Pipeline and Commercial Insight: Insomnia - Future of innovative orexin drug class in doubt

  • OVERVIEW
    • Catalyst
    • Summary
  • EXECUTIVE SUMMARY
    • Strategic scoping and focus
    • Datamonitor insight into the disease market
    • Related reports
  • 1. PATIENT POTENTIAL
    • Key findings
    • Definition of insomnia
    • Classification of insomnia
      • Insomnia is classified according to etiology and duration
      • Etiology
      • Diagnosis
    • Epidemiology
      • Seven major markets
      • BRIC (Brazil, Russia, India, China) countries
    • Clinical unmet need in insomnia
      • Unmet need one: reduction of residual daytime sedation
      • Unmet need two: lack of potential for tolerance and addiction
      • Unmet need three: more effective treatments for insomnia in the elderly
      • Unmet need four: improvement in sleep maintenance
      • Unmet need five: more effective treatments for pediatric insomnia
    • Environmental unmet need in insomnia
      • Improvement in the recognition, diagnosis and treatment rate of insomnia
  • 2. MARKET OVERVIEW
    • Key findings
    • Market definition for this report
    • Current assessment of the seven major insomnia markets
      • Three new brands entered the US insomnia market in 2005
      • Japan represents an attractive market for both prospective market entrants and established players
      • Insomnia treatment in Germany is characterized by widespread use of herbal hypnotics and benefits from a relatively high number of sleep laboratories
    • Future assessment of the seven major insomnia markets
      • By 2019 uptake of pipeline candidates will offset contraction in market value caused by generic erosion
      • Growth of US market value is set to be inhibited by generic erosion from 2011
      • Japan will represent the key growth region in the insomnia market over the next 10 years
      • Generic erosion of the Ambien franchise in the US will see Sanofi-Aventis lose its market-leading status
    • Patient acquisition process
      • Introduction
      • Patient care path
      • Points of influence in the patient care path
      • Drivers of drug choice
  • 3. BRAND DYNAMICS
    • Key findings
    • Overview of competitive landscape
      • Widespread availability of generic zolpidem is the greatest barrier to uptake of recent and prospective market entrants
      • Regulatory agencies are becoming increasingly stringent when reviewing New Drug Applications
    • Reimbursement: tiering of brands
      • Availability of generic GABA agonists negatively impacts the tier status of branded insomnia drugs
    • Ambien franchise (zolpidem; Sanofi-Aventis)
      • Drug overview
      • Drug profile
      • Product positioning
    • Lunesta (eszopiclone; Sepracor)
      • Drug overview
      • Drug profile
      • Product positioning
      • SWOT analysis
      • Brand forecast to 2019
    • Rozerem (ramelteon; Takeda)
      • Drug overview
      • Drug profile
      • Product positioning
      • SWOT analysis
      • Brand forecast to 2019
    • Circadin (melatonin; Neurim)
      • Drug overview
      • Drug profile
      • Clinical trial data
      • Product positioning
      • SWOT analysis
      • Brand forecast to 2019
    • Edluar (zolpidem sublingual tablet; Orexo/Meda)
      • Drug overview
      • Drug profile
      • Clinical trial data
      • Product positioning
      • SWOT analysis
      • Brand forecast to 2019
  • 4. PIPELINE OVERVIEW AND R&D DYNAMICS
    • Key findings
    • Pipeline overview
      • Late-stage candidates dominate the insomnia pipeline in 2010
