[Report] Asthma and COPD Drug Discoveries: What the future holds TOC

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

Asthma and COPD Drug Discoveries: What the future holds

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