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Frontier Pharma: Schizophrenia and Associated Indications - Small but Diverse Range of First-in-Class Molecular Targets Hold Promise for Treatment of Negative and Cognitive Symptoms

Published: Mar 31, 2016 | Pages: 73 | Publisher: GBI Research | Industry: Pharmaceuticals & Healthcare | Report Format: Electronic (PDF)

Frontier Pharma: Schizophrenia and Associated Indications - Small but Diverse Range of First-in-Class Molecular Targets Hold Promise for Treatment of Negative and Cognitive Symptoms

Summary

Schizophrenia is a severe mental disorder that is characterized by abnormal social behavior and failure to recognize what is real; its symptoms are broadly divided into positive, negative and cognitive. The treatment of schizophrenia is multi-factorial and includes medical, psychological and psychosocial inputs. Antipsychotic medication is the main pharmacological agent used, along with counselling, job training, and social rehabilitation. Both typical and atypical antipsychotics are used, and the choice of medication is usually left to the discretion of the treating physician. Clozapine, which is an atypical antipsychotic that binds to serotonin and dopamine receptors, is often given to patients who do not improve with other antipsychotics.

Current treatments, although effective for positive symptoms, have not proven as effective for negative symptoms and cognitive dysfunction, nor are there are any disease-modifying drugs currently available. The pipeline for schizophrenia is small, particularly given the large patient population, it also has low levels of innovation in comparison to other psychiatric indications in the pharmaceutical industry. However, the overall level of innovation in the pipeline for schizophrenia-related indications (which includes depression, panic disorders, obsessive compulsive disorder, post-traumatic stress disorder and cognitive deficit) is far higher, with these related products having the potential to provide some benefit to patients with schizophrenia.

Scope

The current clinical landscape of schizophrenia
  - What is the pathophysiology of schizophrenia?
  - How is schizophrenia diagnosed?
  - What are the current treatment options?
The schizophrenia pipeline is small, although there is a much larger pipeline for its related indications.
  - What are the common targets and mechanisms of action of pipeline therapies?
  - Will the pipeline address unmet needs such as a lack of diverse treatment options for schizophrenia patients, particularly those with negative or cognitive symptoms?
  - What is the composition of the pipeline for schizophrenia-related indications, and will they be of benefit to schizophrenia patients?
First-in-class products and targets currently within the schizophrenia  pipeline
  - What are the most promising first-in-class targets for schizophrenia?
Detailed outlook on first-in-class targets and whether they have other therapeutic potential across the industry
Licensing deals are the most common form of strategic alliance in schizophrenia
  - How do deal frequency and value compare between target families and molecule types?
  - How do licensing and co-development deals compare between first-in-class and non-first-in-class profiles?

Reasons to buy

This report will allow you to - 
- Understand the current clinical and commercial landscape by considering disease pathogenesis, diagnosis, prognosis, and the treatment options available at each stage of diagnosis, including a clinical comparison of marketed therapies
- Visualize the composition of the schizophrenia market in terms of dominant therapies for each patient subset along with their clinical and commercial standing. Unmet needs in the current market are highlighted to allow a competitive understanding of gaps in the current market.
- Analyze the schizophrenia pipeline and stratify pipeline therapies by stage of development, molecule type and molecular target. There are promising signs in the pipeline that the industry is seeking novel approaches to treating schizophrenia.
- Assess the therapeutic potential of first-in-class targets. Using a proprietary matrix, first-in-class products have been assessed and ranked according to clinical potential. Promising early-stage targets have been further reviewed in greater detail.
- Identify commercial opportunities in the schizophrenia deals landscape by analyzing trends in licensing and co-development deals and producing a list of schizophrenia therapies that are not yet involved in deals, and may be potential investment opportunities.
 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 A Complex and Poorly Understood Disorder, with Numerous Unmet Needs 5
2.2 Small Pipeline for Schizophrenia with Few Signs of Innovation 5
2.3 Extensive Pipeline for Associated Indications 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 GBI Research Report Guidance 8

4 Clinical and Commercial Landscape 9
4.1 Disease Overview 9
4.2 Epidemiology 9
4.3 Disease Etiology 9
4.4 Disease Pathophysiology 10
4.4.1 Susceptibility Genes 10
4.4.2 Neurotransmission Alterations 11
4.4.3 Phosphatidylinositol Signaling 11
4.5 Disease Symptoms 11
4.6 Indications Associated With Schizophrenia 11
4.6.1 Panic Disorder 11
4.6.2 Depression 12
4.6.3 Post-Traumatic Stress Disorder 13
4.6.4 Obsessive Compulsive Disorder 13
4.6.5 Cognitive Impairment 13
4.7 Diagnosis 14
4.8 Prognosis 15
4.9 Treatment Options 15
4.10 Overview of Marketed Products 16
4.10.1 Molecule Type and Target Analysis 16
4.11 Current Unmet Needs 17

