Boehringer Ingelheim to present highly anticipated Phase III data in IPF and COPD at ATS International Conference

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•First results of the two confirmatory Phase III INPULSISTM trials investigating the efficacy and safety of nintedanib* in the treatment of idiopathic pulmonary fibrosis (IPF)

•COPD: First Phase III results presented from the TOviTOTM trial programme for tiotropium + olodaterol fixed-dose combination (tiotropium + olodaterol FDC*)

•In total 14 abstracts with key data across IPF, COPD and asthma will be presented

For media outside UK, U.S. and Canada

Ingelheim, Germany, 30 April 2014 – Boehringer Ingelheim announced today that the first results of the two confirmatory Phase III INPULSISTM trials, investigating nintedanib* in the treatment of idiopathic pulmonary fibrosis (IPF), will be presented at the 2014 American Thoracic Society (ATS) International Conference taking place 16 – 21 May in San Diego. IPF is a rare, debilitating and fatal lung disease for which treatment options are limited.

The first Phase III trial results to be released from the TOviTOTM programme, investigating the once-daily fixed-dose combination of tiotropium + olodaterol in patients with chronic obstructive pulmonary disease (COPD) will also be presented. Despite available management options, many patients with COPD continue to experience symptoms which impact their quality of life, highlighting the need for new and innovative treatments.

In total 14 abstracts submitted by Boehringer Ingelheim have been accepted for presentation at ATS. The extensive data being presented highlights the company’s leadership in pioneering innovative respiratory therapies to treat life-threatening lung diseases.

"We are excited to present the first Phase III data for tiotropium + olodaterol FDC which marks another important milestone in our goal of developing innovative therapies to address the unmet medical needs in COPD," said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim. "Leveraging our extensive heritage and expertise in the Respiratory Therapeutic Area, Boehringer Ingelheim is expanding into further chronic respiratory areas, including rare diseases where few treatment options exist. We are dedicated to our research in idiopathic pulmonary fibrosis, which is a progressive and deadly condition but still is relatively unknown. We look forward to presenting the pivotal Phase III data in San Diego."

Boehringer Ingelheim's abstracts in respiratory research can be accessed through the ATS website, http://conference.thoracic.org. The data will remain under embargo until the date and time that the data are presented (details below).

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


 

Efficacy And Safety Of Nintedanib* In Patients With Idiopathic Pulmonary Fibrosis: Results Of Two 52-
Week, Phase III, Randomized, Placebo-Controlled Trials (INPULSIS™)
L. Richeldi Late-Breaking Presentation
Mini Symposium # A95
Date: May 20, 2014
Presentation Time: 14:00 – 16:30 PM PT
Room: Ballroom 20 B-C (Upper Level)



Nintedanib* attenuates motility of lung fibroblasts from patients with IPF (pre-clinical) L. Wollin Poster Board # C67
Date: May 18, 2014
Session Time: 8:15 AM – 4:30 PM PT
Poster Viewing: 10:45 AM – 12:30 PM PT
Room: Area C (Hall B2-C, Ground Level)



Tiotropium+Olodaterol FDC*
The fixed-dose combination of tiotropium + olodaterol delivered via the Respimat® inhaler is currently being investigated as a once-daily maintenance treatment for patients with COPD.


 

The 24-Hour Lung Function Profile of Once-Daily Tiotropium and Olodaterol Fixed-Dose Combination Compared with Placebo and Monotherapies in Chronic Obstructive Pulmonary Disease E. Derom Late-Breaking Presentation
Poster board #A148
Date: May 21, 2014
Session Time: 8:15 AM – 4:30 PM PT
Poster Viewing: 10:45 AM – 12:30 PM PT
Room: : Area A (Hall B2-C, Ground Level)




SPIRIVA® (tiotropium bromide)
Tiotropium bromide inhalation powder is a once-daily long-acting inhaled muscarinic antagonist (LAMA) indicated for both the maintenance treatment of bronchospasm (narrowing of the airways) associated with COPD, including chronic bronchitis and emphysema, and to reduce exacerbations.


