Pipeline Insight: Insomnia - Targeting the sleep maintenance market
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the Disease pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Datamonitor insight into the insomnia market - page 4
- Key metrics - page 6
- Datamonitor Pipeline Assessment Summary - page 7
- CHAPTER 2 PIPELINE OVERVIEW AND DYNAMICS - page 20
- Drugs in late-stage development focus on treating sleep maintenance - page 21
- Recently discontinued pipeline drugs - page 25
- Gaboxadol - page 26
- A big blow for Lundbeck but good news for competition - page 26
- Sonata MR - page 28
- Further disappointment from the underperforming Sonata brand - page 28
- Gaboxadol - page 26
- Key companies involved in the insomnia pipeline - page 28
- Sanofi-Aventis: Endeavoring to maintain leadership of the insomnia market - page 29
- CNS is Sanofi-Aventis's second largest franchise - page 29
- Ambien currently dominates the insomnia market - page 29
- Ambien CR will fail to sustain the Ambien franchise growth - page 30
- Breaking into the depression market will strengthen relationship with insomnia prescribers - page 31
- Neurocrine: Focused on penetrating insomnia market - page 32
- Neurocrine has six drug candidates in clinical development but has yet to market a product - page 32
- Indiplon is Neurocrine's most advanced product candidate - page 33
- Neurocrine will face difficulty in securing a big-pharmaceutical partnering company for indiplon - page 33
- Sanofi-Aventis: Endeavoring to maintain leadership of the insomnia market - page 29
- Key R&D company strategies - page 33
- Key drug delivery strategies in the insomnia pipeline - page 34
- Controlled release formulations offer the greatest commercial potential - page 34
- Oral and nasal delivery reformulations are expected to be of limited commercial value - page 35
- Investigating insomnia drugs in co-morbid disorders - page 36
- Co-morbid psychiatric disorders are prevalent in insomnia - page 36
- Four pipeline hypnotics are under investigation for co-morbid disorders - page 37
- Potential marketing partners for small pharmaceutical companies - page 38
- GSK is in contact with key prescribers through Requip - page 38
- Cephalon has experience in the sleep disorders market with Provigil for hypersomnia - page 39
- Sepracor requires a follow-on compound to Lunesta - page 39
- Key drug delivery strategies in the insomnia pipeline - page 34
- CHAPTER 3 INSOMNIA - DISEASE OVERVIEW AND MARKET POTENTIAL - page 41
- Definition of insomnia - page 42
- Segmentation of insomnia - page 43
- Insomnia is categorized according to etiology and duration - page 43
- Transient insomnia - page 43
- Intermittent or short-term insomnia - page 44
- Chronic insomnia - page 44
- Other forms of insomnia - page 44
- Etiology of insomnia - page 45
- Insomnia is categorized according to etiology and duration - page 43
- Epidemiology of insomnia - page 46
- Diagnosis of insomnia - page 48
- Only a small percentage of individuals with symptoms of insomnia receive a diagnosis - page 48
- Insomnia is more prevalent in women than in men - page 52
- Symptoms of the menopause are associated with insomnia - page 53
- Insomnia is most prevalent in young adults and the elderly - page 54
- Insomnia impacts on quality of life and occupational functioning - page 56
- Insomnia carries a high socioeconomic impact - page 57
- Diagnosis of insomnia - page 48
- Unmet need in insomnia - page 58
- Unmet need 1: Reduction of residual daytime sedation - page 61
- Unmet need 2: More effective treatments for insomnia in the elderly - page 61
- Unmet need 3: Improvement in sleep maintenance - page 62
- Unmet need 4: Lack of potential for tolerance and addiction - page 62
- Unmet need 5: More effective treatments for pediatric insomnia - page 63
- CHAPTER 4 R&D Approach - page 65
- Classification of insomnia pharmaceutical therapies - page 66
- Drug classes of currently marketed insomnia products and non-pharmacological therapy - page 66
