Pipeline Insight: Asthma, COPD and Allergic Rhinitis - The Needs of Severe Patients Must be Addressed

Published by: Datamonitor

Published: May. 12, 2003 - 292 Pages

Table of Contents

• Scope of the analysis
  
• Datamonitor insight into the asthma, COPD and allergic rhinitis market
  
• Although indicated for allergic asthma, the US launch of Xolair in 2003 will also
  revolutionize the severe allergic rhinitis market. Clinical results have been far more
  promising for Xolair than for any of the other monoclonal antibodies in development
  for asthma. Nevertheless, exorbitant costs, prescribing restrictions and safety
  concerns will slow initial sales growth.
  
• The launch of the oral PDE-4 inhibitor roflumilast will allow Pfizer to gain a
  significant presence in the respiratory COPD sector and will provide fierce
  competition to GlaxoSmithKline’s first-to-market Ariflo. The lack of major pipeline
  developments means that quality of life benefits will become increasingly important
  clinical trial endpoints in COPD.
  
• Altana/Aventis/Teijin’s ciclesonide will face significant barriers to entry into a
  corticosteroid class that is facing significant genericization and cannibalization by
  combination therapies. Increased reimbursement costs and patent challenges will
  severely limit the commercial prospects for Sepracor’s antihistamine, Soltara.
  
• Summary
  
• Key metrics

CHAPTER 2 PATIENT POTENTIAL

• Definition of asthma
  
• Etiology of asthma
  
• Th1/Th2 theory
  
• Segmentation of asthma
  
• Epidemiology of asthma
  
• Methodology
  
• EU
  
• Japan
  
• US
  
• Future trends
  
• US
  
• EU and Japan
  
• Definition of allergic rhinitis
  
• Etiology of allergic rhinitis
  
• Segmentation of allergic rhinitis
  
• Epidemiology of allergic rhinitis
  
• Methodology
  
• EU
  
• US
  
• Japan
  
• Future trends
  
• Definition of COPD
  
• Etiology of COPD
  
• Segmentation of COPD
  
• Epidemiology of COPD
  
• Methodology
  
• US
  
• EU
  
• Japan
  
• Future trends
  
• Unmet need
  
• Unmet need in asthma
  
• Reduced side effects
  
• Drug delivery formulation
  
• Dosing regimens
  
• Greater efficacy
  
• Increased disease awareness and patient education
  
• Unmet need in allergic rhinitis
  
• Reduced side effects
  
• Drug delivery formulation
  
• Greater efficacy
  
• Increased patient education
  
• Unmet need in COPD
  
• Efficacy
  
• Increased disease awareness and patient education
  
• Reduced side effects
  
• Drug delivery formulation
  
• Dosing regimens

CHAPTER 3 R&D APPROACH

• Classification of pipeline products
  
• Antihistamines
  
• Corticosteroids
  
• Beta2-agonists
  
• Phosphodiesterase-4 inhibitors
  
• Leukotriene inhibitors
  
• Adenosine modulators
  
• 5-Lipoxygenase inhibitors
  
• Leukotriene receptor antagonists
  
• Monoclonal antibodies
  
• Anti-IgE
  
• Anti-IL-4, anti-IL-5
  
• Anti-eotaxin1
  
• Anti-IL-2
  
• Specific immune therapy
  
• Cell-surface adhesion inhibitors
  
• VLA-4 integrin antagonists
  
• Selectin antagonists
  
• Definition of current comparator therapy
  
• Asthma/COPD comparator
  
• Allergic rhinitis comparator
  
• Clinical trial endpoints in asthma
  
• Improvement in lung function
  
• Decrease in steroid usage
  
• Reduction in the incidence of acute exacerbations
  
• Decrease in use of rescue medication
  
• Others
  
• Clinical trial endpoints in COPD
  
• Improvement in lung function
  
• Reductions in the incidence of acute exacerbations
  
• Health status
  
• Dyspnea
  
• Other
  
• Clinical trial endpoints in allergic rhinitis
  
• Improvement in nasal symptoms
  
• Rescue antihistamine use
  
• Reduction in nasal inflammatory cell counts
  
• Quality of life
  
• Clinical trial design critique
  
• Animal models
  
• Clinical trial design
  
• Follow-up periods
  
• Head-to-head trials
  
• Surrogate markers

CHAPTER 4 ASTHMA, COPD AND ALLERGIC RHINITIS
PIPELINE ANALYSIS

• Pipeline overview
  
• Key companies involved in the respiratory pipeline and their strategies for success
  
• GlaxoSmithKline: set to remain on top for now
  
• Merck: all eggs in Singulair basket
  
• Pfizer: a force to be reckoned with
  
• Aventis: under threat
  
• Schering-Plough: badly wounded
  
• AstraZeneca: a shrinking presence
  
• Novartis: a minor player no longer?
  
