Frontier Pharma: Alzheimer’s Disease and Associated Indications – Exceptional Level of First-in-Class Innovation within AD, and Diverse Range of Therapies in Development for Disorders Such as Anxiety and Depression

Alzheimer’s disease (AD), the most common form of dementia, is a progressive, neurodegenerative and currently incurable disease characterized by loss of memory and other mental abilities. It has a devastating impact on independence and quality of life, with patients requiring full-time care in the later disease stages. In addition to cognitive impairment, AD is associated with behavioral and psychological changes, which often represent the greatest challenges for patients and caregivers.

The prevalence of AD is escalating rapidly, largely owing to aging populations, as advancing age is the most important epidemiological risk factor for the disease. This will amplify the already substantial societal and economic costs of the disease over the coming years. This has led to high levels of R&D investment over the past two decades, but clinical trial failure rates within the indication are extremely high and treatment options remain limited. There are no disease-modifying therapies for AD, and current approaches can only temporarily slow the worsening of symptoms.

The report focuses on AD alongside four key associated behavioral and psychological indications: anxiety, depression, psychosis and insomnia. These four conditions are highly prevalent in AD and contribute substantially to the disease burden.

Scope

Unmet need is extremely high in AD, with behavioral and psychological complications contributing significantly to the disease burden

– What are the most important etiological risk factors and pathophysiological processes implicated in AD?

– What is the current treatment algorithm?

– How common are anxiety, depression, psychosis and insomnia in AD?

The AD pipeline is large and contains a very high proportion of first-in-class product innovation

– Which molecule types and molecular targets are most prominent across AD and its associated indications?

– What are the connections, in terms of first-in-class innovation, between AD and its associated indications?

– Which first-in-class targets are most promising?

– How does the level of first-in-class innovation differ between products in development for anxiety, depression, psychosis and insomnia?

– How does first-in-class target diversity differ by stage of development and molecular target class?

The deals landscape is active and dominated by G-protein coupled receptor (GPCR)-targeting products

– Which indications attract the highest deal values?

– How has deal activity fluctuated over the past decade?

– Which first-in-class pipeline products have no prior involvement in licensing or co-development deals?

Reasons to buy

This report will allow you to -

- Appreciate the current clinical and commercial landscapes by considering disease pathogenesis, etiology, epidemiology, symptoms, diagnosis and treatment options.

- Identify leading products and key unmet needs within the market.

- Recognize innovative pipeline trends by analyzing therapies by stage of development, molecule type and molecular target.

- Assess the therapeutic potential of first-in-class targets. Using proprietary matrix assessments, first-in-class targets in the pipeline have been assessed and ranked according to clinical potential. Individual matrix assessments are provided for targets identified in the pipeline for AD, anxiety, depression, psychosis and insomnia. Promising early-stage first-in-class targets are reviewed in greater detail.

- Consider first-in-class pipeline products with no prior involvement in licensing and co-development deals that may represent potential investment opportunities.

