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Pipeline Insight: ADHD
Shire Driving Diversity in ADHD
Publication Date June 2005
Publisher Datamonitor
Product Type Report
Pages 205
ISBN Number not applicable
Product Code DAT324
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Summary
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.
Highlights
- The current global ADHD market is worth $2.7billion and is expected to reach $3.3billion 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.
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
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
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Content
- Chapter 1 Executive Summary
- Scope of the analysis
- Datamonitor insight into the ADHD market
- ADHD market - key metrics
- Datamonitor pipeline assessment summary
- Chapter 2 Patient Potential
- Disease definition and classification
- Etiology of ADHD
- Structural abnormalities
- Genetic predisposition
- Neurotransmitter dysfunction
- Diagnostic criteria of ADHD
- Epidemiology of ADHD
- Key patient segments
- Gender
- Comorbidities
- Clinical unmet needs of ADHD
- Diagnostic complications
- Hyperkinesis versus attention deficit hyperactivity disorder
- Gender
- Age
- Duration of symptoms
- Diagnostic tools
- ADHD Rating Scale
- Conners' Rating Scale-Revised (CRS-R)
- Copeland symptom checklist
- Barkley's Current Symptoms Scale-Self Report Form (home and school)
- Brown ADD Scale (diagnostic form)
- Parent-completed Child Behavior Checklist
- Teacher Report Form (TRF) of Child Behavior Checklist
- ADD-H: Comprehensive Teacher Rating Scale (ACTeRS)
- The IOWA Conners Rating scale
- Diagnostic unmet needs
- Chapter 3 R&d Approach
- Classification of marketed and pipeline products
- Marketed products
- Stimulants - methylphenidate and amphetamines
- Non-stimulants - Strattera
- Pipeline compounds
- Clinical trials and drug development
- Regulatory barriers to the development of pediatric medications
- Non-regulatory barriers to the development of pediatric medications
- Novel approaches to enhance traditional pediatric clinical trials
- Drug models in clinical trial development
- Chapter 4 Adhd Pipeline Analysis
- Pipeline overview
- Drugs launched in 2005
- Registered and Phase III overview
- Phase II overview
- Phase I overview
- Preclinical overview
- Key companies involved in the ADHD pipeline
- Shire
- Despite an initial decline in ADHD revenues, Shire's pipeline ADHD drugs will save the day
- Novartis
- Focalin XR will rejuvenate Novartis's ADHD franchise, nearly doubling current revenues
- Strategies for success
- Innovation is key - manufacturers can no longer expect significant returns on standard extended-release formulations
- Comparative positioning of pipeline drugs
- Methodology of SWOT analysis
- Chapter 5 Late-Stage Methylphenidate Drug Analysis & Forecasts
- Methylphenidate drugs
- Recently launched drugs
- Pipeline summary
- Concerta - the gold-standard methylphenidate drug therapy
- SWOT analysis of Concerta
- Equasym XL
- Equasym XL is more effective than Concerta during the morning hours
- Equasym XL effective and safe in treating ADHD symptoms throughout the school day
- SWOT analysis of Equasym XL
- The proven safety and pharmacologic profile of Equasym XL will aid uptake in Europe
- UCB's delayed launch strategy in Europe will impact long-term revenues
- Equasym XL will reach peak share after the first two years of launch
- Focalin XR
- Focalin XR is generally perceived to act in less than one hour and remain effective for over eight hours
- Focalin XR is effective in treating children and adolescents with ADHD with few adverse effects
- SWOT analysis of Focalin XR
- Despite the strong therapeutic profile of Focalin XR, it will face competition from numerous branded and generic extended-release stimulants in the near future
- Approval for adult ADHD will significantly boost revenues
- Despite the strength of Focalin XR's therapeutic profile and marketing potential, it will be hindered by generic stimulants and novel ADHD drugs
- MTS
- MTS
- MTS failed to demonstrate clinical significance on the primary endpoint in its first Phase III clinical trial
- MTS is significantly superior to placebo, with significantly improved scores in teacher, parent and clinician ratings of patient behavior and attention
- MTS demonstrates significant efficacy compared to placebo in Phase II classroom study
- MTS demonstrates significant efficacy compared to placebo in Phase II classroom study
- SWOT analysis of MTS
- Kids will love MTS
- Patch technology improves safety, compliance and duration of action
- MTS will become the market-leading stimulant by 2010
- Chapter 6 Late-Stage Amphetamine Drug Analysis & Forecasts
- Amphetamine drugs
- Pipeline summary
- Adderall XR - the gold-standard amphetamine drug therapy
- SWOT analysis of Adderall XR
- NRP-104
- NRP-104 achieves similar blood amphetamine levels to current extended-release amphetamine products
- NRP-104 demonstrates comparable efficacy to Adderall XR
- SWOT analysis of NRP-104
- NRP-104 - the first non-scheduled stimulant
- Equivalent efficacy to Adderall XR in treating children and adults
- NRP-104 will become the market-leading amphetamine by 2010
- SPD-465
- SWOT analysis of SPD-465
- SPD-465 may sustain effect for too long in pediatric patients, limiting uptake
- With Shire's already strong ADHD pipeline, what will be the fate of SPD-465?
- SPD-465 will be overshadowed by NRP-104
- Chapter 7 Late-Stage Other Adhd Drug Analysis & Forecasts
- Other ADHD drugs
- Pipeline summary
- Strattera - the gold-standard non-stimulant drug therapy
- SWOT analysis of Strattera
- Attenace (modafinil)
- Attenace consistently exhibits a robust efficacy on both the inattentive and hyperactive symptoms of ADHD
- Attenace significantly improves ADHD symptoms and is well tolerated in children with ADHD
- Attenace improves ADHD symptoms in children
- Attenace improves cognition and response inhibition in adult ADHD
- SWOT analysis of Attenace
- 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
- Attenace to target comorbid cognitive deficits in ADHD
- Attenace will climb to fourth position in the ADHD market by 2012
- SPD-503
- Guanfacine in the treatment of adult ADHD
- Guanfacine treatment of hyperactivity and inattention in pervasive developmental disorders
- Increased prescribing of guanfacine, in the absence of severe side effects
- Guanfacine is a safe and effective treatment for children with tic disorders and ADHD
- Ongoing Phase III pivitol studies
- SWOT analysis of SPD-503
- SPD-503 will have little time to maximize revenues before genericization
- CX-516 & CX-717 (AMPAKINE)
- SWOT analysis of AMPAKINES
- AMPAKINES - a additive cognitive enhancer to traditional ADHD therapy
- SGS-742
- SWOT analysis of SGS-742
- The first drug to solely target adult ADHD
- Late-stage development compounds recently discontinued
- TC-5231 (mecamylamine oral gel capsules)
- SPD473
- NS-2359
- ABT-089
- Chapter 8 Innovative Early-Stage Projects
- Innovative early-stage projects
- SON-216 (bifemelane)
- DOV-102677
- Dextroamphetamine (transdermal patch)
- Lobeline
- DAR-0300
- PGI-256 and PGI-415
- SPD-483
- Appendix A
- ADHD market data
- KOL interviews
- Contributing experts
- Bibliography
- Appendix B
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