Pipeline Insight: Acute Stroke - Considerable Unmet Need Is Balanced By Substantial Commercial Risk

Published by: Datamonitor

Published: Mar. 31, 2006 - 250 Pages

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

About the cardiovascular pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the analysis

Datamonitor insight into the acute stroke market

The R&D pipeline for acute stroke is a diverse and bisegmental collection of 26 novel agents at the clinical stages of drug development

The R&D landscape in the setting of acute stroke is not dominated by any one company. It is shaped by the need to minimize the commercial risk associated with developing drugs for the acute-care stroke market

The acute stroke market is characterized by high unmet market need as well as high unmet clinical need

Datamonitor has identified four late-stage candidate drugs likely to be launched into the acute stroke market within the next three years: the neuroprotectant NXY-059 (formerly Cerovive), the thrombolytic desmoteplase, the hemostatic NovoSeven (rFVIIa) and the defibrinogenating agent Viprinex (ancrod)

CHAPTER 2 PIPELINE OVERVIEW

Pipeline overview

Acute stroke: a diversified pipeline

Acute stroke: a balanced pipeline?

The R&D landscape is not dominated by any one company and is shaped by the need to minimize commercial risk associated with developing drugs for the acute care stroke market

CHAPTER 3 PATIENT POTENTIAL

Disease definition and segmentation

Symptoms

Epidemiology and patient potential

Incidence of stroke

Incidence of pre-hospital mortality in stroke

Types of stroke: relative frequency of ischemic stroke over hemorrhagic stroke

Ischemic stroke

Patient potential: incidence of patients presenting with ischemic stroke

Hemorrhagic stroke

Intracerebral hemorrhage

Subarachnoid hemorrhage

Patient potential: incidence of patients presenting with hemorrhagic stroke

Transient ischemic attack

Marketability considerations: barriers to market entry and uptake

Points of consideration: factors influencing market entry and uptake

Unmet market needs

Physician education: tackling physician competence and attitude

Patient education: raising stroke-symptom awareness

Infrastructural unmet needs: establishing, maintaining and expanding the network of dedicated stroke units

Unmet clinical needs

Procoagulation

Neuroprotection

Revascularization

CHAPTER 4 R&D APPROACH

Classification of pipeline products

Acute stroke pipeline

Mechanisms affecting the status of hemostasis

Hemostasis and the coagulation cascade

Coagulation factors (procoagulants)

Thrombolytics

The current comparator therapies: alteplase and tenecteplase

Mechanisms affecting the status of neuronal tissue

Neurotrophic drugs

Glutamate antagonists

GABA agonists

Ion channel modulators

Free radical scavengers

Other mechanisms

The current comparator therapies: citicoline and edavarone

Clinical trial design

Patient population should be assessed for severity and potential responders.

The concept of the ischemic penumbra: the potential of diagnosing salvageable tissue

Safety endpoints

Efficacy endpoints

Critique of previous failures

Animal studies are poor predictors of therapeutic success in stroke patients

There have been discrepancies in the effective therapeutic window between treatment protocols for animals and treatment algorithms in humans.

There have been discrepancies between the dosing schedules used in animal studies and those used in clinical trials.

The projected treatment outcomes may have been overambitious

Possible answers for future clinical trials

CHAPTER 5 LATE-STAGE DRUG ANALYSIS & FORECASTS: NEUROPROTECTIVE THERAPIES

Overview of neuroprotective therapies in late stage development for acute stroke

Pipeline summary

Comparator therapy

NXY-059 (formerly Cerovive)

Drug overview

Clinical data

Phase II clinical trials

Phase III trials

Patient potential

Marketing factors

SWOT analysis: NXY-059

Forecast to 2015

Datamonitor comments

CHAPTER 6 LATE-STAGE DRUG ANALYSIS & FORECASTS: REPERFUSION THERAPIES

Overview of reperfusion therapies in late-stage development for acute stroke

Pipeline summary

Comparator therapy

Desmoteplase

Drug overview

Preclinical data

Pharmacokinetics

Toxicity

Neuroprotection

Clinical data

Phase I/II

Phase II: DIAS

Phase II: DEDAS

Phase III: DIAS-II

Patient potential

Marketing factors

SWOT analysis: desmoteplase

Forecast to 2015

Datamonitor comments

NovoSeven (rFVIIa)