      • Four candidates in the late-stage insomnia pipeline were discontinued/suspended over 2008–2010
      • Classification of pipeline products
      • Insomnia subtypes under investigation
    • Key companies involved in the insomnia pipeline
      • GlaxoSmithKline: aiming to penetrate insomnia market with novel compounds
      • Merck: looks towards novel mechanism of action following the 2007 failure of GABAa agonist gaboxadol
    • Definition of current comparator therapy
      • Ambien represents the gold standard treatment for insomnia
  • 5. PIPELINE DRUG ANALYSIS AND FORECASTS: GABA MODULATORS
    • Key findings
    • Overview of pipeline GABA modulators
    • ZolpiMist (zolpidem; NovaDel Pharma Inc/ECR Pharmaceuticals)
      • Drug overview
      • Drug profile
      • Clinical trial data
      • SWOT analysis
      • Clinical and commercial attractiveness
      • Satisfaction of unmet needs
      • Forecasts to 2019
    • Indiplon (NBI34060; Neurocrine Biosciences)
      • Drug overview
      • Drug profile
      • Clinical trial data
      • SWOT analysis
      • Clinical and commercial attractiveness
      • Satisfaction of unmet needs
      • Forecasts to 2019
    • Intermezzo (zolpidem tartrate; Transcept Pharmaceuticals)
      • Drug overview
      • Drug profile
      • Clinical trial data
      • SWOT analysis
      • Clinical and commercial attractiveness
      • Satisfaction of unmet needs
      • Forecasts to 2019
    • Other pipeline GABA modulators
      • SKP-1041 (zaleplon; Somnus Therapeutics/SkyePharma)
      • AZ-007 (Alexza Pharmaceuticals)
      • Zaleplon GR (Intec Pharma)
    • Discontinued/suspended pipeline GABA modulators
      • Evotec ceased internal investment for its Phase II insomnia candidate—EVT201—in March 2009
      • Development of Neurogen’s NG-273 was suspended in July 2008
      • Development of Fabre-Kramer’s TGARO1H (triazolam) is assumed to be discontinued
  • 6. PIPELINE DRUG ANALYSIS AND FORECASTS: OREXIN RECEPTOR ANTAGONISTS
    • Key findings
    • Overview of pipeline orexin receptor antagonists
    • Almorexant (ACT-078573; Actelion Pharmaceuticals/GlaxoSmithKline)
      • Drug overview
      • Drug profile
      • Clinical trial data
      • SWOT analysis
      • Clinical and commercial attractiveness
      • Satisfaction of unmet needs
      • Forecasts to 2019
    • MK-4305 (Merck & Co.)
      • Drug overview
      • Drug profile
      • Clinical trial data
      • SWOT analysis
      • Clinical and commercial attractiveness
      • Satisfaction of unmet needs
      • Forecasts to 2019
    • Other pipeline orexin receptor antagonists
      • GSK649868 (GlaxoSmithKline): Phase II candidate looks to be a back-up compound for almorexant
  • 7. PIPELINE DRUG ANALYSIS AND FORECASTS: MELATONIN RECEPTOR AGONISTS
    • Key findings
    • Overview of pipeline melatonin agonists
    • Tasimelteon (VEC-162; Vanda)
      • Drug overview
      • Drug profile
      • Clinical trial data
      • SWOT analysis
      • Clinical and commercial attractiveness
      • Forecasts to 2019
    • Other pipeline melatonin receptor agonists
      • Orlogin (Neurim Pharmaceuticals)
      • Neu-P11 (Neurim Pharmaceuticals)
  • 8. LATE-STAGE DRUG ANALYSIS AND FORECASTS: 5-HT MODULATORS
    • Key findings
    • Overview of pipeline 5-HT modulators
    • Silenor (doxepin hydrochloride; Somaxon Pharmaceuticals)
      • Drug overview
      • Drug profile
      • Clinical trial data
      • SWOT analysis
      • Clinical and commercial attractiveness
      • Satisfaction of unmet needs
      • Forecasts to 2019
    • Other pipeline 5-HT modulators
