Pipeline and Commercial Insight: Insomnia - Future of Innovative Orexin Drug Class in Doubt Now Available at ReportsandReports

Dallas, TX -- (SBWire) -- 08/09/2010 -- ReportsandReports announce it will carry Pipeline and Commercial Insight: Insomnia - Future of innovative orexin drug class in doubt Market Research Report in its Store.

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The availability of generic versions of Ambien (zolpidem, Sanofi-Aventis) in the US from April 2007 onwards has intensified competition for both existing and prospective players in the insomnia market. Following the discontinuation of three 5-HT antagonists in late-stage development over 20092010, orexin receptor antagonists now represent the most innovative candidates in the insomnia pipeline.

Scope

• Analysis of insomnia epidemiology, drug recommendations, patient acquisition process and unmet medical needs.
• In depth analysis of historic (200509) and future (201019) seven major market prescription sales dynamics.
• Review of prescription sales data in the Rest of World (200509) and analysis of insomnia epidemiology in Brazil and China.
• Commercial and clinical assessment of key late-stage pipeline drugs, with key opinion leader comment and country-specific sales forecasts to 2019.

Highlights

In 2019, the value of the seven major insomnia market is forecast to reach $3.5 billion. While growth of the US market is set to be inhibited by further generic erosion from 2011 onwards, Japan will represent the key growth region over the next 10 years.

Sanofi-Aventis's dominance in the insomnia market is under threat due to patent challenges to Ambien CR and Datamonitor expects generic versions of this market leading brand to enter the US over the forecast period. In the absence of pipeline insomnia candidates, Sanofi-Aventis is not expected to regain its market leading status.

Three orexin receptor antagonists are currently under late stage clinical development by two Big Pharma players; GlaxoSmithKline and Merck. While safety observations raised in a Phase III trial of almorexant are of concern to developers, it has potential to become the most successful pipeline candidate.

Reasons to Purchase

• Quantify the current and future size of the insomnia market in the seven major pharmaceutical markets.
• Identify potential licensing opportunities based on product portfolios and anticipated market needs.
• Understand the country-specific impact of key events in the insomnia market during the forecast period 2010 to 2019.

Table Of contents

Overview 1
Catalyst 1
Summary 1
About Datamonitor Healthcare 2
About the central nervous system pharmaceutical analysis team 2
Executive Summary 3
Strategic scoping and focus 3
Datamonitor insight into the disease market 3
Related reports 5

1. Patient Potential 7
Key findings 7
Definition of insomnia 8
Classification of insomnia 8
Insomnia is classified according to etiology and duration 8
Other forms of insomnia 9
Etiology 10
Diagnosis 10
Epidemiology 11
Seven major markets 11
Only a small percentage of individuals with symptoms of insomnia receive a diagnosis 12
Insomnia is more prevalent in women than in men 14
Insomnia is most prevalent in young adults and the elderly 15
BRIC (Brazil, Russia, India, China) countries 16
Detailed studies of the prevalence of insomnia in the BRIC region are sparse 16
Clinical unmet need in insomnia 17
Unmet need one: reduction of residual daytime sedation 19
Unmet need two: lack of potential for tolerance and addiction 20
Unmet need three: more effective treatments for insomnia in the elderly 22
Unmet need four: improvement in sleep maintenance 22
Unmet need five: more effective treatments for pediatric insomnia 23
Environmental unmet need in insomnia 24
Improvement in the recognition, diagnosis and treatment rate of insomnia 24