Table of Contents

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 4

1.2 List of Figures 4

2 Executive Summary 6

2.1 Limited Treatment Options despite Large Market Opportunity 6

2.2 Exceptionally High Level of First-in-Class Innovation within Alzheimer’s Disease Pipeline 6

2.3 Active Deals Landscape Dominated by GPCR-Targeting Products 6

3 The Case for Innovation 7

3.1 Growing Opportunities for Biologic Products 8

3.2 Diversification of Molecular Targets 8

3.3 Innovative First-in-Class Product Developments Remain Attractive 9

3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation 9

3.5 Sustained Innovation in Alzheimer’s Disease 10

3.6 GBI Research Report Guidance 10

4 Clinical and Commercial Landscape 12

4.1 Disease Overview 12

4.2 Classification of Dementia and Mild Cognitive Impairment 12

4.3 Symptoms, Disease Staging and Prognosis 13

4.4 Diagnosis 14

4.4.1 Mini Mental State Exam 15

4.4.2 Alzheimer’s Disease Assessment Scale - Cognitive 15

4.4.3 Alzheimer’s Disease Co-operative Study - Activities of Daily Living Inventory 16

4.4.4 Imaging Techniques 16

4.4.5 Lumbar Puncture 17

4.4.6 Blood Tests 17

4.5 Epidemiology 17

4.6 Etiology and Pathophysiology 17

4.6.1 Etiological Risk Factors 17

4.6.2 Pathophysiology 18

4.7 Management and Treatment of Alzheimer’s Disease 21

4.7.1 Pharmacological Intervention 21

4.7.2 Non-pharmacological Intervention 22

4.8 Overview of Marketed Products 23

4.9 Indications Associated with Alzheimer’s Disease 26

4.9.1 Anxiety 26

4.9.2 Depression 27

4.9.3 Psychosis 28

4.9.4 Insomnia 29

5 Assessment of Pipeline Product Innovation 30

5.1 Overview 30

5.2 Pipeline by Stage of Development and Molecule Type 30

5.2.1 Alzheimer’s Disease 30

5.2.2 Alzheimer’s-Disease-Associated Indications 31

5.3 Pipeline by Molecular Target 33

5.3.1 Alzheimer’s Disease 33

5.3.2 Alzheimer’s-Disease-Associated Indications 35

5.4 Comparative Distribution of Programs between the Market and Pipeline by Molecular Target Class 36

5.4.1 Alzheimer’s Disease 36

5.4.2 Alzheimer’s-Disease-Associated Indications 37

5.5 First-in-Class Programs Targeting Novel Molecular Targets 37

5.5.1 Alzheimer’s Disease 37

5.5.2 Alzheimer’s-Disease-Associated Indications 41

5.6 Ratio of First-in-Class Products to First-in-Class Targets 44

5.6.1 Alzheimer’s Disease 44

5.6.2 Alzheimer’s-Disease-Associated Indications 46

5.7 List of All First-in-Class Pipeline Programs 48

6 Signaling Network, Disease Causation and Innovation Alignment 58

6.1 Complexity of Signaling Networks 58

6.2 Signaling Pathways and First-in-Class Molecular Target Integration 58

6.3 First-in-Class Matrix Assessment 59

7 First-in-Class Target Profiles 64

7.1 Pipeline Programs Targeting Presenilin 1 for Alzheimer’s Disease 64

7.2 Pipeline Programs Targeting Apolipoprotein E for Alzheimer’s Disease 65

7.3 Pipeline Programs Targeting Apoptosis Regulator BAX for Alzheimer’s Disease 66

7.4 Pipeline Programs Targeting Sortilin for Alzheimer’s Disease 69

7.5 Pipeline Programs Targeting Metabotropic Glutamate Receptors 1, 2, 3, 4, 5 and 7 for Alzheimer’s Disease, Anxiety, Depression and Psychosis 70

