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Idiopathic Pulmonary Fibrosis - A New Hope


Description: Introduction

Idiopathic pulmonary fibrosis is a devastating, relentlessly progressive and lethal disease for which current therapy is minimally effective. However, several promising anti-fibrotic agents, such as Enbrel (etanercept), are now in clinical trials, which may lead to significant improvements in disease survival and create a new high-value indication, estimated to be worth up to $2 billion annually.

Scope

- Examination of the impact of novel drugs on future treatment, supported by interviews with key opinion leaders

- Assessment of the trends in epidemiology to 2015, including the impact of changing demographics and improvements in diagnosis

- Discussion of the challenges to future clinical trial design, including optimization of patient recruitment and inclusion of novel endpoints

- Case study forecasting the global sales of Enbrel (etanercept) to 2015

Highlights

Idiopathic pulmonary fibrosis has a five-year survival rate of 20%, affecting 218,000 people in the global market, of which 60% or 125,000, are diagnosed. The aging of the population, combined with improvements in diagnosis, will result in a 40% increase in the diagnosed patient population to 146,000 by 2015.

Novel therapies which demonstrate progression-free survival will be initiated at diagnosis rather than limited to those patients with advanced disease, analogous to the treatment of rheumatoid arthritis or a malignancy, and will create an estimated market of up to $2 billion annually.

Future clinical trials should exclude patients with stable minimal to moderate and end-stage disease to ensure maximum response to therapy. The inclusion of acute exacerbation and pharmacoeconomic endpoints is vital, as is ensuring aggressive treatment with a novel drug that does not exacerbate pulmonary infections.

Reasons to Purchase

- Identify the long-term patient potential and market segmentation of Idiopathic pulmonary fibrosis

- Gain insight into the current challenges and commercial opportunities associated with this devastating disease

- Explore the strengths and weaknesses associated with compounds in clinical development


Contents:
CHAPTER 1 3.

Scope 3
Insight into the disease market 3

CHAPTER 2 DISEASE INSIGHT 8.

IPF is defined by fibroblastic foci, honeycombing type fibrosis and minimal inflammation 8
Cytokine-mediated fibrosis is the critical pathway to end-stage fibrosis 11
Most patients do not have any obvious risk factors 14
Diagnosing patients with early-stage IPF remains the greatest challenge 14
Current therapeutic approaches are minimally effective 19
Survival rates are lower than many neoplastic diseases 21
Aging population and improved diagnosis drive increasing prevalence 23
Most centers of excellence are in the US 32

CHAPTER 3 NOVEL THERAPEUTIC APPROACHES 36.

Interferon gamma-1b – difficult to prove post hoc analysis 38
Etanercept appears to improve or stabilize lung function 41
Pirfenidone’s affect on acute exacerbations is a strong result 43
Bosentan may address both the initiation and maintenance of fibrosis 44
GC-1008’s blockade of TGF-beta problematic due to unwanted side effects 45
FG-3019 acts downstream of TGF-beta 46
Imatinib mesylate potential limited by side effects 46
N-acetylcysteine is a very safe, if ineffective drug 47
Interleukin-13 deficient mice showed an almost complete abrogation of fibrosis 48
Blockade of CCR2 may decrease fibrocyte recruitment 49
AS-602801 may reestablish normal alveolar re-epithelialization 49
Low-dose oral interferon alpha appears to arrest progression 50
Angiotensin II antagonists, statins and ACE inhibitors have limited potential 50

CHAPTER 4 FUTURE TREATMENT DIRECTION 51.

Therapy will be initiated at diagnosis in all patients severities 52
Do patients remain stable without therapeutic intervention? 54
Acute exacerbations is an important endpoint 55
No biomarkers are sensitive to the presence of IPF 57

CHAPTER 5 OPINION LEADER TRANSCRIPTS 58.

Canadian opinion leader 58
US opinion leader 64
Irish opinion leader 74
US opinion leader 81
US opinion leader 90
US opinion leader 102

CHAPTER 6 APPENDIX 113.

Launch forecast methodology 113
Press releases 114
Literature references 114







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