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Asthma and COPD Drug Discoveries: What The Future Holds

Published by: Espicom Healthcare Intelligence

Published: Aug. 17, 2006 - 96 Pages


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




List of Tables

Deaths from COPD and Asthma in Major Markets, 2002

Deaths from COPD and Asthma in the USA, 2002

GINA Stepwise Approach to Asthma Medication

GOLD Therapy Recommendations for COPD

Leading Asthma and COPD Therapies by Sales Value, 2004-2005 (US$ Million)

US Patent Expiry for Major Asthma and COPD Therapies

Launched Products in Development

Novel Drugs in Development

Competitor Ratio Analysis Summary

Xopenex Sales, 2001-2005 (US$ Million)

Flixotide/Flovent Sales, 2001-2005 (£ & US$ Million)

Pulmicort Sales, 2001-2005 (US$ Million)

Spiriva Sales, 2002-2005 (Euros & US$ Million)

Advair/Seretide Sales, 2001-2005 (£ & US$ Million)

Symbicort Sales, 2001-2005 (US$ Million)

Singulair Sales, 2002-2005 (US$ Million)

Xolair Sales, 2003-2005 (US$ Million)

Xolair Projected Sales, 2005-2011 (US$ Million)




List of Figures

Novel Drugs in Clinical Development by Activity

Xopenex Projected Sales, 2005-2011 (US$ Million)

Flixotide/Flovent Projected Sales, 2005-2011 (US$ Million)

Pulmicort Projected Sales, 2005-2011 (US$ Million)

Asmanex Twisthaler Projected Sales, 2005-2011 (US$ Million)

Alvesco Projected Sales, 2005-2012 (US$ Million)

Spiriva Projected Sales, 2005-2011 (US$ Million)

Seretide/Advair Projected Sales, 2005-2011 (US$ Million)

Symbicort Projected Sales, 2005-2011 (US$ Million)

Singulair Projected Sales, 2005-2011 (US$ Million)

Ariflo Projected Sales, 2007-2012 (US$ Million)

Daxas Projected Sales, 2008-2013 (US$ Million)

Arformoterol Projected Sales, 2007-2012 (US$ Million)

Indacaterol Projected Sales, 2009-2014 (US$ Million)

GSK 159797 Projected Sales, 2008-2013 (US$ Million)

NVA237 Projected Sales, 2009-2014 (US$ Million)

Abstract

A fast growing sector with strong products and players - but what will the COPD/Asthma landscape look like 5 years from now?

The global asthma and COPD market is currently worth around US$20 billion. The top twelve pharmaceutical products by value had combined global sales of US$15.7 billion in 2005. Six brands had sales in excess of US$1 billion. Combined sales of the top ten products were 21.1% higher than in 2004.

A number of older therapies, for asthma in particular, are widely available generically and there is fierce competition in the market. The asthma market accounts for the majority of the total and is valued at around US$15 billion. The COPD market is currently valued at US$4 - US$5 billion and is set to double in the next five years.

Future market growth will be driven by increasing disease awareness, an increasing patient pool, both in the paediatric asthma sector and the ageing population susceptible to COPD, and the launch of newer, more expensive therapies targeting areas of high unmet clinical need. These will be offset to some extent by the launch of new generics and the sales erosion of monotherapies by combination products.

Providing
  • Product/Market Forecast by value 2006/2011 for current and future therapies
  • 15 key products assessed
  • Market Context
  • Competitive Evaluation
  • Research Reviews
Covering
  • Beta-2 Agonists
  • Inhaled Corticosteroids
  • Combination Therapies
  • Leukotrine Receptor Antagonists
  • Anti-Immunoglobulin E Therapy
  • Muscarinic Antagonists/ Anticholinergics
  • PDE-IV Inhibitors


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