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Abstract

The CNS drug market presents significant profit opportunities, but also carries high risks for companies aiming to achieve blockbuster status; pipelines based on novel molecular targets to treat underlying disease promise to transform the treatment of psychiatric and neurological diseases, however research and development of these drugs requires an innovative approach to ensure investment is maximized. ' Innovations in CNS: Novel therapeutics and future R&D strategies' assesses novel treatments in development for major CNS disorders, comparing them with existing medications in terms of unmet need and forecasting their success in the commercial market. This report will enable you to understand the research tactics of your competitors and develop winning strategies for future growth in the lucrative CNS market. The report provides a survey of the pipelines of all of the major players in the CNS area. Detailed company profiles featured in the report include: AstraZeneca, GlaxoSmithKline, Merck &Co, Pfizer, and Sanofi-Aventis. Use this report to understand the factors that will ensure your product pipeline achieves clinical and commercial success and analyze the product pipelines of the leading companies in the CNS market.

Table of Contents

Executive Summary

• Current market landscape & dynamics
• Major depressive disorder
• Anxiety disorders
• Schizophrenia
• Sleep disorders
• Alzheimer' s disease and other dementias
• Movement disorders
• Epilepsy
• Pain
• Pipeline analysis: paradigm shift and incremental innovation

Chapter 1 Current market landscape & dynamics

• Summary
• Introduction
• Patient potential
• The current CNS market
  • CNS sales by disease and top 5 brands per disease category
  • CNS sales by drug class
  • CNS sales by country
• Top CNS companies
• Top CNS brands
• Unmet needs
  • Psychiatric disorders
    • Depression
    • Anxiety
    • Schizophrenia
    • Sleep disorders
  • Neurologic disorders
    • Alzheimer' s
    • Epilepsy
    • Movement disorders
    • Pain
• Innovations in CNS

Chapter 2 Major depressive disorder

• Summary
• Introduction
• Epidemiology and economic burden
• Current drug treatments
  • Limitations
  • Key unmet needs
• Novel treatments for major depressive disorder
  • Directly acting serotonergic receptor agonists
  • Specific noradrenaline reuptake inhibitors (NARI)
  • Serotonin/noradrenaline reuptake inhibitors (SSNRI) and mixed, multiple
  • reuptake inhibitors (MMRI)
  • Multi-target strategies
  • Neuropeptides and stress
  • Neurokinins
  • CRF-1
  • Others
• Future directions
• Conclusions

Chapter 3 Anxiety disorders

• Summary
• Introduction
• Epidemiology and economic burden
• Current drug treatments
  • Limitations
  • Key unmet needs
• Novel treatments for anxiety disorders
  • GABA-A positive modulators
  • 5-HT1A receptor agonists
  • ƒÀ-3-adrenoceptor agonists
  • NK-1 and CRF-1 receptor antagonists
  • AVP V1b antagonists
  • Cholecystokinin-2 (CCK-2) receptor antagonists
  • Fatty acid amide hydrolase (FAAH) inhibitors
  • Metabotropic glutamate 3 (mGlu3) receptor agonists and mGlu5 receptor
  • antagonists
  • Vomeropherins
• Future directions
• Conclusions

Chapter 4 Schizophrenia

• Summary
• Introduction
• Epidemiology and economic burden
• Current drug treatments
  • Limitations
  • Key unmet needs
• Novel treatments for schizophrenia
  • Monoaminergic systems
    • Dopamine
    • 5-HT2A receptor antagonists and inverse agonists
  • Combined monoamine receptor antagonists
    • D2/5-HT2A
    • D2/5-HT1A
  • Non-monoaminergic strategies
    • Glutamate
    • Cholinergics
    • Neuropeptides
• Future directions
• Conclusions

Chapter 5 Sleep disorders

• Summary
• Introduction
• Epidemiology and economic burden
• Current drug treatments
  • Limitations
  • Key unmet needs
• Novel treatments for sleep disorders
  • GABA-ergic treatments
  • Serotonergic treatments
  • Others
• Future directions
• Conclusions

Chapter 6 Alzheimer' s disease & other dementias

• Summary
• Introduction
• Epidemiology and economic burden
• Current drug treatments
  • Acetylcholinesterase inhibitors
  • NMDA antagonists
  • Limitations
  • Key unmet needs
• Novel treatments for Alzheimer' s disease
  • Symptomatic treatments
    • Cholinergic mechanisms
    • Glutamatergic mechanisms
    • Serotonergic mechanisms
    • Other mechanisms
  • Disease process modifiers
    • Amyloid cascade based treatments
    • Neuroinflammatory approaches
    • Neurotrophic factor approaches
• Future directions
• Conclusions