2. Market Overview 27
Key findings 27
Market definition for this report 28
Current assessment of the seven major insomnia markets 28
Generic erosion caused the insomnia market to decline by a CAGR of 2.7% over 2005-09 to $3.4 billion in 2009 28
The US remained the largest insomnia market in 2009, despite undergoing the greatest decline in sales over 2005-09 30
Japan experienced the greatest growth of all the seven major insomnia markets over 2005-2009 32
Germany represents the largest of the 5EU insomnia markets, accounting for 28% of 5EU sales in 2009 33
Plain non-barbiturate drugs dominate the market, with the leading five brands comprising 67% of the total market in 2009 34
Sanofi-Aventis's Ambien CR reigns as the leading brand in the insomnia market with a 28% share 34
Future assessment of the seven major insomnia markets 37
By 2019 uptake of pipeline candidates will offset contraction in market value caused by generic erosion 37
Market volume to maintain consistent growth over forecast period 38
Growth of US market value is set to be inhibited by generic erosion from 2011 39
Japan will represent the key growth region in the insomnia market over the next 10 years 40
Generic erosion of the Ambien franchise in the US will see Sanofi-Aventis lose its market-leading status 41
Rest of the world snapshot 43
Rest of the world insomnia market accounted for 22% of the global value in 2009 43
Rest of the world region market value grows over 2005-09, while the seven major markets contract 44
Rest of the world accounts for over half of the global insomnia market volume 45
Patient acquisition process 47
Introduction 47
Patient care path 47
Primary care physicians play a central role in the management of insomnia 48
Behavioral interventions are recommended as an initial approach to the treatment of insomnia
Drug treatments 50
Points of influence in the patient care path 51
Drive up patient presentation rates through conveying the message that insomnia is not a trivial condition 51
Drivers of drug choice 52

3. Brand Dynamics 54
Key findings 54
Overview of competitive landscape 55
Widespread availability of generic zolpidem is the greatest barrier to uptake of recent and prospective market entrants 55
Regulatory agencies are becoming increasingly stringent when reviewing New Drug Applications 56
Reimbursement/tiering of brands 57
Availability of generic GABA agonists negatively impacts the tier status of branded insomnia drugs 57
Ambien franchise (zolpidem; Sanofi-Aventis) 58
Drug overview 58
Drug profile 58
Product positioning 59
Despite failing to match the peak sales achieved by Ambien, Ambien CR is the leading insomnia brand 59
Entry of generic competition poses threat to future Ambien CR sales 61
SWOT analysis 63
Brand forecast to 2019 63
Lunesta (eszopiclone; Sepracor) 65
Drug overview 65
Drug profile 65
Product positioning 66
Launch of Ambien CR and Ambien generics has exerted a negative impact on Lunesta's growth trajectory 66
Lunesta's geographical availability is set to include Japan 67
Marketing deal called off in EU after EMA maintains that Lunesta should not be regarded as a new active substance 67
FDA's clinical hold on pediatric studies of Lunesta has been lifted 68
SWOT analysis 69
Patent challenges represent the greatest threat to future sales of Lunesta 69
Brand forecast to 2019 71
Rozerem (ramelteon; Takeda) 72
Drug overview 72
Drug profile 72
Product positioning 73
Rozerem remains a niche product in the insomnia market 73
July 2010 launch in Japan has expanded Rozerem's geographical reach 74
Resubmission of MAA in Europe is currently under consideration by Takeda 74
Patent challenges pose threat to future sales of Rozerem 75
SWOT analysis 76
Brand forecast to 2019 77
Circadin (melatonin; Neurim) 78
Drug overview 78
Drug profile 78
Clinical trial data 79
Trial one: Circadin significantly improves quality of sleep compared with placebo 80
Trial two: Circadin leads to significant improvement in sleep quality and morning alertness 80
Trial three: Circadin (2mg) does not impair daytime psychomotor performance 81
Circadin demonstrates long-term efficacy and safety of elderly patients 82
Product positioning 82
Circadin is the first prescription melatonin treatment to gain EU approval for insomnia 82
'Sleep quality' indication differentiates Circadin from established market players 83
SWOT analysis 85
Neurim has seized a key opportunity through gaining approval of Circadin for long-term use in EU 85
Brand forecast to 2019 87
Edluar (zolpidem sublingual tablet; Orexo/Meda) 89
Drug overview 89
Drug profile 90
Clinical trial data 90
Edluar renders a 34% faster onset of sleep than Ambien 90
Product positioning 91
Edluar represents the first rapidly acting zolpidem reformulation to enter the US market 91
SWOT analysis 92
Brand forecast to 2019 93

