Pipeline Insight: Insomnia - Targeting the sleep maintenance market

Published by: Datamonitor

Published: Apr. 12, 2007 - 240 Pages

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

About the Disease pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Datamonitor insight into the insomnia market Key metrics Datamonitor Pipeline Assessment Summary

CHAPTER 2 PIPELINE OVERVIEW AND DYNAMICS

Drugs in late-stage development focus on treating sleep maintenance Recently discontinued pipeline drugs Gaboxadol A big blow for Lundbeck but good news for competition Sonata MR Further disappointment from the underperforming Sonata brand Key companies involved in the insomnia pipeline Sanofi-Aventis: Endeavoring to maintain leadership of the insomnia market CNS is Sanofi-Aventis's second largest franchise Ambien currently dominates the insomnia market Ambien CR will fail to sustain the Ambien franchise growth Breaking into the depression market will strengthen relationship with insomnia prescribers Neurocrine: Focused on penetrating insomnia market Neurocrine has six drug candidates in clinical development but has yet to market a product Indiplon is Neurocrine's most advanced product candidate Neurocrine will face difficulty in securing a big-pharmaceutical partnering company for indiplon Key R&D company strategies Key drug delivery strategies in the insomnia pipeline Controlled release formulations offer the greatest commercial potential Oral and nasal delivery reformulations are expected to be of limited commercial value Investigating insomnia drugs in co-morbid disorders Co-morbid psychiatric disorders are prevalent in insomnia Four pipeline hypnotics are under investigation for co-morbid disorders Potential marketing partners for small pharmaceutical companies GSK is in contact with key prescribers through Requip Cephalon has experience in the sleep disorders market with Provigil for hypersomnia Sepracor requires a follow-on compound to Lunesta

CHAPTER 3 INSOMNIA - DISEASE OVERVIEW AND MARKET POTENTIAL

Definition of insomnia Segmentation of insomnia Insomnia is categorized according to etiology and duration Transient insomnia Intermittent or short-term insomnia Chronic insomnia Other forms of insomnia Etiology of insomnia Epidemiology of insomnia Diagnosis of insomnia Only a small percentage of individuals with symptoms of insomnia receive a diagnosis Insomnia is more prevalent in women than in men Symptoms of the menopause are associated with insomnia Insomnia is most prevalent in young adults and the elderly Insomnia impacts on quality of life and occupational functioning Insomnia carries a high socioeconomic impact Unmet need in insomnia Unmet need 1: Reduction of residual daytime sedation Unmet need 2: More effective treatments for insomnia in the elderly Unmet need 3: Improvement in sleep maintenance Unmet need 4: Lack of potential for tolerance and addiction Unmet need 5: More effective treatments for pediatric insomnia

CHAPTER 4 R&D Approach

Classification of insomnia pharmaceutical therapies Drug classes of currently marketed insomnia products and non-pharmacological therapy Benzodiazepines Melatonin agonists Herbal hypnotics and sedatives Anti-histamines Antidepressants Other drugs Non-pharmacological therapy Drug classes of pipeline insomnia products GABAa receptor agonists Melatonin agonists Serotonin receptor antagonists (5-HT) Other drug classes Clinical trial design in insomnia Objective and subjective measures provide complementary information Clinical trial endpoints in insomnia Sleep questionnaires Alertness tests Quality of life measures Psychological measures Sleep monitoring Recommended directions for insomnia research National Institutes of Health recommendations NICE: A broader range of outcome measures are required, including those that evaluate QOL

CHAPTER 5 GABA A RECEPTOR AGONIST LATE-STAGE DRUG ANALYSIS & FORECASTS

Comparative forecasts Comparative Datamonitor drug assessment summaries Overview of GABAa receptor agonist drugs Pipeline summary Definition of current comparator therapy Clinical trials Adverse reactions and next-day residual effects reported with the use of Ambien Ambien's major competitors and key strengths and weaknesses Indiplon Profile Drug overview Clinical data - Indiplon IR Clinical data - Indiplon MR Patient potential Marketing factors Satisfaction of unmet need Forecasts to 2016 Datamonitor drug assessment summary Zolpidem (sublingual spray) Profile Drug overview Clinical data Patient potential Marketing factors Satisfaction of unmet needs Forecasts to 2016 Datamonitor drug assessment summary Sublinox Profile Drug overview Clinical data Patient potential Marketing factors Satisfaction of unmet needs Forecasts to 2016 Datamonitor drug assessment summary Other drugs NG2-73 Drug overview Clinical data Patient potential Marketing factors Satisfaction of unmet needs EVT-201 Drug overview Limited clinical data for EVT-201 Datamonitor comments Hypnostat (triazolam) Drug overview Limited clinical trial data published for Hypnostat Datamonitor comments

