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Frontier Pharma: Pain-Identifying and Commercializing First-in-Class Innovation

Frontier Pharma: Pain-Identifying and Commercializing First-in-Class Innovation

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Executive Summary

Frontier Pharma: Pain-Identifying and Commercializing First-in-Class Innovation

Large and Innovative Pipeline

The active pain pipeline is populated by 796 products across all stages of development, which exhibit a highly diverse range of molecular targets. GBI Research's analyses identified 122 first-in-class programs in active development, constituting 13.6% of the pipeline and acting on 65 first-in-class molecular targets, indicating a high degree of innovation. This is in stark contrast to the pain therapeutics market, which has been largely characterized by only incremental product innovation over the last decade, as most market segments continue to be dominated by long-established active pharmaceutical ingredients and the concomitant mechanisms of action. Moderate-to-severe pain continues to be dominated by opioids that are increasingly being reformulated to offer abuse-resistance, while mild pain is effectively treated with Non-Steroidal Anti-Inflammatory Drugs (NSAID). However, significant unmet needs remain, as chronic pain and some neuropathic pain subtypes do not respond well to existing therapies, which are not adequate to treat associated hypersensitization and do not align to the underlying molecular pathophysiological profile.

Despite being mostly distributed in the early stages of development, first-in-class innovation is particularly concentrated on novel molecular targets that are aligned to the central sensitization associated with neuropathic pain, which is arguably the most debilitating and difficult-to-treat type of chronic pain. This gives them the potential to transform the future market by expanding the range of drug classes.

Highly Diversified Range of Innovative Programs in Early Pipeline and in Granted Patents

Pain is a complex and multifaceted disorder with a complex interplay between different pathological processes, and different pain subtypes exhibit distinct underlying etiologies and pathophysiologies. While technological advances and extensive research efforts have furthered the understanding of these complex underpinnings, gaps remain. However, these insights have translated into the expanding pool of novel therapeutic targets, as reflected by the highly innovative pipeline. GBI Research's proprietary analysis shows that early-stage, first-in-class programs exhibit a higher level of diversity with respect to novel therapeutic targets. The significant diversity in terms of targets is a reflection of the complex underpinnings of distinct pain subtypes. Although the pipeline continues to feature established therapies, the range of mechanisms of action employed by novel compounds is extremely diverse, with the vast majority residing in the Preclinical stage. This innovation and diversity is maintained throughout the pipeline from early- to late-stage development, although the degree of innovation diminishes from Phase II. Additionally, although NSAIDs and opioids remain the cornerstone of pain treatment, GBI Research analysis indicates a shift towards pain subtypes that are more difficult to treat. Encouragingly, these first-in-class compounds often target molecules which are strongly implicated in pain and its associated signaling pathways. Although there are significant differentiations in the scientific rationale and clinical prospects across these first-in-class products, the majority demonstrate significant Preclinical evidence and alignment to molecular pathophysiological changes.

In addition, GBI Research's comprehensive and complementary analysis of granted patents highlighted a significant number of first-in-class product technologies, many of which have not been identified in the pain product pipelines or even in pipelines across the industry. The distribution of these products across the molecular target superfamilies and families highlighted that they predominantly align with the proportional distribution observed across the pain pipeline, with G-protein-coupled receptors and enzymes inhibitors constituting the two major categories. However, an array of novel molecular targets within those groups has been identified, which do not present in any pipeline or marketed products across the industry. A significant degree of innovation has also been identified in other molecular target categories.

Active Deals Landscape with Numerous Investment Opportunities

The pain deals landscape has been highly active over the past eight years, with 261 licensing deals and 112 co-development deals. However, despite high levels of investment activity, deals for first-in-class products have been relatively rare.

Overall, more than 50% of deals involving first-in-class targets were settled in the early stages of development, which is a striking contrast with non-first-in-class products, which are more frequently entered into deals in the later stages of development. This reflects companies' willingness to invest despite the high-risk profile of first-in-class products.

