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Frontier Pharma: Parkinsons Disease - Identifying and Commercializing First-in-Class Innovation

Published: Nov-2014 | Format: PDF | GBI Research | Number of pages: 121 | Code: MRS - 2863

Large Degree of Innovation in Parkinson’s Disease Pipeline

The Parkinson’s disease (PD) pipeline currently has 302 products in active development across all stages, but a stark contrast between the mechanisms of action employed in the current market and the pipeline is evident. Where the market relies on symptomatic treatments that target neuromodulatory receptors, the pipeline shows a diverse range of neuroprotective therapies targeting dysfunctional disease processes. This diversity is partially due to the presence of 90 first-in-class products, which accounts for 37% of the overall pipeline therapies that disclosed their target. In an industry, market and development landscape that favors first-in-class over non-first-in-class development in many ways, such as through faster approval or greater revenue, this finding has strategic implications for a wide array of market participants, both large and small. Despite their historically high attrition rate, first-in-class therapies that reach the market have the potential to transform and improve the PD treatment landscape.

Alignment of First-in-Class Molecular Target with Disease Processes and Genetics

PD is a complex and multifaceted disease with a complex interplay between different pathological processes. Enormous research efforts and significant technological advances have furthered knowledge of the neuroanatomy of the basal ganglia and of the fundamental processes underlying neurodegeneration, helped by the ongoing identification of susceptibility genes and causative genes in familial PD. Although the exact mechanisms that initiate onset remain unclear, these insights have been translated into the pool of novel therapeutic targets, which may potentially become disease-modifying therapies by aligning to the disease processes and some genetic determinants of PD.

GBI Research’s proprietary analysis showed substantial variation in how well the functional roles of PD first-in-class targets align to the pathophysiology of PD. Further in-depth analysis identified the most promising first-in-class targets based on various scientific and clinical parameters. Examining scientific and clinical data of promising first-in-class targets showed that first-in-class status is not, in its own right, enough for a successful product; however, the first-in-class products substantiated by scientific and clinical evidence will be exciting future prospects with the potential to transform the PD market.

First-in-Class Products in Licensing and Co-development Deals

Strategic consolidation is relatively uncommon in the PD market. Concerning first-in-class specifically, only nine first-in-class products that are currently in development have been involved in licensing or co-development deals since 2006. Despite the low sample size, it is clear that the first-in-class PD products offer an attractive investment prospect as they command much higher deal values and, on average, deals occur earlier in development compared to non-first-in-class counterparts. Both trends were substantiated by industry-wide data that showed that, particularly in Phase I, first-in-class products would attract larger mean and median total deal values. The data highlight that the first-in-class deals landscape is different and indicates a greater chance of becoming much more lucrative than the deals landscape for addition-to-class or advance-in-class therapies.

A total of 81 first-in-class products that are currently in development have not yet been entered into a licensing or co-development deal. Under a growing unmet need for disease-modifying therapies and increasing understanding of disease processes allowed by technological advances, there are numerous opportunities for strategic alliances to bolster a first-in-class portfolio or fund clinical development. Some of these first-in-class products are supported by promising scientific and clinical data, making them attractive prospects as both therapeutics and investment opportunities.

Scope

  • The report analyzes innovation in PD in the context of the overall pipeline and current market landscape. It also analyzes the deals landscape surrounding first-in-class products and pinpoints in-licensing opportunities.The report includes 
  • A brief introduction to PD, including symptoms, pathophysiology, and an overview of pharmacotherapy and treatment algorithms
  • Coverage of the changing molecular target landscape and particular points of innovation in the pipeline
  • A comprehensive review of the pipeline for first-in-class therapies, analyzed by stage of development, molecule type and molecular target
  • Identification and assessment of first-in-class molecular targets with a particular focus on early-stage programs of which clinical utility has yet to be evaluated, as well as literature reviews of novel molecular targets
  • Industry-wide analysis of first-in-class deals compared to non-first-in-class deals
  • An assessment of the licensing and co-development deal landscape for PD therapies and benchmarking of deals comparing first-in-class and non-first-in-class-products

Reasons to buy

  • The report will enable business development and enable marketing executives to strategize their product launches by allowing them to 
  • Understand the focal shifts in molecular targets in the PD pipeline
  • Understand the distribution of pipeline programs by phase of development, molecule type and molecular target
  • Access a scientific and clinical analysis of first-in-class developmental programs for PD, benchmarked against non-first-in-class targets
  • Assess the valuations of licensed and co-developed PD treatments
  • Access a list of the first-in-class therapies potentially open to deal-making opportunities

Table of Contents

 

1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 3
1.2 List of Figures 3

 

2 Executive Summary 5
2.1 Highly Innovative and Diverse Pipeline 5
2.2 Alignment of Innovation to Disease Processes and Genetics 5
2.3 Deals Landscape Present Substantial Investment Opportunities 5

 

3 The Case for Innovation 6
3.1 Growing Opportunities for Biologic Products 7
3.2 Diversification of Molecular Targets 7
3.3 Innovative First-in-Class Product Developments Remain Attractive 7
3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation 8
3.5 Sustained Innovation 8
3.6 GBI Research Report Guidance 9