7.6 Pipeline Programs Targeting Sodium Dependent Neutral Amino Acid Transporter B(0) AT2 for Depression and Anxiety 76

7.7 Pipeline Programs Targeting Cytochrome P450 1A2 for Insomnia and Anxiety 78

8 Strategic Consolidations 80

8.1 Industry-Wide First-in-Class Deals 80

8.2 Licensing Deals 82

8.2.1 Deals by Region, Value and Year 82

8.2.2 Deals by Indication 83

8.2.3 Deals by Stage of Development and Value 83

8.2.4 Deals by Molecule Type, Molecular Target and Value 84

8.2.5 List of Deals with Deal Values Exceeding $100m 86

8.3 Co-development Deals 87

8.3.1 Deals by Region, Value and Year 87

8.3.2 Deals by Indication 88

8.3.3 Deals by Stage of Development and Value 88

8.3.4 Deals by Molecule Type, Molecular Target and Value 89

8.3.5 List of Deals with Deal Values Exceeding $100m 90

8.4 First-in-Class Programs with and without Prior Involvement in Licensing and Co-development Deals 90

9 Appendix 91

9.1 References 91

9.2 Abbreviations 98

9.3 Research Methodology 99

9.3.1 Data integrity 99

9.3.2 Innovative and meaningful analytical techniques and frameworks: 99

9.3.3 Evidence based analysis and insight: 99

9.4 Secondary Research 99

9.4.1 Market Analysis 99

9.4.2 Pipeline Analysis 99

9.4.3 First-in-Class Matrix Assessment 100

9.4.4 First-in-Class Target Profiles 100

9.4.5 Licensing and Co-Development Deals 101

9.5 Contact Us 101

9.6 Disclaimer 101

List of Tables

1.1 List of Tables

Table 1: Alzheimer’s Disease and Associated Indications, Global, Common Forms of Dementia, 2017 13

Table 2: Alzheimer’s Disease and Associated Indications, Global, Common Alzheimer’s Disease Symptoms by Disease Stage, 2017 14

Table 3: Alzheimer’s Disease and Associated Indications, Global, Scoring for Mini-Mental State Exam, 2017 15

Table 4: Alzheimer’s Disease and Associated Indications, Global, Scoring for the Alzheimer’s Disease Assessment Scale-Cognitive , 2017 16

Table 5: Alzheimer’s Disease and Associated Indications, Global, Common Physical and Psychological Symptoms Associated with Anxiety Disorders, 2017 26

Table 6: Alzheimer’s Disease and Associated Indications, Global, Common Forms of Depression, 2017 28

Table 7: Alzheimer’s Disease and Associated Indications, Global, Key Features of Presenilin 1, 2017 64

Table 8: Alzheimer’s Disease and Associated Indications, Global, Pipeline Programs Targeting Presenilin 1, 2017 65

Table 9: Alzheimer’s Disease and Associated Indications, Global, Key Features of Apolipoprotein E, 2017 66

Table 10: Alzheimer’s Disease and Associated Indications, Global, Pipeline Programs Targeting Apolipoprotein E, 2017 66

Table 11: Alzheimer’s Disease and Associated Indications, Global, Key Features of Apoptosis Regulator BAX, 2017 68

Table 12: Alzheimer’s Disease and Associated Indications, Global, Pipeline Programs Targeting Apoptosis Regulator BAX, 2017 68

Table 13: Alzheimer’s Disease and Associated Indications, Global, Key Features of Sortilin, 2017 69

Table 14: Alzheimer’s Disease and Associated Indications, Global, Pipeline Programs Targeting Sortilin, 2017 70

Table 15: Alzheimer’s Disease and Associated Indications, Global, Key Features of Metabotropic Glutamate Receptor 1, 2017 71

Table 16: Alzheimer’s Disease and Associated Indications, Pipeline Programs Targeting Metabotropic Glutamate Receptor 1, 2017 71

Table 17: Alzheimer’s Disease and Associated Indications, Global, Key Features of Metabotropic Glutamate Receptor 2, 2017 72

Table 18: Alzheimer’s Disease and Associated Indications, Pipeline Programs Targeting Metabotropic Glutamate Receptor 2, 2017 72

Table 19: Alzheimer’s Disease and Associated Indications, Global, Key Features of Metabotropic Glutamate Receptor 3, 2017 73

Table 20: Alzheimer’s Disease and Associated Indications, Pipeline Programs Targeting Metabotropic Glutamate Receptor 3, 2017 73

Table 21: Alzheimer’s Disease and Associated Indications, Global, Key Features of Metabotropic Glutamate Receptor 4, 2017 74

Table 22: Alzheimer’s Disease and Associated Indications, Pipeline Programs Targeting Metabotropic Glutamate Receptor 4 (GRM4), 2017 74

Table 23: Alzheimer’s Disease and Associated Indications, Global, Key Features of Metabotropic Glutamate Receptor 5, 2017 75

Table 24: Alzheimer’s Disease and Associated Indications, Pipeline Programs Targeting Metabotropic Glutamate Receptor 5, 2017 75