Chapter 7 Movement disorders

• Summary
• Introduction
• Parkinson' s disease
  • Epidemiology and economic burden
  • Current drug treatments
    • Limitations
    • Key unmet needs
  • Novel treatments for Parkinson' s disease
    • Adenosine A2A receptor antagonists
    • Stem cell and gene therapy for the dopaminergic system
    • Disease modifying strategies for PD
    • Glutamatergic strategies
• Motor neuron disease/amyolateral sclerosis
  • Epidemiology and economic burden
  • Current drug treatments
  • Novel treatments for motor neuron disease/amyolateral sclerosis
    • Drug discovery approaches
  • Future directions
• Huntington' s disease
  • Epidemiology and economic burden
  • Current drug treatments
  • Novel treatments for Huntington' s disease
  • Future directions
• Conclusions

Chapter 8 Epilepsy

• Summary
• Introduction
• Epidemiology and economic burden
• Current drug treatments
  • Limitations
  • Key unmet needs
• Novel treatments for epilepsy
  • GABA-ergic treatments
  • Ion channels
  • Glutamate
    • NMDA antagonists
  • AMPA antagonists
    • NS1209
    • E2007
    • Talampanel/LY300164
  • Junction gap blockers
• Future directions
• Conclusions

Chapter 9 Pain

• Summary
• Introduction
• Epidemiology and economic burden
• Current drug treatments
  • Limitations
  • Key unmet needs
• Novel treatments for pain disorders
  • Pain
    • NMDA receptor antagonists
    • Cannabinoids
    • Calcium channel modulators
    • Nicotinic receptor agonists
    • Mu opiate receptor agonists
    • Delta opiates
  • Migraine
    • Triptans and NSAIDs
    • Non-serotonergic treatments
    • Calcitonin Gene Related Peptide (CGRP)
    • Gap junction blockers
    • Vanilloids
    • Ion channel blockers
    • Other novel mechanisms
• Conclusions

Chapter 10 Pipeline analysis: paradigm shift and incremental innovation

• Summary
• Introduction
• Risk and innovation: not a straight choice
  • Sanofi-Aventis
  • Pfizer
  • AstraZeneca
  • GlaxoSmithKline
  • Merck & Co.
• Building on the value of the pipeline
• Conclusions
  • Limited impact of the genomics revolution
  • The problem of diagnosis
  • Away from the blockbuster model: smaller markets, smaller indications, and the place of smaller companies

Chapter 11 Appendix

• Reference
• Index

List of Figures

• Figure 1.1: Evaluation of current treatment options for CNS indications
• Figure 2.2: Competitive dynamics of drug classes and leading brands in the depression market, 2005
• Figure 4.3: Competitive dynamics of drug classes and leading brands in the schizophrenia market, 2005
• Figure 6.4: Competitive dynamics of drug classes and leading brands in the Alzheimer' s disease market, 2005
• Figure 7.5: Competitive dynamics of leading brands in the Parkinson' s disease market, 2005
• Figure 8.6: Competitive dynamics of drug classes and leading brands in the epilepsy market,

List of Tables

• Table 1.1: Prevalence of CNS disorders in the 7 major markets (US, Japan, France, Germany, Italy, Spain, UK), 2005
• Table 1.2: Global CNS market dales by disease category, 2004-05
• Table 1.3: Top 5 brands in each disease category, 2005
• Table 1.4: Global CNS market sales by drug class, 2004-05
• Table 1.5: CNS drug sales by country, 2005
• Table 1.6: Top 20 companies in the CNS market by sales, 2005
• Table 1.7: Top 20 global CNS brands, 2005
• Table 1.8: Medicinal chemical properties of a successful CNS drug
• Table 2.9: Present development status of potential antidepressants, 2006
• Table 3.10: Present development status of potential anxiolytics - Phase II and III, 2006
• Table 3.11: Present development status of potential anxiolytics - Phase I and Preclinical, 2006
• Table 4.12: Present development status of potential antipsychotics, 2006
• Table 5.13: Drugs currently in use for the treatment of insomnia, 2006
• Table 5.14: Present development status of potential hypnotics, 2006
• Table 6.15: Present development status of potential symptomatic treatments for Alzheimer' s disease, 2006
• Table 6.16: Present development status of potential disease modifying treatments for Alzheimer' s disease, 2006
• Table 7.17: Present development status of potential treatments for Parkinson' s disease, 2006
• Table 7.18: Present development status of potential treatments for motor neuron disease/ALS, 2006
• Table 7.19: Present development status of potential treatments for Huntington' s disease, 2006
• Table 8.20: Present development status of potential novel anti-epileptic drugs, 2006
• Table 9.21: Side effects limiting the pharmacological treatment of pain with present pharmaceuticals
• Table 9.22: Present development status of potential treatments for pain disorders, 2006
• Table 9.23: Present development status of potential treatments for migraine disorders, 2006
• Table 10.24: Sanofi-Aventis' CNS pipeline, 2006
• Table 10.25: Pfizer' s CNS pipeline, 2006
• Table 10.26: AstraZeneca' s CNS pipeline, 2006
• Table 10.27: GlaxoSmithKline CNS pipeline, 2006
• Table 10.28: Merck & Co.' s CNS pipeline, 2006