PharmaFocus: Tauopathies–Global Market Analysis

Tauopathies are a class of more than 20 neurodegenerative diseases characterized by tau protein aggregation in the brain. There are currently no treatments approved in this therapy area and five tauopathies are attracting increasing attention from pharmaceutical companies in particular. These are: progressive supranuclear palsy (PSP), corticobasal degeneration (CBD), frontotemporal dementia with parkinsonism linked to chromosome 17 (FTDP-17), Pick’s disease (clinically referred to as bvFTD), and chronic traumatic encephalopathy (CTE). In these indications, symptoms often present as behavioral (e.g. disinhibition, apathy), cognitive (e.g. memory loss), language (e.g. slurring of speech), or motor (e.g. falls, tremor) deficits. A multitude of treatments are used off-label to alleviate patients’ symptoms and they include those indicated for Parkinson’s disease, Alzheimer’s disease, or depression. Growth in tauopathies market is likely to be driven by the introduction of novel treatments into the market while continued lack of quantitative biomarkers will be a major barrier to the growth of the tauopathies market.

Scope

Overview of tauopathies including, etiology, pathophysiology, symptoms, diagnosis, and clinical trial challenges.

Key topics covered include market characterization, unmet needs, R&D and clinical trials assessment, late stage clinical trial analysis and implications for the tauopathy therapeutics market.

Pipeline analysis: focus on four late-stage pipeline tauopathy drugs, discussing emerging trends as well as an overview of earlier phase and preclinical drugs.

Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Key Highlights

The report will enable you to:

Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline. Additionally a list of acquisition targets included in the pipeline product company list.

Develop business strategies by understanding the trends shaping and driving the global tauopathy therapeutics market.

Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global tauopathy therapeutics market in future.

Formulate effective sales and marketing strategies by understanding the competitive landscape.

Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.

Key Questions Answered

The tauopathies market is in its infancy with limited choices of symptomatic treatments being offered off-label. In light of this, what are the current clinical and environmental unmet needs? Will there be opportunities in this market for drug developers in the near future?

There are five substantial unmet needs that exist in the tauopathies market. Will pipeline drugs fulfil any of the unmet needs for tauopathies? Which unmet needs will provide opportunity for drug developers?

Four products are currently in late-stage of development. What unmet needs will these drugs fulfil? How will they affect the treatment algorithm for tauopathy patients?

Many challenges exist for companies entering the tauopathies market. What are the key challenges involved in clinical trials? What strategies are companies using to enter the tauopathies market?"

Companies mentioned

AbbVie

AB Science

Alectos Therapeutics

AlzProtect

Anavex Life Sciences

Asceneuron

Avanir Pharmaceuticals

Biogen

Brighton Biotech

Bristol-Myers Squibb

Catalent

Cortice Biosciences

C2N Diagnostics

Déclion Pharmaceuticals

Delta ...

AbbVie

AB Science

Alectos Therapeutics

AlzProtect

Anavex Life Sciences

Asceneuron

Avanir Pharmaceuticals

Biogen

Brighton Biotech

Bristol-Myers Squibb

Catalent

Cortice Biosciences

C2N Diagnostics

Déclion Pharmaceuticals

Delta Crystallon

Eli Lilly

Gismo Therapeutics

GSK

Intellect Neurosciences

Kannalife Sciences

Merck & Co.