 

Effects of tiotropium and salmeterol in COPD patients with low or high risk of exacerbations: a post-hoc analysis from the POET-COPD® trial C. Vogelmeier Poster Board # A22
Date: May 19, 2014
Session Time: 8:15 AM - 4:30 PM PT
Poster Viewing: 10:45AM -12:30PM PT
Room: Area A (Hall B2-C, Ground Level)



Effect size of open-label versus double-blind administration of tiotropium in trials investigating health-related quality of life in COPD H. Schmidt Poster Board # A98
Date: May 21, 2014
Session Time: 8:15 AM - 4:30 PM PT
Poster Viewing: 10:45AM -12:30PM PT
Room: Area A (Hall B2-C, Ground Level)



Risk of cardiovascular mortality in COPD using the new GOLD classification: Data from the Tiotropium Safety and Performance in Respimat (TIOSPIR™) study D. Dusser Poster Board # 421
Date: May 18, 2014
Session Time: 8:15 AM – 10:45 AM PT
Poster Viewing: 8:15 AM – 9:15 AM PT
Discussion: 9:15 AM – 10:45 AM PT
Room: Room 8 (Upper Level)




Effects of tiotropium on exacerbations in patients with COPD with low or high risk of exacerbations: a post-hoc analysis from the 4-year UPLIFT® trial B. Celli Poster Board # A28
Date: May 19, 2014
Session Time: 8:15 AM - 4:30 PM PT
Poster Viewing: 10:45AM -12:30PM PT
Room: Area A (Hall B2-C, Ground Level)



Tiotropium HandiHaler® and Respimat® in COPD: a safety analysis on pooled data D. Halpin Poster Board # A100
Date: May 21, 2014
Session Time: 8:15 AM - 4:30 PM PT
Poster Viewing: 10:45AM -12:30PM PT
Room: Area A (Hall B2-C, Ground Level)



Efficacy And Safety Of Tiotropium In Patients With Chronic Obstructive Pulmonary Disease (COPD) Experiencing An Acute Respiratory Tract Infection E. Clerisme-Beaty Poster Board # A132
Date: May 21, 2014
Session Time: 8:15 AM - 4:30 PM PT
Poster Viewing: 10:45AM -12:30PM PT
Room: Area A (Hall B2-C, Ground Level)



Striverdi® Respimat® (Olodaterol)
Olodaterol, which is marketed as Striverdi® Respimat® in the European Union by Boehringer Ingelheim, and is under review by the Food and Drug Administration in the United States, is a once-daily, fast-acting and long-lasting bronchodilator (LABA), which has been specifically developed as the preferred combination partner to SPIRIVA® (tiotropium) to provide added benefit for patients with COPD.


 

PK/PD and safety analysis of a single dose of olodaterol (30 µg administered via the Respimat® Soft Mist™ inhaler) in patients with severe renal impairment L. Groenke Poster Board # A102
Date: May 21, 2014
Session Time: 8:15am – 4:30pm PT
Poster Viewing: 10:45am – 12:30pm PT
Room: Area A (Hall B2-C, Ground Level)



PK/PD and safety analysis of a single dose of olodaterol administered via the Respimat® Soft Mist™ inhaler in patients with mild and moderate liver impairment L. Groenke Poster Board # 406
Date: May 19, 2014
Session Time: 2:00pm – 4:30pm PT
Poster Viewing: 2:00pm – 3:00pm PT
Discussions: 3:00pm – 4:30pm PT
Room: 8 (Upper Level)




Tiotropium Respimat®* in asthma
Tiotropium Respimat® is being investigated in asthma to assess its efficacy and safety as add-on treatment for adult patients who are symptomatic on at least inhaled corticosteroids (ICS)/long-acting beta-2 agonist (LABA) therapy (current standard treatment).


