Pipeline and Commercial Perspectives: Insomnia

TABLE OF CONTENTS
CHAPTER 1 EXECUTIVE SUMMARY 3
Scope of the analysis 3
Datamonitor insight into the Insomnia market 4
Key metrics 7
CHAPTER 2 PATIENT POTENTIAL 20
Definition of insomnia 20
Segmentation of insomnia 21
Types of insomnia 21
Transient insomnia 21
Intermittent or short-term insomnia 22
Chronic insomnia 22
Other types of insomnia 22
Epidemiology of insomnia 24
Prevalence of insomnia 24
Gender 24
Age 26
Diagnosis of insomnia 28
Diagnosis rates of insomnia 28
Impacts of insomnia and working life 31
Economic consequences 32
Unmet needs in insomnia 33
CHAPTER 3 MARKET OVERVIEW 38
The current insomnia market 38
The insomnia market players and franchises 42
Sanofi-Aventis’s insomnia franchise 42
King/Wyeth’s Sonata 46
Benzodiazepines 49
Herbal hypnotics and sedatives 50
Antihistamines 51
Antidepressants 51
Other drugs 52
Non-pharmacological therapy 52
Consumer trends in sleep aids 54
Summary of major players and their vital statistics 57
CHAPTER 4 COUNTRY MARKET ASSESSMENT 59
Global opportunities and threats 59
Opportunities 59
Global aging population 59
New EU legislation will increase data exclusivity period, providing increased return on investment for new products 60
Threats 60
Parallel imports; EU expansion is likely to drive down price 60
Drive towards generic prescribing 61
US 61
Opportunities 64
High public awareness driven by advocacy and DTC campaigns 64
Direct access to specialist physicians helps patients receive optimal treatment quicker 65
High price of branded drugs 65
Threats 65
Clamp down on DTC advertising 65
Generic substitution 66
Widespread parallel importing is driving down drug prices 67
Japan 69
Opportunities 72
Rising population over the age of 65 72
Pricing process slows generic incursion 73
Separation of manufacturing and marketing entities opens market to overseas companies 73
Faster product approval accelerates the time to market 74
Threats 74
Biennial price cuts restrict profit 74
Restriction of physician incentives decreases pharmaceutical influence on prescribers 75
Genericization is slowly taking off 75
European market 76
EU cost differential 79
Opportunities 80
Revisions to EU pharmaceutical laws 80
Threats 80
NICE fails to distinguish second-generation hypnotics from benzodiazepines 80
Single European pricing 81
Facilitated entry of generics 82
Generic substitution 82
France 83
Market overview 83
Germany 86
Market overview 86
Italy 89
Market overview 89
Spain 92
Market overview 92
UK 95
Market overview 95
CHAPTER 5 R&D APPROACH 98
Clinical trials and drug development 98
Measurement scales in insomnia 98
Sleep questionnaires 98
Alertness tests 99
Quality of life measures 100
Sleep monitoring 101
Novel approaches to enhance traditional clinical trials 102
Manufacturers need to demonstrate drug cost-effectiveness 102
More diverse clinical trial endpoints need to be investigated 105
Patient reported outcomes and endpoints are key 107
NIH recommendations 108
CHAPTER 6 RECENTLY LAUNCHED HYPNOTIC ANALYSIS & FORECASTS 110
Recently launched drugs 110
Comparative positioning of novel hypnotics 111
Methodology of competitive positioning analysis 112
Ambien – the gold-standard insomnia drug therapy 116
Competitive positioning analysis of Ambien 117
Recently launched hypnotic drug analysis 118
Lunesta 118
Lunest demonstrates long-term efficacy 118
Competitive positioning analysis of Lunesta 122
The first hypnotic approved for sleep onset and maintenance 123
Lunesta grows hypnotics market? 126
Cost-effective Lunesta? 128
Lunesta will reach peak revenues in 2008 130
Rozerem 133
Rozerem demonstrates a strong safety profile 133
Competitive positioning analysis of Rozerem 135
Lack of scheduling and no next day residual effects key features of Rozerem 137
Young professionals and the elderly are likely to be key markets 139