 

4 Clinical and Commercial Landscape 10
4.1 Epidemiology 10
4.2 Disease Etiology 11
4.2.1 Exposure to Environmental Toxins 11
4.2.2 Genetic Causes of Familial Parkinson’s Disease 11
4.2.3 Susceptibility Genes for Parkinson’s Disease 13
4.3 Disease Pathophysiology 13
4.3.1 Basal Ganglia Anatomy and Physiology 13
4.3.2 Processes Underlying Neurodegeneration in Parkinson’s Disease 16
4.4 Disease Symptoms 20
4.5 Co-morbidities and Complications 20
4.6 Diagnosis 21
4.6.1 Classification 21
4.7 Prognosis and Disease Staging 23
4.8 Treatment Options 24
4.8.1 Pharmacological Treatment 24
4.8.2 Non-pharmacological Treatments 28
4.9 Marketed Product Overview 28
4.10 Overview of Marketed Products for Parkinson’s Disease 29
4.11 Efficacy and Safety of Marketed Products 31
4.12 Treatment Algorithm 33
4.13 Current Unmet Needs 35

 

5 Assessment of Pipeline Product Innovation 37
5.1 Parkinson’s Disease Pipeline by Molecule Type, Phase and Therapeutic Targets 37
5.2 Comparative Distribution of Programs between the Parkinson’s Disease Market and Pipeline by Therapeutic Target Family 41

 

6 Signaling Network, Parkinson’s Disease Genetics and Innovation Alignment 46
6.1 The Complexity of Signaling Network in Central Nervous System 46
6.2 Signaling Pathways, Disease-Causing Mutations and First-in-Class Molecular Target Integration 47
6.3 First-in-Class Target Matrix Assessment 51

 

7 First-in-Class Target and Pipeline Program Evaluation 54
7.1 Overview of Pipeline Programs Targeting α-synuclein 54
7.2 Overview of Pipeline Programs Targeting LRRK2 57
7.3 Overview of Pipeline Programs Targeting Glial Cell-Derived Neurotrophic Factor 60
7.4 Overview of Pipeline Programs Targeting Progranulin 63
7.5 Overview of Pipeline Programs Targeting Cerebral Dopamine Neurotrophic Factor 66
7.6 Overview of Pipeline Programs Targeting Mesencephalic Astrocyte-Derived Neurotrophic Factor 68
7.7 Overview of Pipeline Programs Targeting Tyrosine Receptor Kinase B 70
7.8 Overview of Pipeline Programs Targeting Metabotropic Glutamate Receptor 4 73
7.9 Overview of Pipeline Programs Targeting Metabotropic Glutamate Receptor 8 75
7.10 Overview of Pipeline Programs Targeting C-jun-N-Terminal Kinases 76
7.11 Overview of Pipeline Programs Targeting DJ-1 79
7.12 Overview of Pipeline Programs Targeting Reactive Oxygen Species 80
7.13 Overview of Pipeline Programs Targeting Heat Shock Transcription Factor 1 82
7.14 Overview of Pipeline Programs Targeting Heat Shock Protein 90 84
7.15 Overview of Pipeline Programs Targeting Growth Hormone Secretagogue Receptor 86
7.16 Overview of Pipeline Programs Targeting Protein Phosphatase 2A 88
7.17 Overview of Pipeline Programs Targeting Cytochrome P450 2D6 90
7.18 Conclusion 91

 

8 Deals and Strategic Consolidations 93
8.1 Industry-wide First-in-Class Deals 93
8.2 Parkinson’s Disease Deals Landscape 95
8.3 Licensing Deals 95
8.3.1 Molecule Type 97
8.3.2 Mechanism of Action 97
8.4 Co-development Deals 100
8.4.1 Mechanism of Action 101
8.5 First-in-Class Programs Not Involved in Licensing or Co-Development Deals 103

 

9 Appendix 106
9.1 Abbreviations 106
9.2 References 108
9.3 Contact Us 121
9.4 Disclaimer 121"

 

List of Tables
 

Table 1: Definition of the Stages of Disability in Hoehn and Yahr Scale, 1967 21
Table 2: Evaluation of Disability by Unified Parkinson Disease Rating Scale, 2013 22"

 

List of Figures

 

