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Pipeline Insight: Asthma, COPD and Allergic Rhinitis - Weak Late Stage Pipeline Leaves Innovation to Phase I/II CandidatesPublished by: Datamonitor Published: Jul. 15, 2004 - 179 Pages Table of ContentsTABLE OF CONTENTS CHAPTER 1 EXECUTIVE SUMMARY 3 Objective of the analysis 3 Datamonitor insight into the respiratory market 3 CHAPTER 2 PATIENT POTENTIAL 14 Definition of asthma 15 Etiology of asthma 15 Segmentation of asthma 18 Epidemiology of asthma 19 Unmet need in asthma 22 Greater efficacy among controller therapies, to reduce need for corticosteroids 22 Disease modification 23 Drug delivery formulation 24 Reduced side effects 25 Dosing regimens 25 Definition of COPD 26 Etiology of COPD 27 Segmentation of COPD 28 Epidemiology of COPD 29 Future trends 31 Unmet need in COPD 31 Improved efficacy, including disease reversal 31 Increased disease awareness and patient education 33 Reduced side effects 33 Drug delivery formulation 33 Dosing regimens 34 Definition of allergic rhinitis 35 Etiology of allergic rhinitis 35 Segmentation of allergic rhinitis 36 Epidemiology of allergic rhinitis 37 Methodology 37 Future trends 39 Unmet need in allergic rhinitis 39 Reduced side effects 39 Drug delivery formulation 40 Greater efficacy 40 Dual asthma/allergic rhinitis treatment 40 CHAPTER 3 R&D APPROACH 42 Classification of pipeline products 43 Corticosteroids 43 Beta2-agonists 45 Leukotriene inhibitors 45 Phosphodiesterase-4 inhibitors 47 Monoclonal antibodies 49 Allergen immunotherapy 52 Cell-surface adhesion inhibitors 54 Definition of current comparator therapy 55 Asthma 55 COPD 55 Allergic rhinitis comparator 56 Clinical trial endpoints in asthma 56 Lung function improvement 57 Decrease in steroid use 57 Reduction in the incidence of acute exacerbations 57 Decrease in use of rescue medication 58 Other clinical endpoints 58 Clinical trial endpoints in COPD 58 Improvement in lung function 59 Reductions in the incidence of acute exacerbations 59 Health status 59 Other 60 Clinical trial endpoints in allergic rhinitis 60 Improvement in nasal symptoms 61 Rescue antihistamine use 61 Reduction in nasal inflammatory cell counts 62 Quality of life 62 CHAPTER 4 ASTHMA, COPD AND ALLERGIC RHINITIS PIPELINE ANALYSIS 63 Pipeline overview 64 Key companies involved in the respiratory pipeline 68 GlaxoSmithKline - Advair help several years away 68 Merck - full reliance on Singulair 69 Pfizer - the giant enters 69 Aventis - help for Allegra on the way? 70 Novartis - partner, or acquisition, needed 70 Altana - key late-stage player 71 Schering-Plough - hurt by delays and shallow pipeline 71 SWOT methodology 72 CHAPTER 5 PDE-4 LATE-STAGE DRUG ANALYSIS & FORECASTS 76 PDE-4 inhibitor pipeline summary 77 Daxas (roflumilast) 78 Profile 78 Forecasts to 2014 83 Ariflo (cilomilast) 85 Profile 85 Forecasts to 2014 92 Arofylline 94 Profile 94 Comparison of key compounds in PDE-4 inhibitor class 96 Comparative strengths and weaknesses 96 Comparative opportunities and threats 97 Other PDE-4s in Phase II development 97 GW-842470 97 IC-485 98 KW-4490 98 ONO-6126 99 Lirimilast 99 CHAPTER 6 ESTABLISHED DRUG CLASSES LATE-STAGE DRUG ANALYSIS AND FORECASTS 100 Alvesco (ciclesonide) 101 Profile 101 Forecasts to 2014 107 Other corticosteroids 109 GW-685698 109 NS-126 110 EPI-12323 110 QAB-149 111 Profile 111 Forecasts to 2014 114 Arformoterol 115 Profile 115 Forecasts to 2014 118 Other long-acting beta-agonists 118 AD-237 118 GW-597901 118 GW-159797 119 Monoclonal antibodies 119 Mepolizumab 119 Daclizumab 122 IDEC-152 124 Bertilimumab 125 Immunosuppressants 127 Pimecrolimus 127 Tacrolimus 128 Other 128 Efletirizine 128 MCC-847 129 Comparison of key compounds in established drug class pipeline 129 Comparative