• Altana: the innovator

CHAPTER 5 MONOCLONAL ANTIBODIES LATE-STAGE
DRUG ANALYSIS & FORECASTS

• Pipeline summary
  
• Xolair
  
• Drug overview
  
• Clinical trial data
  
• Asthma
  
• Datamonitor comments
  
• Allergic rhinitis
  
• Datamonitor comments
  
• Patient potential
  
• Marketing factors
  
• Satisfaction of unmet need
  
• Efficacy
  
• Dosing regimen and drug delivery formulation
  
• Reduced side effects
  
• SWOT analysis
  
• Forecasts to 2010
  
• Impacts
  
• Other drugs in monoclonal antibody class
  
• Mepolizumab
  
• Drug overview
  
• Clinical trials
  
• Datamonitor comments
  
• Pascolizumab
  
• Drug overview
  
• Clinical trials
  
• Datamonitor comments
  
• Daclizumab
  
• Drug overview
  
• Clinical trials
  
• Datamonitor comments
  
• IDEC-152 (anti-CD23)
  
• Drug overview
  
• Clinical trials
  
• Datamonitor comments
  
• CAT-213 (anti-eotaxin)
  
• Drug overview
  
• Clinical trials
  
• Datamonitor comments
  
• Pitrakinra
  
• Late-stage development compounds recently discontinued
  
• Reslizumab
  
• Drug overview
  
• Clinical trials
  
• Datamonitor comments

CHAPTER 6 PHOSPHODIESTERASE-4 INHIBITORS LATESTAGE
DRUG ANALYSIS AND FORECASTS

• Pipeline summary
  
• Ariflo
  
• Drug overview
  
• Clinical trials
  
• Phase II
  
• Phase III
  
• Additional studies
  
• Datamonitor comments
  
• Patient potential
  
• Marketing factors
  
• Satisfaction of unmet need
  
• SWOT analysis
  
• Forecasts to 2010
  
• Impacts
  
• Roflumilast
  
• Drug overview
  
• Clinical trials
  
• Preclinical data
  
• Asthma
  
• COPD
  
• Datamonitor comments
  
• Patient potential
  
• Marketing factors
  
• Satisfaction of unmet need
  
• SWOT analysis
  
• Forecasts to 2010
  
• Impacts
  
• Comparison of Ariflo and roflumilast PDE-4 inhibitors
  
• Satisfaction of unmet need
  
• Comparative forecasts
  
• Other drugs in PDE-4 inhibitors class
  
• GW-842470
  
• Drug overview
  
• Datamonitor comments
  
• Arofylline
  
• KW-4490
  
• Lirmilast
  
• Late-stage PDE-4 inhibitors recently discontinued
  
• Undisclosed Merck/Celltech candidate

CHAPTER 7 CORTICOSTEROID AND ANTIHISTAMINE DRUG
ANALYSIS AND FORECASTS

• Pipeline summary
  
• Ciclesonide (Alvesco)
  
