Pipeline Insight: Acute Stroke: Commercial risk offsets high unmet need

Published by: Datamonitor

Published: May. 23, 2008 - 22 Pages

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

About the cardiovascular pharmaceutical analysis team

CHAPTER EXECUTIVE SUMMARY

Scope of the analysis

Experts interviewed for this report (interviewed in April 2008)

Experts interviewed for Pipeline Insight 2006: Acute Stroke, DMHC2167 (interviewed in February 2006)

Experts interviewed for Stakeholder Insight 2007: Acute Stroke, DMHC2286 (interviewed in October 2007)

Datamonitor insight into the acute stroke market

The R&D pipeline for acute stroke is a diverse and bisegmental collection of 34 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

The numerous failures of agents in development for acute stroke management result mainly from clinical trial design issues

Datamonitor has identified four candidate drugs that have potential to be launched into the acute stroke market within the near future - the vasoprotectant clazosentan, the thrombolytics desmoteplase and tenecteplase and the defibrinogenating agent Viprinex (ancrod)

CHAPTER PIPELINE OVERVIEW AND DYNAMICS

Pipeline overview

Acute stroke: a diversified pipeline

Acute stroke: a balanced pipeline

The R&D landscape is not dominated by any one company

CHAPTER PATIENT POTENTIAL

Disease definition and segmentation

Symptoms

Epidemiology and patient potential

Epidemiology methodology

US

Japan

Europe

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 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 therapy: alteplase

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

Mechanisms affecting the status of vasospasm

ET-A antagonists

The current comparator therapy: nimodipine

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

Currently available neuroprotectants - failure to make an impact?

Neuroprotectants - brief history of development

Recent failures

Neuroprotectants - potential reasons for failure

Possible answers for future clinical trials

CHAPTER LATE-STAGE DRUG ANALYSIS & FORECASTS: VASOPROTECTIVE THERAPIES

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

Pipeline summary

Comparator therapy

Nimodipine

Clazosentan

Drug overview

Preclinical data

Clinical data

Phase I

Phase II

Phase II/III - CONSCIOUS-I

Phase III - CONSCIOUS-II

Patient potential

Marketing factors

Satisfaction of unmet needs

Forecast to 2017

Datamonitor comments

Datamonitor drug assessment summary

CHAPTER 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 II: DIAS

Phase II: DEDAS

Phase III: DIAS-2

Phase III: new trial

Patient potential

Marketing factors

Satisfaction of unmet needs

Forecast to 2017

Datamonitor comments

Datamonitor drug assessment summary

Viprinex (ancrod)

Drug overview

Clinical data

Phase II clinical trials

Phase III clinical trials

Patient potential

Marketing factors

Satisfaction of unmet needs

Forecast to 2017

Datamonitor comments

Datamonitor drug assessment summary

Tenecteplase

Drug overview

Clinical data

Phase I clinical trials

Phase II clinical trials

Patient potential

Marketing factors

Satisfaction of unmet needs

Forecast to 2017

Datamonitor comments

Datamonitor drug assessment summary

CHAPTER OTHER ACUTE STROKE DRUGS

AEOL-10150

Drug overview

Preclinical data

Clinical data

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

Drug overview

Preclinical data

AL-208

Drug overview

Preclinical data

Clinical data

Phase I

AX-200

Drug overview

Preclinical data

Clinical data

Caffeinol

Drug overview

Preclinical data

Clinical data

Candesartan

Drug overview

Clinical data

Phase III - ACCESS

Phase III - SCAST

CellBead Neuro

Drug overview

DP-b99

Drug overview

Preclinical data

Clinical data

Phase I

Phase II

Enecadin

Drug overview

Preclinical development

HTU-PA

Drug overview

Preclinical data

Clinical data

Phase I

KN-38-7271

Drug overview

Preclinical data

MC-1

Drug overview

Preclinical data

Clinical data

Phase I

Phase II

MC-1 (IV)

Drug overview

Microplasmin

Drug overview

Preclinical data

Clinical data

Phase I

Phase II

Neu-2000

Drug overview

Preclinical data

Clinical data

Phase I

NH-02D

Drug overview

NTx-265

Drug overview

Preclinical data

Clinical data

Phase I

Phase II

ONO-2506 (proglia, Arocyte)

