Boehringer Ingelheim Welcomes the Inclusion of OFEV® (nintedanib*) in the Updated International Treatment Guidelines for Idiopathic Pulmonary Fibrosis (IPF)

Boehringer Ingelheim welcomes the international evidence-based 2015 ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of Idiopathic Pulmonary Fibrosis " An Update of the 2011 Guideline.

PRESS RELEASE

Ingelheim, Germany 15 July 2015 Boehringer Ingelheim welcomes the international evidence-based 2015 ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of Idiopathic Pulmonary Fibrosis — An Update of the 2011 Guideline which suggests that clinicians use OFEV

®

(nintedanib

*

) in patients with IPF

***

.

1

The committee noted the high value of OFEV

®

on patient-important outcomes such as disease progression as measured by rate of forced vital capacity (FVC) decline and mortality. The recommendation also takes into account the expected cost of treatment and potentially significant adverse effects. However, it noted that there was no increase in serious adverse events with OFEV

®

, and relatively few patients discontinued the study drug secondary to adverse effects.

1

Dr Toby Maher, Consultant Respiratory Physician at the Royal Brompton Hospital in London, United Kingdom commented: “These guidelines are important because they provide valuable recommendations to physicians to improve the treatment and management of devastating conditions like IPF. These new guidelines clearly emphasise the role of OFEV

®

in the treatment of IPF.”

Dr Christopher Corsico, Chief Medical Officer Boehringer Ingelheim commented: “The inclusion of OFEV

®

in the international guideline marks an important step forward for patient care. Until recently no approved treatment options were recommended. OFEV

®

offers IPF patients a convenient, twice daily medicine that slows disease progression across a broad range of IPF patients

**

, resulting in a 50% reduction in the annual rate of decline of lung function.”

2

The committee analysed the evidence accumulated since the publication of the 2011 official guidelines and updated the treatment recommendations accordingly.

3

OFEV

®

has been studied in two replicate Phase 3 trials (INPULSIS

®

-1 and INPULSIS

®

-2) involving more than 1,000 patients in 24 countries

2

and a Phase II trial (TOMORROW) involving 432 patients.

4

The joint guidelines committee consists of representatives from an international group of leading respiratory societies including the American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS) and Latin American Thoracic Association (ALAT).