CHAPTER 6 MELATONIN AGONIST LATE-STAGE DRUG ANALYSIS AND FORECASTS

Comparative forecasts Comparative Datamonitor drug assessment summaries Overview of melatonin agonist drugs Pipeline summary Definition of current comparator therapy Clinical trial data Side effect profile and key strengths and weaknesses VEC-162 Profile Drug overview Clinical data Patient potential Marketing factors Satisfaction of unmet need Forecasts to 2016 Datamonitor drug assessment summary PD-6735 Profile Drug overview Clinical data Patient potential Marketing factors Satisfaction of unmet need Forecasts to 2016 Datamonitor drug assessment summary

CHAPTER 7 SEROTONIN RECEPTOR ANTAGONISTS AND AGONISTS LATE-STAGE DRUG ANALYSIS & FORECASTS

Comparative forecasts Comparative Datamonitor drug assessment summaries Overview of serotonin receptor antagonists and agonists Pipeline summary Definition of current comparator therapy Eplivanserin Profile Drug overview Clinical data Patient potential Marketing factors Satisfaction of unmet need Forecasts to 2016 Datamonitor drug assessment summary Org-50081 Drug overview Clinical data Patient potential Marketing factors Satisfaction of unmet needs Forecasts to 2016 Datamonitor drug assessment summary Other drugs HY-10275 Drug overview Clinical data Patient potential Marketing factors Satisfaction of unmet needs ACP-103 Drug overview Clinical trial data Patient potential Marketing factors Satisfaction of unmet needs Pruvanserin Datamonitor comments Volinanserin Clinical trial data Datamonitor comments MN-305 Clinical trial data Ongoing clinical trials Datamonitor comments APD-125 Datamonitor comments

CHAPTER 8 OTHER LATE-STAGE DRUG ANALYSIS AND FORECASTS

Comparative forecasts Comparative Datamonitor drug assessment summaries Pipeline summary Definition of current comparator therapy Doxepin (Silenor) Profile Drug overview: NDA filing expected in Q3 2007 Clinical data Patient potential Marketing factors Satisfaction of unmet needs Forecasts to 2016 Datamonitor drug assessment summary ACT-078573 Profile Drug overview Clinical data Patient potential Marketing factors Satisfaction of unmet needs Forecasts to 2016 Datamonitor drug assessment summary PD-200390 Datamonitor comments

CHAPTER 9 INNOVATIVE EARLY-STAGE PROJECTS

Key Phase I and preclinical compounds in insomnia The early stage insomnia pipeline is characterized by a dearth of innovation G-protein-coupled receptor modulator PGR-683 Melatonin agonist BDD- 40001 BIBLIOGRAPHY Books and journals Datamonitor Reports Websites

APPENDIX

A Methodology Datamonitor forecast methodology Product forecasts Definition of a standard unit Patient expiry and generic assumptions Datamonitor drug assessment summary Contributing experts Report methodology

APPENDIX B

About Datamonitor

About Datamonitor Healthcare

Datamonitor Healthcare's therapy area capabilities

About the Disease analysis team

Disclaimer

List of Tables

Table 1: Forecast key pipeline products for insomnia in the seven major markets ($m), 2006-2016

Table 2: Pipeline drugs in pre-registration and Phase III development for insomnia, 2007

Table 3: Pipeline drugs in Phase II development for insomnia, 2007

Table 4: Pipeline drugs in Phase I development and discovery for insomnia, 2007

Table 5: Number of key insomnia drugs by class and phase of development, 2007

Table 6: Insomnia drugs recently discontinued from development

Table 7: Key events preceding the discontinuation of gaboxadol's development

Table 8: Sanofi-Aventis's marketed CNS products, 2007

Table 9: Sanofi-Aventis's marketed and pipeline insomnia drugs, 2007

Table 10: ICSD-R Criteria for severity of insomnia

Table 11: Epidemiology of diagnosed insomnia in the seven major markets, 2007

Table 12: Prevalence of diagnosed insomnia in the seven major markets, 2007

Table 13: The average rating of the clinical unmet needs in insomnia

Table 14: Non-pharmacological insomnia therapy

Table 15: Advantages and disadvantages of pharmacological therapy, alone and combined with drug treatment

Table 16: Widely used primary and secondary clinical trial endpoints Table 17: Important directions for insomnia related research

Table 18: Key products in late-stage R&D pipeline of the benzodiazepine class, 2007

Table 19: Sanofi Aventis's Ambien: key facts

Table 20: Key events and launch dates impacting indiplon IR and MR revenue forecasts for insomnia in the seven major markets, 2007-2016

Table 21: Key events and launch dates impacting revenue forecasts of zolpidem sublingual spray in the seven major markets, 2007-2016

Table 22: Key events and launch dates impacting revenue forecasts of Sublinox in the seven major markets, 2007-2016

Table 23: Key products in late-stage R&D pipeline of the melatonin agonist class, 2007

Table 24: Rozerem: Key facts

Table 25: Key events and launch dates impacting revenue forecasts of VEC-162 in the seven major markets, 2007-2016

Table 26: Key events and launch dates impacting revenue forecasts of PD6735 in the seven major markets, 2007-2016

