropium)

Title Lead Author      Presentation Details
Evaluating the cardiac safety of tiotropium in patients with COPD: combined analysis of Holter-ECG data from four trials ED Bateman Session: Poster Discussion: Clinical trials of drugs and biomarkers for respiratory diseases
Location: Room A2-3
Session time: 08:30–10:30
Date: Sunday 7 September 2014


Tiotropium Respimat®: Comparison of bronchodilator efficacy of 5 µg and 2.5 µg doses P Calverley Session: Thematic Poster Session: Asthma and COPD devices and treatments
Location: Hall B2-22
Session time: 12:50-14:40
Date: Sunday 7 September 2014


Mixed treatment analysis comparing tiotropium HandiHaler® and Respimat® R Dahl Session: Thematic Poster Session: Asthma and COPD devices and treatments
Location: Hall B2-22
Session time: 12:50-14:40
Date: Sunday 7 September 2014


Safety of tiotropium in renally impaired patients D Tashkin Session: Thematic Poster Session: Asthma and COPD devices and treatments
Location: Hall B2-22
Session time: 12:50-14:40
Date:
Sunday 7 September 2014

Exacerbator subtypes in the tiotropium safety and performance in Respimat® (TIOSPIR™) trial P Calverley Session: Thematic Poster Session: New clinical evidence for asthma and COPD treatments
Location: Hall B2-22
Session time: 12:50-14:40
Date:
Monday 8 September 2014

Prognostic factors of mortality and cardiovascular outcomes in the tiotropium safety and performance in Respimat® (TIOSPIR™) trial R Dahl Session: Thematic Poster Session: New clinical evidence for asthma and COPD treatments
Location: Hall B2-22
Session time: 12:50-14:40
Date: Monday 8 September 2014


The impact of stepwise withdrawal of inhaled corticosteroids on exacerbations in COPD patients receiving dual bronchodilation: WISDOM study H Magnussen Session: Oral presentation: Bronchodilators for asthma and COPD
Location: Room A2-2
Session time: 10:45-12:45
Date:
Monday 8 September 2014

The impact of stepwise withdrawal of inhaled corticosteroids on exacerbations in COPD patients receiving dual bronchodilation: WISDOM study H Magnussen Session: Thematic poster session: New clinical evidence for asthma and COPD treatments
Location: Hall B2-22
Session time: 12:50-14:40
Date: Monday 8 September 2014


Keynote lecture: Presentation of the WISDOM study ‘ICS withdrawal on exacerbations in patients with severe COPD’ H Magnussen Session: Oral presentation: COPD - from biomarkers to novel therapeutic opportunities
Location: Room A2-2
Session time: 10:45-12:45
Date: Tuesday 9 September 2014


Tiotropium Respimat® in asthma
Tiotropium Respimat® for use in asthma is currently being reviewed by regulatory authorities; it is approved as Spiriva® Respimat® for use in asthma in Chile, Colombia, Ecuador, Russia, and Thailand.


Title Lead Author Presentation Details
Once-daily tiotropium Respimat® add-on to ICS±LABA improves control across asthma severities JM FitzGerald       Session: Oral presentation: Bronchodilators for asthma and COPD
Location: Room A2-2
Session time: 10:45-12:45
Date: Monday 8 September 2014


 
Once-daily tiotropium Respimat® add-on to at least ICS maintenance therapy reduces exacerbation risk in patients with uncontrolled symptomatic asthma D Halpin          

Session: Thematic poster session: New clinical evidence for asthma and COPD treatments
Location: Room B2-22
Session time: 12:50-14:40
Date: Monday 8 September 2014


1-year efficacy and safety study of tiotropium Respimat® add-on to ICS in adolescent patients with symptomatic asthma A Boner Session: Oral presentation: Bronchodilators for asthma and COPD
Location: Room A2-2
Session time: 10:45-12:45
Date:
Monday 8 September 2014

Once-daily tiotropium Respimat® add-on to at least ICS in adult patients with symptomatic asthma: pooled safety analysis D Dusser Session: Thematic poster session: Asthma and COPD management
Location: Hall B2-21
Session time: 12:50-14:40
Date: Sunday 7 September 2014


Nintedanib

Nintedanib is being investigated to determine its efficacy and safety in treating patients with IPF and is not approved for this indication

Title Lead Author Presentation Details
Nintedanib (BIBF 1120) prevents TGF-β-induced pro-fibrotic effects in primary human lung myofibroblasts derived from patients with idiopathic pulmonary fibrosis K Hostettler            Session: Thematic Poster Session: ILDs: 1
Location: Hall B2-13
Session time: 12:50-14:40
Date: Sunday 7 September 2014


Reduction in disease progression with nintedanib in INPULSISTM trials V Cottin Session: Oral Presentation: Clinical trials in IPF
Location: Room A1-2
Session time: 10:45-12:45
Presentation time: 11:45
Date: Monday 8 September 2014



