Asthma and COPD Drug Discoveries: What the future holds

Table of Contents

• Foreword
• Executive Summary
• What are Asthma and COPD?
• Morbidity and Mortality
• Diagnosis and Treatment
• Asthma Management
• COPD Management
• Pharmacotherapy
  • Current Market Leaders
  • Drugs in the Pipeline
  • Competitor Ratio Analysis
• Short-Acting Beta-2 Agonists
  • Xopenex (levalbuterol)
  • Sales Forecast
  • Patent Challenges
  • Clinical Trials
    • Xopenex versus racemic albuterol in COPD
    • Xopenex HFA study
    • Xopenex in the emergency room
• Inhaled Corticosteroids
  • Flixotide/Flovent (fluticasone propionate)
    • Sales Forecasts
    • Clinical Trials
  • Pulmicort (budesonide)
    • Sales Forecast
    • Patent Challenge
    • Clinical Trials
      • START - budesonide during pregnancy
      • START - budesonide in children with mild persistent asthma
      • START - safety outcome data
      • EUROSCOP
      • Long-term data from early intervention study in Finland
  • Asmanex (mometasone furoate)
    • Sales Forecasts and Assumptions
    • Competitor Ratio Analysis
    • Novelty/rationale for mechanism of action
    • Proof of concept/clinical data
    • Management/clinical expertise
    • Competition within marketplace
    • Risks associated with drug development in therapeutic class
  • Clinical Trials
    • Patients previously maintained on bronchodilators alone
    • Patients previously maintained on inhaled corticosteroids
    • Patients previously maintained on oral corticosteroids
  • Alvesco (ciclesonide)
    • Sales Forecast and Assumptions
    • Competitor Ratio Analysis
      • Novelty/rationale for mechanism of action
      • Proof of concept/clinical data
      • Management/clinical expertise
      • Competition within marketplace
      • Risks associated with drug development in therapeutic class
    • Clinical trials
      • Ciclesonide versus fluticasone propionate
      • Low incidence of oropharyngeal side effects
      • Ciclesonide versus budesonide and fluticasone
      • Intranasal formulation
      • Ciclesonide versus budesonide
• Muscarinic Antagonists
  • Spiriva (tiotropium)
    • Sales Forecast and Assumptions
    • Competitor Ratio Analysis
      • Novelty/rationale for mechanism of action
      • Proof of concept/clinical data
      • Management/clinical expertise
      • Competition within marketplace
      • Risks associated with drug development in therapeutic class
  • Clinical Trials
    • Pooled Studies
    • Study on COPD patients in France
    • Spiriva+formoterol versus salmeterol+fluticasone propionate
    • UPLIFT
    • TIPHON
• Combination Therapy
  • Seretide/Advair (salmeterol+fluticasone propionate)
    • Sales Forecasts
    • Patent Challenge
    • Safety Issues
    • Clinical Trials: COPD
      • TORCH
      • TRISTAN
    • Clinical Trials: Asthma
      • Biopsy Study in Moderate Asthma
      • EXCEL
      • GOAL
      • Advair versus montelukast
  • Symbicort (budesonide+formoterol)
    • Sales Forecast
    • European patent challenge
    • Clinical Trials: COPD
      • Calverly et al.
    • Clinical Trials: Asthma
      • SUND
      • STAY
      • Head to head study: Symbicort Turbuhaler versus Seretide (salmeterol+fluticasone)
    • Clinical Trials: Asthma+COPD
      • ASSURE
• Leukotriene Receptor Antagonists
  • Singulair (montelukast)
    • Sales Forecast
    • Clinical Trials
      • PREVIA
• Anti-Immunoglobulin E Therapy
  • Xolair (omalizumab)
    • Sales Forecast and Assumptions
    • Competitor Ratio Analysis
      • Novelty/rationale for mechanism of action
      • Proof of concept/clinical data
      • Management/clinical expertise
      • Competition within marketplace
      • Risks associated with drug development in therapeutic class
    • Clinical Trials
      • Long-term data
      • Pooled study data
• Drugs in Development
• PDE-IV Inhibitors
  • Ariflo (cilomilast)
    • Sales Forecasts and Assumptions
    • Competitor Ratio Analysis
      • Novelty/rationale for mechanism of action
      • Proof of concept/clinical data
      • Management/clinical expertise
      • Competition within marketplace
      • Risks associated with drug development in therapeutic class
    • Clinical trials
  • Daxas (roflumilast)
    • Sales Forecasts and Assumptions
    • Competitor Ratio Analysis
      • Novelty/rationale for mechanism of action
      • Proof of concept/clinical data
      • Management/clinical expertise
      • Competition within marketplace
      • Risks associated with drug development in therapeutic class
    • Clinical Trials
      • Efficacy & safety study in COPD
      • RATIO/M2-112
      • RECORD
      • Other studies
• Long-Acting Beta Agonists
  • Arformoterol
    • Sales Forecasts and Assumptions
    • Competitor Ratio Analysis
      • Novelty/rationale for mechanism of action
      • Proof of concept/clinical data
      • Management/clinical expertise
      • Competition within marketplace
      • Risks associated with drug development in therapeutic class
    • Clinical Trials
  • Indacaterol
    • Sales Forecast and Assumptions
    • Competitor Ratio Analysis
      • Novelty/rationale for mechanism of action
      • Proof of concept/clinical data
      • Management/clinical expertise
      • Competition within marketplace
      • Risks associated with drug development in therapeutic class
    • Clinical Trials
  • GSK 159797
  • Sales Forecasts and Assumptions
  • Competitor Ratio Analysis
    • Novelty/rationale for mechanism of action
    • Proof of concept/clinical data
    • Management/clinical expertise
    • Competition within marketplace
    • Risks associated with drug development in therapeutic class
  • Clinical Trials
• Long-Acting Muscarinic Antagonists
  • NVA237
    • Sales Forecast and Assumptions
    • Competitor Ratio Analysis
      • Novelty/rationale for mechanism of action
      • Proof of concept/clinical data
      • Management/clinical expertise
      • Competition within marketplace
      • Risks associated with drug development in therapeutic class
    • Clinical Trials
• SOURCES
• Espicom Sources
• Others