Drug overview

Clinical data

Phase II clinical trials

Phase III clinical trial

Patient potential

Marketing factors

SWOT Analysis: NovoSeven

Forecast to 2015

Datamonitor comments

Viprinex (ancrod)

Drug overview

Clinical data

Phase II clinical trials

Phase III clinical trials

Patient potential

Marketing factors

SWOT analysis: Viprinex (ancrod)

Forecast to 2015

Datamonitor comments

CHAPTER 7 OTHER ACUTE STROKE DRUGS

Alfimeprase

Drug overview

AEOL-10150

Drug overview

Preclinical data

Clinical data

AGY-94806 (SA-4503, Msc-1)

Drug overview

Preclinical data

AX-200

Drug overview

Preclinical data

Clinical data

BAY-387271

Drug overview

Preclinical data

Cerebril (tramiprosate, NC-758)

Drug overview

Preclinical data

Clinical data

DP-b99

Drug overview

Preclinical data

Clinical data

Phase I

Phase II

Enecadin

Drug overview

Preclinical development

HF0220

Drug overview

Preclinical data

HF0420

Drug overview

Preclinical data

MC-1

Drug overview

Microplasmin

Drug overview

NH-02B

Drug overview

NTx-265

Drug overview

ONO-2506 (proglia)

Drug overview

Preclinical data

Clinical data

ONO-2231

Drug overview

S-18986

Drug overview

Preclinical data

SUN-N4057

Drug overview

Preclinical data

Clinical data

SUN-N8075

Drug overview

Preclinical data

TS-011

Drug overview

Preclinical data

Traxoprodil (CP-101,606)

Drug overview

Preclinical data

Clinical data

Phase I

Phase II

V-10153

Drug overview

Clinical data

CHAPTER 8 COMPARATIVE COMMERCIAL ANALYSIS OF KEY LATE-STAGE ACUTE STROKE DRUGS

Introduction

Datamonitor drug assessment summary

Research feasibility

Clinical feasibility

Commercial value

Commercial risk

Strategic value

APPENDIX A

Datamonitor drug assessment summary

Contributing experts

Bibliography

Forecasting methodology

Report methodology

APPENDIX B

About Datamonitor

About Datamonitor Healthcare

Datamonitor Healthcare's therapy area capabilities

About the cardiovascular analysis team

Disclaimer

List of Tables

Table 1: Acute stroke pipeline (overall), 2006

Table 2: Acute stroke pipeline (agents acting on CNS), 2006

Table 3: Acute stroke pipeline (agents acting on hemostasis), 2006

Table 4: Acute stroke pipeline by mechanism of action, 2006

Table 5: Acute stroke pipeline by company, 2006

Table 6: Current and future estimated incidence of stroke in the seven major markets, 2006-16 (000s)

Table 7: Overall stroke patients: annual pre-hospital mortality, 2005

Table 8: Overall stroke patients: future estimated incidence of pre-hospital mortality in the seven major markets, 2006-16 (in 000s)

Table 9: Proportion of stroke patients with ischemic stroke versus hemorrhagic stroke, 2005

Table 10: Current and future estimated incidence of patients presenting with ischemic stroke in the seven major markets, 2006-16 (in 000s)

Table 11: Current and future estimated incidence of patients presenting with hemorrhagic stroke in the seven major markets, 2006-16 (000s)

Table 12: Comparison of alteplase and tenecteplase

Table 13: Standardized outcome scales frequently used in clinical trials for acute stroke

