Stakeholder Perspectives: Pulmonary Arterial Hypertension - A small market gets big attention

Table of Contents

• About the cardiovascular pharmaceutical analysis team
• CHAPTER 1 EXECUTIVE SUMMARY
• CHAPTER 2 PULMONARY ARTERIAL HYPERTENSION OVERVIEW
  • Pulmonary arterial hypertension background
  • Pulmonary arterial hypertension is a deadly disease
  • Epidemiology
    • Idiopathic pulmonary arterial hypertension rates support market estimates
    • An estimated 146,000 patients in US, Europe, and Japan
    • Pulmonary arterial hypertension severity is segmented into four classes
  • Presentation and diagnosis of pulmonary arterial hypertension
    • Breakdown by class
  • Current treatment of pulmonary arterial hypertension
    • Three approved drug classes have improved outlook for patients.
  • Unmet need in pulmonary arterial hypertension management
    • Efficacy, improved delivery, and reduced costs linked needs in treatment
    • Combination therapy unproven, but growing in popularity
    • Increased awareness needed, particularly for oral therapy success
    • Greater understanding of patient population required
• CHAPTER 3 CURRENT PULMONARY ARTERIAL HYPERTENSION THERAPIES
  • Tracleer (bosentan)
    • BREATHE-1 trial data forms basis for approval
    • Bosentan has also been supported by several other BREATHE studies
    • Datamonitor comment
  • Flolan (epoprostenol sodium)
    • Pivotal study, follow-up studies, show survival benefit
    • Datamonitor comment
  • Remodulin (treprostinil)
    • Bioequivalence data used for intravenous extension
    • Phase IV clinical study data looks promising
    • Datamonitor comment
  • Ventavis (iloprost)
    • Clinical trial data
    • Datamonitor comment
  • Revatio (sildenafil)
    • Clinical trial data
    • Cost of Revatio
    • Datamonitor comment
  • Benchmarking therapies
• CHAPTER 4 PULMONARY ARTERIAL HYPERTENSION THERAPIES IN DEVELOPMENT
  • Thelin (sitaxsentan)
    • Clinical data supports benefit
      • STRIDE-1
      • STRIDE-2
      • Additional trials
    • Datamonitor comment
  • Ambrisentan
    • Clinical data points to potential class winner
      • ARIES-1
      • ARIES-2
    • Datamonitor comment
  • Tadalafil
    • Datamonitor comment
  • Inhaled treprostinil
    • Oral treprostinil also holds considerable promise
    • Datamonitor comment
  • Aviptadil
    • Datamonitor comment
  • Other early stage therapies
    • UK-369003
    • ABT-306552
    • PRX-08066
    • PulmoLAR
    • Gleevec (imatinib)
• CHAPTER 5 PULMONARY ARTERIAL HYPERTENSION MARKET FORECAST
  • Oral therapies forecast assumptions
  • Prostacyclin forecast assumptions
  • Timings of pulmonary arterial hypertension launches
  • PAH market forecasts, 2005-2014
• APPENDIX
  • About Datamonitor
    • About Datamonitor Healthcare
    • Disclaimer
  • List of Tables
    • Table 1: Estimated PAH prevalence, US, Europe, and Japan, 2005
    • Table 2: Current breakdown of presenting PAH patients, by severity
    • Table 3: Currently available PAH therapies and 2004 sales
    • Table 4: Timeline of product launches and other key regulatory events
    • Table 5: US PAH market forecast, $m, 2005-2014
    • Table 6: Global PAH market forecast, $m, 2005-2014
  • List of Figures
    • Figure 1: ProDose (top) and I-neb AAD systems (bottom)
    • Figure 2: Position of currently available therapies, by disease severity
    • Figure 3: Comparative strengths and weaknesses of PAH therapies, including late-stage therapies