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Pipeline Insight: ADHD - Shire Driving Diversity in ADHD
Datamonitor, June 2005, Pages: 205
CHAPTER 1 - - EXECUTIVE SUMMARY 3.
Scope of the analysis 3
Our insight into the ADHD market 5
ADHD market – key metrics 7
Our 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 Us 202
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