- Benzodiazepines - page 66
- Melatonin agonists - page 67
- Herbal hypnotics and sedatives - page 68
- Anti-histamines - page 68
- Antidepressants - page 69
- Other drugs - page 69
- Non-pharmacological therapy - page 70
- Drug classes of pipeline insomnia products - page 72
- GABAa receptor agonists - page 72
- Melatonin agonists - page 73
- Serotonin receptor antagonists (5-HT) - page 73
- Other drug classes - page 73
- Drug classes of currently marketed insomnia products and non-pharmacological therapy - page 66
- Clinical trial design in insomnia - page 73
- Objective and subjective measures provide complementary information - page 73
- Clinical trial endpoints in insomnia - page 74
- Sleep questionnaires - page 75
- Alertness tests - page 76
- Quality of life measures - page 78
- Psychological measures - page 79
- Sleep monitoring - page 80
- Recommended directions for insomnia research - page 82
- National Institutes of Health recommendations - page 82
- NICE: A broader range of outcome measures are required, including those that evaluate QOL - page 83
- Classification of insomnia pharmaceutical therapies - page 66
- CHAPTER 5 GABA A RECEPTOR AGONIST LATE-STAGE DRUG ANALYSIS & FORECASTS - page 86
- Comparative forecasts - page 87
- Comparative Datamonitor drug assessment summaries - page 88
- Overview of GABAa receptor agonist drugs - page 88
- Pipeline summary - page 88
- Definition of current comparator therapy - page 90
- Clinical trials - page 91
- Adverse reactions and next-day residual effects reported with the use of Ambien - page 92
- Ambien's major competitors and key strengths and weaknesses - page 92
- Indiplon - page 93
- Profile - page 94
- Drug overview - page 94
- Clinical data - Indiplon IR - page 95
- Clinical data - Indiplon MR - page 99
- Patient potential - page 102
- Marketing factors - page 103
- Satisfaction of unmet need - page 105
- Forecasts to 2016 - page 107
- Datamonitor drug assessment summary - page 110
- Profile - page 94
- Zolpidem (sublingual spray) - page 111
- Profile - page 112
- Drug overview - page 112
- Clinical data - page 112
- Patient potential - page 113
- Marketing factors - page 114
- Satisfaction of unmet needs - page 114
- Forecasts to 2016 - page 116
- Datamonitor drug assessment summary - page 118
- Profile - page 112
- Sublinox - page 119
- Profile - page 119
- Drug overview - page 119
- Clinical data - page 119
- Patient potential - page 120
- Marketing factors - page 120
- Satisfaction of unmet needs - page 121
- Forecasts to 2016 - page 122
- Datamonitor drug assessment summary - page 124
- Profile - page 119
- Other drugs - page 124
- NG2-73 - page 124
- Drug overview - page 125
- Clinical data - page 125
- Patient potential - page 127
- Marketing factors - page 127
- Satisfaction of unmet needs - page 128
- EVT-201 - page 129
- Drug overview - page 129
- Limited clinical data for EVT-201 - page 129
- Datamonitor comments - page 131
- Hypnostat (triazolam) - page 131
- Drug overview - page 131
- Limited clinical trial data published for Hypnostat - page 131
- Datamonitor comments - page 132
- NG2-73 - page 124
- CHAPTER 6 MELATONIN AGONIST LATE-STAGE DRUG ANALYSIS AND FORECASTS - page 134
- Comparative forecasts - page 135
- Comparative Datamonitor drug assessment summaries - page 135
- Overview of melatonin agonist drugs - page 136
- Pipeline summary - page 136
- Definition of current comparator therapy - page 137
- Clinical trial data - page 138
- Side effect profile and key strengths and weaknesses - page 139
- VEC-162 - page 140
- Profile - page 140
- Drug overview - page 140
- Clinical data - page 141
- Patient potential - page 143
- Marketing factors - page 144
- Satisfaction of unmet need - page 146
- Forecasts to 2016 - page 147
- Datamonitor drug assessment summary - page 148
- Profile - page 140
- PD-6735 - page 149
- Profile - page 149
- Drug overview - page 149
- Clinical data - page 150
- Patient potential - page 151
- Marketing factors - page 151
