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PharmaFocus: Tauopathies - Global Market Analysis

  • ID:RM0034521
  • Published: February-2017
  • Pages:196
  • GlobalData
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PharmaFocus: Tauopathies - Global Market Analysis Summary 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
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PharmaFocus: Tauopathies - Global Market Analysis Summary 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. Highlights Key Findings 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. 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. Reasons to buy 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.


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1 Table of Contents 1 Table of Contents 7 1.1 List of Tables 11 1.2 List of Figures 13 2 Introduction 14 2.1 Catalyst 14 2.2 Related Reports 15 3 Disease Overview 16 3.1 Etiology and Pathophysiology 16 3.1.1 Etiology 19 3.1.2 Pathophysiology 21 3.2 Classification 25 3.2.1 Clinical Classification 25 3.2.2 Pathological Classification 27 3.2.3 Classification According to 4R:3R Ratio 29 3.3 Symptoms 29 3.4 Diagnosis 32 3.4.1 Patient Journey 32 3.4.2 Clinical Assessments 35 3.5 Biomarkers 41 3.5.1 Diagnostic Markers 41 3.5.2 Biomarkers in Drug Development 42 3.5.3 Promising Biomarkers 43 3.6 Prognosis 47 3.7 Quality of Life 48 4 Current Treatment Paradigm 50 4.1 Overview 50 4.2 Treatment Paradigm 51 4.3 Anti-Parkinson s Drugs 52 4.3.1 Amantadine 52 4.3.2 Dopamine Receptor Agonists 53 4.3.3 Levodopa 55 4.4 Antidepressant Drugs 57 4.4.1 Selective Serotonin Reuptake Inhibitors 57 4.4.2 Trazodone 59 4.4.3 Tricyclic Antidepressants 60 4.5 Anti-Alzheimer s Drugs 61 4.5.1 Acetylcholinesterase Inhibitors 61 4.5.2 Memantine 63 4.6 Other Therapeutic Agents 63 4.6.1 Antiepileptics 63 4.6.2 Antipsychotics 65 4.6.3 Onabotulinum Toxin A 66 4.7 Non-pharmacological Therapies 68 5 Unmet Needs and Opportunities 70 5.1 Overview 70 5.2 Development of Disease-Modifying Therapies 71 5.2.1 Unmet Need 71 5.2.2 Gap Analysis 72 5.2.3 Opportunity 74 5.3 Development of More Effective Symptomatic Treatments 76 5.3.1 Unmet Need 76 5.3.2 Gap Analysis 77 5.3.3 Opportunity 78 5.4 Improved Biomarkers to Evaluate Drug Efficacy 80 5.4.1 Unmet Need 80 5.4.2 Gap Analysis 81 5.4.3 Opportunity 82 5.5 Biomarkers for Clinical Diagnosis 84 5.5.1 Unmet Need 84 5.5.2 Gap Analysis 85 5.5.3 Opportunity 86 5.6 Greater Support for Patients 88 5.6.1 Unmet Need 88 5.6.2 Gap Analysis 89 5.6.3 Opportunity 89 6 Pipeline Assessment 91 6.1 Overview 91 6.2 Clinical Trial Mapping 91 6.2.1 Clinical Trials by Class of Therapy 91 6.3 Drugs in Late-Stage Clinical Development 92 6.3.1 AVP-786 94 6.3.2 Masitinib 98 6.3.3 TRx-237 103 6.3.4 Zolpidem Tartrate 108 6.4 Drugs in Early-Stage Clinical Development 113 6.4.1 ABBV-8E12 114 6.4.2 AZP-2006 115 6.4.3 BMS-986168 116 6.4.4 DC-TAB 117 6.4.5 MK-8719 118 6.4.6 TPI-287 120 6.5 Drugs in Preclinical/Discovery Development 121 6.5.1 ASN-561 122 6.5.2 ANAVEX-3-71 123 6.5.3 Cannabidiol 123 6.5.4 DP-C016 124 6.5.5 EU-C-001 124 6.5.6 GTC-6000 125 6.5.7 N-acetylcysteine Amide 126 6.5.8 NI-205/NI-308 126 6.5.9 PBT-434 127 6.5.10 Anti-TauC3 128 7 R&D Strategies and Clinical Trial Design 129 7.1 Overview 129 7.1.1 Trends in Corporate Strategies 129 7.1.2 Novel Research Strategies 132 7.1.3 Clinical Trial Design 143 8 Market Drivers and Barriers 153 8.1 Overview 153 8.2 Driver: First-to-Market Drug Will Boost Sales and Encourage Pharma Companies to Focus R&D Efforts in This Market 153 8.3 Driver: Approval of Drug in One Tauopathy Indication is Likely to Prompt its Off-Label Use in Others 154 8.4 Driver: Any Tauopathy-Approved Drug Is Likely to Enter the Lucrative Alzheimer s DiseaseMarket 155 8.5 Driver: Regulatory Agencies Provide Orphan Designations to Drug Candidates 155 8.6 Driver: Therapies Are Likely to Have Premium Pricing 156 8.7 Barrier: No Biomarker to Measure Clinical Efficacy 156 8.8 Barrier: Low Accuracy in Diagnostic Methods 157 8.9 Barrier: Tauopathies Market Is a High-Risk Indication 157 8.10 Barrier: Low Public Awareness of These Disorders 158 9 Appendix 159 9.1 Bibliography 159 9.2 Abbreviations 185 9.3 Methodology 190 9.4 Primary Research - KOLs Interviewed for This Report 191 9.5 About the Authors 193 9.5.1 Analyst 193 9.5.2 Therapy Area Director 193 9.5.3 Global Director of Therapy Analysis and Epidemiology 194 9.6 About The Author 195 9.7 Disclaimer 195



