Pipeline Insight: Asthma/COPD - Targeted therapies on the horizon
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the Infectious Disease and Respiratory pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 4
- Scope of the analysis - page 4
- Contributing experts - page 5
- Datamonitor insight into the asthma/COPD market - page 5
- CHAPTER 2 PATIENT POTENTIAL - page 13
- Definition and etiology of asthma - page 13
- Segmentation of asthma - page 15
- Childhood asthma - page 16
- Adult asthma - page 17
- Refractory asthma - page 17
- Epidemiology of asthma - page 19
- Unmet needs in asthma - page 21
- Lack of disease control in patients with refractory asthma - page 22
- Lack of compliance and disease understanding - page 23
- Side effects - page 23
- Lack of cure - page 23
- The allergic march - page 23
- Definition and etiology of COPD - page 24
- Segmentation of COPD - page 28
- Epidemiology of COPD - page 28
- Unmet needs in COPD - page 30
- Lack of cure/halt to disease progression - page 31
- Difficult to suppress inflammation - page 32
- Poor management of exacerbations - page 32
- Low awareness and diagnosis - page 33
- CHAPTER 3 R&D APPROACH - page 34
- Classification of asthma/COPD pipeline products - page 35
- Bronchodilators - page 35
- Anti-inflammatories - page 38
- ICS/LABA combinations - page 41
- Biologicals - page 42
- Clinical trial design in asthma/COPD - page 43
- Comparing to gold standard - page 43
- Combination products - page 44
- Life-cycle management (LCM) strategies - page 45
- Clinical trial endpoints in asthma/COPD - page 46
- FEV1 remains most frequently used endpoint - page 46
- FDA recognizes need for new endpoints - page 47
- Exacerbations become increasingly significant target - page 48
- Mortality endpoint can differentiate treatments in COPD - page 49
- Clinical outcomes versus markers - page 50
- Classification of asthma/COPD pipeline products - page 35
- CHAPTER 4 ASTHMA/COPD PIPELINE ANALYSIS - page 52
- Key companies involved in the asthma/COPD pipeline - page 55
- GlaxoSmithKline (GSK) - page 56
- AstraZeneca (AZ) - page 58
- Boehringer-Ingelheim (BI) - page 60
- Merck & Co (Merck) - page 62
- Novartis/Schering-Plough - page 63
- Strategies for success - page 64
- Key companies involved in the asthma/COPD pipeline - page 55
- CHAPTER 5 FIXED DOSE ICS/LABA COMBINATIONS ANALYSIS & FORECASTS - page 68
- Definition of current comparator therapy - page 70
- Gold standard Advair/Seretide is threatened from several sides - page 70
- Symbicort's US approval will boost sales - page 73
- Super Advair unable to repeat Advair's success - page 75
- Clinical trial data - page 78
- Symbicort SMART indication differentiates it from Advair - page 82
- Clinical trial data - page 85
- Foster - similar efficacy at half the price? - page 90
- Clinical trial data - page 92
- Alvesco combo - potentially best ICS/LABA combination held back by trial delays - page 96
- Clinical trial data - page 97
- Mometasone/formoterol and mometasone/indacaterol - page 99
- Flutiform will need to compete on price - page 100
- Definition of current comparator therapy - page 70
- CHAPTER 6 INHALED CORTICOSTEROIDS ANALYSIS AND FORECAST - page 103
- Definition of current comparator therapy - page 105
- Alvesco's development fraught with uncertainties and setbacks - page 105
- Clinical trial data - page 107
- Asmanex too late to have a big impact - page 110
- CHAPTER 7 NOVEL ANTI-INFLAMMATORIES ANALYSIS AND FORECASTS - page 112
- Definition of current comparator therapy - page 116
- Targeting the leukotriene cascade - page 117
- 5-LO - Zileuton CR no competition for Singulair - page 119
- cPLA2-antagonists are promising target - page 123
- Chemokine inhibitors are a mixed group - page 125
- CCR antagonists - page 125
- CXCR antagonists - page 126
- VLA-4 antagonists - many development failures - page 128
- PDEIV inhibitors only promising in COPD? - page 130
- Daxas - page 130
- Other PDEIV inhibitors - page 134
- Inhaled immunostimulatory DNA (ISS) - page 136
- Targeting oligonucleotides - page 138
- Other novel anti-inflammatories - page 140
- CHAPTER 8 BIOLOGICALS ANALYSIS AND FORECASTS - page 144
- Anti-IgE - Xolair to remains unchallenged - page 146