5 Assessment of Pipeline Product Innovation 18
5.1 Schizophrenia Pipeline by Molecule Type, Phase and Therapeutic Target 18
5.2 Comparative Distribution of Programs between Schizophrenia Disease Market and Pipeline by Therapeutic Target Family 22
5.3 First-in-Class Pipeline Programs 23

6 Schizophrenia Pathophysiology and Innovation Alignment 32
6.1 The Complexity of Signaling Networks in the Central Nervous System 32
6.2 First-in-Class Target Matrix Assessment 32

7 First-in-Class Target Evaluation 37
7.1 Pipeline Programs Targeting D-Amino Acid Oxidase 37
7.2 Pipeline Programs Targeting Gamma-Aminobutyric Acid Receptor, Subunit Alpha 5 38
7.3 Pipeline Programs Targeting Glutamate Carboxypeptidase 2 40
7.4 Pipeline Programs Targeting Phosphodiesterase 9 41
7.5 Pipeline Programs Targeting Potassium Voltage-Gated Channel Subfamily C, Member 1 43
7.6 Pipeline Programs Targeting Probable G Protein-Coupled Receptor 52 44
7.7 Pipeline Programs Targeting G Protein-Coupled Receptor 78 45
7.8 Pipeline Programs Targeting Probable G Protein-Coupled Receptor 85 46
7.8.1 Pipeline Programs Targeting Pipeline Programs Targeting Probable G Protein-Coupled Receptor 173 47
7.8.2 Pipeline Programs Targeting Pipeline Programs Targeting Probable G Protein-Coupled Receptor 27 48
7.9 Pipeline Programs Targeting Sodium and Chloride Dependent Glycine Transporter 1 49
7.10 Pipeline Programs Targeting Trace Amine-Associated Receptor 1 51
7.11 Conclusion 52

8 Deals and Strategic Consolidations 54
8.1 Licensing Deals 55
8.2 Co-development Deals 60
8.3 First-in-Class Programs not Involved in Licensing or Co-development Deals 64

9 Appendix 65
9.1 Abbreviations 65
9.2 Bibliography 65
9.3 Research Methodology 71
9.4 Secondary Research 71
9.4.1 Marketed Product Heatmaps and Treatment Algorithm 72
9.4.2 Pipeline Analysis 72
9.4.3 First-in-Class Matrix Assessment 72
9.4.4 First-in-Class Target Profiles 72
9.4.5 Licensing and Co-development Deals 73
9.5 Contact Us 73
9.6 Disclaimer 73
List of Tables

Table 1: American Psychiatry Association DSM-5 Schizophrenia Criteria 14
Table 2: World Health Organization ICD-10 Schizophrenia criteria 15
Table 3: Data for D-Amino Acid Oxidase as a Therapeutic Target 37
Table 4: Evidence for D-Amino Acid Oxidase as a Therapeutic Target 37
Table 5: Data for Gamma-Aminobutyric Acid Receptor, Subunit Alpha 5 as a Therapeutic Target 38
Table 6: Evidence for Gamma-Aminobutyric Acid Receptor, Subunit Alpha 5 as a Therapeutic Target 39
Table 7: Data for Glutamate Carboxypeptidase 2 as a Therapeutic Target 40
Table 8: Evidence for Glutamate Carboxypeptidase 2 as a Therapeutic Target 41
Table 9: Data for Phosphodiesterase 9 as a Therapeutic Target 42
Table 10: Evidence for Phosphodiesterase 9 as a Therapeutic Target 42
Table 11: Data for Potassium Voltage-Gated Channel Subfamily C, Member 1 as a Therapeutic Target 43
Table 12: Evidence for Potassium Voltage-Gated Channel Subfamily C, Member 1 as a Therapeutic Target 44
Table 13: Data for Probable G Protein-Coupled Receptor 52 as a Therapeutic Target 45
Table 14: Evidence for Probable G Protein-Coupled Receptor 52 as a Therapeutic Target 45
Table 15: Data for G Protein-Coupled Receptor 78 as a Therapeutic Target 46
Table 16: Evidence for G Protein-Coupled Receptor 78 as a Therapeutic Target 46
Table 17: Data for Probable G Protein-Coupled Receptor 85 as a Therapeutic Target 47
Table 18: Evidence for Probable G Protein-Coupled Receptor 85 as a Therapeutic Target 47
Table 19: Data for Probable G Protein-Coupled Receptor 173 as a Therapeutic Target 48
Table 20: Evidence for Probable G Protein-Coupled Receptor 173 as a Therapeutic Target 48
Table 21: Data for Probable G Protein-Coupled Receptor 27 as a Therapeutic Target 49
Table 22: Evidence for Probable G Protein-Coupled Receptor 27 as a Therapeutic Target 49
Table 23: Data for Sodium and Chloride Dependent Glycine Transporter 1 as a Therapeutic Target 50
Table 24: Evidence for Sodium and Chloride Dependent Glycine Transporter 1 as a Therapeutic Target 50
Table 25: Data for Trace Amine-Associated Receptor 1 as a Therapeutic Target 52
Table 26: Evidence for Trace Amine-Associated Receptor 1 as a Therapeutic Target 52