Figure 1: Innovation Trends in Product Approvals, 1987–2013 6
Figure 2: Sales Performance of First-in-Class and Non-First-in-Class Products Post Marketing Approval, 2006–2013 8
Figure 3: Indirect and Direct Pathways in Basal Ganglia, 2014 15
Figure 4: Molecular Targets of Marketed Products, 2014 30
Figure 5: Efficacy and Safety Heat Map for Marketed Products, Part 1 31
Figure 6: Efficacy and Safety Heat Map for Marketed Products, Part 2 32
Figure 7: Treatment Algorithm of Parkinson’s Disease, 2010 34
Figure 8: Treatment Algorithm of Advanced Parkinson’s Disease, 2010 35
Figure 9: Developmental Pipeline Overview 39
Figure 10: Breakdown of Molecular Target Family 40
Figure 11: Molecular Target Category Comparison, Pipeline and Marketed Products 42
Figure 12: Molecular Target Category Comparison, Pipeline First-in-Class and Established Molecular Targets 43
Figure 13: Parkinson’s Disease, Global, Pipeline, First-in-class Products in the Pipeline, Part 1/2, 2014 44
Figure 14: Parkinson’s Disease, Global, Pipeline, First-in-class Products in the Pipeline, Part-2 45
Figure 15: Signaling Networks of Functional Families in PD 49
Figure 16: Tabular Representation of the Parkinson’s Disease-related Processes First-in-Class Targets, Familial Mutants and Susceptibility Genes 50
Figure 17: First-in-Class Molecular Target Analysis Matrix (Part 1) 52
Figure 18: First-in-Class Molecular Target Analysis Matrix (Part 2) 53
Figure 19: Preclinical Evidence for α-synuclein as a Therapeutic Target 56
Figure 20: Pipeline Programs Targeting α-synuclein 57
Figure 21: Data and Evidence for Leucine-Rich Repeat Kinase 2 as a Therapeutic Target 59
Figure 22: Pipeline Programs Targeting LRRK2 60
Figure 23: Data and Evidence for Glial Cell-derived Neurotrophic Factor as a Therapeutic Target 62
Figure 24: Pipeline Programs Targeting Glial-cell Derived Neurotrophic Factor 63
Figure 25: Data and Evidence for Progranulin as a Therapeutic Target 65
Figure 26: Pipeline Programs Targeting Progranulin 65
Figure 27: Data and Evidence for Cerebral Dopamine Neurotrophic Factor as a Therapeutic Target 67
Figure 28: Pipeline Programs Targeting Cerebral Dopamine Neurotrophic Factor 67
Figure 29: Data and Evidence for Mesencephalic Astrocyte-Derived Neurotrophic Factor as a Therapeutic Target 69
Figure 30: Pipeline Programs Targeting Mesencephalic Astrocyte-Derived Neurotrophic Factor 69
Figure 31: Parkinson’s Disease, Global, First-in-Class Tyrosine Receptor Kinase B 72
Figure 32: Pipeline Programs Targeting Tyrosine Receptor Kinase B 73
Figure 33: Data and Evidence for Metabotropic Glutamate Receptor 4 as a Therapeutic Target 74
Figure 34: Pipeline Programs Targeting Metabotropic Glutamate Receptor 4 74
Figure 35: Data and Evidence for Metabotropic Glutamate Receptor 8 as a Therapeutic Target 76
Figure 36: Pipeline Programs Targeting Metabotropic Glutamate Receptor 8 76
Figure 37: Data and Evidence for C-jun-N-Terminal Kinases as a Therapeutic Target 78
Figure 38: Pipeline Programs Targeting C-jun-N-Terminal Kinases 78
Figure 39: Data and Evidence for DJ-1 as a Therapeutic Target 80
Figure 40: Pipeline Programs Targeting DJ-1 80
Figure 41: Data and Evidence for Reactive Oxygen Species as a Therapeutic Target 82
Figure 42: Pipeline Programs Targeting Reactive Oxygen Species 82
Figure 43: Data and Evidence for Heat Shock Transcription Factor 1 as a Therapeutic Target 84
Figure 44: Pipeline Programs Targeting Heat Shock Transcription Factor 1 84
Figure 45: Data and Evidence for Heat Shock Protein 90 as a Therapeutic Target 86
Figure 46: Pipeline Programs Targeting Heat Shock Protein 90 86
Figure 47: Data and Evidence for Growth Hormone Secretagogue Receptor as a Therapeutic target 88
Figure 48: Pipeline Programs Targeting Growth Hormone Secretagogue Receptor 88
Figure 49: Data and Evidence for Protein phosphatase 2A as a Therapeutic Target 89
Figure 50: Pipeline Programs Targeting Protein Phosphatase 2A 89
Figure 51: Data and Evidence for Cytochrome P450 2D6 as a Therapeutic Target 91
Figure 52: Pipeline Programs Targeting Cytochrome P450 2D6 91
Figure 53: Industry Wide Deals by Stage of Development, 2006–2014 93
Figure 54: Industry Licensing Deal Values by Stage of Development, 2006–2014 94
Figure 55: Licensing Deals, 2006–2014 96
Figure 56: Regional Network of Licensing Deals, 2006–2014 97
Figure 57: Licensing Deals by Molecule Type and Phase, 2006–2014 97
Figure 58: Licensing Deals by Target, 2006–2014 98
Figure 59: Summary of Licensing Deals, 2006–2014 99
Figure 60: Co-Development Deals, 2006–2014 100
Figure 61: Regional Network of Co-Development Deals, 2006–2014 101
Figure 62: Co-Development Deals by Target, 2006–2014 101
Figure 63: Summary of Co-Development Deals, 2006–2014 102
Figure 64: First-in-class Programs with no Recorded Prior Deal Involvement, 2006–2014 (Part 1) 104
Figure 65: First-in-class Programs with no Recorded Prior Deal Involvement, 2006–2014 (Part 2) 105

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