Table 25: Alzheimer’s Disease and Associated Indications, Global, Key Features of Metabotropic Glutamate Receptor 7 (GRM7), 2017 76

Table 26: Alzheimer’s Disease and Associated Indications, Pipeline Programs Targeting Metabotropic Glutamate Receptor 7 (GRM7), 2017 76

Table 27: Alzheimer’s Disease and Associated Indications, Global, Sodium Dependent Neutral Amino Acid Transporter B0 AT2, 2017 77

Table 28: Alzheimer’s Disease and Associated Indications, Global, Pipeline Programs Targeting Sodium Dependent Neutral Amino Acid Transporter B0 AT2, 2017 78

Table 29: Alzheimer’s Disease and Associated Indications, Global, Key Features of Cytochrome P450 1A2, 2017 79

Table 30: Alzheimer’s Disease and Associated Indications, Global, Pipeline Programs Targeting Cytochrome P450 1A2, 2017 79

List of Figures

1.2 List of Figures

Figure 1: Alzheimer’s Disease and Associated Indications, Global, US, Innovation Trends in Product Approvals, 1987-2014 8

Figure 2: Alzheimer’s Disease and Associated Indications, US, Sales Performance of First-in-Class and Non-First-in-Class Products Post Marketing Approval, 2006-2013 9

Figure 3: Alzheimer’s Disease and Associated Indications, Global, Alzheimer’s Disease Market by Molecular Target, 2017 24

Figure 4: Alzheimer’s Disease and Associated Indications, Global, Alzheimer’s Disease Associated Indications Market by Molecular Target, 2017 25

Figure 5: Alzheimer’s Disease and Associated Indications, Global, Pipeline by Therapy Area, 2017 30

Figure 6: Alzheimer’s Disease, Global, Pipeline by Stage of Development and Molecule Type, 2017 31

Figure 7: Anxiety, Depression, Psychosis and Insomnia, Global, Pipelines by Stage of Development, 2017 32

Figure 8: Anxiety, Depression, Psychosis and Insomnia, Global, Pipelines by Molecule Type, 2017 33

Figure 9: Alzheimer’s Disease, Global, Pipeline by Molecular Target, 2017 34

Figure 10: Anxiety, Depression, Psychosis and Insomnia, Global, Pipelines by Molecular Target, 2017 36

Figure 11: Alzheimer’s Disease, Global, Pipeline and Marketed Products by Molecular Target Class, 2017 37

Figure 12: Alzheimer’s-Disease-Associated Indications, Global, Pipeline and Marketed Products by Molecular Target Class, 2017 37

Figure 13: Alzheimer’s Disease, Global, Pipeline by Molecular Target Class, First-in-Class Status and Stage of Development, 2017 39

Figure 14: Alzheimer’s Disease, Global, Percentage Distribution of First-in-Class and Non-First-in-Class Pipeline Products by Stage of Development and Molecular Target Class, 2017 40

Figure 15: Alzheimer’s-Disease-Associated Indications, Global, Pipeline by Molecular Target Class, First-in-Class Status and Stage of Development, 2017 42

Figure 16: Alzheimer’s-Disease-Associated Indications, Global, Percentage Distribution of First-in-Class and Non-First-in-Class Pipeline Products by Stage of Development and Molecular Target Class, 2017 43

Figure 17: Alzheimer’s Disease, Global, Ratio of First-in-Class Products to First-in-Class Targets for Pipeline Products by Stage of Development and Molecular Target Class, 2017 45

Figure 18: Alzheimer’s-Disease-Associated Indications, Global, Ratio of First-in-Class Products to First-in-Class Targets for Pipeline Products by Stage of Development and Molecular Target Class, 2017 47

Figure 19: Alzheimer’s Disease and Associated Indications, Global, List of All First-in-Class Pipeline Programs, 2017 (part 1) 48

Figure 20: Alzheimer’s Disease and Associated Indications, Global, List of All First-in-Class Pipeline Programs, 2017 (part 2) 49