opportunities and threats 129 Comparative strengths and weaknesses 130 Late-stage development compounds recently discontinued 130 Pascolizumab 130 Soltara 131 CHAPTER 7 NEW INNOVATIVE DRUG CLASSES LATE-STAGE DRUG ANALYSIS AND FORECASTS 132 Specific immune therapy 133 Tablet-grass SIT 133 AIC 134 Immunomodulatory therapies 137 ISS-1018 137 Oralgen Graspollen 140 SRP-299 140 Bimosiamose 141 Profile 141 Andolast 142 Lactoferrin 143 Nepadutant 143 Pumactant 143 R-667 145 Profile 145 TH9507 147 Profile 147 AVE-0547/IPL-512602 148 CS-003 149 R-411 150 RBx-7796 150 GW-274150 151 Inhaled lidocaine 152 Profile 152 GW-766994 154 Comparison of key compounds in novel drug class pipeline 155 Comparative opportunities and threats 155 Comparative strengths and weaknesses 155 Late-stage development compounds recently discontinued 156 EPI-2010 156 Recombinant AAT 156 559090 156 TAK-427 157 CHAPTER 8 INNOVATIVE EARLY-STAGE PROJECTS 158 Nitric oxide inhibitors 158 AAT replacement therapy 158 PDE-4 inhibitors 159 5-lipoxygenase inhibitors 160 IgE inhibitors 161 Immunomodulators 161 Leukotriene antagonists 162 LABA/ICS combinations 163 Pitrakinra 163 Other novel concepts 164 Cytokine trap 164 Degranulation inhibitor 164 Mast cell activation inhibitor 165 Surfactant 165 Chemokine antagonist 166 Other projects 166 APPENDIX A 168 Bibliography 168 Epidemiology 168 Clinical trial data 171 Report methodology 174 Japanese market data 174 Standard units 175 Pricing forecasts 175 APPENDIX B 176 About Datamonitor 176 About Datamonitor Healthcare 176 Datamonitor Healthcare’s research and analysis methodologies 177 About the IDI analysis team 177 Disclaimer 179 AbstractIntroductionFollowing several successful drug launches to the respiratory market in the past five years, companies are seeking the next blockbuster drug in a high potential market. While the late-stage pipeline is relatively sparse, a number of moderately successful launches will help bridge the gap between drugs like Advair and the high number of Phase I and Phase II therapies. Scope Evaluation of over 70 drugs in development for asthma, COPD, and allergic rhinitis. Opinion leader insight into early stage therapies and treatment strategies, including recommendations for areas of focus Forecasts of key late-stage therapies: Alvesco (ciclesonide), Daxas (roflumilast), Ariflo (cilomilast), arformoterol, and QAB-149 Detailed SWOT analysis of key compounds, and comparison to current gold standards Highlights Multiple potential treatment pathways, an enormous patient population, and a relatively high level of unmet need in COPD have promoted a deep respiratory pipeline. However, among over 70 products in Phase I development or later, only six are in Phase III or registration. PDE-4 inhibitors will be the next novel drug class to reach the respiratory market, with the launch of roflumilast and cilomilast over the next two years, but the superiority of Spiriva will likely lead to these 'second-to-market' drugs battling for market share with xanthines and other add-on therapies. With a number of novel therapies showing disappointing results, and many others without enough data to evaluate potential sales, few companies have developed drugs that have the potential to become the class standard. Among late-stage candidates in established classes, only Altana/Aventis's Alvesco (ciclesonide) is expected to attain high sales. Reasons to Purchase Understand unmet needs in the respiratory market, and how late-stage compounds address these needs Identify potential licensing opportunities for respiratory market entry or portfolio expansion Benchmark key late-stage asthma and COPD compounds against market leaders Get Full Details About This Report >> |
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