Table 27: Key products in late-stage R&D pipeline of the 5-HT class, 2007

Table 28: Ambien CR: Key facts

Table 29: Key events and launch dates impacting revenue forecasts of eplivanserin in the seven major markets, 2007-2016

Table 30: Key events and launch dates impacting revenue forecasts of Org-50081 in the seven major markets, 2007-2016

Table 31: Other key products in late-stage R&D pipeline, 2007

Table 32: Key events and launch dates impacting revenue forecasts of Silenor in the seven major markets, 2007-2016

Table 33: Key events and launch dates impacting revenue forecasts of ACT-078573 in the seven major markets, 2007-2016

Table 34: Drugs in Phase 1 and discovery for insomnia, 2007

Table 35: Estimated generic discounts by country, 2006*

Table 36: Estimates of brand erosion by following patent expiry by country

Table 37: Datamonitor's pipeline drug assessment weighting scale

List of Figures

Figure 1: Datamonitor's insomnia drug assessment summary for the seven major markets ($m), 2007-2016)

Figure 2: Symptoms of insomnia affecting the US population at least a few times a week

Figure 3: Breakdown of the prevalence of insomnia

Figure 4: Symptoms of insomnia experienced by the US population at least a few times a week (male vs female)

Figure 5: Prevalence of sleep disorders in peri-menopausal and post-menopausal women

Figure 6: Symptoms of insomnia in the US population at least a few times a week (age)

Figure 7: Impairment of quality of life associated with insomnia

Figure 8: Clinical unmet needs in insomnia, 2007

Figure 9: Characteristics of the ideal hypnotic drug

Figure 10: Drug classes in development for the treatment of insomnia, 2007

Figure 11: Datamonitor's comparative forecast of sales for late-stage GABAa products across the seven major markets ($m), 2007-2016

Figure 12: Datamonitor's competitive positioning analysis for indiplon IR, indiplon MR, zolpidem sublingual spray and Sublinox in the seven major markets, 2007-2016

Figure 13: Datamonitor's forecast sales on indiplon IR across the seven major markets for insomnia ($m), 2007-2016

Figure 14: Datamonitor's forecast sales of indiplon MR across the seven major markets for insomnia ($m) 2007-2016

Figure 15: Datamonitor's competitive positioning analysis for indiplon IR in the seven major markets, 2007-2016

Figure 16: Datamonitor's competitive positioning analysis for indiplon MR in the seven major markets, 2007-2016

Figure 17: Datamonitor's forecast sales of zolpidem sublingual spray across the seven major markets for insomnia ($m), 2007-2016

Figure 18: Datamonitor's competitive positioning analysis for zolpidem sublingual spray in the seven major markets, 2007-2016

Figure 19: Datamonitor's forecast sales of Sublinox across the seven major markets for insomnia ($m), 2007-2016

Figure 20: Datamonitor's competitive positioning analysis for Sublinox in the seven major markets, 2007-2016

Figure 21: Datamonitor's comparative forecast of sales for late-stage melatonin agonists across the seven major markets ($m), 2007-2016

Figure 22: Datamonitor's competitive positioning analysis for VEC-162 and PD-6735 in the seven major markets, 2007-2016

Figure 23: Datamonitor's forecast sales of VEC-162 across the seven major markets for insomnia ($m), 2007-2016

Figure 24: Datamonitor's competitive positioning analysis for VEC-162 in the seven major markets, 2007-2016

Figure 25: Datamonitor's forecast sales of PD-6735 across the seven major markets for insomnia ($m), 2007-2016

Figure 26: Datamonitor's competitive positioning analysis for PD-6735 in the seven major markets, 2007-2016

Figure 27: Datamonitor's comparative forecast of sales for eplivanserin and VEC-162 across the seven major markets ($m), 2007-2016

Figure 28: Datamonitor's competitive positioning analysis for eplivanserin and Org-50081 in the seven major markets, 2007-2016

Figure 29: Datamonitor's forecast sales of eplivanserin across the seven major markets for insomnia ($m), 2007-2016

Figure 30: Datamonitor's competitive positioning analysis for eplivanserin the seven major markets, 2007-2016

Figure 31: Datamonitor's forecast sales of Org-50081 across the seven major markets for insomnia ($m), 2007-2016

Figure 32: Datamonitor's competitive positioning analysis for Org-50081 in the seven major markets, 2007-2016

Figure 33: Datamonitor's comparative forecast of sales for Silenor and ACT-078573 across the seven major markets ($m), 2007-2016

Figure 34: Datamonitor's competitive positioning analysis for Silenor and ACT-078573 in the seven major markets, 2007-2016

Figure 35: Datamonitor's forecast sales of Silenor across the seven major markets for insomnia ($m), 2007-2016

Figure 36: Datamonitor's competitive positioning analysis for Silenor in the seven major markets, 2007-2016

Figure 37: Datamonitor's forecast sales of ACT-078573 across the seven major markets for insomnia ($m), 2007-2016

Figure 38: Datamonitor's competitive positioning analysis for ACT-078573 in the seven major markets, 2007-2016

Abstract

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