Pipeline Insight: ADHD
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the CNS pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Datamonitor insight into the ADHD market - page 5
- ADHD market - key metrics - page 7
- Datamonitor pipeline assessment summary - page 8
- CHAPTER 2 PATIENT POTENTIAL - page 17
- Disease definition and classification - page 17
- Etiology of ADHD - page 17
- Structural abnormalities - page 17
- Genetic predisposition - page 17
- Neurotransmitter dysfunction - page 18
- Diagnostic criteria of ADHD - page 18
- Etiology of ADHD - page 17
- Epidemiology of ADHD - page 20
- Key patient segments - page 25
- Gender - page 25
- Comorbidities - page 26
- Clinical unmet needs of ADHD - page 27
- Diagnostic complications - page 28
- Hyperkinesis versus attention deficit hyperactivity disorder - page 28
- Gender - page 28
- Age - page 28
- Duration of symptoms - page 29
- Diagnostic complications - page 28
- Diagnostic tools - page 29
- ADHD Rating Scale - page 30
- Conners' Rating Scale-Revised (CRS-R) - page 30
- Copeland symptom checklist - page 30
- Barkley's Current Symptoms Scale-Self Report Form (home and school) - page 31
- Brown ADD Scale (diagnostic form) - page 31
- Parent-completed Child Behavior Checklist - page 31
- Teacher Report Form (TRF) of Child Behavior Checklist - page 32
- ADD-H: Comprehensive Teacher Rating Scale (ACTeRS) - page 32
- The IOWA Conners Rating scale - page 32
- Diagnostic unmet needs - page 33
- Disease definition and classification - page 17
- CHAPTER 3 R&D APPROACH - page 37
- Classification of marketed and pipeline products - page 37
- Marketed products - page 37
- Stimulants - methylphenidate and amphetamines - page 37
- Non-stimulants - Strattera - page 39
- Pipeline compounds - page 39
- Clinical trials and drug development - page 40
- Regulatory barriers to the development of pediatric medications - page 40
- Non-regulatory barriers to the development of pediatric medications - page 40
- Novel approaches to enhance traditional pediatric clinical trials - page 41
- Drug models in clinical trial development - page 43
- Marketed products - page 37
- Classification of marketed and pipeline products - page 37
- CHAPTER 4 ADHD PIPELINE ANALYSIS - page 45
- Pipeline overview - page 45
- Drugs launched in 2005 - page 45
- Registered and Phase III overview - page 45
- Phase II overview - page 48
- Phase I overview - page 49
- Preclinical overview - page 49
- Key companies involved in the ADHD pipeline - page 50
- Shire - page 50
- Despite an initial decline in ADHD revenues, Shire's pipeline ADHD drugs will save the day - page 56
- Novartis - page 60
- Focalin XR will rejuvenate Novartis's ADHD franchise, nearly doubling current revenues - page 63
- Strategies for success - page 65
- Innovation is key - manufacturers can no longer expect significant returns on standard extended-release formulations - page 65
- Comparative positioning of pipeline drugs - page 71
- Methodology of SWOT analysis - page 73
- Pipeline overview - page 45
- CHAPTER 5 LATE-STAGE METHYLPHENIDATE DRUG ANALYSIS & FORECASTS - page 77
- Methylphenidate drugs - page 77
- Recently launched drugs - page 77
- Pipeline summary - page 77
- Concerta - the gold-standard methylphenidate drug therapy - page 78
- SWOT analysis of Concerta - page 80
- Equasym XL - page 81
- Equasym XL is more effective than Concerta during the morning hours - page 81
- Equasym XL effective and safe in treating ADHD symptoms throughout the school day - page 82
- SWOT analysis of Equasym XL - page 83
- The proven safety and pharmacologic profile of Equasym XL will aid uptake in Europe - page 84
- UCB's delayed launch strategy in Europe will impact long-term revenues - page 85