 

Once-daily tiotropium Respimat® is well tolerated and efficacious over 52 weeks in Japanese patients with symptomatic asthma receiving inhaled corticosteroids (ICS) ± long-acting ß2-agonist (LABA): a randomized, double-blind, placebo-controlled study T. Ohta Poster Board # B30
Date: May 18, 2014
Session Time: 8:15am – 4:30pm PT
Poster Viewing: 10:45am – 12:30pm PT
Room: Area B (Hall B2-C, Ground Level)



Tiotropium Respimat® in asthma: evaluation of dosing regimens by comparing once-daily 5 µg with twice-daily 2.5 µg R. Buhl Poster Board # B28
Date: May 18, 2014
Session Time: 8:15am – 4:30pm PT
Poster Viewing: 10:45am – 12:30pm PT
Room: Area B (Hall B2-C, Ground Level)



Tiotropium Respimat® add-on therapy to inhaled corticosteroids (ICS) + long-acting ß2-agonists (LABAs) in patients with symptomatic severe asthma: efficacy by level of airway obstruction HAM Kerstjens Poster Board # B31
Date: May 18, 2014
Session Time: 8:15am – 4:30pm PT
Poster Viewing: 10:45am – 12:30pm PT
Room: Area B (Hall B2-C, Ground Level)



About nintedanib*
Nintedanib* is an investigational small molecule tyrosine kinase inhibitor (TKI) in development by Boehringer Ingelheim for idiopathic pulmonary fibrosis (IPF).1 It targets growth factor receptors, which have been shown to be potentially involved in pathomechanisms of pulmonary fibrosis, most importantly the platelet-derived growth factor receptor (PDGFR), fibroblast growth factor receptor (FGFR) and vascular endothelial growth factor receptor (VEGFR).1,2,3 By blocking the signalling pathways that are involved in fibrotic processes, it is believed that nintedanib* has the potential to reduce disease progression in IPF by slowing the decline of lung function.1,2 Nintedanib* 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 Tiotropium+Olodaterol fixed dose combination *
Tiotropium+olodaterol FDC is a once-daily fixed-dose combination of the long-acting muscarinic antagonist (LAMA) tiotropium and the long-acting β2-agonist (LABA) olodaterol delivered by the Respimat® Soft Mist™ Inhaler. Tiotropium+olodaterol FDC delivered via the Respimat® inhaler is currently under investigation in the large-scale Phase III TOviTOTM trial programme as a once-daily maintenance treatment for patients with COPD. Results from the pivotal 52-week Phase III TONADO® 1&2 trials (part of TOviTOTM), investigating the long-term effect of tiotropium+olodaterol FDC on lung function and quality of life in patients with COPD, are due to report in 2014.

About Tiotropium Respimat® in Asthma*
Tiotropium Respimat® is an inhaled long-acting anticholingeric bronchodilator being investigated in asthma to assess its efficacy and safety as add-on treatment for adult patients who are symptomatic on at least inhaled corticosteroids (ICS)/long-acting beta-2 agonist (LABA) therapy (current standard treatment). The first data to come from the Phase III clinical trial programme, UniTinA-asthma®, 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. Data from the PrimoTinA-asthma® studies have since been published in the New England Journal of Medicine.4

About Striverdi® Respimat® (Olodaterol)
Olodaterol (Striverdi®) is a once-daily, fast-acting and long-lasting bronchodilator (LABA), which has been specifically developed as the preferred combination partner to tiotropium (Spiriva®) to provide added benefit for patients with COPD. Large-scale, phase III studies have shown that once-daily Striverdi® Respimat® monotherapy provides significant bronchodilator effects to patients within 5 minutes after the first dose and provides sustained improvement in lung function over 24 hours.5,6,7,8

About SPIRIVA® (tiotropium bromide) in COPD
SPIRIVA®, a long-acting anticholinergic medication, is the first inhaled maintenance treatment to provide significant and sustained improvements in lung function with once-daily dosing. SPIRIVA® positively impacts the clinical course of COPD, helping to change the way patients live with their disease.9 It is the most prescribed maintenance therapy for COPD worldwide.10 SPIRIVA® helps COPD patients breathe more easily by opening narrowed airways and helping to keep them open for 24 hours. SPIRIVA® works through targeting of a dominant reversible mechanism of COPD – cholinergic bronchoconstriction.

SPIRIVA® is delivered via HandiHaler®, a breath-actuated, single-dose dry powder inhaler, or by SPIRIVA® Respimat® Soft Mist Inhaler™ propellant-free, new generation inhaler that combines innovative technology with the proven efficacy of SPIRIVA®.