      • ITI-722 (Intra-Cellular Therapies): Phase II candidate in development for sleep maintenance insomnia
      • LY2624803 (Eli Lilly): Phase II results in chronic insomnia were expected in first half of 2010
    • Discontinued/suspended pipeline 5-HT modulators
      • Ciltyri (eplivanserin; Eli Lilly): US and EU submission dossiers withdrawn in December 2009
      • Volinanserin (M100908; Sanofi-Aventis): Phase III program discontinued in February 2009
      • Esmirtazapine (SCH900265; Merck & Co.): discontinuation of development program announced in March 2010
  • BIBLIOGRAPHY
    • Books and journal papers
    • Websites
  • APPENDIX
    • Forecasting assumptions
      • New product launches
      • Patent expiries
    • Forecast methodology
      • Datamonitor drug assessment scorecard
    • Contributing experts
    • Conference attendance
  • TABLES
    • Table: ICSD-2 criteria for severity of insomnia
    • Table: Epidemiology of DSM-IV defined insomnia in the seven major markets, 2010
    • Table: Prevalence of DSM-IV defined insomnia in the seven major markets, 2010
    • Table: Regional insomnia market sales value ($m) dynamics across the seven major markets, 2010–2019
    • Table: Sanofi-Aventis’s marketed insomnia drug franchise, 2010
    • Table: Representative formulary tier status in the US for prescription insomnia brands, 2010
    • Table: Ambien/Ambien CR (zolpidem, Sanofi-Aventis) – drug profile, 2010
    • Table: Sales forecasts for Ambien/Ambien CR franchise in the seven major markets ($m), 2010–2019
    • Table: Impacting factors on the revenues of Ambien/Ambien CR, 2010–2019
    • Table: Lunesta (eszopiclone, Sepracor) – drug profile, 2010
    • Table: Sales forecasts for Lunesta in the seven major markets ($m), 2010–2019
    • Table: Impacting factors on the revenue of Lunesta, 2010–19
    • Table: Rozerem (ramelteon, Takeda) – drug profile, 2010
    • Table: Sales forecasts for Rozerem in the seven major markets ($m), 2010–19
    • Table: Impacting factors on the revenue of Rozerem, 2010–19
    • Table: Circadin (melatonin) – drug profile, 2010
    • Table: Sales forecasts for Circadin in the seven major markets ($m), 2010–19
    • Table: Impacting factors on the revenue of Circadin, 2010–19
    • Table: Edluar (zolpidem sublingual tablet, Orexo/Meda) – drug profile, 2010
    • Table: Sales forecasts for Edluar in the seven major markets ($m), 2010–19
    • Table: Impacting factors on the revenue of Edluar, 2010–19
    • Table: Key pipeline candidates for the treatment of insomnia, 2010
    • Table: Insomnia/sleep disorder indications sought by late-stage and approved candidates, 2010
    • Table: GlaxoSmithKline’s marketed CNS products, 2010
    • Table: Key clinical trial data for Ambien (zolpidem, Sanofi-Aventis)
    • Table: Key clinical trial data for Ambien CR (zolpidem, Sanofi-Aventis)
    • Table: Key GABA modulators in clinical development for the treatment of insomnia, 2010
    • Table: ZolpiMist (zolpidem; NovaDel Pharma/ECR Pharmaceuticals) – drug profile, 2010
    • Table: Datamonitor’s drug assessment scorecard for ZolpiMist (NovaDel Pharma Inc/ ECR Pharmaceuticals) in insomnia, 2010
    • Table: Sales forecasts for ZolpiMist in the seven major markets ($m), 2010–19
    • Table: Impacting factors on the revenue of ZolpiMist, 2010–19
    • Table: Indiplon (NBI34060, Neurocrine Biosciences) – drug profile, 2010
    • Table: Clinical efficacy of trials of indiplon capsules in adults
    • Table: Clinical efficacy of trials of indiplon capsules in the elderly
    • Table: Datamonitor’s drug assessment scorecard for Indiplon (NBI34060; Neurocrine Biosciences) in insomnia, 2010