Drug overview

Preclinical data

Clinical data

ONO-2231

Drug overview

Preclinical data

PGX-100

Drug overview

Preclinical data

RVX-208

Drug overview

Preclinical data

Clinical data

Phase I

S-0139

Drug overview

Solulin

Drug overview

Preclinical data

Clinical data

Phase I

SonoLysis+tPA

Drug overview

S-18986

Drug overview

Preclinical data

SUN-N4057

Drug overview

Preclinical data

Clinical data

SUN-N8075

Drug overview

Preclinical data

Clinical data

TAT-NR2B9c

Drug overview

Preclinical data

Tissue protective cytokines, Warren/Lundbeck/Shire

Drug overview

Preclinical data

V10153

Drug overview

Preclinical data

Clinical data

APPENDIX A

Bibliography

Epidemiology

Other

Forecasting methodology

Datamonitor drug assessment 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: Products in clinical development for acute stroke, 2008

Table 2: Acute stroke pipeline (agents acting on CNS), 2008

Table 3: Acute stroke pipeline (agents acting on hemostasis), 2008

Table 4: Acute stroke pipeline by mechanism of action, 2008

Table 5: Acute stroke pipeline by company, 2008

Table 6: Estimated incidence of acute stroke across the seven major markets, 2008-2017

Table 7: Overall stroke patients: annual pre-hospital mortality, 2007

Table 8: Overall stroke patients: future estimated incidence of pre-hospital mortality in the seven major markets, 2008-2017 (000s)

Table 9: Proportion of stroke patients with ischemic stroke versus hemorrhagic stroke, 2007

Table 10: Estimated incidence of patients presenting with ischemic stroke in the seven major markets, 2008-2017 (000s)

Table 11: Estimated incidence of patients presenting with hemorrhagic stroke in the seven major markets, 2008-2017 (000s)

Table 12: Standardized outcome scales frequently used in clinical trials for acute stroke

Table 13: Key pipeline vasoprotective therapies in late-stage development for acute stroke, 2008

Table 14: Ability of clazosentan to satisfy the unmet needs, 2008

Table 15: Clazosentan sales forecast for acute stroke across the seven major markets, 2011-2017

Table 16: Key pipeline reperfusion therapies late-stage development for acute stroke, 2008

Table 17: DEDAS: safety endpoints

Table 18: Ability of desmoteplase to satisfy the unmet needs, 2008

Table 19: Desmoteplase sales forecast for acute stroke across the seven major markets, 2012-2017

Table 20: Percentage of stroke patients presenting to hospital withinhours (cumulative), 2007

Table 21: Ability of ancrod to satisfy the unmet needs, 2008

Table 22: Viprinex sales forecast for acute stroke across the seven major markets, 2011-2017

Table 23: Comparison of alteplase and tenecteplase

Table 24: Ability of tenecteplase to satisfy the unmet needs, 2008

Table 25: Tenecteplase sales forecast for acute stroke across the seven major markets, 2012-2017

Table 26: Datamonitor drug assessment parameters

List of Figures

Figure 1: Acute stroke pipeline, 2008

Figure 2: Pipeline maturity: percentage of R&D products in each phase of development, 2008

Figure 3: Acute stroke pipeline maturity: percentage of R&D products in each phase of development by class, 2008

Figure 4: Acute stroke pipeline maturity: percentage of R&D products in each phase of development by type of company, 2008

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

Figure 6: Urokinase mechanism of action

Figure 7: Ancrod acts indirectly on the thrombolytic pathways

Figure 8: ECASS-III trial: extending the treatment window of tPA

Figure 9: Trial design of EPITHET

Figure 10: The ischemic cascade

Figure 11: Clazosentan sales forecast for acute stroke across the seven major markets, 2010-2017

Figure 12: Datamonitor drug assessment summary for clazosentan and nimodipine in acute stroke.

Figure 13: Desmoteplase sales forecast for acute stroke across the seven major markets, 2012-2017

Figure 14: Datamonitor drug assessment summary of thrombolytic agents (desmoteplase according to the current data)

Figure 15: Datamonitor drug assessment summary of thrombolytic agents (desmoteplase according to Phase II data)

Figure 16: Viprinex sales forecast for acute stroke across the seven major markets, 2012-2017

Figure 17: Datamonitor drug assessment summary of thrombolytic agents (desmoteplase according to Phase II data)

Figure 18: Tenecteplase sales forecast for acute stroke across the seven major markets, 2012-2017

Figure 19: Datamonitor drug assessment summary of tenecteplase

Figure 20: Multimodal efficacy of AX-200

Figure 21: Datamonitor drug assessment summary of pipeline molecular targeted therapies in development for hematological malignancies, 2007

Abstract

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