About Idiopathic Pulmonary Fibrosis
Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, severely debilitating and ultimately fatal lung disease for which there are only limited treatment options.11 IPF affects as many as 14-43 people per 100,000 worldwide.12,13 IPF is characterised by progressive scarring of lung tissue and loss of lung function over time.8,14 Development of scarred tissue is called fibrosis.10 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.10 As a result, individuals with IPF experience shortness of breath, cough and often have difficulty participating in everyday physical activities.15

For more information please visit www.inIPF.com

About Asthma
Asthma is a chronic disorder of the airways characterised by airway inflammation and bronchoconstriction. When 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.

People suffering from asthma experience recurrent episodes of wheezing, breathlessness, chest tightness and coughing. These episodes may be punctuated by periods of more severe and sustained deterioration in the management of symptoms, termed an asthma exacerbation.

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.16,17

About COPD
Chronic Obstructive Pulmonary Disease (COPD) – including emphysema and/or chronic bronchitis – is a preventable lung disease caused by the long-term inhalation of pollutants, most commonly cigarette smoke, that progressively and permanently reduce the ability of adults to breathe well and maintain active lives.18 Total deaths from COPD are projected to increase by more than 30% in the next 10 years unless urgent action is taken to reduce underlying risk factors, especially tobacco use.19 WHO predicts that COPD will become the third leading cause of death worldwide by 2030.19

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
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.




References

1Richeldi L, Costabel U., Selman M, et al. Efficacy of a tyrosine kinase inhibitor in idiopathic pulmonary fibrosis. N Engl J Med September 22, 2011; 365: 1079-1087.
2Selman M, King TE, Pardo A, et al. Idiopathic pulmonary fibrosis: prevailing and evolving hypotheses about its pathogenesis and implications for therapy. Ann Intern Med. 2001;134:136-51
3Hilberg F, Roth GJ, Krssak M, et al. BIBF 1120: triple angiokinase inhibitor with sustained recptor blockade and good antitumor efficacy. Cancer Res 2008; 68(12):4774-4782.
4Kerstjens HAM, Engel M, Dahl R et al. Tiotropium in asthma poorly controlled with standard combination therapy. N Engl J Med 2012; 367 (13): 1198-1207
5Ferguson GT, Feldman GJ, Hofbauer P, et al. Lung function efficacy of olodaterol QD delivered via Respimat® in COPD patients: results from two 48-week studies. ERS 2013 oral presentation number 186
6Koch A, Pizzichini E, Hamilton A, et al. Lung function efficacy of olodaterol QD delivered via Respimat® vs placebo and formoterol BID in patients with COPD: two 48-week studies. ERS 2013 poster no. P764.
7Koch A, Paggiaro P, Hamilton A, et al. Symptomatic benefit of olodaterol QD delivered via Respimat® vs placebo and formoterol BID in patients with COPD: combined analysis from two 48-week studies. ERS 2013 poster no. P763.
8Lange P, Aumann J-L, Derom E, et al. The 24-h FEV1 time profile of olodaterol QD delivered via Respimat® in COPD: results from two 6-week studies. ERS 2013 oral presentation 4635.
9Vincken W, van Noord JA, Greefhorst APM, et al. Improved health outcomes in patients with COPD during 1 year’s treatment with tiotropium. Eur Respir J 2002;19:209-216.
10IMS Health, IMS MIDAS™, Q3 2012.
11Raghu G, Collard HR, Egan JJ, et al. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011;183:788-824.
12Fernández Pérez E, Daniels C, Schroeder D, et al. Incidence, prevalence, and clinical course of idiopathic pulmonary fibrosis: a population-based study. Chest. 2010;137:129-37
13Raghu G, et al. Incidence and prevalence of idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2006; 174:810-816
14NHLBI, NIH. What Is Idiopathic Pulmonary Fibrosis? nhlbi.nih.gov/health/health-topics/topics/ipf/. Accessed April 2014
15Pulmonary Fibrosis Foundation. Symptoms. Available at: pulmonaryfibrosis.org/Symptoms. Accessed March 2014
16Bateman 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;170:836-844
17Partridge 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
18Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease. 2013. http://www.goldcopd.org/guidelines-global-strategy-for-diagnosis-management.html (Accessed Mar 2014)
19World Health Organization. Chronic respiratory diseases, Burden of COPD. http://www.who.int/respiratory/copd/burden/en/index.html. (Accessed Mar 2014)



















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