    • Table: Sales forecasts for indiplon in the seven major markets ($m), 2010–19
    • Table: Impacting factors on the revenue of indiplon, 2010–19
    • Table: Intermezzo (zolpidem tartrate) – drug profile, 2010
    • Table: Key facts: clinical trial to assess driving performance after middle-of-the-night dosing of Intermezzo
    • Table: Datamonitor’s drug assessment scorecard for Intermezzo (zolpidem; Transcept Pharmaceuticals) in insomnia, 2010
    • Table: Sales forecasts for Intermezzo in the seven major markets ($m), 2010–19
    • Table: Impacting factors on the revenue of Intermezzo, 2010–2019
    • Table: Key facts: Phase II trial of SKP-1041 in patients with primary insomnia
    • Table: Discontinued/suspended pipeline GABA modulators
    • Table: Key orexin receptor antagonists in clinical development for the treatment of insomnia, 2010
    • Table: Almorexant (ACT-078573; Actelion Pharmaceuticals/GlaxoSmithKline) – drug profile, 2010
    • Table: Key facts: Phase III clinical trial of almorexant in adult patients with chronic primary insomnia (RESTORA 1)
    • Table: Datamonitor’s drug assessment scorecard for Almorexant (ACT-078573; Actelion Pharmaceuticals/GlaxoSmithKline) in insomnia, 2010
    • Table: Sales forecasts for almorexant in the seven major markets ($m), 2010–19
    • Table: Impacting factors on the revenue of almorexant, 2010–2019
    • Table: MK-4603 – drug profile, 2010
    • Table: Key facts: Phase III, long-term safety study of MK-4305 in patients with primary insomnia
    • Table: Key facts: Phase III safety and efficacy study in primary insomnia patients
    • Table: Datamonitor’s drug assessment scorecard for MK-4305 (Merck & Co.) in insomnia, 2010
    • Table: Sales forecasts for MK-4305 in the seven major markets ($m), 2010–19
    • Table: Impacting factors on the revenue of MK-4305, 2010–19
    • Table: Key melatonin receptor agonists in clinical development for the treatment of insomnia, 2010
    • Table: Tasimelteon (VEC-162, Vanda Pharmaceuticals) – drug profile, 2010
    • Table: Phase III sleep efficacy measures: tasimelteon in induced transient insomnia
    • Table: Phase III results: tasimelteon’s effects on time to sleep onset in patients with chronic insomnia
    • Table: Datamonitor’s drug assessment scorecard for tasimelteon (VEC-162; Vanda Pharmaceuticals) in insomnia, 2010
    • Table: Sales forecasts for tasimelteon in the seven major markets ($m), 2010–2019
    • Table: Impacting factors on the revenue of tasimelteon, 2010–2019
    • Table: Key assumptions relating to the patient potential of tasimelteon in the US
    • Table: Key 5-HT modulators in clinical development for the treatment of insomnia, 2010
    • Table: Silenor (doxepin hydrochloride, Somaxon Pharmaceuticals) – drug profile, 2010
    • Table: Phase III trial of Silenor in adult patients: PSG sleep measures
    • Table: Datamonitor’s drug assessment scorecard for Silenor (doxepin; Somaxon Pharmaceuticals) in insomnia, 2010
    • Table: Sales forecasts for Silenor in the seven major markets ($m), 2010–2019
    • Table: Impacting factors on the revenue of Silenor, 2010–2019
    • Table: ITI-722 – drug profile, 2010
    • Table: Phase II clinical trial results: ITI-722 in patients with sleep maintenance insomnia
    • Table: Key facts: Phase II study of LY2624803 in patients with chronic insomnia
    • Table: Discontinued/suspended pipeline 5-HT modulators
    • Table: Datamonitor’s estimated launch dates for recently approved and key late-stage pipeline insomnia drugs in the seven major markets, 2010–2019