Effect of baseline FVC on decline in lung function with nintedanib: Results from the INPULSISTM trials U Costabel Session: Oral Presentation: Clinical trials in IPF
Location: Room A1-2
Session time: 10:45-12:45
Presentation time: 12:00
Date: Monday 8 September 2014



Sensitivity analyses from the INPULSISTM trials of nintedanib M Kolb Session: Oral Presentation: Clinical trials in IPF
Location: Room A1-2
Session time: 10:45-12:45
Presentation time: 12:15
Date:
Monday 8 September 2014


Nintedanib prevents IL-1β-stimulated proliferation of primary human lung fibroblasts from patients with idiopathic pulmonary fibrosis or from control donors F Herrmann Session: Poster Discussion: ILDs: pathogenesis and clinical features
Location: Room A2-3
Session time: 10:45-12:45
Date: Tuesday 9 September 2014


* The fixed-dose combination of tiotropium + olodaterol is an investigational    treatment. Its safety and efficacy have not yet been fully established.
Tiotropium Respimat® for use in asthma is currently being reviewed by regulatory authorities;  it is approved as Spiriva® Respimat® for use in asthma in Chile, Colombia, Ecuador, Russia, and Thailand.
Nintedanib is an investigational compound. Its safety and efficacy has not yet been fully established.


§  TONADO™ consists of two replicate Phase III studies called TONADO™ 1&2
**18 µg delivered via HandiHaler®
††While Spiriva® 18 µg via HandiHaler® did not alter the rate of decline in lung function, a coprimary endpoint in the UPLIFT® study, it sustained greater improvements in lung function vs. placebo


Nintedanib is an investigational compound. Its safety and efficacy has not yet been fully established.

Leading Respiratory Forward

Through research, treatments and patient-centric support services, the Boehringer Ingelheim (BI) respiratory 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.

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 142 affiliates and a total of more than 47,400 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.

Taking social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative “Making more Health” and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.

In 2013, Boehringer Ingelheim achieved net sales of about 14.1 billion euros. R&D expenditure corresponds to 19.5% of its net sales.
For more information please visit www.boehringer-ingelheim.com













References

1 Boehringer Ingelheim. Data on file.
2 Wise RA, Anzueto A, Cotton D, et al. Tiotropium Respimat Inhaler and the Risk of Death in COPD: The TIOSPIR Trial. N Engl J Med 2013;369(16):1491-501.
3 Casaburi R, Mahler DA, Jones PW, et al. A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease. Eur Respir J 2002;19:217-24.
4 Anzueto A, Tashkin D, Menjoge S, et al. One-year analysis of longitudinal changes in spirometry in patients with COPD receiving tiotropium. Pulm Pharmacol Ther 2005;18:75-81.
5 Celli B, ZuWallack R, Wang S, et al. Improvement in resting inspiratory capacity and hyperinflation with tiotropium in COPD patients with increased static lung volumes. Chest 2003;124:1743-8
6 Tashkin DP, Celli B, Senn S, et al. On behalf of the UPLIFT® (Understanding Potential Long-term Impacts on Function with Tiotropium) study investigators. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med 2008;359:1543-54.
7 Bateman E, Tashkin D, Siafakas N, et al. The one-year trial of tiotropium Respimat plus usual therapy in COPD patients. Respir Med 2010; 104: 1460-1472.
8 Vogelmeier C, Hederer B, Glaab T, et al. Tiotropium versus salmeterol for the prevention of exacerbations of COPD. N Engl J Med 2011;364:1093-103.
9 Bateman ED, Boushey HA, Bousquet J, et al. GOAL Investigators Group. Can guideline-defined asthma control be achieved? The Gaining Optimal Asthma ControL study. Am J Respir Crit Care Med. 2004; 170 (8): 836-844.
10Partridge MR, Dal Negro RW, Olivieri D. Understanding patients with asthma and COPD: insights from a European study. Prim Care Respir J 2011; 20 (3): 315-323.
11Demoly P, Paggiaro P, Plaza V, et al. Prevalence of asthma control among adults in France, Germany, Italy, Spain and the UK. Eur Respir Rev 2009; 18: (112): 105–112.
12Richeldi L, du Bois RM, Raghu G, et al. Efficacy and Safety of Nintedanib in Idiopathic Pulmonary Fibrosis. N Engl J Med. 2014 May 29;370(22):2071-82.
13Kolb M, Collard HR, Stowasser S, et al., Sensitivity analyses from the INPULSIS™ trials of nintedanib. Data to be presented at ERS International Congress, Sept 2014.
14Costabel U, Inoue Y, Richeldi L, et al., Effect of baseline FVC on decline in lung function with nintedanib: results from the INPULSIS™ trials. Data to be presented at ERS International Congress, Sept 2014.
15Cottin V, Taniguchi H, Collard HR, et al., Reduction in disease progression with nintedanib in the INPULSIS™ trials. Data to be presented at ERS International Congress, Sept 2014.













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