Takeda should primarily target PCPs 140
Rozerem forecast to be next drug launched in Japan 142
Forecast revenues 143
Ambien CR 145
Improving the Ambien brand 145
Competitive positioning analysis of Ambien CR 148
Building upon the safety, efficacy and commercial strength of the Ambien 149
Ambien CR grows Sanofi-Aventis’s insomnia franchise in the short-term 150
The threat of generic incursion 151
Ambien CR will fail to sustain the Ambien franchise 158
CHAPTER 7 LATE-STAGE PIPELINE HYPNOTIC ANALYSIS & FORECASTS 161
Pipeline summary 161
Registered and Phase III overview 161
Phase II overview 162
Phase I and preclinical overview 163
Recently discontinued pipeline drugs 165
Physician awareness of pipeline drugs 166
Pipeline drug analysis 168
Indiplon 168
Clinical data – Indiplon IR 168
Clinical data – Indiplon MR 172
Competitive positioning analysis of indiplon 175
Two formulations will give indiplon a key profile 176
Pfizer’s marketing prowess will win through for indiplon 179
Indiplon set to become the US market leader from 2008 180
Gaboxadol 184
Limited clinical trial data published for gaboxadol 184
Competitive positioning analysis of gaboxadol 186
More efficacy data required 187
Focus on lack of next day residual effects 190
Gaboxadol expected to grow throughout the forecast period 191
Silenor 193
Targeting sleep maintenance 193
Competitive positioning analysis of Silenor 195
Concerns over the 17 hour half life 196
Limited commercial potential in re-marketing an existing generic 197
Limited uptake due to availability of superior hypnotics 199
Phase II 5-HT 2a receptor antagonists 201
Eplivanserin 201
M-100907 201
Org-50081 202
Differentiating factors of the 5-HT 2a antagonists 204
Competition in the insomnia market from 2009 onwards limits revenue potential of 5-HT 21 antagonists 207
PD-6735 209
Limited clinical trial data published for PD-6735 209
Competitive positioning analysis of PD-6735 209
Another Rozerem? 211
Potential marketing partners 211
PD-6735 will face strong competition form Rozerem and the GABA A hypnotics, limiting uptake 213
CHAPTER 8 FORECAST ANALYSIS 215
Assumptions and events 215
2005 215
US launch of Lunesta 215
US launch of Rozerem 215
US launch of Ambien CR 216
2006 217
US launch of indiplon 217
Ambien US patent expiry 217
2008 218
Sonata US patent expiry 218
US and EU launch of gaboxadol 218
US launch of Silenor 219
2009 219
US launch of PD-6735 219
EU launch of Org-50081 220
2010 220
US launch of eplivanserin or M-100907 220
2011 220
Sonata EU patent expiry 220
2012 221
Ambien Japanese patent expiry 221
Lunesta patent expiry 221
2013 222
Silenor patent expiry 222
Ongoing events 222
CHAPTER 9 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES 224
Comparative drug launches and DTC marketing 224
Lunesta 224
Rozerem 228
Ambien CR 230
Innovation is key – manufacturers need to differentiate their drugs from the influx of generic GABA A agonists 231
Novel non-stimulant, non-scheduled drugs 232
Extended-release formulations and treatment of sleep maintenance 234
Long-term treatment of chronic insomnia 237
Lack of next day residual effects 240
Targeting comorbid disorders 243
Changing physicians’ prescribing strategies 247
Targeting additional sleep disorders 248
No-go comorbid niches for hypnotics 252
Future directions 253
Pediatric and adolescent insomnia still a no go area 253
Targeting transient insomnia 255
Transient insomnia market is severely under treated 255
Erosion of the OTC market may prove difficult 257
Targeting transient insomnia 258
Reformulation of hypnotics 263
APPENDIX A 265
Insomnia market data 265
Contributing experts 276
Anonymous US Sleep Disorders Expert – Requested total anonymity. 276
Bibliography 277
Websites 283
APPENDIX B 287
Syndicated Forecasting Methodology 287
Regional launch dates for new products 289
About Datamonitor 290