- Equasym XL will reach peak share after the first two years of launch - page 86
- Focalin XR - page 88
- Focalin XR is generally perceived to act in less than one hour and remain effective for over eight hours - page 88
- Focalin XR is effective in treating children and adolescents with ADHD with few adverse effects - page 89
- SWOT analysis of Focalin XR - page 92
- Despite the strong therapeutic profile of Focalin XR, it will face competition from numerous branded and generic extended-release stimulants in the near future - page 93
- Approval for adult ADHD will significantly boost revenues - page 94
- Despite the strength of Focalin XR's therapeutic profile and marketing potential, it will be hindered by generic stimulants and novel ADHD drugs - page 96
- MTS - page 98
- MTS - page 98
- MTS failed to demonstrate clinical significance on the primary endpoint in its first Phase III clinical trial - page 98
- MTS is significantly superior to placebo, with significantly improved scores in teacher, parent and clinician ratings of patient behavior and attention - page 99
- MTS demonstrates significant efficacy compared to placebo in Phase II classroom study - page 100
- MTS demonstrates significant efficacy compared to placebo in Phase II classroom study - page 101
- SWOT analysis of MTS - page 102
- Kids will love MTS - page 103
- Patch technology improves safety, compliance and duration of action - page 104
- MTS will become the market-leading stimulant by 2010 - page 107
- Methylphenidate drugs - page 77
- CHAPTER 6 LATE-STAGE AMPHETAMINE DRUG ANALYSIS & FORECASTS - page 109
- Amphetamine drugs - page 109
- Pipeline summary - page 109
- Adderall XR - the gold-standard amphetamine drug therapy - page 110
- SWOT analysis of Adderall XR - page 111
- NRP-104 - page 112
- NRP-104 achieves similar blood amphetamine levels to current extended-release amphetamine products - page 113
- NRP-104 demonstrates comparable efficacy to Adderall XR - page 114
- SWOT analysis of NRP-104 - page 116
- NRP-104 - the first non-scheduled stimulant - page 117
- Equivalent efficacy to Adderall XR in treating children and adults - page 118
- NRP-104 will become the market-leading amphetamine by 2010 - page 119
- SPD-465 - page 121
- SWOT analysis of SPD-465 - page 122
- SPD-465 may sustain effect for too long in pediatric patients, limiting uptake - page 123
- With Shire's already strong ADHD pipeline, what will be the fate of SPD-465? - page 124
- SPD-465 will be overshadowed by NRP-104 - page 125
- Amphetamine drugs - page 109
- CHAPTER 7 LATE-STAGE OTHER ADHD DRUG ANALYSIS & FORECASTS - page 127
- Other ADHD drugs - page 127
- Pipeline summary - page 127
- Strattera - the gold-standard non-stimulant drug therapy - page 128
- SWOT analysis of Strattera - page 130
- Attenace (modafinil) - page 131
- Attenace consistently exhibits a robust efficacy on both the inattentive and hyperactive symptoms of ADHD - page 132
- Attenace significantly improves ADHD symptoms and is well tolerated in children with ADHD - page 132
- Attenace improves ADHD symptoms in children - page 133
- Attenace improves cognition and response inhibition in adult ADHD - page 134
- SWOT analysis of Attenace - page 135
- Attenace (modafinil) will be well received as it is an established schedule IV drug with a proven safety record, approved across the seven major markets - page 136
- Attenace to target comorbid cognitive deficits in ADHD - page 137
- Attenace will climb to fourth position in the ADHD market by 2012 - page 139
- SPD-503 - page 141
- Guanfacine in the treatment of adult ADHD - page 142
- Guanfacine treatment of hyperactivity and inattention in pervasive developmental disorders - page 142
