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Press Release Initiation of first multinational study to evaluate safety of OFEV® (nintedanib) with add-on of pirfenidone in patients with IPF New study explores safety and tolerability of OFEV® with addon of pirfenidone versus OFEV® alone1 First multinational study involving 100 patients to investigate add-on treatment with two approved drugs for idiopathic pulmonary fibrosis (IPF)1 OFEV® slows disease progression with approximately 50% reduction in the decline of lung function across a broad range of IPF patient types*2,3,4,5,6,7,8 Ingelheim, Germany 14 December 2015 – Boehringer Ingelheim today announces the initiation of trial 1199.222 (ClinicalTrials.gov Identifier: NCT02579603), a new 12 week study to assess the safety, tolerability and pharmacokinetics of add-on treatment with pirfenidone to background therapy with OFEV® in patients with idiopathic pulmonary fibrosis (IPF).1 The trial’s primary endpoint is the percentage of patients with on-treatment gastrointestinal (GI) adverse events from baseline to week 12.1 Dr Christopher Corsico, Corporate Senior Vice President Medicine and Chief Medical Officer at Boehringer Ingelheim, commented “The safety and wellbeing of patients is at the centre of everything we do. We are initiating this trial to ensure that we provide the scientific community with important information regarding OFEV® combination therapy. This trial is part of our continued commitment to tackling the global burden of progressive fibrotic lung diseases.” IPF is a rare condition that causes thickening and scarring of the lung tissue over time, a process known as fibrosis. 9,10 This fibrosis limits the amount of oxygen that can be delivered to the major organs and also causes difficulty breathing.10 The median survival of IPF patients following diagnosis is just 2-3 years11, underlining the importance of early and accurate diagnosis and the vital role of treatments that can help to slow disease progression. “With the publication in July 2015 of the updated international evidence-based guideline for IPF, we now have conditional *Including those with preserved lung function (FVC>90%pred), no honeycombing on HRCT and concomitant emphysema Boehringer Ingelheim Press Release page 1 of 5 Contact: Boehringer Ingelheim Corporate Communications Media + PR Dr. Kristin Jakobs 55216 Ingelheim/Germany Phone: +49 6132 – 77 144553 Fax: +49 6132 – 77 6601 Email: [email protected] More information www.boehringer-ingelheim.com 2 Press Release recommendations for the use of two approved treatment options for patients with IPF; nintedanib and pirfenidone.” said Prof. Carlo Vancheri of the Regional Centre for Rare Lung Diseases, Catania, Italy. “However, there has been limited evidence to date to establish the safety of combining these treatments. This new trial will provide essential information regarding the safety of adding pirfenidone to core treatment with nintedanib, and could help guide future therapy decisions in IPF.” ~ ENDS ~ Additional Information About trial 1199.222 (ClinicalTrials.gov Identifier: NCT02579603) A 12 week, open-label, randomised, parallel-group study evaluating safety, tolerability and pharmacokinetics (PK) of oral OFEV® when taken in combination with oral pirfenidone, compared to treatment with OFEV® alone, in patients with idiopathic pulmonary fibrosis (IPF).1 Patient enrolment for trial 1199.222 started on November 2nd 2015. The study will enrol approximately 100 patients with confirmed IPF from 25 study centres in the USA, Canada, Italy, Germany, France and the Netherlands.1 The primary endpoint is percentage of patients with on-treatment gastrointestinal (GI) adverse events (SOC GI disorders) from baseline to week 12, as the most frequent adverse events for both products are of gastrointestinal nature.1 On-treatment adverse events (AEs) are defined as AEs with an onset from the first dose of randomised treatment up to the last dose of randomised treatment (inclusive).1 As a secondary endpoint, the amount of OFEV® and pirfenidone circulating in the blood will be measured during the trial in order to assess if pirfenidone interacts with OFEV® and influences the amount found in the blood.1 Eligible participants will be randomised to receive OFEV® 150 mg twice daily or OFEV® 150 mg twice daily combined with pirfenidone (titrated up to a dose of 801 mg three times daily).1 Randomised treatment will Boehringer Ingelheim Press Release page 2 of 5 3 Press Release last 12 weeks. During the randomised treatment period, dose reductions and/or temporary interruptions are allowed for both drugs in case of AEs.1 About OFEV® (nintedanib) OFEV® is a small molecule tyrosine kinase inhibitor developed by Boehringer Ingelheim for IPF.12 OFEV®, one capsule twice a day, slows disease progression by reducing the annual rate of decline in lung function by 50% in a broad range of IPF patient types. 2,3,4,5,6,7,8 This includes patients with early disease (FVC >90% pred) 4 limited radiographic fibrosis (no honeycombing) on high resolution computed tomography (HRCT)5 and those with emphysema.6 Side effects with OFEV® can be effectively managed in most patients. 