4. Pipeline Overview and R&D Dynamics 96
Key findings 96
Pipeline overview 97
Late-stage candidates dominate the insomnia pipeline in 2010 97
Drugs in late-stage development show relatively high attrition rate 99
Classification of pipeline products 100
GABA modulators account for over one third of the clinical insomnia pipeline 100
Insomnia subtypes under investigation 102
Companies are increasingly looking towards circadian rhythm sleep disorders 102
Key companies involved in the insomnia pipeline 103
GlaxoSmithKline: keen to penetrate insomnia market with novel compounds 103
Merck: looks towards novel mechanism of action following the 2007 failure of GABAa agonist gaboxadol 104
Definition of current comparator therapy 105
Ambien represents the gold standard treatment for insomnia 105
Clinical trials 106
Key strengths and weaknesses 107

5. Pipeline Drug Analysis and Forecasts: GABA Modulators 109
Key findings 109
Overview of pipeline GABA modulators 110
ZolpiMist (zolpidem; NovaDel Pharma Inc/ECR Pharmaceuticals) 111
Drug overview 111
Despite receiving FDA approval in December 2008, ZolpiMist has yet to launch 111
Drug profile 112
Clinical trial data 113
Studies have demonstrated bioequivalence between ZolpiMist and Ambien 113
SWOT analysis 115
Clinical and commercial attractiveness 116
Safety concerns surrounding ZolpiMist's rapid onset of action reduces the product's clinical attractiveness 116
Limited commercial potential appeared to slow the process of securing a commercialization partner 117
ECR Pharmaceuticals's lack of experience in the insomnia market will hinder uptake of ZolpiMist 117
Satisfaction of unmet needs 118
ZolpiMist's rapid onset of action fails to address key unmet needs in the treatment of insomnia
Forecasts to 2019 119
Sales revenue will be limited by safety concerns and inability to address key unmet clinical needs 119
Indiplon (NBI34060; Neurocrine Biosciences) 120
Drug overview 121
Indiplon capsules remains unapproved despite receiving two Approvable Letters from the FDA
Drug profile 124
Clinical trial data 124
SWOT analysis 128
Clinical and commercial attractiveness 129
Neurocrine lacks the marketing strength to successfully commercialize indiplon independently
Satisfaction of unmet needs 130
Indiplon capsules may satisfy need for reduction in residual daytime sedation 130
Forecasts to 2019 130
Launch of indiplon is dependent upon Neurocrine meeting the three additional requirements of the FDA 130
Intermezzo (zolpidem tartrate; Transcept Pharmaceuticals) 132
Drug overview 133
The FDA's Complete Response Letter of October 2009 represented a setback to Transcept 133
Transcept estimates resubmission of Intermezzo's NDA to take place in Q4 2010 133
Drug profile 134
Clinical trial data 134
Phase III sleep laboratory study: Intermezzo improves objective and subjective measures of sleep onset 134
Phase III outpatient study: Intermezzo improves time to sleep onset after MOTN awakening by 18 minutes 136
The pharmacokinetic profile of Intermezzo is characterized by very rapid absorption 138
Upcoming highway driving study aims to determine Intermezzo's next day residual effects 138
SWOT analysis 139
Clinical and commercial attractiveness 141
Potential need for repeat dosing may lead to preference for products indicated for pre-sleep use 141
Transcept's decision to promote Intermezzo to only psychiatrists is a promising strategy 141
Satisfaction of unmet needs 142
Intermezzo may be an appropriate treatment option for elderly patients with sleep maintenance insomnia 142
Forecasts to 2019 143
Approval of Intermezzo is dependent upon demonstration of lack of effect on next-morning driving ability 143
Other pipeline GABA modulators 145
SKP-1041 (zaleplon; Somnus Therapeutics/SkyePharma): Phase II study commenced in May 2010 145
AZ-007 (Alexza Pharmaceuticals): partnership necessary for future development 147
Zaleplon GR (Intec Pharma): sleep maintenance insomnia is the indication likely to be sought
Discontinued/suspended pipeline GABA modulators 149
Evotec ceased internal investment for its Phase II insomnia candidate-EVT201-in March 2009
Development of Neurogen's NG-273 was suspended in July 2008 150
Development of Fabre-Kramer's TGARO1H (triazolam) is assumed to be discontinued 151