• Drug overview
  
• Clinical trials
  
• Datamonitor comments
  
• Patient potential
  
• Marketing factors
  
• Satisfaction of unmet needs
  
• Reduced side effects
  
• Drug delivery formulation and dosing regimens
  
• Greater efficacy
  
• Marketing strength
  
• SWOT analysis
  
• Forecasts to 2010
  
• Impacts
  
• Other corticosteroids
  
• NS-126
  
• Late-stage corticosteroid recently discontinued
  
• Rofleponide
  
• Soltara
  
• Drug overview
  
• Clinical trials
  
• Toxicology
  
• Datamonitor comments
  
• Patient potential
  
• Marketing factors
  
• Satisfaction of unmet need
  
• Reduced side effects
  
• Drug delivery formulation
  
• Greater efficacy
  
• Marketing strength
  
• SWOT analysis
  
• Forecast to 2010
  
• Other antihistamines
  
• Rupatadine
  
• Drug overview
  
• Clinical trial update
  
• Datamonitor comments
  
• Efletirizine
  
• Drug overview
  
• Clinical trial update
  
• Datamonitor comments

CHAPTER 8 OTHER LATE-STAGE DRUG ANALYSIS

• Pipeline summary
  
• Replacement alpha1 anti-trypsin
  
• Overview
  
• Plasma-based
  
• Clinical trial update
  
• Recombinant-based
  
• Clinical trial update
  
• Datamonitor comments
  
• Tablet specific immune therapy
  
• Drug overview
  
• Clinical trial update
  
• Datamonitor comments
  
• Immunomodulatory oligonucleotides
  
• AIC
  
• Drug overview
  
• Clinical trial update
  
• Datamonitor comments
  
• ISS-1018
  
• Drug overview
  
• Clinical trial update
  
• Datamonitor comments
  
• SRP-299
  
• Drug overview
  
• Clinical trial update
  
• Datamonitor comments
  
• General immunosuppressants
  
• Cell-surface adhesion inhibitors
  
• R411
  
• Drug overview
  
• Preclinical update
  
• Datamonitor comments
  
• 559090
  
• Drug overview
  
• Preclinical update
  
• Datamonitor comments
  
• Bimosiamose
  
• Drug overview
  
• Clinical trial update
  
• Datamonitor comments
  
• Other allergic rhinitis therapies
  
• TAK-427
  
• Drug overview
  
• Preclinical trial update
  
• Datamonitor comments
  
• Other asthma therapies
  
• EPI-2010
  
• Drug overview
  
• Clinical trials
  
• Datamonitor comments
  
• Inflarest (PB005)
  
• Drug overview
  
• Clinical trials
  
• Datamonitor comments
  
• Pumactant
  
• Drug overview
  
• Clinical trial update
  
• Datamonitor comments
  
• QAB-149
  
• Drug overview
  
• Datamonitor comments
  
• Other COPD-specific therapies
  
• R-667
  
• Drug overview
  
• Clinical trial update
  
• Datamonitor comments
  
• TH9507
  
• Drug overview
  
• Clinical trial update
  
• Datamonitor comments

CHAPTER 9 INNOVATIVE EARLY-STAGE PROJECTS

• Pipeline summary
  
• Phosphodiesterase-4 inhibitors
  
• Inflazyme
  
• Ono
  
• Pfizer
  
• ICOS
  
• Altana
  
• Schering-Plough/Celltech-discontinued
  
• Datamonitor comments
  
• Cell surface adhesion VLA-4 inhibitors
  
• GlaxoSmithKline/Tanabe
  
• 683699 (T-0047)
  
• Merck/Biogen
  
• Schering-Plough/Texas Biotechnology
  
• Celltech
  
• Roche
  
• Datamonitor comments
  
• AAT replacement therapy
  
• Recombinant therapy
  
• Gene therapy
  
• Immunomodulatory oligonucleotides
  
• AVAC
  
• CpG 7279
  
• Drug overview
  
• Datamonitor comments
  
• IgE inhibitor
  
• AVP-13358
  
• IgE-026
  
• Adenosine modulator
  
• EPI-12323
  
• Already marketed drug groups
  
• 5-lipoxygenase inhibitors
  
• MLN-977
  
• UCB-35440
  
• Beta2-agonists
  
• Long-acting (597901, 159797)
  
• NO donor (NCX-950)
  
• Corticosteroids
  
• NCX-1020
  
• Novel concepts in asthma
  
• Leukocyte-suppressing anti-inflammatories (LSAIDs)
  
