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Pipeline perspectives: Peripheral artery disease Poor disease awareness hinders new agents

Published by: Datamonitor

Published: Dec. 19, 2007 - 90 Pages


Table of Contents


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


Abstract

Introduction

Peripheral artery disease, sometimes also referred to as peripheral vascular disease, is atherosclerosis in peripheral regions, which can lead to loss of blood flow to the limbs, and can result in loss of life, limb amputation and cardiovascular events. The current pharmacological treatment options are limited, and there are large unmet needs associated with the disease.

Scope

Evaluate therapies under development for peripheral artery disease (PAD) A detailed clinical and commercial assessment of all key emerging therapies Epidemiological based sales forecasts for key late-stage developmental heart failure agents in the seven major markets to 2016

Highlights

PAD is severely undertreated and underdiagnosed. Despite the high prevalence (23.4 million subjects by 2016) and grave consequences, such as cardiovascular events, amputations and death, PAD is not considered as fascinating as coronary artery disease and the lack of PAD awareness even among physicians is staggering. Drug therapy plays a limited role in the management of PAD, due to the restricted treatment options. For intermittent claudication (IC) patients the mainstay of pharmacological treatment is prevention of CV events with antiplatelets and statins. Cilostazol (Pletal), an antiplatelet, is recommended as first-line therapy for claudication The new agents in development for PAD are primarily as secondary indications. This is due to the issues new agents will face reaching the underdiagnosed, undertreated patient population. Overall, there are very few clinical trials to develop PAD agents, and the trials are very much underpowered.

Reasons to Purchase

Understand patient segmentation relevant to pipeline products and analyze competitive environment at time of product launch Justify go/no-go decisions on basis of potential return on investment Utilize product profiles to aid pricing and reimbursement decisions.


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