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Pipeline Insight Asthma/COPD/Allergic Rhinitis - As Patents Expire, Novel Combinations Inspire

The asthma, COPD and allergic rhinitis global market was $25.5 billion in 2004, with five brands selling over $1.0 billion. While a number of moderately successful launches are expected within the next five years, companies are seeking novel combination therapies to create the next generation of blockbuster drugs.

Scope

Evaluation of over 75 drugs in clinical development for asthma, COPD, and allergic rhinitis, including launch forecasts

Opinion leader insight into early stage therapies and treatment strategies

Forecasts of key late-stage therapies: Alvesco (ciclesonide), Daxas (roflumilast), Xolair (omalizumab), Xopenex (levalbuterol)

Forecasted sales of the respiratory market in the next 10 years, exploring the potential impact of early phase therapies

Report Highlights
Inhaled corticosteroid/long-acting b2-agonist fixed combinations will remain the leading asthma/COPD class in 2015, almost exclusively represented by sales of GSK's Super Advair, with its once-daily profile setting the new gold standard.

Merck may invigorate the oral asthma market through the development of a Singulair/ prostaglandin-D2 combination product, while monoclonal antibodies will be the fastest growing asthma class, with therapies that are effective in non-atopic asthma having a $1.0 billion sales opportunity.

Novel, long-acting, dual-action bronchodilator combinations will expand the COPD market from 2012, with novel triple combinations on the horizon. Altana/Pfizer's Daxas will achieve peak sales of $750 million by 2010, although 12-month data and combination trials with Spiriva will be key to success.

Reasons to Purchase

Understand unmet needs in the respiratory market, and how late-stage compounds address these needs

Identify potential licensing opportunities for respiratory market entry or portfolio expansion

Benchmark key late-stage asthma and COPD compounds against market leaders

Table of Contents

• CHAPTER 1 EXECUTIVE SUMMARY - page 3
  • Objective of the analysis - page 3
  • Datamonitor insight into the disease market - page 3
  • Market definition for this report - page 4
• CHAPTER 2 MARKET DYNAMICS - page 10
  • Current market: US accounts for 63% of global respiratory sales - page 10
  • Asthma/COPD: GSK's "Super Advair" sets the new gold standard - page 11
  • Allergic rhinitis: Merck develops a "Super Singulair" combination? - page 13
• CHAPTER 3 PATIENT POTENTIAL - page 16
  • Asthma patient potential - page 16
    • Definition and etiology of asthma - page 16
    • Treatment options - page 17
    • Prevalence of asthma - page 18
    • Segmentation of asthma - page 19
  • COPD patient potential - page 22
    • Definition and etiology of COPD - page 22
    • Treatment options - page 23
    • Prevalence of COPD - page 24
    • Segmentation of COPD - page 25
  • Allergic rhinitis patient potential - page 26
    • Definition and etiology of allergic rhinitis - page 26
    • Treatment options - page 27
    • Prevalence of allergic rhinitis - page 27
    • Segmentation of allergic rhinitis - page 28
• CHAPTER 4 ASTHMA R&D PIPELINE - page 29
  • Combination ICS/LABAs: GSK race to develop once-daily formulation - page 29
    • GSK first to market with once-daily LABA/ICS, but US launch ominously close to Advair patent expiry - page 30
    • Novartis/Schering-Plough alliance most significant threat to GSK - page 32
      • AstraZeneca Symbicort US launch uncertain - page 34
      • Sanofi-Aventis/Altana's ciclesonide/formoterol combination dependant on gaining US approval at the highest 320μg dose for Alvesco monotherapy - page 35
      • Boehringer Ingelheim unlikely to develop ICS/LABA combination - page 36
      • Few in-licensing opportunities in long-acting beta-2 agonist class - page 36
  • Inhaled Corticosteroids: Alvesco and Asmanex will struggle with positioning - page 37
    • Alvesco's EU launch handicapped by 160µg maximum dose - page 37
    • Asmanex finally gains approval in US - page 41
  • Oral non-steroidal anti-inflammatories: Singulair to face competition before patent expiry in 2012 - page 41
    • Merck targeting a Singulair/PG-D2 combination? - page 42
    • CCR3 antagonists most likely to threaten Singulair - page 44
    • Future of oral VLA-4 antagonists decided in 2005 - page 47
    • Wyeth's cPLA2 antagonist - a next-generation anti-inflammatory? - page 48
    • PDE-IV inhibitors - limited prospects in asthma - page 49
  • The mast cell: time for revaluation in asthma - page 51
  • Severe asthmatics remain a challenging population - page 53
    • Monoclonal antibodies: can blockade of a single target work? - page 53
      • Xolair to achieve peak sales of $890m - page 55
      • Anti-IL-13 mAb offers potential for disease modification - page 58
      • Roche and Wyeth target severe asthma with Zenapax and Enbrel - page 60
    • Inhaled immunostimulatory DNA - correcting the Th1/Th2 imbalance - page 61
    • Can Novartis's Elidel reduce the risk of developing asthma? - page 63
    • Role for novel COPD therapies in severe neutrophilic asthma? - page 64
  • Short-acting B2-agonists: generic CFC converts to a HFA branded market - page 65
    • Sepracor's Xopenex to capture 50% of albuterol HFA market - page 65
  • Gene therapy: Topigen's ASM-8 enters Phase I - page 68
  • Airway remodeling: dominant molecular mechanism yet to emerge - page 69
• CHAPTER 5 COPD R&D PIPELINE - page 71
  • Long-acting antimuscarinics: novel inhaled "Spiriva" combinations the next battleground - page 71
    • GSK develop next-generation Spiriva - page 71
    • Pfizer/BI, GSK and Novartis target novel long-acting LAMA/LABA combinations - page 72
    • Novel triple combinations on the horizon - page 73
    • Limited licensing opportunities in antimuscarinic class - page 75
  • Novel oral anti-inflammatories: modest uptake will generate significant revenues - page 76
    • PDE-IV inhibitors: Daxas to reach market in 2006 - page 76
      • Daxas - awaiting 12-month efficacy data - page 76
      • Ono or Merck expected to launch second-to-market oral PDE-IV inhibitor - page 81
    • CXCR2 antagonists - a focus for GSK, AZ and Schering-Plough? - page 81
    • Restoring the proteinase-antiproteinase balance - page 82
  • Search for disease-modifying therapy continues - page 83
• CHAPTER 6 ALLERGIC RHINITIS R&D PIPELINE - page 86
  • Novel oral anti-inflammatories: Singulair/PG-D2 combination for allergic rhinitis? - page 86
    • Singulair's status as an asthma drug protects its low co-pay classification - page 86
    • PG-D2 antagonists may address nasal congestion - page 87
  • Novel intranasal non-steroidal therapies - page 89
    • Pfizer has limited option to license Rigel's R-112 for allergic rhinitis - page 90
    • Evolutec's "Tick saliva" - the new antihistamine? - page 92
    • Biolipox's NCX-1510 - the gold standard intranasal antihistamine? - page 93
  • Incremental innovation in established classes - page 94
    • GSK's Allermist US launch most significant near-term event - page 94
    • Novel oral antihistamines struggle to offer differentiation to current market leaders - page 96
      • Xyzal succeeds Zyrtec in US? - page 96
  • Gap in market for improved allergen vaccination technologies - page 98
    • Oral allergen tablets will considerably simplify treatments - page 99
    • Novel "Immunodrug" approaches may have vastly improved delivery schedules - page 100
• CHAPTER 7 COMPANY PORTFOLIO ANALYSIS - page 104
  • GSK leads in inhaled therapy, but lacks an oral anti-inflammatory - page 104
  • AstraZeneca has a broad early development pipeline in asthma and COPD - page 104
  • Novartis requires partner to be successful in inhaled therapies - page 105
  • Merck's future lies in developing a Singulair/PG-D2 combination product - page 106
  • Pfizer/BI building franchise in COPD around Spiriva combinations - page 106
  • Sanofi-Aventis's pipeline lacks a blockbuster product - page 107
• CHAPTER 8 APPENDIX - page 108
  • Asthma/COPD sales mix - what are asthma and COPD products used for? - page 108
  • Launch forecasting methodology - page 109
  • Compounds in clinical development for asthma, COPD and allergic rhinitis - page 111
  • References - page 114
  • About Datamonitor - page 122
    • About Datamonitor Healthcare - page 122
    • About the Respiratory & Infectious Diseases analysis team - page 123
    • Disclaimer - page 124


