Introduction
 
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
 
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
 

TABLE OF CONTENTS
 
CHAPTER 1 EXECUTIVE SUMMARY 3
 
Scope of the analysis 3
 
Datamonitor insight into the ADHD market 5
 
ADHD market – key metrics 7
 
Datamonitor pipeline assessment summary 8
 
CHAPTER 2 PATIENT POTENTIAL 17
 
Disease definition and classification 17
 
Etiology of ADHD 17
 
Structural abnormalities 17
 
Genetic predisposition 17
 
Neurotransmitter dysfunction 18
 
Diagnostic criteria of ADHD 18
 
Epidemiology of ADHD 20
 
Key patient segments 25
 
Gender 25
 
Comorbidities 26
 
Clinical unmet needs of ADHD 27
 
Diagnostic complications 28
 
Hyperkinesis versus attention deficit hyperactivity disorder 28
 
Gender 28
 
Age 28
 
Duration of symptoms 29
 
Diagnostic tools 29
 
ADHD Rating Scale 30
 
Conners’ Rating Scale-Revised (CRS-R) 30
 
Copeland symptom checklist 30
 
Barkley’s Current Symptoms Scale-Self Report Form (home and school) 31
 
Brown ADD Scale (diagnostic form) 31
 
Parent-completed Child Behavior Checklist 31
 
Teacher Report Form (TRF) of Child Behavior Checklist 32
 
ADD-H: Comprehensive Teacher Rating Scale (ACTeRS) 32
 
The IOWA Conners Rating scale 32
 
Diagnostic unmet needs 33
 
CHAPTER 3 R&D APPROACH 37
 
Classification of marketed and pipeline products 37
 
Marketed products 37
 
Stimulants – methylphenidate and amphetamines 37
 
Non-stimulants – Strattera 39
 
Pipeline compounds 39
 
Clinical trials and drug development 40
 
Regulatory barriers to the development of pediatric medications 40
 
Non-regulatory barriers to the development of pediatric medications 40
 
Novel approaches to enhance traditional pediatric clinical trials 41
 
Drug models in clinical trial development 43
 
CHAPTER 4 ADHD PIPELINE ANALYSIS 45
 
Pipeline overview 45
 
Drugs launched in 2005 45
 
Registered and Phase III overview 45
 
Phase II overview 48
 
Phase I overview 49
 
Preclinical overview 49
 
Key companies involved in the ADHD pipeline 50
 
Shire 50
 
Despite an initial decline in ADHD revenues, Shire’s pipeline ADHD drugs will save the day 56
 
Novartis 60
 
Focalin XR will rejuvenate Novartis’s ADHD franchise, nearly doubling current revenues 63
 
Strategies for success 65
 
Innovation is key – manufacturers can no longer expect significant returns on standard extended-release formulations 65
 
Comparative positioning of pipeline drugs 71
 
Methodology of SWOT analysis 73
 
CHAPTER 5 LATE-STAGE METHYLPHENIDATE DRUG ANALYSIS & FORECASTS 77
 
Methylphenidate drugs 77
 
Recently launched drugs 77
 
Pipeline summary 77
 
Concerta – the gold-standard methylphenidate drug therapy 78
 
SWOT analysis of Concerta 80
 
Equasym XL 81
 
Equasym XL is more effective than Concerta during the morning hours 81
 
Equasym XL effective and safe in treating ADHD symptoms throughout the school day 82
 
SWOT analysis of Equasym XL 83
 
The proven safety and pharmacologic profile of Equasym XL will aid uptake in Europe 84
 
UCB’s delayed launch strategy in Europe will impact long-term revenues 85
 
Equasym XL will reach peak share after the first two years of launch 86
 
Focalin XR 88
 
Focalin XR is generally perceived to act in less than one hour and remain effective for over eight hours 88
 
Focalin XR is effective in treating children and adolescents with ADHD with few adverse effects 89
 
SWOT analysis of Focalin XR 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 93
 
Approval for adult ADHD will significantly boost revenues 94
 
Despite the strength of Focalin XR’s therapeutic profile and marketing potential, it will be hindered by generic stimulants and novel ADHD drugs 96
 