List of Figures

Figure 1: Innovation Trends in Product Approvals, 1987-2012 6
Figure 2: Sales Performance of First-in-Class and Non-First-in-Class Products Post Marketing Approval, 2006-2013 8
Figure 3: Molecular Targets of Marketed Products 16
Figure 4: Schizophrenia Pipeline by Stage of Development and Molecule Type 18
Figure 5: Schizophrenia-Associated Indications  Pipeline by Stage of Development and Molecule Type 20
Figure 6: Pipeline for Schizophrenia by Molecular Target 21
Figure 7: Pipeline for Schizophrenia-Associated Indications by Molecular Target 22
Figure 8: Molecular Target Category Comparison, Pipeline and Marketed Products 22
Figure 9: Molecular Target Category Comparison, Pipeline and Marketed Products 23
Figure 10: Molecular Target Category Comparison, Pipeline and Marketed Products 24
Figure 11: First-in-Class and Established Molecular Targets in the Pipeline for Schizophrenia 25
Figure 12: First-in-Class and Established Molecular Targets in the Pipeline for Schizophrenia-Associated Indications 26
Figure 13: Schizophrenia, Global, First-in-Class Pipeline Products - Part 1 27
Figure 14: Schizophrenia, Global, First-in-Class Pipeline Products - Part 2 28
Figure 15: Schizophrenia, Global, First-in-Class Pipeline Products - Part 3 29
Figure 16: Schizophrenia, Global, First-in-Class Pipeline Products - Part 4 30
Figure 17: Schizophrenia, Global, First-in-Class Pipeline Products - Part 5 31
Figure 18: First-in-Class Molecular Target Analysis Matrix (Schizophrenia Pipeline) 33
Figure 19: First-in-Class Molecular Target Analysis Matrix (Depression Pipeline) 34
Figure 20: First-in-Class Molecular Target Analysis Matrix (Panic Disorders Pipeline) 35
Figure 21: First-in-Class Molecular Target Analysis Matrix (Post-Traumatic Stress Disorder Pipeline) 35
Figure 22: First-in-Class Molecular Target Analysis Matrix (Obsessive Compulsive Disorder Pipeline) 36
Figure 23: First-in-Class Molecular Target Analysis Matrix (Cognitive Deficit Pipeline) 36
Figure 24: Pipeline Programs Targeting D-Amino Acid Oxidase 38
Figure 25: Pipeline Programs Targeting Gamma-Aminobutyric Acid Receptor, Subunit Alpha 5 39
Figure 26: Pipeline Programs Targeting Glutamate Carboxypeptidase 2 41
Figure 27: Pipeline Programs Targeting Phosphodiesterase 9 43
Figure 28: Pipeline Programs Targeting Potassium Voltage-Gated Channel Subfamily C, Member 1 44
Figure 29: Pipeline Programs Targeting Probable G Protein-Coupled Receptor 52 45
Figure 30: Pipeline Programs Targeting G Protein-Coupled Receptor 78 46
Figure 31: Pipeline Programs Targeting Probable G Protein-Coupled Receptor 85 47
Figure 32: Pipeline Programs Targeting Probable G Protein-Coupled Receptor 173 48
Figure 33: Pipeline Programs Targeting Probable G Protein-Coupled Receptor 27 49
Figure 34: Pipeline Programs Targeting Sodium and Chloride Dependent Glycine Transporter 1 51
Figure 35: Pipeline Programs Targeting Trace Amine-Associated Receptor 1 52
Figure 36: Industry-Wide Deals by Stage of Development, 2006-2014 54
Figure 37: Industry-Wide Deals by Stage of Development, 2006-2014 55
Figure 38: Licensing Deals by Region and Value, 2006-2015 56
Figure 39: Licensing Deals by Year, 2006-2015 56
Figure 40: Licensing Deals by Stage of Development 57
Figure 41: Licensing Deal Value by Molecule Type 57
Figure 42: Licensing Deal Value by Molecular Target 58
Figure 43: Summary of Licensing Deals, 2006-2015 59
Figure 44: Co-development Deals by Region and Value, 2006-2015 60
Figure 45: Co-development Deals by Year, 2006-2015 60
Figure 46: Co-development Deals by Stage of Development 61
Figure 47: Co-development by Stage of Development and Molecule Type 61
Figure 48: Co-development by Stage of Development and Molecular Target 62
Figure 49: Summary of Co-development Deals, 2006-2015 63
Figure 50: First-in-Class Programs for Schizophrenia and its Associated Indications with No Recorded Prior Deal Involvement, 2006-2016 64 



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