- Satisfaction of unmet need - page 153
- Forecasts to 2016 - page 154
- Datamonitor drug assessment summary - page 155
- Profile - page 149
- CHAPTER 7 SEROTONIN RECEPTOR ANTAGONISTS AND AGONISTS LATE-STAGE DRUG ANALYSIS & FORECASTS - page 157
- Comparative forecasts - page 158
- Comparative Datamonitor drug assessment summaries - page 158
- Overview of serotonin receptor antagonists and agonists - page 159
- Pipeline summary - page 159
- Definition of current comparator therapy - page 160
- Eplivanserin - page 162
- Profile - page 162
- Drug overview - page 162
- Clinical data - page 163
- Patient potential - page 164
- Marketing factors - page 164
- Satisfaction of unmet need - page 165
- Forecasts to 2016 - page 166
- Datamonitor drug assessment summary - page 168
- Profile - page 162
- Org-50081 - page 169
- Drug overview - page 169
- Clinical data - page 169
- Patient potential - page 170
- Marketing factors - page 171
- Satisfaction of unmet needs - page 172
- Forecasts to 2016 - page 173
- Datamonitor drug assessment summary - page 174
- Drug overview - page 169
- Other drugs - page 175
- HY-10275 - page 175
- Drug overview - page 175
- Clinical data - page 176
- Patient potential - page 176
- Marketing factors - page 176
- Satisfaction of unmet needs - page 177
- ACP-103 - page 178
- Drug overview - page 178
- Clinical trial data - page 179
- Patient potential - page 179
- Marketing factors - page 180
- Satisfaction of unmet needs - page 181
- Pruvanserin - page 182
- Datamonitor comments - page 182
- Volinanserin - page 182
- Clinical trial data - page 183
- Datamonitor comments - page 184
- MN-305 - page 184
- Clinical trial data - page 184
- Ongoing clinical trials - page 185
- Datamonitor comments - page 185
- APD-125 - page 186
- Datamonitor comments - page 186
- HY-10275 - page 175
- CHAPTER 8 OTHER LATE-STAGE DRUG ANALYSIS AND FORECASTS - page 188
- Comparative forecasts - page 189
- Comparative Datamonitor drug assessment summaries - page 189
- Pipeline summary - page 190
- Definition of current comparator therapy - page 191
- Doxepin (Silenor) - page 191
- Profile - page 192
- Drug overview: NDA filing expected in Q3 2007 - page 192
- Clinical data - page 192
- Patient potential - page 198
- Marketing factors - page 198
- Satisfaction of unmet needs - page 201
- Forecasts to 2016 - page 202
- Datamonitor drug assessment summary - page 204
- Profile - page 192
- ACT-078573 - page 204
- Profile - page 205
- Drug overview - page 205
- Clinical data - page 205
- Patient potential - page 206
- Marketing factors - page 206
- Satisfaction of unmet needs - page 207
- Forecasts to 2016 - page 208
- Datamonitor drug assessment summary - page 209
- Profile - page 205
- PD-200390 - page 210
- Datamonitor comments - page 210
- CHAPTER 9 INNOVATIVE EARLY-STAGE PROJECTS - page 212
- Key Phase I and preclinical compounds in insomnia - page 213
- The early stage insomnia pipeline is characterized by a dearth of innovation - page 213
- G-protein-coupled receptor modulator - page 214
- PGR-683 - page 214
- Melatonin agonist - page 215
- BDD- 40001 - page 215
- Key Phase I and preclinical compounds in insomnia - page 213
- BIBLIOGRAPHY - page 217
- Books and journals - page 217
- Datamonitor Reports - page 225
- Websites - page 225
- APPENDIX A - page 233
- Methodology - page 233
- Datamonitor forecast methodology - page 233
- Product forecasts - page 233
- Definition of a standard unit - page 233
- Patient expiry and generic assumptions - page 233
- Datamonitor drug assessment summary - page 235
- Datamonitor forecast methodology - page 233
- Contributing experts - page 235
- Report methodology - page 236
- Methodology - page 233
- APPENDIX B - page 237
- About Datamonitor - page 237
- About Datamonitor Healthcare - page 237
- Datamonitor Healthcare's therapy area capabilities - page 238
- About the Disease analysis team - page 239
- Disclaimer - page 240
- About Datamonitor - page 237
- List of Tables