- Anti-TNF-α - page 148
- Promising in severe asthma... - page 148
- ...disappointing in COPD - page 150
- Anti-IL-13 - page 150
- Anti-IL-5 - page 152
- Anti-IL-2 - page 153
- Other monoclonal antibodies targeting cytokines - page 154
- CHAPTER 9 BRONCHODILATORS ANALYSIS AND FORECASTS - page 155
- Competition for Spiriva on the horizon - page 155
- Definition of current comparator therapy - page 157
- LAS 34273 - page 161
- NVA 237 - page 162
- 233705 - page 164
- Long-acting beta2-agonists will be once-daily - page 165
- Definition of current comparator therapy - page 166
- GSK's once-daily LABAs 159797 and 542444 - page 168
- Indacaterol (QAB-149) - page 169
- Clinical trial data - page 169
- CHF-4226 - page 171
- Brovana - page 172
- LABA/LAMA combination products have blockbuster potential in COPD - page 175
- The SABA CFC-HFA switch in the US - page 179
- Xopenex HFA - page 181
- Competition for Spiriva on the horizon - page 155
- APPENDIX A - page 184
- Methodology - page 184
- Datamonitor forecast methodology - page 184
- Bibliography - page 185
- Epidemiology - page 185
- Disease background - page 186
- Clinical trial data - page 204
- Press Releases - page 208
- Methodology - page 184
- APPENDIX B - page 211
- About Datamonitor - page 211
- About Datamonitor Healthcare - page 211
- Datamonitor Healthcare's therapy area capabilities - page 212
- About the Infectious Disease and Respiratory analysis team - page 213
- Disclaimer - page 214
- About Datamonitor - page 211
- List of Tables
- Table 1: Asthma prevalence and diagnosed population by country and age, 2006 - page 21
- Table 2: COPD prevalence by country and severity among adults over 45 years old, 2006 - page 30
- Table 3: Outcome measures for COPD - page 51
- Table 4: Overview of asthma/COPD drug development pipeline, 2006 - page 52
- Table 5: GSK's marketed respiratory portfolio, 2005 - page 58
- Table 6: AstraZeneca's marketed respiratory portfolio, 2005 - page 60
- Table 7: Boehringer-Ingelheim's marketed respiratory portfolio, 2005 - page 62
- Table 8: Key marketed and late-stage products for ICS/LABA combinations, 2006 - page 69
- Table 9: ICS/LABA combinations sales in the six major markets ($m), 2005-2015 - page 69
- Table 10: GSK is performing one study with 159797 and two with 642444 - page 80
- Table 11: Studies presented at the ERS Conference in September 2006 regarding Symbicort SMART - page 89
- Table 12: Key marketed and late-stage products for inhaled corticosteroids, 2006 - page 103
- Table 13: ICS sales in the six major markets ($m), 2005-2015, $millions - page 104
- Table 14: Key marketed and late-stage products for novel anti-inflammatories, 2006 - page 113
- Table 15: Key marketed and late-stage products for compounds affecting the leukotriene cascade, 2006 - page 117
- Table 16: Key products for CXCR2 agonists, 2006 - page 126
- Table 17: Key marketed and late-stage products for PDEIV inhibitors, 2006 - page 134
- Table 18: Key marketed and late-stage products for biologicals, 2006 - page 144
- Table 19: Key marketed and late-stage products for anticholinergics, 2006 - page 155
- Table 20: Long-acting anticholinergics sales in the six major markets ($m), 2005-2015 - page 156
- Table 21: Key marketed and late-stage products for LABAs, 2006 - page 165
- Table 22: Long-acting beta2-agonists sales in the six major markets ($m), 2005-2015 - page 165
- Table 23: GSK pool of LABA candidates in Phase II trials, 2006 - page 168
- List of Figures
- Figure 1: Basic etiology of asthma - page 15
- Figure 2: Classification of asthma by clinical, pretreatment features - page 16
- Figure 3: Prevalence of asthma according to classification of severity - page 20
- Figure 4: Key unmet needs in asthma, 2006 - page 22
- Figure 5: The allergic march is influences by several factors - page 24
- Figure 6: Rate of decline of FEV1 with age in COPD patients - page 26
- Figure 7: The inflammation associated with COPD involves neutrophils and alveolar macrophages - page 27
- Figure 8: Classification of COPD as measured by airflow limitation - page 28
- Figure 9: Prevalence of COPD at diagnosis according to classification of severity - page 29
- Figure 10: Key unmet needs in COPD - page 31