Table 14: Key pipeline neuroprotective therapies, 2006

Table 15: Percentage of stroke patients presenting to hospital within six hours, 2005

Table 16: Percentage of stroke patients presenting to hospital within 24 hours, 2005

Table 17: Percentage of stroke patients presenting to hospital within three hours, 2005

Table 18: Global sales forecast for NXY-059, 2008-15

Table 19: Key pipeline reperfusion therapies, 2006

Table 20: DEDAS: safety endpoints

Table 21: Global sales forecast for desmoteplase, 2008-15

Table 22: Distribution of strokes by stroke type, 2005

Table 23: Global sales forecast for NovoSeven, 2008-15

Table 24: Percentage of stroke patients presenting to hospital within six hours (cumulative), 2005

Table 25: Global sales forecast for Viprinex, 2008-15

Table 26: Research, clinical and commercial attractiveness of key pipeline anticoagulants

Table 27: Datamonitor drug assessment parameters

List of Figures

Figure 1: Acute stroke pipeline, 2006

Figure 2: Pipeline maturity: percentage of R&D products in each phase of development, 2006

Figure 3: Pipeline maturity: percentage of R&D products in each phase of development by class, 2006

Figure 4: Pipeline maturity: percentage of R&D products in each phase of development by type of company, 2006

Figure 5: The targets of developmental antithrombotics in the setting of acute stroke

Figure 6: Ancrod acts indirectly on the thrombolytic pathways

Figure 7: ECASS-III trial: extending the treatment window of tPA

Figure 8: The ischemic cascade

Figure 9: SWOT analysis: NXY-059

Figure 10: Global sales forecast for NXY-059, 2008-15

Figure 11: SWOT analysis: desmoteplase

Figure 12: Global sales forecast for desmoteplase, 2008-2015

Figure 13: SWOT analysis: NovoSeven

Figure 14: Global sales forecast NovoSeven, 2008-2015

Figure 15: SWOT analysis: Viprinex (ancrod)

Figure 16: Global sales forecast for Viprinex, 2008-2015

Figure 17: Research, clinical and commercial attractiveness of late-stage candidate drugs in the acute stroke setting: bubble chart

Figure 18: Research, clinical and commercial attractiveness of late-stage candidate drugs in the acute stroke setting: radar plot

Figure 19: Example of Datamonitor drug assessment scorecard

Figure 20: Example of Datamonitor drug assessment graph

Abstract

Stroke is one of the top three causes of death and its incidence in the seven major markets is expected to increase in the next ten years because of an aging population. Long term disability caused by stroke is a major economic burden on healthcare systems, current treatment options are limited and general awareness of stroke is poor.

• Assessment of the patient potential for developmental agents in the setting of acute stroke over the period 2006-15
• Overview of the acute stroke R&D pipeline, with detailed information on the classes in development, comparator drugs and trial design features
• Commercial analysis of key agents in development in terms of their ability to satisfy key unmet needs, supported by the views of key opinion leaders
• Sales forecasts for key late-stage developmental acute stroke drugs in the seven major markets to 2015

In the setting of acute stroke, a patient's treatment options and recovery prospects are a function of time. Therefore any delay related to the time-to-treatment constitutes a resistor to market entry and uptake for stroke therapies in the acute care hospital setting.

The unmet in the setting of acute hemorrhagic stroke is high for hemostatic agents whose action is immediate, short lasting and localized to the site of vascular injury. However, despite the great extent of unmet need in this setting, stroke physicians are concerned with the cost of therapy.

Since stroke is a vascular condition that precipitates neurological damage, there is a need for non-causative therapies addressing the neurological aspect of the condition. However, in order to experience satisfactory market penetration, developmental neuroprotective agents will have to show compatibility with current reperfusion therapies.

• Understand the key factors that will contribute to the success of the next generation of acute stroke drugs
• View independent sales forecasts for products in late stage development for therapy of acute stroke
• Understand physician sentiment on clinical trial endpoints and late stage candidate drugs for the stroke market

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