List Of Tables

1.1 List of Tables Table 1: Main Distinctions of the FiveTauopathies 17 Table 2: Genetic Traits in Tauopathies 19 Table 3: Isoform Expressions in Tauopathies 22 Table 4: Cellular Tau Pathology in Different Tauopathies 28 Table 5: Characteristic Symptoms of Tauopathies 30 Table 6: Classification and Criteria of FTD According to DSM-V and ICD-10-CM 40 Table 7: Diagnostic Markers for Tauopathies 41 Table 8: Treatments for Tauopathies, 2016 52 Table 9: Unmet Need and Opportunity in Tauopathies 71 Table 10: Drugs in Clinical Development for Tauopathies, 2016 93 Table 11: Comparison of Drugs in Development for Tauopathies, 2016 94 Table 12: Product Profile - AVP-786 96 Table 13: AEs at 3% Incidence in PBA Trials of Nuedexta 97 Table 14: SWOT Analysis - AVP-786, 2016 98 Table 15: Product Profile - Masitinib 101 Table 16: SWOT Analysis - Masitinib, 2016 103 Table 17: Product Profile - TRx-237 105 Table 18: SWOT Analysis - TRx-237, 2016 108 Table 19: Product Profile - Zolpidem 110 Table 20: AEs at 1% Incidence in Insomnia Trials of Zolpidem Lasting up to 10 Nights 111 Table 21: AEs at 1% Incidence in Insomnia Trials of Zolpidem Lasting up to 35 Nights 112 Table 22: SWOT Analysis - Zolpidem, 2016 113 Table 23: Drugs in Early-Stage Clinical Development for Tauopathies, 2016 113 Table 24: Drugs in Preclinical Development for Tauopathies, 2016 122 Table 25: Comparison of Novel Research Strategies for Tauopathies, 2016 133 Table 26: Clinical Trial Design of Key Pipeline Drugs for Tauopathies, 2016 144 Table 27: Recently failed major trials in tauopathies 145 Table 28: Common Primary and Secondary Outcome Measures in Tauopathies Clinical Trials 146 Table 29: Tauopathies - Market Drivers and Barriers 153



List of Figures

1.2 List of Figures Figure 1: Key Atrophic Brain Regions Involved in Tauopathies 18 Figure 2: Location of MAPT Gene Within Chromosome 17 20 Figure 3: Tau 3R and 4R Isoforms Coded by the MAPT Gene 23 Figure 4: Mechanisms Involved in Tau Dissociation from the MTs 24 Figure 5: Classification of Tauopathies According to Symptoms 26 Figure 6: Classification of Primary and Secondary Tauopathies 27 Figure 7: Tauopathies Therapeutics - Clinical Trials in the 7MM, 2016 92 Figure 8: Tauopathies Phase II/Phase III Pipeline, 2016 93 Figure 9: Novel Strategies for Tauopathy Treatment, 2016 134


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