- Figure 11: Overview of asthma and COPD treatments, 2006 - page 35
- Figure 12: Appropriate LCM strategy depends on time and financial investment - page 46
- Figure 13: Overview of forecasted asthma/COPD drugs in the pipeline, 2006 - page 55
- Figure 14: Key players in the asthma/CODP market, 2005 - page 56
- Figure 15: Pulmicort: a combination of strategies - page 65
- Figure 16: GSK and AZ continue to develop their ICS/LABA combination products - page 66
- Figure 17: Sepracor takes advantage of CFC-HFA switch in the US in 2008 - page 67
- Figure 18: ICS/LABA combinations sales in the six major markets ($m), 2005-2015 - page 70
- Figure 19: Warning in Advair prescribing information regarding salmeterol - page 71
- Figure 20: Advair/Seretide and Symbicort sales in the six major markets, 2001-05 - page 75
- Figure 21: Formoterol is preferred LABA due to short onset of action, long duration and limited side effects - page 77
- Figure 22: Characteristics of ICS/LABA drugs on the market and in development - page 78
- Figure 23: ICS/LABA combination sales in the six major markets, 2005-15 - page 82
- Figure 24: Symbicort adjustable maintenance dosing - page 83
- Figure 25: SMILE study design - page 86
- Figure 26: ICS/LABA combinations sales in the six major markets, 2005-2015 - page 90
- Figure 27: Study design of two studies - page 93
- Figure 28: Foster versus Advair/Seretide and Foster versus Symbicort, PEF - page 94
- Figure 29: ICS/LABA combinations sales in the five major European markets, 2005-2015 - page 96
- Figure 30: ICS/LABA combinations sales in the six major markets, 2005-2015 - page 98
- Figure 31: Mometasone/indacaterol combination shows most promise for Novartis and Schering-Plough - page 99
- Figure 32: ICS/LABA combinations sales in the six major markets, 2005-2015 - page 100
- Figure 33: ICS/LABA combinations sales in the six major markets, 2005-2015 - page 102
- Figure 34: ICS sales in the six major markets, 2005-2015 - page 104
- Figure 35: Study design and primary endpoint of ciclesonide 160µg versus 640µg - page 108
- Figure 36: ICS sales in the six major markets, 2005-2015 - page 110
- Figure 37: ICS sales in the six major markets ($m), 2005-2015 - page 111
- Figure 38: Novel anti-inflammatory market is moving towards targeted therapy - page 114
- Figure 39: Blockbuster potential of anti-inflammatories in COPD is uncertain, 2006-2020 - page 115
- Figure 40: Effect of tipelukast on inflammation cascade - page 118
- Figure 41: Zileuton affects inflammatory cascade earlier than montelukast - page 120
- Figure 42: Patient potential breakdown for Zileuton CR in the US - page 122
- Figure 43: Singulair and Zileuton CR sales in the US ($m), 2005-2015 - page 123
- Figure 44: Efipladib affects inflammatory cascade earlier than montelukast and zileuton - page 124
- Figure 45: Results from roflumilast RECORD and RATIO studies - page 132
- Figure 46: Xolair sales in the six major markets, 2005-2015 - page 148
- Figure 47: Long-acting anticholinergics sales in the six major markets, 2005-2015 - page 156
- Figure 48: Respimat SMI demonstrates better lung deposition compared with conventional MDIs - page 159
- Figure 49: The battle to be second to the once-daily LAMA market is between Almirall, Novartis and GSK - page 160
- Figure 50: Long-acting anticholinergics sales in the six major markets, 2005-2015 - page 161
- Figure 51: Long-acting beta2-agonists sales in the six major markets ($m), 2005-2015 - page 166
- Figure 52: Long-acting beta2-agonists sales in the six major markets ($m), 2005-2015 - page 167
- Figure 53: Mean serum potassium over time - page 170
- Figure 54: Patient potential breakdown for arformoterol in the US, 2006 - page 173
- Figure 55: Brovana sales in the US, 2005-2015 - page 174
- Figure 56: LABA/LAMA peak sales in the six major markets - page 175
- Figure 57: Three possible LABA/LAMA combination drugs in development - page 177
- Figure 58: The (levo)salbutamol market according to type of delivery device, 2005 - page 180
- Figure 59: The volume and sales values of the (levo)salbutamol market according to type of delivery device, 2005 - page 181
- Figure 60: Xopenex sales in the US, 2005-2015 - page 182
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