INTRODUCTION
Sleep disorders, such as insomnia, narcolepsy and restless leg syndrome, are becoming an increasing focus for pharmaceutical manufacturers.
Sanofi-Synthlabo is testimony to this with its insomnia drug Ambien (zolpidem), which now boasts blockbuster revenues. Different commercial
opportunities exist in each of the analyzed sleep disorders for competing pharmaceutical manufacturers of all sizes.
SCOPE OF THE REPORT
- Analysis of the key epidemiological data points across each major pharmaceutical market for insomnia, narcolepsy and restless leg syndrome
- In-depth profiles of the current leading compounds in each sleep disorder, including future growth strategies, off-label case studies and
R&D strategy
- Detailed coverage of the entire R&D pipelines for insomnia, narcolepsy and restless leg syndrome, including profiles of all leading
candidates
- Comprehensive opinion leader research to compliment strategic recommendations for both marketed and pipeline drugs
REPORT HIGHLIGHTS
The entry of Pfizer into the insomnia market will generate a huge change in the current market dynamics. To continue to grow at a rapid rate, the
market has to be driven through primary care physicians. The success of Pfizer in driving markets through primary care illustrates why Neurocrine
chose Pfizer as a development partner for indiplon
Sanofi's Ambien will remain the market leader for the foreseeable future but its position will be
threatened by the launch of Estorra, coupled with the patent expiry of the original brand in 2006. The company must learn from the introduction of
other new versions of existing drugs in other CNS markets to maximize the potential of Ambien MR.
KEY REASONS TO BUY THIS REPORT
- Understand the epidemiological barriers to market growth in each highlighted sleep disorder
- Enhance your understanding of how the entry of Pfizer and other new players will impact the insomnia market
- Identify the likely market positions of future drugs, such as indiplon and Estorra
TABLE OF CONTENTS
CHAPTER 1 EXECUTIVE SUMMARY 3
- 1.1 Scope 3
- 1.2 Datamonitor insight into the strategic opportunities available in the sleep disorders market 3
- Conclusion 8
CHAPTER 2 INSOMNIA 15
- 2.1 Introduction 15
- 2.2 Disease Overview 15
- 2.3 Epidemiology 17
- Prevalence of insomnia 17
- Insomnia in the general population 17
- Insomnia in the elderly 18
- Insomnia in primary care 19
- Insomnia in other conditions 19
- Diagnosis rate 20
- Treatment rate 21
- Conclusion 22
- 2.4 Current Therapies 23
- Ambien/Stilnox (zolpidem) 23
- The future: a number of strategic issues will impact Ambien revenues 23
- Sonata (zaleplon) 25
- Benzodiazepines 27
- Drugs used off-label 28
- Case study: Remeron (mirtazapine) 28
- 2.5 Pipeline Compounds 29
- Indiplon 30
- APSS 2003: the first look at fullscale indiplon data 31
- Strategic analysis 31
- Conclusion 35
- Estorra 35
- APSS 2003: outlining the unique data for Estorra 35
- Recommended co-marketing partners 37
- Conclusion 38
- Indiplon vs. Estorra: a strategic conclusion 38
- TAK-375 39
CHAPTER 3 NARCOLEPSY 41
- 3.1 Disease Overview 41
- 3.2 Epidemiology 42
- Prevalence of narcolepsy 42
- Diagnosis rate 43
- Conclusion 44
- 3.3 Current Therapies 45
- Provigil (modafinil) 45
- An expanded label: key to the revenue prospects for Provigil 46
- APA 2003: establishing future growth strategies for Provigil 46
- Single isomer Provigil: the best method to stop generic substitution? 49
- Conclusion 50
- Xyrem (sodium oxybate) 51
- CNS stimulants 52
- Methylphenidate 52
- Adderall 53
- Others 53
- Agents used off-label 53
- Cylert (pemoline) 53
- Eldepryl (selegiline) 53
- Antidepressants 54
- 3.4 Pipeline Compounds 54
CHAPTER 4 RESTLESS LEG SYNDROME 56
- 4.1 Disease Overview 56
- Primary features 56
- Associated features 56
- 4.2 Epidemiology 57
- Prevalence of restless leg syndrome 57
- RLS in the US 57
- RLS in the EU 58
- RLS in Japan 58
- Diagnosis rate 59
- Treatment rate 59
- Conclusion 60
- 4.3 Current Therapies 62
- Requip (ropinirole) 62
- AAM 2003: targeting the key Requip prescribers 62
- Differentiation is the key for long-term growth 63
- Mirapex (pramipexole) 63
- Building the data in RLS 64
- L-dopa 65
- An opportunity for Novartis? 65
- Neurontin (gabapentin) 66
- Encouraging off-label use in RLS: the need for strong data 66
- Why did Pfizer target Neurontin at RLS? 67
- Other compounds 68
- Opioids 68
- 4.4 Pipeline Compounds 68
- Rotigotine CDS 68
- 4.5 Strategic Issues 69
- Comparative data will change the current fragmented market dynamics 70
- Educating physicians is key to generating market expanse 70
- Future research opportunities 71
CHAPTER 5 APPENDIX A: ABOUT THE REPORT 72
- 5.1 Contributing Experts 72
- 5.2 Bibliography 72
- Insomnia 72
- Narcolepsy 74
- Restless Leg Syndrome 76
- 5.3 Websites 78
- 5.4 Table of tables 78
- 5.5 Table of figures 79
CHAPTER 6 APPENDIX B: ABOUT DATAMONITOR 80
- 6.1 About Datamonitor 80
- About Datamonitor Healthcare 80
- Datamonitor Healthcare' s research and analysis methodologies 81
- 6.2 Datamonitor Healthcare' s therapy area capabilities 81
- About the CNS analysis team 82
- Datamonitor Healthcare' s Consulting expertise 84
- Datamonitor' s Therapeutic Consulting expertise 85
- Key therapy team members 85
- Nick Alcock, Managing Analyst, Central Nervous System 85
- David Abramson, Therapeutic Lead Consultant 86
- Disclaimer 88
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