- Table 1: Forecast key pipeline products for insomnia in the seven major markets ($m), 2006-2016 - page 6
- Table 2: Pipeline drugs in pre-registration and Phase III development for insomnia, 2007 - page 21
- Table 3: Pipeline drugs in Phase II development for insomnia, 2007 - page 23
- Table 4: Pipeline drugs in Phase I development and discovery for insomnia, 2007 - page 24
- Table 5: Number of key insomnia drugs by class and phase of development, 2007 - page 25
- Table 6: Insomnia drugs recently discontinued from development - page 25
- Table 7: Key events preceding the discontinuation of gaboxadol's development - page 27
- Table 8: Sanofi-Aventis's marketed CNS products, 2007 - page 29
- Table 9: Sanofi-Aventis's marketed and pipeline insomnia drugs, 2007 - page 31
- Table 10: ICSD-R Criteria for severity of insomnia - page 44
- Table 11: Epidemiology of diagnosed insomnia in the seven major markets, 2007 - page 50
- Table 12: Prevalence of diagnosed insomnia in the seven major markets, 2007 - page 51
- Table 13: The average rating of the clinical unmet needs in insomnia - page 59
- Table 14: Non-pharmacological insomnia therapy - page 70
- Table 15: Advantages and disadvantages of pharmacological therapy, alone and combined with drug treatment - page 71
- Table 16: Widely used primary and secondary clinical trial endpoints - page 74
- Table 17: Important directions for insomnia related research - page 83
- Table 18: Key products in late-stage R&D pipeline of the benzodiazepine class, 2007 - page 89
- Table 19: Sanofi Aventis's Ambien: key facts - page 90
- Table 20: Key events and launch dates impacting indiplon IR and MR revenue forecasts for insomnia in the seven major markets, 2007-2016 - page 107
- Table 21: Key events and launch dates impacting revenue forecasts of zolpidem sublingual spray in the seven major markets, 2007-2016 - page 116
- Table 22: Key events and launch dates impacting revenue forecasts of Sublinox in the seven major markets, 2007-2016 - page 122
- Table 23: Key products in late-stage R&D pipeline of the melatonin agonist class, 2007 - page 137
- Table 24: Rozerem: Key facts - page 138
- Table 25: Key events and launch dates impacting revenue forecasts of VEC-162 in the seven major markets, 2007-2016 - page 147
- Table 26: Key events and launch dates impacting revenue forecasts of PD6735 in the seven major markets, 2007-2016 - page 154
- Table 27: Key products in late-stage R&D pipeline of the 5-HT class, 2007 - page 160
- Table 28: Ambien CR: Key facts - page 161
- Table 29: Key events and launch dates impacting revenue forecasts of eplivanserin in the seven major markets, 2007-2016 - page 167
- Table 30: Key events and launch dates impacting revenue forecasts of Org-50081 in the seven major markets, 2007-2016 - page 173
- Table 31: Other key products in late-stage R&D pipeline, 2007 - page 191
- Table 32: Key events and launch dates impacting revenue forecasts of Silenor in the seven major markets, 2007-2016 - page 202
- Table 33: Key events and launch dates impacting revenue forecasts of ACT-078573 in the seven major markets, 2007-2016 - page 208
- Table 34: Drugs in Phase 1 and discovery for insomnia, 2007 - page 213
- Table 35: Estimated generic discounts by country, 2006* - page 234
- Table 36: Estimates of brand erosion by following patent expiry by country - page 234
- Table 37: Datamonitor's pipeline drug assessment weighting scale - page 235
- List of Figures
- Figure 1: Datamonitor's insomnia drug assessment summary for the seven major markets ($m), 2007-2016) - page 7
- Figure 2: Symptoms of insomnia affecting the US population at least a few times a week - page 42
- Figure 3: Breakdown of the prevalence of insomnia - page 49
- Figure 4: Symptoms of insomnia experienced by the US population at least a few times a week (male vs female) - page 53
- Figure 5: Prevalence of sleep disorders in peri-menopausal and post-menopausal women - page 54
- Figure 6: Symptoms of insomnia in the US population at least a few times a week (age) - page 55