    • Table: Estimated generic launch dates for the approved insomnia drugs in the seven major markets, 2010–2019
    • Table: Datamonitor’s drug assessment parameters for key late-stage insomnia drugs
  • FIGURES
    • Figure: Symptoms of insomnia experienced by the US population at least a few times a week (male vs female)
    • Figure: Symptoms of insomnia in the US population at least a few times per week (age)
    • Figure: Clinical unmet needs for insomnia, 2010
    • Figure: Characteristics of the ideal hypnotic drug
    • Figure: Insomnia market sales value ($ billion) across the seven major markets, 2010–2019
    • Figure: Seven major market sales forecast of Sanofi-Aventis’s insomnia franchise 2010–2019
    • Figure: Insomnia evaluation and treatment pathway
    • Figure: Timeline: key events in the insomnia market, 2005–2010
    • Figure: Ambien/Ambien CR (zolpidem, Sanofi-Aventis) SWOT analysis 2010
    • Figure: Lunesta (eszopiclone, Sepracor) SWOT analysis 2010
    • Figure: Rozerem (ramelteon, Takeda) SWOT analysis 2010
    • Figure: Insomnia indications of key marketed products, 2010
    • Figure: Circadin (melatonin, Neurim/Nycomed/Lundbeck) SWOT analysis, 2010
    • Figure: Edluar (zolpidem sublingual tablet, Orexo/Meda) SWOT analysis, 2010
    • Figure: Insomnia pipeline split by development phase, 2010
    • Figure: Key developments in the insomnia pipeline, 2008–10
    • Figure: Clinical insomnia pipeline by mode of action, 2010
    • Figure: ZolpiMist (Zolpidem; NovaDel): Pivotal NVD003
    • Figure: ZolpiMist (Zolpidem; NovaDel): Pivotal NVD004
    • Figure: ZolpiMist (zolpidem, NovaDel Pharma Inc/ECR Pharmaceuticals) SWOT analysis, 2010
    • Figure: Datamonitor’s drug assessment summary for ZolpiMist (zolpidem; NovaDel Pharma Inc/ECR Pharmaceuticals) in insomnia, 2010
    • Figure: Indiplon’s US regulatory review process in insomnia, 2005–10
    • Figure: Indiplon (NBI34060, Neurocrine Biosciences) SWOT analysis, 2010
    • Figure: Datamonitor’s drug assessment summary for indiplon (NBI34060; Neurocrine Biosciences) in insomnia, 2010
    • Figure: Phase III sleep laboratory study: Intermezzo 1.75mg and 3.5mg versus placebo
    • Figure: Phase III outpatient study: placebo versus Intermezzo 1.75mg and 3.5mg versus placebo
    • Figure: Intermezzo (zolpidem, Transcept Pharmaceuticals) SWOT analysis, 2010
    • Figure: Datamonitor’s drug assessment summary for Intermezzo (zolpidem; Transcept Pharmaceuticals) in insomnia, 2010
    • Figure: Almorexant (Actelion Pharmaceuticals, GlaxoSmithKline) SWOT analysis, 2010
    • Figure: Datamonitor’s drug assessment summary for almorexant (Actelion Pharmaceuticals/GlaxoSmithKline) in insomnia, 2010
    • Figure: Phase IIb trial of MK4305: improvement in sleep efficiency at night 1 and end of 4 weeks
    • Figure: Phase IIb trial of MK4305: reduction in wake after sleep onset at night 1 and end of 4 weeks
    • Figure: MK-4305 (Merck & Co.) SWOT analysis, 2010
    • Figure: Datamonitor’s drug assessment summary for MK-4305 (Merck & Co.) in insomnia, 2010
    • Figure: Tasimelteon (VEC-162, Vanda) SWOT analysis, 2010
    • Figure: Datamonitor’s drug assessment summary for tasimelteon (VEC-162; Vanda Pharmaceuticals) in insomnia, 2010
    • Figure: Timeline: Silenor’s US regulatory review process in insomnia
    • Figure: Silenor (doxepin, Somaxon Pharmaceuticals) SWOT analysis, 2010
    • Figure: Datamonitor’s drug assessment summary for Silenor (doxepin; Somaxon Pharmaceuticals) in insomnia, 2010
    • Figure: ITI-722 SWOT analysis, 2010

Report

Published by
Datamonitor
Published on
14 Jul 2010
Product code
DMHC2616
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