Health Canada approves OFEV™ (nintedanib) for the treatment of idiopathic pulmonary fibrosis

New treatment option provides hope for Canadians living with fatal lung disease

BURLINGTON, ON, July 6, 2015 /CNW/ - Boehringer Ingelheim (Canada) Ltd. announced today that on June 24, 2015 Health Canada approved OFEV™ (nintedanib) to treat idiopathic pulmonary fibrosis (IPF) in adults.1 OFEV™ has been clinically proven to reduce the decline in lung function in IPF patients.2,3

IPF is a debilitating and fatal lung disease, which causes progressive, irreversible scarring of the lungs, resulting in lung function decline and difficulty breathing.4,5 There is no cure.6 There are approximately 5,000 to 15,000 Canadians currently living with IPF, and the approval of OFEV™ offers IPF patients a new treatment option to manage this fatal disease.7,8,9

"The approval of OFEV™ is a significant advancement for IPF patients, offering a proven treatment option to people living with this disease," says Dr. Martin Kolb, M.D. PhD, Director, Division of Respirology at McMaster University. "Not only does OFEV™ offer another treatment choice for IPF patients to manage their disease, it has been shown to significantly reduce the risk of adjudicated acute exacerbations, which can be deadly."

The symptoms of IPF – shortness of breath, dry hacking cough, "crackling" sounds in the lungs, and cyanosis (blue lips) – can have a significant impact on quality of life, and make it difficult to perform everyday activities.10,11 The median survival rate for people with IPF is two to three years after diagnosis; however, early and accurate diagnosis can help to ensure access to appropriate care.12

"The Canadian Pulmonary Fibrosis Foundation welcomes the approval of OFEV™ as a new treatment option for IPF. Every advancement in treatment brings us one step closer to finding a cure, and putting an end to early death from IPF," says Robert Davidson, President, Canadian Pulmonary Fibrosis Foundation (CPFF). "We must now support efforts to ensure that Canadians have full and timely access to this treatment in a disease area with few choices."

About OFEV™ (nintedanib)

The approval of OFEV™ is based on the results from the replicate Phase III INPULSIS™ trials, involving 1,066 patients from 24 countries. Primary endpoint results showed that OFEV™ significantly reduced the annual rate of decline in lung function by approximately 50 per cent in a broad range of IPF patient types (for INPULSIS™-1, 95% CI: 77.7, 172.8, p-value <0.0001 and for INPULSIS™-2, 95% CI: 44.8, 142.7, p-value = 0.0002).1,2

OFEV™ has been shown to reduce the risk of adjudicated acute exacerbations, a secondary endpoint for INPULSIS™-1 (hazard ratio (HR) 0.55 [95% CI: 0.20, 1.54]) and for INPULSIS™-2 (HR 0.20 [95% CI: 0.07, 0.56]).1,2 This can be critical given that approximately 50 per cent of patients hospitalized for an adjudicated IPF exacerbation die during hospitalization.13

Further, there was a significant benefit of OFEV™ versus placebo in change in Saint George's Respiratory Questionnaire (SGRQ) total score in INPULSIS™-2, but no significant difference between groups in INPULSIS™-1.2 SGRQ is a self-administered questionnaire that is used to assess health-related quality of life.2

OFEV™ is administered orally by one capsule taken twice-daily.1 The most frequently reported adverse events associated with the use of OFEV™ included diarrhea, nausea and vomiting, abdominal pain, decreased appetite, weight decreased and hepatic enzyme increased.1

Boehringer Ingelheim (Canada) Ltd.

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.

The Canadian headquarters of Boehringer Ingelheim was established in 1972 in Montreal, Quebec and is now located in Burlington, Ontario. Boehringer Ingelheim employs more than 550 people across Canada. For more information please visit www.boehringer-ingelheim.ca.

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1 OFEV Product Monograph. June 24, 2015.

2 Richeldi L, et al. Efficacy and Safety of Nintedanib in Idiopathic Pulmonary Fibrosis. N Engl J Med. 2014;370:2071-82.

3 Richeldi L, et al. Efficacy of a tyrosine kinase inhibitor in idiopathic pulmonary fibrosis. N Engl J Med. 2011;365:1079-1087.

4 Collard H, et al. Acute Exacerbations of Idiopathic Pulmonary Fibrosis. Am J Respir Crit Care Med. 2007;176:636–643.

5 The Lung Association. Idiopathic Pulmonary Fibrosis: Overview. http://www.lung.ca/lung-health/lung-disease/idiopathic-pulmonary-fibrosis. Accessed April 2015.

6 The Canadian Pulmonary Fibrosis Foundation. Treatment & Care. http://www.canadianpulmonaryfibrosis.ca/about-pulmonary-fibrosis/treatment-and-care/. Accessed May 2015.

7 The Lung Association. Idiopathic Pulmonary Fibrosis: Treatment. http://www.lung.ca/lung-health/lung-disease/idiopathic-pulmonary-fibrosis/treatment. Accessed April 2015.

8 Raghu G. Weycker D. Edelsberg J. et al. Incidence and prevalence of idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2006; 174(7):810-816.

9 Statistics Canada. Population of Canada. http://www.statcan.gc.ca/start-debut-eng.html. Accessed April 2015.

10 Shapera, S. Idiopathic Pulmonary Fibrosis (IPF). University Health Network. http://www.uhn.ca/docs/HealthInfo/Shared%20Documents/Idiopathic_pulmonary_fibrosis_IPF.pdf. Accessed April 2015.

11 The Canadian Pulmonary Fibrosis Foundation. Idiopathic pulmonary fibrosis (IPF). Accessed May 2015. http://www.canadianpulmonaryfibrosis.ca/wordpress/wp-content/uploads/2009/11/IPF-fact-sheet-FINAL-September-7-2012.pdf

12 Raghu G, 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.

13 Song JW, et al. Acute exacerbation of idiopathic pulmonary fibrosis: incidence, risk factors and outcome. Eur Respir J. 2011;37:356-363.

SOURCE Boehringer Ingelheim (Canada) Ltd.

Video with caption: "IPF causes progressive and permanent scarring of the lungs, and over time it becomes difficult to take a deep breath. Dr. Martin Kolb explains.". Video available at: http://stream1.newswire.ca/cgi-bin/playback.cgi?file=20150706_C5747_VIDEO_EN_433538.mp4&posterurl=http%3a%2f%2fphotos.newswire.ca%2fimages%2f20150706_C5747_PHOTO_EN_433538.jpg&order=1&jdd=20150706&cnum=C5747

Video with caption: "Dr. Martin Kolb, M.D. PhD, Director, Division of Respirology at McMaster University discusses acute exacerbations in IPF.". Video available at: http://stream1.newswire.ca/cgi-bin/playback.cgi?file=20150706_C5747_VIDEO_EN_433540.mp4&posterurl=http%3a%2f%2fphotos.newswire.ca%2fimages%2f20150706_C5747_PHOTO_EN_433540.jpg&order=2&jdd=20150706&cnum=C5747

Image with caption: "Idiopathic Pulmonary Fibrosis (IPF) is a progressive and rare lung disease, with no cure. To date there have been limited treatment options for the 5,000 to 15,000 Canadians currently living with the disease. (CNW Group/Boehringer Ingelheim (Canada) Ltd.)". Image available at: http://photos.newswire.ca/images/download/20150706_C5747_PHOTO_EN_433499.jpg

For further information: Jennifer Mota, Boehringer Ingelheim (Canada) Ltd., 905-631-4739, jennifer.mota@boehringer-ingelheim.com

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