Table of Contents

Table of Contents
ABOUT DATAMONITOR HEALTHCARE 2
About the Disease pharmaceutical analysis team 2
CHAPTER 1 EXECUTIVE SUMMARY 4
Scope of the analysis 4
Datamonitor insight into the PAD market 5
Key metrics 7
Datamonitor Pipeline Assessment Summary 9
CHAPTER 2 PIPELINE OVERVIEW AND DYNAMICS 12
Pipeline overview 12
The PAD pipeline shows diverse mechanisms of action 16
The PAD pipeline is rich in Phase II candidates 17
Numerous companies have their stake in the R&D landscape 18
Key companies involved in the PAD pipeline 19
Key R&D company strategies 20
PAD as a secondary indication 20
Identifying suitable patient groups 21
CHAPTER 3 Peripheral artery disease - MARKET POTENTIAL 22
Definition of Peripheral Artery Disease 22
Intermittent claudication 23
Critical Limb Ischemia 23
Consequences of PAD 23
Segmentation of PAD 24
Epidemiology of PAD 26
Forecasts of PAD 27
Unmet needs in PAD 28
Major obstacles between the drugs and the market 29
Patient awareness of PAD 29
Physician awareness of PAD 30
Clinical unmet needs 32
More treatment options required 32
Drugs trialed in patients with concomitant disease 33
Drugs with no / lower resistance 34
Drugs with greater efficacy 34
Ability to prevent cardiovascular events and amputations 35
More cost-effective care 36
Drugs with fewer side-effects 37
CHAPTER 4 R&D APPROACH 38
Classification of pipeline products 38
Gene therapy 41
Antiplatelets 43
Thrombolytics 44
Prostaglandins 45
Others 47
Clinical trial design in PAD 47
Absolute claudication distance/initial claudication distance 47
Ankle to brachial index 48
Imaging 48
Pulse volume recording waveform analysis 48
Duplex arterial imaging or ultrasound imaging 48
Angiography 49
Improvement in symptoms and quality of life 49
Long-term morbidity and mortality 49
Potential areas for improvement in the clinical trial design 50
Trialing of new agents in specific patient subsets 50
Size of clinical trials 50
Outcome trials 51
CHAPTER 5 ANTIPLATELETS LATE-STAGE DRUG ANALYSIS & FORECASTS 52
Overview for antiplatelets 52
Pipeline summary 52
Definition of current comparator therapy 54
Parogrelil (INDI-702) 57
Drug overview 57
Clinical trial data 58
Patient potential 59
Marketing factors 60
Conduct more trials on efficacy and resistance 60
Satisfaction of unmet needs 61
Forecasts to 2016 62
Datamonitor drug assessment summary 62
CHAPTER 6 PROSTAGLANDINS LATE-STAGE DRUG ANALYSIS & FORECASTS 64
Overview for prostaglandins 64
Pipeline summary 64
Definition of current comparator therapy - Prostavasin 66
Liprostin (liposomal prostaglandin E-1, Endovasc) 68
Drug overview 68
Clinical trial data 68
Patient potential 69
Marketing factors 70
Satisfaction of unmet needs 71
Forecasts to 2016 72
Datamonitor drug assessment summary 72
BIBLIOGRAPHY 74
Epidemiology 74
Clinical trial data and other 75
APPENDIX A 78
Methodology 78
Datamonitor forecast methodology 78
Epidemiology forecasts 78
Product forecasts 81
APPENDIX B 84
About Datamonitor 84
About Datamonitor Healthcare 84
Datamonitor Healthcare's therapy area capabilities 85
About the Disease analysis team 86
Disclaimer 87
List of Tables
Table 1: Forecast prevalence of PAD (excluding borderline PAD) in the seven major markets (000), 2007-2016 7
Table 2: R&D pipeline for the treatment of PAD, 2007 14
Table 3: PAD pipeline by company, 2007 18
Table 4: Fontaine classification system for PAD 24
Table 5: Rutherford's classification of PAD 24
Table 6: Forecast prevalence of PAD (excluding borderline PAD) in the seven major markets (000), 2007-2016 27
Table 7: PAD pipeline agents by drug class 39
Table 8: Antiplatelets for the treatment of PAD 52
Table 9: Otsuka and Pfizer's Pletal: key facts 55
Table 10: Ability of parogrelil to satisfy the unmet needs, 2007 61
Table 11: Prostaglandins for the treatment of PAD 64
Table 12: Prostavasin: key facts 66
Table 13: Ability of Liprostin to satisfy the unmet needs, 2007 71
Table 14: Forecast prevalence of PAD (including borderline PAD) in the seven major markets (000), 2007-2016 80
Table 15: Datamonitor drug assessment parameters 82
List of Figures
Figure 1: Sales forecasts for antiplatelets, 7 major markets, 2007-16 8
Figure 2: Sales forecasts for prostaglandins, 7 major markets, 2007-16 8
Figure 3: Datamonitor drug assessment summary of antiplatelets in development for PAD, 2007 9
Figure 4: Datamonitor drug assessment summary of prostaglandins in development for PAD, 2007 10
Figure 5: R&D Pipeline for PAD agents, 2007 12
Figure 6: Main classes of agents in development for PAD, 2007 16
Figure 7: Percentage of R&D products in each Phase of development for PAD, 2007 17
Figure 8: Breakdown of PAD population 25
Figure 9: The most important unmet needs in PAD, 2007 28
Figure 10: Datamonitor drug assessment summary of antiplatelets in development for PAD, 2007 53
Figure 11: The percent mean improvement in maximal walking distance in trials with cilostazol 57
Figure 12: Sales forecast for parogrelil in PAD to 2016, seven major markets 62
Figure 13: Datamonitor's competitive positioning analysis of parogrelil, 2007 63
Figure 14: Datamonitor drug assessment summary of prostaglandins in development for PAD, 2007 65
Figure 15: Sales forecast for Liprostin in PAD to 2016, seven major markets 72
Figure 16: Datamonitor's competitive positioning analysis of Liprostin, 2007 73
Figure 17: Datamonitor drug assessment summary of pipeline molecular targeted therapies in development for hematological malignancies, 2007 83