Contents:

Chapter 1 Executive summary 6 Introduction 6 Scope and coverage of the Brief 6 Key findings from this Brief 7 Chapter 2 Disease classification and epidemiology 8 Asthma is a significant global health problem 8 Characterising asthma pathophysiology: the role of the Th2 pathway in asthma symptoms 9 The Th2 pathway plays a central role in asthma 9 A series of complex events underlie asthma symptoms 9 A broad range of mediators are involved in asthma pathophysiology 10 Asthma attacks are triggered by a wide variety of factors 11 Asthma is a collection of inflammatory respiratory conditions 12 Eosinophilic/mast cell asthma, and neutrophilic asthma 12 Atopic vs. non-atopic asthma and how it ties in with early-onset vs. late-onset asthma 15 Characterizing asthma by symptom frequency and severity 16 Characteristics of the severe asthma patient population 17 Corticosteroids and bronchodilators are currently the most common asthma treatments 19 Chapter 3 Using monoclonal antibodies to treat asthma 20 The evolution of the whole mAbs sector into a $10 billion market 20 Business model evolution 20 Therapy area evolution 22 Market potential for respiratory mAbs: the pros and cons with using mAbs for asthma 23 Chapter 4 Current respiratory monoclonal antibody treatments for asthma: xolair 26 What is the rationale behind targeting IgE in asthma? 26 Xolair: a $1 billion market potential by 2015 27 Xolair’s path to approval: what do other mAbs need to demonstrate? 28 Xolair label extension: opportunity in non-atopic asthma 29 Chapter 5 Pipeline innovations and potential targets 31 Targeting mediators that underlie asthma symptoms 31 The development of mAbs that target these mediators: the pipeline 33 Pipeline evaluation: IL-13 set to drive interest 36 Technology evolution: development of humanized and fully human mAbs set to drive market growth 38 Maximizing market potential by effective patient population capture: addressing clinical trial design issues 39 APPENDIX 41 Bibliography 41 Papers 41 Miscellaneous 47