Pipeline Insight: ADHD

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Publication Date: 2005-06-02

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The current ADHD market has long been saturated with traditional methylphenidate and amphetamine based drugs, with the only innovations being the development of extended release versions. However, the recent launch of Strattera (atomoxetine) has already shattered the traditional approach to drug therapy, opening the door for the uptake of new novel drug therapies.

Scope

Overview of the epidemiology, diagnosis and management of ADHD across the seven major pharmaceutical markets

Examination of the ADHD pipeline with in-depth clinical and commercial profiles of late-stage candidates, incorporating Datamonitor opinion

Seven market sales forecasts, commercial potential and research/clinical/commercial assessment of late-stage products to 2015

Insight and commentary from qualitative interviews with ADHD opinion leaders in the US and Europe

Report Highlights
The current global ADHD market is worth $2.7m and is expected to reach $3.4m by 2015, driven primarily by the launch of pipeline drugs and the continued growth of Strattera.

Innovation is key - manufacturers can no longer expect significant returns on standard extended release formulations. The current pipeline offers drugs with novel delivery mechanisms; improved durations of action and anti-abuse profiles, which will help differentiate these pipeline drugs from the current established ADHD therapies.

Although ADHD drugs have demonstrated significant efficacy in improving the three main symptoms of ADHD - inattention, hyperactivity and impulsivity - none have shown efficacy in treating the cognitive deficits of ADHD.

Reasons to Purchase

Understand unmet needs in the ADHD market based on opinion leader comments regarding both currently marketed and pipeline products

Benchmark key late-stage ADHD compounds against current market leaders

Assess the global sales forecasts of late-stage pipeline drugs for ADHD and examine their clinical and commercial potential

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
- 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 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
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
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
  - Comparative positioning of pipeline drugs - page 71
  - Methodology of SWOT analysis - page 73
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
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
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
CHAPTER 8 INNOVATIVE EARLY-STAGE PROJECTS - page 161
- 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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Pipeline Insight: ADHD

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