• List of Figures
• Figure 1: Asthma/COPD and allergic rhinitis sales ($m) and market share (%) by class, in US and 5EU, 2004 - page 10
• Figure 2: Global sales in asthma/COPD 2005-15, by launched and development products - page 12
• Figure 3: Global sales in asthma/COPD ($m), 2005 & 2015, by class - page 13
• Figure 4: Global sales in allergic rhinitis ($m), 2005 & 2015, by class - page 14
• Figure 5: Eosinophils and mast cells are central to the pathophysiology of atopic asthma - page 17
• Figure 6: The inflammation associated with COPD involves neutrophils and alveolar macrophages - page 23
• Figure 7: Global forecast sales of combination ICS/LABA products ($m), 2005-15 - page 30
• Figure 8: "Super Advair" will set the new gold-standard in the combination therapy class - page 32
• Figure 9: Launch forecasts for inhaled corticosteroid/long-acting beta-2 agonist fixed combinations - page 33
• Figure 10: Advantages and disadvantages of Altana's Alvesco - page 40
• Figure 11: Novel oral anti-inflammatories - balancing safety with efficacy - page 43
• Figure 12: Global forecast sales in asthma for Singulair and Singulair/PG-D2 combination product ($m), 2005-15 - page 45
• Figure 13: CCR3 antagonists and Singulair/PG-D2 combination hold greatest promise in oral anti-inflammatory class - page 46
• Figure 14: Launch forecasts for novel oral anti-inflammatories - page 47
• Figure 15: Wyeth's efipladib has a broad anti-inflammatory profile - page 49
• Figure 16: Forecast sales of Xolair and second-to-market monoclonal antibody ($m), 2005-15 - page 54
• Figure 17: 74,000 patients treated with Xolair by 2010, 74% in US market - page 57
• Figure 18: Global forecast sales of Xopenex-HFA and Xopenex inhalation solution ($m), 2000-10 - page 68
• Figure 19: Launch forecasts for compounds in clinical development for asthma - page 70
• Figure 20: Global forecast sales of antimuscarinic class ($m), 2005-15 - page 73
• Figure 21: Novel triple combinations on the horizon - page 74
• Figure 22: Results from roflumilast RECORD study in patients with moderate-to-severe COPD - page 77
• Figure 23: Sales forecast for Daxas in EU and US ($m), 2005-15 - page 78
• Figure 24: Targets for future COPD therapy - page 82
• Figure 25: Launch forecasts for products in clinical development for COPD - page 85
• Figure 26: Global forecast sales for Singulair and Singulair/PG-D2 combination product in allergic rhinitis ($m), 2005-15 - page 89
• Figure 27: US sales for intranasal corticosteroid ($m), 2005-15 - page 96
• Figure 28: EU sales of Zyrtec and Xyzal in allergic rhinitis ($m), 2000-04 - page 97

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