- Increased prescribing of guanfacine, in the absence of severe side effects - page 143
- Guanfacine is a safe and effective treatment for children with tic disorders and ADHD - page 144
- Ongoing Phase III pivitol studies - page 144
- SWOT analysis of SPD-503 - page 146
- SPD-503 will have little time to maximize revenues before genericization - page 150
- CX-516 & CX-717 (AMPAKINE) - page 151
- SWOT analysis of AMPAKINES - page 152
- AMPAKINES - a additive cognitive enhancer to traditional ADHD therapy - page 153
- SGS-742 - page 155
- SWOT analysis of SGS-742 - page 156
- The first drug to solely target adult ADHD - page 157
- Late-stage development compounds recently discontinued - page 158
- TC-5231 (mecamylamine oral gel capsules) - page 158
- SPD473 - page 159
- NS-2359 - page 160
- ABT-089 - page 160
- Other ADHD drugs - page 127
- CHAPTER 8 INNOVATIVE EARLY-STAGE PROJECTS - page 161
- Innovative early-stage projects - page 161
- SON-216 (bifemelane) - page 161
- DOV-102677 - page 162
- Dextroamphetamine (transdermal patch) - page 163
- Lobeline - page 163
- DAR-0300 - page 163
- PGI-256 and PGI-415 - page 164
- SPD-483 - page 164
- Innovative early-stage projects - page 161
- APPENDIX A - page 165
- ADHD market data - page 165
- KOL interviews - page 172
- Contributing experts - page 191
- Bibliography - page 191
- APPENDIX B - page 200
- Report methodology - page 200
- About Datamonitor - page 202
- List of Tables
- Table 1: Forecast revenues of pipeline ADHD drugs to 2015 across the seven major markets - page 7
- Table 2: Summary of ADHD pipeline drug SWOT analysis and peak US market share - page 8
- Table 3: Symptoms for ADHD/HKD in the DSM-IV and ICD-10 - page 19
- Table 4: Definition of ADHD in the DSM-IV - page 20
- Table 5: Prevalence of ADHD - page 20
- Table 6: Prevalence, diagnosis and drug treatment rates of patients with ADHD across the seven major markets - page 22
- Table 7: Forecast prevalence (000s) of ADHD across the seven major markets to 2010 - page 24
- Table 8: ADHD drugs in launched in 2005 - page 45
- Table 9: ADHD drugs in pre-registration, 2005 - page 45
- Table 10: ADHD drugs in Phase III clinical development, 2005 - page 46
- Table 11: ADHD drugs in Phase II clinical development, 2005 - page 48
- Table 12: ADHD drugs in preclinical development, 2005 - page 49
- Table 13: Revenues ($m) from Shire's marketed CNS drugs across the seven major markets, (2001-04) - page 50
- Table 14: Shire's marketed and pipeline ADHD drugs, 2005 - page 51
- Table 15: Revenues ($m) from Novartis's marketed CNS drugs across the seven major markets, 2001-04 - page 60
- Table 16: Novartis's marketed and pipeline ADHD drugs, 2005 - page 61
- Table 17: Opportunity/threat factors and weightings - page 73
- Table 18: Opportunity/threat factors - scoring definitions - page 74
- Table 19: Strength/weakness factors and weightings - page 75
- Table 20: Strength/weakness factors - scoring definitions - page 76
- Table 21: Methylphenidate drugs in launched in 2005 to date - page 77
- Table 22: Methylphenidate drugs in late stage development, 2005 - page 77
- Table 23: SWOT analysis of Concerta - page 80
- Table 24: SWOT analysis of Equasym XL - page 83
- Table 25: Forecast revenues of Metadate CD/Equasym XL across the seven major markets to 2015 - page 87
- Table 26: SWOT analysis of Focalin XR - page 92
- Table 27: Promotional spend vs. drug revenues in the first year after launch - page 96
- Table 28: Forecast revenues of Focalin XR across the seven major markets - page 97
- Table 29: SWOT analysis of MTS - page 102
- Table 30: Forecast revenues of MTS across the seven major markets - page 108
- Table 31: Amphetamine drugs in late stage development, 2005 - page 109
- Table 32: SWOT analysis of Adderall XR - page 111