6. Pipeline Drug Analysis and Forecasts: Orexin Receptor Antagonists 152
Key findings 152
Overview of pipeline orexin receptor antagonists 153
Almorexant (ACT-078573; Actelion Pharmaceuticals/GlaxoSmithKline) 155
Drug overview 155
Almorexant is currently being investigated in a Phase III program in primary insomnia 155
Drug profile 156
Clinical trial data 156
Almorexant meets primary endpoint in Phase III trial, although safety observations require investigation 157
Proof-of-concept/dose-ranging study: Almorexant significantly improves sleep efficiency 158
Long-term Phase III trials examining the safety profile of almorexant are expected to be initiated in 2010 159
SWOT analysis 159
Clinical and commercial attractiveness 160
'Safety observations' made in RESTORA 1 trial will remain a concern until long-term data prove otherwise 160
Although Phase III results are encouraging, future demonstration of superiority over zolpidem is necessary 162
Almorexant's novel mechanism of action will generate much interest among physicians 162
Licensing deal with GlaxoSmithKline will enable the realization of almorexant's full commercial potential 163
Development in additional orexin-related disorders will expand the patient potential of almorexant 164
Satisfaction of unmet needs 164
Almorexant has the potential to address several key unmet needs in the treatment of insomnia
Forecasts to 2019 165
Almorexant is forecast to achieve the greatest sales revenue of all late-stage pipeline products
MK-4305 (Merck & Co.) 168
Drug overview 168
MK-4305: Merck & Co. anticipates filing for insomnia approval in 2012 168
Drug profile 169
Clinical trial data 169
Phase IIb trial: MK-4305 improves sleep efficiency, sleep onset and maintenance 169
Phase III trials in adults with primary insomnia are in progress 172
SWOT analysis 174
Clinical and commercial attractiveness 176
Ascertaining MK-4305's safety should be a priority for Merck in light of almorexant's 'safety observations' 176
MK-4305 is expected to experience direct competition from almorexant upon launch 176
Merck's sales and marketing capabilities bode well for uptake of MK-4305 in insomnia 176
Satisfaction of unmet needs 177
MK-4305 may satisfy the need for more effective treatments for elderly patients and improvement in sleep maintenance 177
Forecasts to 2019 178
MK-4305 is forecast to launch in the US market in Q1 2014 178
Other pipeline orexin receptor antagonists 180
GSK649868: Phase II candidate looks to be a back-up compound for almorexant 180