Figure 21: Alzheimer’s Disease and Associated Indications, Global, List of All First-in-Class Pipeline Programs, 2017 (part 3) 50

Figure 22: Alzheimer’s Disease and Associated Indications, Global, List of All First-in-Class Pipeline Programs, 2017 (part 4) 51

Figure 23: Alzheimer’s Disease and Associated Indications, Global, List of All First-in-Class Pipeline Programs, 2017 (part 5) 52

Figure 24: Alzheimer’s Disease and Associated Indications, Global, List of All First-in-Class Pipeline Programs, 2017 (part 6) 53

Figure 25: Alzheimer’s Disease and Associated Indications, Global, List of All First-in-Class Pipeline Programs, 2017 (part 7) 54

Figure 26: Alzheimer’s Disease and Associated Indications, Global, List of All First-in-Class Pipeline Programs, 2017 (part 8) 55

Figure 27: Alzheimer’s Disease and Associated Indications, Global, List of All First-in-Class Pipeline Programs, 2017 (part 9) 56

Figure 28: Alzheimer’s Disease and Associated Indications, Global, List of All Pipeline Programs, 2017 (part 10) 57

Figure 29: Alzheimer’s Disease and Associated Indications, Global, First-in-Class Matrix Assessment for Alzheimer’s Disease Products, 2017 60

Figure 30: Alzheimer’s Disease and Associated Indications, Global, First-in-Class Matrix Assessment for Anxiety Products, 2017 61

Figure 31: Alzheimer’s Disease and Associated Indications, Global, First-in-Class Matrix Assessment for Depression Products, 2017 62

Figure 32: Alzheimer’s Disease and Associated Indications, Global, First-in-Class Matrix Assessment for Psychosis Products, 2017 62

Figure 33: Alzheimer’s Disease and Associated Indications, Global, First-in-Class Matrix Assessment for Insomnia Products, 2017 63

Figure 34: Alzheimer’s Disease and Associated Indications, Global, Industry-Wide Licensing Deals by First-in-Class Status and Stage of Development, 2006-2014 80

Figure 35: Alzheimer’s Disease and Associated Indications, Global, Industry-Wide Licensing Deals by Deal Value, Upfront Payment Value, Stage of Development and First-in-Class Status, 2006-2014 81

Figure 36: Alzheimer’s Disease and Associated Indications, Global, Licensing Deals by Region, Value and Year, 2006-2017 82

Figure 37: Alzheimer’s Disease and Associated Indications, Global, Licensing Deals by Indication and Deal Value, 2006-2017 83

Figure 38: Alzheimer’s Disease and Associated Indications, Global, Licensing Deals by Deal Value, Upfront Payment Value and Stage of Development, 2006-2017 84

Figure 39: Alzheimer’s Disease and Associated Indications, Global, Number and Aggregate Deal Value of Licensing Deals by Molecule Type, 2006-2017 84

Figure 40: Alzheimer’s Disease and Associated Indications, Global, Number and Aggregate Deal Value of Licensing Deals by Molecular Target, 2006-2017 85

Figure 41: Alzheimer’s Disease and Associated Indications, Global, Licensing Deals Exceeding $100m in Value, 2006-2017 86

Figure 42: Alzheimer’s Disease and Associated Indications, Global, Co-development Deals by Region, Value and Year, 2006-2017 87

Figure 43: Alzheimer’s Disease and Associated Indications, Global, Co-development Deals by Indication and Deal Value, 2006-2017 88

Figure 44: Alzheimer’s Disease and Associated Indications, Global, Co-development Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2017 88

Figure 45: Alzheimer’s Disease and Associated Indications, Global, Number and Aggregate Deal Value of Co-development Deals by Molecule Type, 2006-2017 89

Figure 46: Alzheimer’s Disease and Associated Indications, Global, Number and Aggregate Deal Value of Co-development Deals by Molecular Target, 2006-2017 89

Figure 47: Alzheimer’s Disease and Associated Indications, Global, Co-development Deals Exceeding $100m in Value, 2006-2017 90

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