• IPL-512602
  
• Nitric oxide inhibitor
  
• GW-274150
  
• Inhibition of chemokines and chemokine receptors
  
• JNK inhibitors
  
• Novel concepts in COPD
  
• Tryptase/Elastase/Metalloproteinase inhibitors
  
• Matrix metalloproteinase inhibitors
  
• Tryptase inhibitors
  
• Protease inhibitors
  
• Neutrophil elastase inhibitors
  
• Cathepsin S inhibitors
  
• Anti-TNF-alpha
  
• Anti-MIF
  
• Antioxidants
  
• Disappointing concepts
  
• Tachykinin receptor antagonists
  
• Thromboxane antagonists
  APPENDIX A
  
  
  • Contributing experts
    
  • Professor Peter Barnes
    
  • Professor Roberto Rodriguez-Roisin
    
  • Professor Bruce Bochner
    
  • Professor William Henderson
    
  • Dr Eckard Hamelmann
    
  • Interview transcript 1
    
  • Pipeline
    
  • Clinical trial design
    
  • Interview transcript 2
    
  • Epidemiology
    
  • Unmet needs
    
  • Clinical trials
    
  • Comparator therapies
    
  • Pipeline
    
  • Interview transcript 3
    
  • Epidemiology
    
  • Unmet needs
    
  • Clinical trial design
    
  • Pipeline
    
  • Interview transcript 4
    
  • Pipeline
    
  • Clinical trial design
    
  • Epidemiology
    
  • Interview transcript 5
    
  • Pipeline
    
  • Clinical trial design
    
  • Unmet needs
    
  • Epidemiology
    
  • Company pipeline tables
    
  • GlaxoSmithKline
    
  • Pfizer
    
  • Merck
    
  • Aventis
    
  • Schering-Plough
    
  • Novartis
    
  • AstraZeneca
    
  • Altana
    
  • List of tables
    
  • List of figures
    
  • Bibliography
    
  • Epidemiology
    
  • Clinical trial data

  
  APPENDIX B
  
  

  • About Datamonitor
    
  • About Datamonitor Healthcare
    
  • Datamonitor Healthcare’s research and analysis methodologies
    
  • Datamonitor Healthcare’s therapy area capabilities
    
  • About Disease analysis team
    
  • Datamonitor Healthcare’s Consulting expertise
    
  • Datamonitor’s Therapeutic Consulting expertise
    
  • Key therapy team members
    
  • Simon Hemsworth, Director of Therapy Area Analysis
    
  • Simon Wright, Director Immune Disorders and Inflammation
    
  • David Abramson, Therapeutic Lead Consultant
    
  • Disclaimer

  
  

  Abstract

  Introduction:
  Both allergic rhinitis and asthma are well served by current therapies. Greater uptake of combination therapies for asthma and COPD, and rising genericization in all sectors provide additional barriers to market entry for novel therapeutics. COPD is massively under-diagnosed, but the lack of effective therapies will continue to hamper attempts to increase patient awareness.
  
  Scope:
  * Evaluation of the prevalence of asthma, COPD and allergic rhinitis in the seven leading country markets
  
  * Identification of clinical and environmental unmet needs in each of the three major respiratory markets
  
  * Profiles of the leading global players: GlaxoSmithKline, Merck, Aventis, Pfizer, Schering-Plough, AstraZeneca, Novartis
  
  * In depth profiles of key drugs in late-stage development, including an evaluation of clinical trial data and an assessment of unmet need satisfaction
  
  Report Highlights:
  Despite the fact that over 90% of asthmatics are well-managed on current therapies, the majority of R&D products are targeted at the asthma market. The greatest potential for products like Xolair is in allergic rhinitis, as 75% of asthmatics suffer from concomitant allergic rhinitis, and aggressive treatment may lead to improved asthma management.
  
  The key unmet need in the COPD sector is effective therapies, yet pipelines are littered with clinical failures, highlighting the difficulty in reversing the effects of destroyed lung tissue. Irrespective of their modest efficacy, PDE-4 inhibitors will be welcomed by the COPD community.
  
  Reasons to Purchase:
  * Plan new product development to meet identified unmet needs in the COPD sector
  
  * Evaluate the market potential of late-stage developmental products, and of innovative, early-stage drugs
  
  * Recognize competitive market dynamics within the respiratory sector with an assessment of company portfolios and strategies
  
  
  
  Get Full Details About This Report >>

About MarketResearch.com
MarketResearch.com is an online aggregator selling over 160,000 market research reports, company profiles and country profiles from over 600 research firms. Our reports will provide you with the critical business and competitive intelligence you need for strategic planning and marketing research. Coverage includes the US, UK, Europe, Asia and global markets.