- Figure 7: Impairment of quality of life associated with insomnia - page 56
- Figure 8: Clinical unmet needs in insomnia, 2007 - page 59
- Figure 9: Characteristics of the ideal hypnotic drug - page 60
- Figure 10: Drug classes in development for the treatment of insomnia, 2007 - page 72
- Figure 11: Datamonitor's comparative forecast of sales for late-stage GABAa products across the seven major markets ($m), 2007-2016 - page 87
- Figure 12: Datamonitor's competitive positioning analysis for indiplon IR, indiplon MR, zolpidem sublingual spray and Sublinox in the seven major markets, 2007-2016 - page 88
- Figure 13: Datamonitor's forecast sales on indiplon IR across the seven major markets for insomnia ($m), 2007-2016 - page 108
- Figure 14: Datamonitor's forecast sales of indiplon MR across the seven major markets for insomnia ($m) 2007-2016 - page 109
- Figure 15: Datamonitor's competitive positioning analysis for indiplon IR in the seven major markets, 2007-2016 - page 110
- Figure 16: Datamonitor's competitive positioning analysis for indiplon MR in the seven major markets, 2007-2016 - page 111
- Figure 17: Datamonitor's forecast sales of zolpidem sublingual spray across the seven major markets for insomnia ($m), 2007-2016 - page 117
- Figure 18: Datamonitor's competitive positioning analysis for zolpidem sublingual spray in the seven major markets, 2007-2016 - page 118
- Figure 19: Datamonitor's forecast sales of Sublinox across the seven major markets for insomnia ($m), 2007-2016 - page 123
- Figure 20: Datamonitor's competitive positioning analysis for Sublinox in the seven major markets, 2007-2016 - page 124
- Figure 21: Datamonitor's comparative forecast of sales for late-stage melatonin agonists across the seven major markets ($m), 2007-2016 - page 135
- Figure 22: Datamonitor's competitive positioning analysis for VEC-162 and PD-6735 in the seven major markets, 2007-2016 - page 136
- Figure 23: Datamonitor's forecast sales of VEC-162 across the seven major markets for insomnia ($m), 2007-2016 - page 148
- Figure 24: Datamonitor's competitive positioning analysis for VEC-162 in the seven major markets, 2007-2016 - page 149
- Figure 25: Datamonitor's forecast sales of PD-6735 across the seven major markets for insomnia ($m), 2007-2016 - page 155
- Figure 26: Datamonitor's competitive positioning analysis for PD-6735 in the seven major markets, 2007-2016 - page 156
- Figure 27: Datamonitor's comparative forecast of sales for eplivanserin and VEC-162 across the seven major markets ($m), 2007-2016 - page 158
- Figure 28: Datamonitor's competitive positioning analysis for eplivanserin and Org-50081 in the seven major markets, 2007-2016 - page 159
- Figure 29: Datamonitor's forecast sales of eplivanserin across the seven major markets for insomnia ($m), 2007-2016 - page 168
- Figure 30: Datamonitor's competitive positioning analysis for eplivanserin the seven major markets, 2007-2016 - page 169
- Figure 31: Datamonitor's forecast sales of Org-50081 across the seven major markets for insomnia ($m), 2007-2016 - page 173
- Figure 32: Datamonitor's competitive positioning analysis for Org-50081 in the seven major markets, 2007-2016 - page 174
- Figure 33: Datamonitor's comparative forecast of sales for Silenor and ACT-078573 across the seven major markets ($m), 2007-2016 - page 189
- Figure 34: Datamonitor's competitive positioning analysis for Silenor and ACT-078573 in the seven major markets, 2007-2016 - page 190
- Figure 35: Datamonitor's forecast sales of Silenor across the seven major markets for insomnia ($m), 2007-2016 - page 203
- Figure 36: Datamonitor's competitive positioning analysis for Silenor in the seven major markets, 2007-2016 - page 204
- Figure 37: Datamonitor's forecast sales of ACT-078573 across the seven major markets for insomnia ($m), 2007-2016 - page 209
- Figure 38: Datamonitor's competitive positioning analysis for ACT-078573 in the seven major markets, 2007-2016 - page 210
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