Media Release

Basel, 21 September 2015

New data will be presented for Roche's Esbriet in idiopathic pulmonary fibrosis at European Respiratory Society Congress 2015

  • Nine abstracts and two symposia demonstrate advances in the Roche respiratory portfolio
  • Presentation of pooled data analysis on the effect of Esbriet on mortality after initiating treatment in patients with idiopathic pulmonary fibrosis (IPF) i,ii

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new Esbriet® (pirfenidone) data analyses in idiopathic pulmonary fibrosis (IPF) will be presented at the European Respiratory Society (ERS) congress in Amsterdam, 26-30 September 2015. Roche is supporting nine different abstracts on IPF data. In addition, Roche is sponsoring two medical symposia to explore treatment strategies in IPF and to highlight the importance of personalised medicines for people with severe asthma.

“Roche is committed to bringing transformative medicines to people with severe respiratory diseases,” said Sandra Horning, M.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Our focus at this meeting will be on new data with Esbriet in idiopathic pulmonary fibrosis and the emerging science on the importance of personalised medicines for severe asthma.”

Roche research being presented as part of the ERS 2015 scientific programme and ongoing respiratory research will be showcased during the Roche media event from 13:15–14:30 CEST on Tuesday, 29 September, 2015, at the Amsterdam RAI Exhibition and Convention Centre ERS Press Conference Room. Leading experts will speak about new IPF management guidelines and Esbriet clinical data and the need for personalised medicines for severe uncontrolled asthma patients. This event, independently organised by Roche, is open to European journalists who have registered as media with the ERS congress 2015.

Overview of oral and poster presentations for Roche at ERS

Presentation title

Abstract number / presentation timings

(all times listed are Central European Time)

Effect of Pirfenidone on Treatment-emergent
(TE) All-cause Mortality (ACM) in Patients with
Idiopathic Pulmonary Fibrosis (IPF): Pooled Data
Analysis from ASCEND and CAPACITY

ORAL (852820)

Tuesday, 29 September

14:45–16:45

Benefit of continued pirfenidone treatment
following hospitalisation within the first six
months of therapy—ad hoc analysis from three
Phase III trials in patients with idiopathic
pulmonary fibrosis (IPF)

ORAL (850166)

Tuesday, 29 September

14:45–16:45

IPF Care, a support program for patients with
idiopathic pulmonary fibrosis in the UK

POSTER (850792)

Tuesday, 29 September

12:50–14:40

Pirfenidone post-authorisation safety registry
(PASSPORT) update

ORAL (850573)

Tuesday, 29 September

16:00

Differences in FVC decline by extent of
emphysema in patients with combined
pulmonary fibrosis and emphysema (CPFE)
syndrome

ORAL (852298)

Tuesday, 29 September

14:45

Safety and Tolerability of Pirfenidone (PFD) in
Patients With Systemic Sclerosis-Associated
Interstitial Lung Disease (SSc-ILD)–The LOTUSS
Study

ORAL (851983)

Tuesday, 29 September

15:00

PANORAMA - A Phase II, double-blind, placebo-
controlled study of N–acetylcysteine in
combination with pirfenidone in patients with
idiopathic pulmonary fibrosis

ORAL (OA3477)

Tuesday, 29 September

11:30

Antiacid therapy and progression free survival in
idiopathic pulmonary fibrosis (IPF)

ORAL (OA3478)

Tuesday, 29 September

11:45

Detrimental effects of medically indicated oral
anticoagulation on survival in idiopathic
pulmonary fibrosis (IPF)

ORAL (OA3479)

Tuesday, 29 September

12:00

Roche will also hold two educational symposia on IPF and Type 2 asthma. The first, entitled “Strategies to improve treatment outcomes in IPF,” will be held on Sunday, 27 September, from 17:15-19:15 CEST in Room 5.2 at the congress centre. The second, entitled “Putting the spotlight on Type 2 biomarkers in severe asthma,” will take place on Monday, 28 September, from 17:15-19:15 CEST in Room 2.1.

Follow Roche on Twitter via @Roche and keep up to date with ERS 2015 news and updates using the hashtag #ERS2015.

About Roche in Respiratory Diseases

Roche is committed to transforming care for patients with severe respiratory diseases. The Roche Group’s 25 years of respiratory experience includes medicines such as XOLAIR (omalizumab) in severe asthma marketed by Genentech in the US, Pulmozyme (dornase alfa) for cystic fibrosis, and Esbriet (pirfenidone) for idiopathic pulmonary fibrosis. Lebrikizumab is in phase III clinical trials for severe uncontrolled asthma and targets IL-13. It reflects Roche’s personalised healthcare approach and includes periostin as a biomarker to identify those patients who are more likely to have a more severe disease and may better respond to treatment with lebrikizumab. Our leadership in bringing personalised healthcare to lung cancer patients includes Tarceva (erlotinib) as well as investigational medicines alectinib and atezolizumab. Avastin (bevacizumab) is also approved for use in lung cancer.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.

In 2014, the Roche Group employed 88,500 people worldwide, invested 8.9 billion Swiss francs in R&D and posted sales of 47.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

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References
i Nathan SJ et al. Effect of Pirfenidone on Treatment-emergent (TE) All-cause Mortality (ACM) in Patients with Idiopathic Pulmonary Fibrosis (IPF): Pooled Data Analysis from ASCEND and CAPACITY. Oral presentation at ERS 2015. Abstract number: 852820. Presentation date: Tuesday, 29 September 2015. Presentation time: 14:45 – 16:45
ii Nathan SJ et al. Benefit of continued pirfenidone treatment following hospitalisation within the first 6 months of therapy—ad hoc analysis from three Phase 3 trials in patients with idiopathic pulmonary fibrosis (IPF). Oral presentation at ERS 2015. Abstract number: 850166. Presentation date: Tuesday, 29 September 2015. Presentation time: 14:45 – 16:4