- Table 33: SWOT analysis of NRP-104 - page 116
- Table 34: Forecast revenues of NRP-104 across the seven major markets - page 120
- Table 35: SWOT analysis of SPD-465 - page 122
- Table 36: Forecast revenues of SPD-465 across the seven major markets - page 126
- Table 37: Other ADHD drugs in late stage development, 2005 - page 127
- Table 38: SWOT analysis of Strattera - page 130
- Table 39: SWOT analysis of Attenace - page 135
- Table 40: Forecast revenues of Attenace across the seven major markets - page 140
- Table 41: SWOT analysis of SPD-503 - page 146
- Table 42: Forecast revenues of SPD-503 across the seven major markets - page 150
- Table 43: SWOT analysis of AMPAKINES - page 152
- Table 44: SWOT analysis of SGS-742 - page 156
- Table 45: ADHD drugs recently suspended or discontinued, 2005 - page 158
- Table 46: ADHD drugs in preclinical development, 2005 - page 161
- Table 47: Strattera key facts - page 165
- Table 48: Key Strattera events, 2003-2005 - page 166
- Table 49: Adderall and Adderall XR key facts - page 167
- Table 50: Key Adderall and Adderall XR events, 2003-2005 - page 168
- Table 51: Concerta key facts - page 169
- Table 52: Key Concerta events, 2003-2005 - page 170
- Table 53: Metadate franchise key facts - page 171
- Table 54: Key Metadate franchise events, 2003-2005 - page 171
- Table 55: ADHD drugs in pre-clinical development, 2005 - page 181
- List of Figures
- Figure 1: SWOT analysis of ADHD pipeline drugs compared to the gold standards marketed comparator products - page 8
- Figure 2: Key findings from the UK ADDIS ADHD study - page 33
- Figure 3: NICE method for measuring cost-effectiveness of drug treatment for ADHD - page 42
- Figure 4: US sales of Shire's Adderall ADHD franchise and its generic competitors - page 52
- Figure 5: US revenue forecast of Shire's ADHD franchise to 2015 - page 59
- Figure 6: SWOT analysis of Shire's ADHD franchise - page 59
- Figure 7: US revenues of Novartis's ADHD franchise - page 62
- Figure 8: US revenue forecast of Novartis' ADHD franchise to 2015. - page 64
- Figure 9: SWOT of Novartis's ADHD pipeline - page 64
- Figure 10: US revenues of stimulants (schedule II, and schedule II or non-classified) and non-stimulants to 2015 - page 68
- Figure 11: SWOT analysis of ADHD pipeline drugs compared to the gold-standard marketed comparator products - page 72
- Figure 12: SWOT analysis of methylphenidate ADHD pipeline drugs compared to the gold standard-Concerta - page 78
- Figure 13: Pharmacologic profile of Equasym XL compared to Concerta - page 84
- Figure 14: Pharmacologic profile of Focalin XR compared to Concerta - page 93
- Figure 15: Pharmacologic profile of MTS compared to Concerta - page 103
- Figure 16: SWOT analysis of amphetamine ADHD pipeline drugs compared to the gold standard-Adderall XR - page 109
- Figure 17: Pharmacokinetic profile of NRP-104 compared to marketed extended-release amphetamines - page 114
- Figure 18: NRP-104 efficacy and duration of action - time course of SKAMP (least mean squares S.E.) - page 115
- Figure 19: Pharmacologic profile of NRP-104 compared to Adderall XR - page 117
- Figure 20: Pharmacologic profile of SPD-465 compared to Adderall XR - page 123
- Figure 21: SWOT analysis of other ADHD pipeline drugs compared to the gold standard-Strattera - page 128
- Figure 22: Pharmacologic profile of Attenace compared to Strattera - page 136
- Figure 23: Change from baseline in ADHD-RS - page 141
- Figure 24: Pharmacologic profile of SPD-503 compared to Strattera - page 147
- Figure 25: Pharmacologic profile of AMPAKINES compared to Strattera - page 153
- Figure 26: Pharmacologic profile of SGS-742 compared to Strattera - page 157
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