MTS 98
 
MTS 98
 
MTS failed to demonstrate clinical significance on the primary endpoint in its first Phase III clinical trial 98
 
MTS is significantly superior to placebo, with significantly improved scores in teacher, parent and clinician ratings of patient behavior and attention 99
 
MTS demonstrates significant efficacy compared to placebo in Phase II classroom study 100
 
MTS demonstrates significant efficacy compared to placebo in Phase II classroom study 101
 
SWOT analysis of MTS 102
 
Kids will love MTS 103
 
Patch technology improves safety, compliance and duration of action 104
 
MTS will become the market-leading stimulant by 2010 107
 
CHAPTER 6 LATE-STAGE AMPHETAMINE DRUG ANALYSIS & FORECASTS 109
 
Amphetamine drugs 109
 
Pipeline summary 109
 
Adderall XR – the gold-standard amphetamine drug therapy 110
 
SWOT analysis of Adderall XR 111
 
NRP-104 112
 
NRP-104 achieves similar blood amphetamine levels to current extended-release amphetamine products 113
 
NRP-104 demonstrates comparable efficacy to Adderall XR 114
 
SWOT analysis of NRP-104 116
 
NRP-104 – the first non-scheduled stimulant 117
 
Equivalent efficacy to Adderall XR in treating children and adults 118
 
NRP-104 will become the market-leading amphetamine by 2010 119
 
SPD-465 121
 
SWOT analysis of SPD-465 122
 
SPD-465 may sustain effect for too long in pediatric patients, limiting uptake 123
 
With Shire’s already strong ADHD pipeline, what will be the fate of SPD-465? 124
 
SPD-465 will be overshadowed by NRP-104 125
 
CHAPTER 7 LATE-STAGE OTHER ADHD DRUG ANALYSIS & FORECASTS 127
 
Other ADHD drugs 127
 
Pipeline summary 127
 
Strattera – the gold-standard non-stimulant drug therapy 128
 
SWOT analysis of Strattera 130
 
Attenace (modafinil) 131
 
Attenace consistently exhibits a robust efficacy on both the inattentive and hyperactive symptoms of ADHD 132
 
Attenace significantly improves ADHD symptoms and is well tolerated in children with ADHD 132
 
Attenace improves ADHD symptoms in children 133
 
Attenace improves cognition and response inhibition in adult ADHD 134
 
SWOT analysis of Attenace 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 136
 
Attenace to target comorbid cognitive deficits in ADHD 137
 
Attenace will climb to fourth position in the ADHD market by 2012 139
 
SPD-503 141
 
Guanfacine in the treatment of adult ADHD 142
 
Guanfacine treatment of hyperactivity and inattention in pervasive developmental disorders 142
 
Increased prescribing of guanfacine, in the absence of severe side effects 143
 
Guanfacine is a safe and effective treatment for children with tic disorders and ADHD 144
 
Ongoing Phase III pivitol studies 144
 
SWOT analysis of SPD-503 146
 
SPD-503 will have little time to maximize revenues before genericization 150
 
CX-516 & CX-717 (AMPAKINE) 151
 
SWOT analysis of AMPAKINES 152
 
AMPAKINES – a additive cognitive enhancer to traditional ADHD therapy 153
 
SGS-742 155
 
SWOT analysis of SGS-742 156
 
The first drug to solely target adult ADHD 157
 
Late-stage development compounds recently discontinued 158
 
TC-5231 (mecamylamine oral gel capsules) 158
 
SPD473 159
 
NS-2359 160
 
ABT-089 160
 
CHAPTER 8 INNOVATIVE EARLY-STAGE PROJECTS 161
 
Innovative early-stage projects 161
 
SON-216 (bifemelane) 161
 
DOV-102677 162
 
Dextroamphetamine (transdermal patch) 163
 
Lobeline 163
 
DAR-0300 163
 
PGI-256 and PGI-415 164
 
SPD-483 164
 
APPENDIX A 165
 
ADHD market data 165
 
KOL interviews 172
 
Contributing experts 191
 
Bibliography 191
 
APPENDIX B 200
 
Report methodology 200
 
About Datamonitor 202