2 OFEV® targets growth factor receptors, which have been shown to be involved in the mechanisms by which pulmonary fibrosis occurs. Most importantly OFEV® inhibits platelet-derived growth factor receptor (PDGFR), fibroblast growth factor receptor (FGFR) and vascular endothelial growth factor receptor (VEGFR).2,9,13 It is believed that OFEV® reduces disease progression in IPF and slows the decline in lung function by blocking the signalling pathways that are involved in fibrotic processes.2,13,14 About idiopathic pulmonary fibrosis IPF is a progressive and life threatening lung disease.11 IPF affects as many as 14–43 people per 100,000 worldwide.15 ,16 IPF is characterised by progressive scarring of lung tissue and loss of lung function over time.9,10 Development of scarred tissue is called fibrosis. 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, a non-productive cough and often have difficulty participating in everyday physical activities. 17 Acute IPF exacerbations are defined as rapid deteriorations of symptoms within days or weeks. These events can occur at any point in the course of the disease, even at first presentation.18 All patients with IPF are at risk of acute IPF exacerbations.18 For further information regarding IPF please visit the Boehringer Ingelheim News Centre: http://bit.ly/1gTNkH7 Boehringer Ingelheim Press Release page 3 of 5 4 Press Release 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 146 affiliates and a total of more than 47,700 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. 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 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. R&D expenditure corresponds to 19.9 per cent of its net sales. For more information please visit www.boehringer-ingelheim.com Intended audiences: This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business. References: 1 Safety, Tolerability and PK of Nintedanib in Combination With Pirfenidone in IPF. Available at: https://clinicaltrials.gov/ct2/show/results/NCT02579603. Accessed December 2, 2015. 2 Richeldi L, du Bois RM, Raghu G, et al; for the INPULSIS Trial Investigators. Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. N Engl J Med. 2014;380(22):2071-2082 3 OFEV® Summary of Product Characteristics. Boehringer Ingelheim International GmbH. January 2015. Boehringer Ingelheim Press Release page 4 of 5 5 Press Release 4 Kolb M, Richeldi L, Kimura T, Stowasser S, Hallmann C, du Bois RM. Effect of baseline FVC on decline in lung function with nintedanib in patients with IPF: results from the INPULSIS® trials. Poster presented at the 110th American Thoracic Society Conference; Denver, Colorado, May 15–20, 2015. 5 Raghu G, Wells A, Nicholson AG, et al. Consistent effect of nintedanib on decline in FVC in patients across subgroups based on HRCT diagnostic criteria: results from the INPULSIS® trials in IPF. Poster presented at the 110th American Thoracic Society Conference; Denver, Colorado, May 15–20, 2015. 6 Cottin V, Taniguchi H, Richeldi L, et al. Effect of baseline emphysema on reduction in FVC decline with nintedanib in the INPULSIS® trials. Abstract presented at the 18th International Colloquium on Lung and Airway Fibrosis; Mont Tremblant, Canada, September 20-24, 2014. Available at: http://iclaf.com/conference/index.php/2014/ICLAF/paper/view/151. Accessed December 2, 2015. 7 Costabel U., et al. Efficacy of nintedanib in idiopathic pulmonary fibrosis across pre-specified subgroups in INPULSIS®. AJRCCM. 2015; 15-10031. 8 Keating GM. Nintedanib: A Review of Its Use in Patients with Idiopathic Pulmonary Fibrosis. Drugs. 2015 Jul;75(10):1131-40. doi: 10.1007/s40265-0150418-6. 9 Selman M, et al. Idiopathic pulmonary fibrosis: prevailing and evolving hypotheses about its pathogenesis and implications for therapy. Ann Intern Med. 2001;134:136-51. 10 NHLBI, NIH. What Is Idiopathic Pulmonary Fibrosis? Available at: http://www.nhlbi.nih.gov/health/health-topics/topics/ipf/. Accessed December 2, 2015. 11 Ley B., et al. Clinical course and prediction of survival in idiopathic pulmonary fibrosis. AJRCCM. 2011;183:431–40. 12 Richeldi L, et al. Efficacy of a tyrosine kinase inhibitor in idiopathic pulmonary fibrosis. N Engl J Med. 2011;365:1079-1087 13 Hilberg F, et al. BIBF 1120: triple angiokinase inhibitor with sustained receptor blockade and good antitumor efficacy. Cancer Res. 2008;68:47744782. 14 Wollin L, et al. Antifibrotic and Anti-inflammatory Activity of the Tyrosine Kinase Inhibitor Nintedanib in Experimental Models of Lung Fibrosis. J Pharmacol Exp Ther. 2014;349:209–220. 15 Raghu G, et al. Incidence and prevalence of idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2006;174:810-816. 16 Fernández Pérez E, et al. Incidence, prevalence, and clinical course of idiopathic pulmonary fibrosis: a population-based study. Chest. 2010;137:12937. 17 Pulmonary Fibrosis Foundation. Symptoms. Available at: http://www.pulmonaryfibrosis.org/life-with-pf/about-pf. Accessed December 2, 2015. 18 Collard H, et al. Acute Exacerbations of Idiopathic Pulmonary Fibrosis. Am J Respir Crit Care Med. 2007;176:636–643. Boehringer Ingelheim Press Release page 5 of 5