7. Pipeline Drug Analysis and Forecasts: Melatonin Receptor Agonists 181
Key findings 181
Overview of pipeline melatonin agonists 182
Tasimelteon (VEC-162; Vanda) 182
Drug overview 182
Non-24-hour sleep/wake disorder in blind individuals is the primary focus for Vanda's Phase III candidate 182
Drug profile 183
Clinical trial data 184
Phase III trial: tasimelteon reduces transient insomnia associated with shifted sleep and wake time 184
Phase III trial: tasimelteon significantly improves sleep onset in patients with chronic insomnia
Trials of tasimelteon in non-24-hour sleep/wake disorder are due to commence in Q2 2010
SWOT analysis 186
Clinical and commercial attractiveness 188
Tasimelteon's clinical utility in both chronic insomnia and CRSDs differentiates it from Rozerem
Tasimelteon demonstrates a superior sleep maintenance profile to Rozerem 188
Although reported to be well tolerated, tasimelteon would benefit from long-term safety data
Depression represents a key indication expansion opportunity 189
Tasimelteon represents a commercialization opportunity for existing and prospective market players 189
Forecasts to 2019 189
Datamonitor assumes that Vanda will seek approval of tasimelteon in non-24-hour sleep/wake disorder only 189
Other pipeline melatonin receptor agonists 192
Orlogin (Neurim Pharmaceuticals) 192
Neu-P11 (Neurim Pharmaceuticals) 193

8. Late-Stage Drug Analysis and Forecasts: 5-HT Modulators 194
Key findings 194
Overview of pipeline 5-HT modulators 195
Silenor (doxepin hydrochloride; Somaxon Pharmaceuticals) 195
Drug overview 195
Silenor received FDA approval for sleep maintenance insomnia in March 2010 and has yet to launch 195
Approval of Silenor was preceded by a lengthy review process by the FDA 196
Drug profile 199
Clinical trial data 199
First Phase III trial: Silenor demonstrates statistically significant improvement in sleep maintenance among adults with chronic insomnia 199
Second Phase III trial: Silenor provides statistically significant improvement in sleep onset in adults with transient insomnia 200
Third Phase III trial: Silenor improves subjective total sleep time in elderly patients with chronic insomnia 201
Fourth Phase III trial: positive results at 12 weeks in elderly patients with insomnia 201
Phase III trial: doxepin produces statistically significant improvement in sleep maintenance measures 201
SWOT analysis 203
Silenor's lack of scheduling differentiates it from all insomnia products indicated for sleep maintenance 204
Availability of generic doxepin represents the greatest barrier to Silenor's market penetration
Absence of commercialization partner indicates that companies believe Silenor offers little commercial potential 206
Ability to alleviate co-morbid conditions will increase commercial potential 207
Satisfaction of unmet needs 207
Silenor addresses three out of five key unmet clinical needs in insomnia 207
Forecasts to 2019 208
Competition from generic doxepin and likely absence of commercialization partner will hinder uptake 208
Other pipeline 5-HT modulators 209
ITI-722 (Intra-Cellular Therapies): Phase II candidate in development for sleep maintenance insomnia 209
Drug profile 210
Clinical trial data: ITI-722 meets primary and key secondary endpoints in Phase II trial in sleep maintenance insomnia 210
SWOT analysis 212
Clinical and commercial attractiveness 213
Satisfaction of unmet needs 213
LY2624803 (Eli Lilly): Phase II results in chronic insomnia were expected in first half of 2010
Discontinued/suspended pipeline 5-HT modulators 214
Ciltyri (eplivanserin; Eli Lilly): US and EU submission dossiers withdrawn in December 2009
Volinanserin (M100908; Sanofi-Aventis): Phase III program discontinued in February 2009
Esmirtazapine (SCH900265; Merck): discontinuation of development program announced in March 2010 217
Bibliography 219
Books and journal papers 219
Websites 226

APPENDIX 246
Forecasting assumptions 246
New product launches 246
Patent expiries 247
Data definitions, limitations and assumptions 247
Standard units 247
Derivation of sales forecasts and pricing trends 247
Exchange rates 248
Country group definitions 248
Rest of European Union 248
Middle East and North Africa (MENA) 248
Rest of World 249
Derivation of sales forecasts and pricing trends 249
Forecast methodology 249
Datamonitor drug assessment scorecard 249
Insomnia pipeline drug assessment scorecard 249
Contributing experts 250
Conference attendance 251
About Datamonitor 252
About Datamonitor Healthcare 252
About the Disease analysis team 252
Datamonitor consulting 253
Disclaimer 255

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