Neurimmune Holding

Otsuka

Pfizer

Prana Biotechnology

PresSura Neuro

Sellas Lifesciences Group

TauRx Pharmaceuticals

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Introduction

2.1 Catalyst

2.2 Related Reports

3 Disease ...

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Introduction

2.1 Catalyst

2.2 Related Reports

3 Disease Overview

3.1 Etiology and Pathophysiology

3.1.1 Etiology

3.1.2 Pathophysiology

3.2 Classification

3.2.1 Clinical Classification

3.2.2 Pathological Classification

3.2.3 Classification According to 4R:3R Ratio

3.3 Symptoms

3.4 Diagnosis

3.4.1 Patient Journey

3.4.2 Clinical Assessments

3.5 Biomarkers

3.5.1 Diagnostic Markers

3.5.2 Biomarkers in Drug Development

3.5.3 Promising Biomarkers

3.6 Prognosis

3.7 Quality of Life

4 Current Treatment Paradigm

4.1 Overview

4.2 Treatment Paradigm

4.3 Anti-Parkinson’s Drugs

4.3.1 Amantadine

4.3.2 Dopamine Receptor Agonists

4.3.3 Levodopa

4.4 Antidepressant Drugs

4.4.1 Selective Serotonin Reuptake Inhibitors

4.4.2 Trazodone

4.4.3 Tricyclic Antidepressants

4.5 Anti-Alzheimer’s Drugs

4.5.1 Acetylcholinesterase Inhibitors

4.5.2 Memantine

4.6 Other Therapeutic Agents

4.6.1 Antiepileptics

4.6.2 Antipsychotics

4.6.3 Onabotulinum Toxin A

4.7 Non-pharmacological Therapies

5 Unmet Needs and Opportunities

5.1 Overview

5.2 Development of Disease-Modifying Therapies

5.2.1 Unmet Need

5.2.2 Gap Analysis

5.2.3 Opportunity

5.3 Development of More Effective Symptomatic Treatments

5.3.1 Unmet Need

5.3.2 Gap Analysis

5.3.3 Opportunity

5.4 Improved Biomarkers to Evaluate Drug Efficacy

5.4.1 Unmet Need

5.4.2 Gap Analysis

5.4.3 Opportunity

5.5 Biomarkers for Clinical Diagnosis

5.5.1 Unmet Need

5.5.2 Gap Analysis

5.5.3 Opportunity

5.6 Greater Support for Patients

5.6.1 Unmet Need

5.6.2 Gap Analysis

5.6.3 Opportunity

6 Pipeline Assessment

6.1 Overview

6.2 Clinical Trial Mapping

6.2.1 Clinical Trials by Class of Therapy

6.3 Drugs in Late-Stage Clinical Development

6.3.1 AVP-786

6.3.2 Masitinib

6.3.3 TRx-237

6.3.4 Zolpidem Tartrate

6.4 Drugs in Early-Stage Clinical Development

6.4.1 ABBV-8E12

6.4.2 AZP-2006

6.4.3 BMS-986168

6.4.4 DC-TAB

6.4.5 MK-8719

6.4.6 TPI-287

6.5 Drugs in Preclinical/Discovery Development

6.5.1 ASN-561

6.5.2 ANAVEX-3-71

6.5.3 Cannabidiol

6.5.4 DP-C016

6.5.5 EU-C-001

6.5.6 GTC-6000

6.5.7 N-acetylcysteine Amide

6.5.8 NI-205/NI-308

6.5.9 PBT-434

6.5.10 Anti-TauC3

7 R&D Strategies and Clinical Trial Design

7.1 Overview

7.1.1 Trends in Corporate Strategies

7.1.2 Novel Research Strategies

7.1.3 Clinical Trial Design

8 Market Drivers and Barriers

8.1 Overview

8.2 Driver: First-to-Market Drug Will Boost Sales and Encourage Pharma Companies to Focus R&D Efforts in This Market

8.3 Driver: Approval of Drug in One Tauopathy Indication is Likely to Prompt its Off-Label Use in Others

8.4 Driver: Any Tauopathy-Approved Drug Is Likely to Enter the Lucrative Alzheimer’s DiseaseMarket

8.5 Driver: Regulatory Agencies Provide Orphan Designations to Drug Candidates

8.6 Driver: Therapies Are Likely to Have Premium Pricing

8.7 Barrier: No Biomarker to Measure Clinical Efficacy

8.8 Barrier: Low Accuracy in Diagnostic Methods

8.9 Barrier: Tauopathies Market Is a High-Risk Indication

8.10 Barrier: Low Public Awareness of These Disorders

9 Appendix

9.1 Bibliography

9.2 Abbreviations

9.3 Methodology

9.4 Primary Research – KOLs Interviewed for This Report

9.5 About the Authors

9.5.1 Analyst

9.5.2 Therapy Area Director

9.5.3 Global Director of Therapy Analysis and Epidemiology

9.6 About GlobalData

9.7 Disclaimer

List of Tables

Table 1: Main Distinctions of the FiveTauopathies

Table 2: Genetic Traits in Tauopathies

Table 3: Isoform Expressions in Tauopathies

Table 4: Cellular Tau Pathology in ...

Table 1: Main Distinctions of the FiveTauopathies

Table 2: Genetic Traits in Tauopathies

Table 3: Isoform Expressions in Tauopathies

Table 4: Cellular Tau Pathology in Different Tauopathies

Table 5: Characteristic Symptoms of Tauopathies

Table 6: Classification and Criteria of FTD According to DSM-V and ICD-10-CM

Table 7: Diagnostic Markers for Tauopathies

Table 8: Treatments for Tauopathies, 2016

Table 9: Unmet Need and Opportunity in Tauopathies

Table 10: Drugs in Clinical Development for Tauopathies, 2016

Table 11: Comparison of Drugs in Development for Tauopathies, 2016

Table 12: Product Profile – AVP-786

Table 13: AEs at ≥3% Incidence in PBA Trials of Nuedexta

Table 14: SWOT Analysis – AVP-786, 2016

Table 15: Product Profile – Masitinib

Table 16: SWOT Analysis – Masitinib, 2016

Table 17: Product Profile – TRx-237

Table 18: SWOT Analysis – TRx-237, 2016

Table 19: Product Profile – Zolpidem

Table 20: AEs at ≥1% Incidence in Insomnia Trials of Zolpidem Lasting up to 10 Nights

Table 21: AEs at ≥1% Incidence in Insomnia Trials of Zolpidem Lasting up to 35 Nights

Table 22: SWOT Analysis – Zolpidem, 2016

Table 23: Drugs in Early-Stage Clinical Development for Tauopathies, 2016

Table 24: Drugs in Preclinical Development for Tauopathies, 2016

Table 25: Comparison of Novel Research Strategies for Tauopathies, 2016

Table 26: Clinical Trial Design of Key Pipeline Drugs for Tauopathies, 2016

Table 27: Recently failed major trials in tauopathies

Table 28: Common Primary and Secondary Outcome Measures in Tauopathies Clinical Trials

Table 29: Tauopathies – Market Drivers and Barriers

List of Figures

Figure 1: Key Atrophic Brain Regions Involved in Tauopathies

Figure 2: Location of MAPT Gene Within Chromosome 17

Figure 3: Tau 3R and 4R Isoforms ...

Figure 1: Key Atrophic Brain Regions Involved in Tauopathies

Figure 2: Location of MAPT Gene Within Chromosome 17

Figure 3: Tau 3R and 4R Isoforms Coded by the MAPT Gene

Figure 4: Mechanisms Involved in Tau Dissociation from the MTs

Figure 5: Classification of Tauopathies According to Symptoms

Figure 6: Classification of Primary and Secondary Tauopathies

Figure 7: Tauopathies Therapeutics – Clinical Trials in the 7MM, 2016

Figure 8: Tauopathies Phase II/Phase III Pipeline, 2016

Figure 9: Novel Strategies for Tauopathy Treatment, 2016

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