Innovations and Pipelines for Respiratory Disorders: Niche markets, new products and future developments

Table of Contents

• Market introduction and outlook
• Asthma
• COPD
• Cystic fibrosis
• Pulmonary hypertension
• Respiratory allergies
• Respiratory tract infections
• Key companies and pipelines

• Summary
• Market introduction
• Respiratory disease classification
• Region-specific product sales revenues

• Existing product pipeline

• Leading marketed innovatives
• Innovatives classification
• Nasal preparations
  • Nasonex
• Anti-asthma and COPD preparations
  • Seretide
  • Singulair
  • Spiriva
• Cough and cold preparations
  • Pulmozyme
• Systemic antihistamines
  • Xyzal
• Key events to impact the respiratory market
• Decreasing numbers of new product approvals
• Regulatory affairs update
• Emergence of molecular testing
• Discontinued gene therapy research for cystic fibrosis
• Patent challenge: Ivax vs Advair
• Positive result for Seretide in COPD
• Emergence of innovative drug classes

• Summary
• Market introduction
• Etiology
• Epidemiology
• Unmet needs

• Future drivers of growth and innovation
• Combination therapies
• Non-steroidal anti-inflammatories
  • PG-D2 agonists
  • CCR3 antagonists
  • Targeting the mast cells directly
• Monoclonal antibodies
• Novel Anti-TNF targets
• Inhaled immunostimulatory DNA
• Novel therapies for severe neutrophilic asthma
• Gene Therapy

• Summary
• Market introduction
• Etiology
• Epidemiology
• Unmet needs

• Future drivers of growth and innovation
• Novel long-acting combination therapies
• Triple combinations
• Oral anti inflammatories
  • Phosphodiesterase inhibitors
  • CXCR2 Agonists
  • Proteinase targets
• Other novel first in class mechanisms

• Summary
• Market introduction
• Etiology
• Epidemiology
• Unmet needs

• Future drivers of growth and innovation
• Gene therapy
• Cystic fibrosis transmembrane regulator (CFTR) Protein Modulators
• Targeting ion channel deficit
• Anti-inflammatories
• Anti-infectives
• Active vaccines

• Summary
• Etiology
• Epidemiology
• Unmet needs

• Future drivers of growth and innovation
• Peptide hormones
• Long-acting therapy
• 5 HT-2B Antagonists
• Monoclonal Antibody therapy

• Summary
• Market introduction
• Etiology
• Epidemiology
• Unmet needs

• Future drivers of growth and innovation
• Corticosteroids
• Antihistamines
• Anti-inflammatories
• Nasal decongestants
• Novel “immunodrug” approach

• Summary
• Market introduction
• Etiology
• Epidemiology
• Unmet needs

• Future drivers of growth and innovation
• Antibiotics
• Anti-virals
• Vaccine development
• Monoclonal antibodies

• Summary
• Introduction
• GlaxoSmithKline
• Leading market revenue drivers
• Upcoming milestones
• Leading Innovatives pipeline
  • Preclinical
  • Phase II
• Boehringer Ingelheim
• Leading market revenue drivers
• Leading innovatives pipeline
  • Preclinical
  • Phase II
• Merck & Co.
• Upcoming milestones
• Leading Innovatives pipeline

• AstraZeneca
• Leading market revenue drivers
• Upcoming milestones
• Leading Innovatives pipeline
  • Preclinical
  • Phase I
  • Phase II

• Index

List of Figures

• Figure 1.1: Growth in global respiratory product sales revenues, 2003-2007 ($m)
• Figure 1.2: Share of respiratory product global sales revenues by ATC2 classification, 2007 ($m)
• Figure 1.3: Global respiratory and pulmonary product pipeline, May 2008
• Figure 1.4: Total respiratory market, growth metrics and sales revenues by therapy area, global, 2003-2007
• Figure 1.5: Global sales by drug class, 2007 ($m)
• Figure 1.6: Global revenues for asthma and COPD related drug classes, 2007 ($m)
• Figure 1.7: NDAs for novel respiratory drugs, FDA, 2003-2008
• Figure 1.8: Key disease pathways, emerging drug targets and company-specific areas of interest for respiratory disorders
• Figure 1.9: Lung alveolar epithelial cell - Key biochemical pathways and respiratory drug targets
• Figure 2.10: Comparative etiology of an asthmatic bronchiole
• Figure 2.11: The Asthma Innovatives R&D Pipeline
• Figure 3.12: The COPD Innovatives R&D pipeline
• Figure 4.13: The cystic fibrosis innovatives R&D pipeline
• Figure 5.14: The PAH Innovatives R&D Pipeline
• Figure 6.15: The respiratory allergies innovatives pipeline
• Figure 7.16: Etiology of common respiratory tract infections
• Figure 8.17: Top 10 companies by sales revenue, total respiratory product sales growth metrics 2003-2007, global
• Figure 8.18: GlaxoSmithKline respiratory and pulmonary product pipeline, July 2008
• Figure 8.19: Boehringer Ingelheim respiratory and pulmonary product pipeline, July 2008
• Figure 8.20: Merck & Co respiratory and pulmonary product pipeline, July 2008
• Figure 8.21: AstraZeneca respiratory and pulmonary product pipeline, July 2008

List of Tables

• Table 1.1: Estimated Annual Incidence for selected respiratory diseases by WHO sub region, 2002, ‘000' s
• Table 1.2: Estimated annual incidence for selected respiratory diseases by sex, 2002, ‘000s
• Table 1.3: Global sales of innovatives by drug class, 2007 ($m)
• Table 1.4: Top five diagnoses - share of total nasal preparations Rx market (EU5, US and Japan), 2007
• Table 1.5: Key anti-asthma and COPD growth drivers, global, 2007 ($m)
• Table 1.6: Global sales of Leading anti-asthma and COPD brands, 2003-2007 ($m)
• Table 1.7: Singulair; major product milestones
• Table 1.8: Leading branded systemic antihistamines, global, 2007 ($m)
• Table 2.9: Asthma prevalence and diagnosed populations, EU5, US and Japan, 2007
• Table 2.10: Anti-asthma Monoclonal Antibodies, June 2008
• Table 3.11: Estimated prevalence of COPD, EU5, US and Japan, 2006 (‘000s)
• Table 4.12: Annual incidence estimates of Cystic fibrosis in the 7MM, 2008
• Table 4.13: P aeruginosa pipeline vaccine candidates
• Table 5.14: Estimated prevalence of PAH by region, 2005 (millions)
• Table 5.15: Current breakdown of presenting PAH patients by severity
• Table 5.16: Strengths and weaknesses, currently marketed pulmonary hypertension therapies
• Table 6.17: Total diagnosed AR population aged over 20 years according to severity (%) and allergen (millions) in the 7 MM, 2006
• Table 7.18: Incidence of RTI diagnoses, US, 2006, millions
• Table 8.19: GlaxoSmithKline; Leading drug class sales for respiratory disorders, global, 2003-2007 ($m)
• Table 8.20: Boehringer Ingelheim; Leading drug class sales for respiratory disorders, global, 2003- 2007 ($m)
• Table 8.21: AstraZeneca; Leading drug class sales for respiratory disorders, global, 2003-2007 ($m)
• Table 9.22: Measurement of severity amongst COPD sufferers