With 107 first-in-class products available for strategic consolidations, a wide variety of investment opportunities are available for licensing deals or co-development deals in pain. This will be encouraged by the growing unmet need for chronic pain therapies, and an increased understanding of the distinct underlying pathophysiologies of distinct pain sub-types, allowed by technological advances. Among these, some first-in-class products have demonstrated promising Preclinical evidence and have significant potential to become game-changing products, representing high-reward investments.


The report covers and includes

A brief introduction to pain, including the different subtypes of pain, pathophysiology, and overview of pharmacotherapy and treatment algorithms

The changing molecular target landscape between market and pipeline and particular focal points of innovation in the pipeline

A comprehensive review of the pipeline for first-in-class therapies, analyzed on the basis of 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 on novel molecular targets

Assessment of the licensing and co-development deal landscape for pain therapies and benchmarking of deals involving first-in-class versus non-first-in-class-products

Reasons To Buy

The report will assist business development and enable marketing executives to strategize their product launches, by allowing them to

Understand the focal shifts in molecular targets in the pain therapeutics 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 pain, benchmarked against non-first-in-class targets.

Access a list of the first-in-class therapies potentially open to deal-making opportunities

1 Table of Contents

1 Table of Contents 2

1.1 List of Figures 3

2 Executive Summary 4

2.1 Large and Innovative Pipeline 4

2.2 Highly Diversified Range of Innovative Programs in Early Pipeline and in Granted Patents 4

2.3 Active Deals landscape with Numerous Investment Oppertunities 4

3 The Case for Innovation 5

3.1 Growing Opportunities for Biologic Products 6

3.2 Diversification of Molecular Targets 6

3.3 Innovative First-in-Class Product Development Remains Attractive 6

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 Disease Overview 10

4.1.1 Chronic and Neuropathic Pain 10

4.1.2 Disease Pathophysiology 11

4.1.3 Diagnosis 14

4.1.4 Treatment Option 15

4.1.5 Treatment Algorithm 16

4.2 Overview of Marketed Products for Pain 17

4.2.1 Analgesic Product Categories 17

4.2.2 Molecular Type Analysis 19

4.2.3 Molecular Target Analysis 20

4.2.4 Current Unmet Needs 22

5 Assessment of Pipeline Product Innovation 23

5.1 Pain Pipeline by Molecule Type, Phase and Therapeutic Targets 23

5.2 Comparative Distribution of Programs between the Pain Market and Pipeline by Therapeutic Target Family 27

5.3 First-in-Class Pipeline Programs 29

5.4 First-in-Class Targets by Pain Subtype 31

6 Pain Patent Analysis 34

7 First-in-Class Target and Pipeline Program Evaluation 43

7.1 Pipeline Programs Targeting Fatty Acid Amide Hydrolase 43

7.2 Pipeline Programs Targeting Purinoceptor 3 45

7.3 Pipeline Programs Targeting Purinoceptor 7 48

7.4 Pipeline Programs Targeting Purinoceptor 4 50

7.5 Pipeline Programs Targeting Orexin Receptor Type 1 51

7.6 Pipeline Programs Targeting Neuronal Nitric Oxide Synthase 53

7.7 Pipeline Programs that Target Tropomyosin-Related Kinase A 55

7.8 Pipeline Programs that Target C-C Chemokine Receptor 2 59

7.9 Pipeline Programs that Target Endomorphin 2 61

7.10 Pipeline Programs that Target Protein Kinase C? 63

7.11 Pipeline Programs that Target Opioid Receptor-Like-1 Receptor 65

7.12 Pipeline Programs that Target Bradykinin B1 Receptor 69

7.13 Pipeline Programs Targeting Galanin Receptor 2 73

7.14 Pipeline Programs Targeting Nerve Growth Factor 76

8 Deals and Strategic Consolidations 80

8.1 Industry Industry-wide First-in-Class Deals 80

8.2 Pain Deals Landscape 81

8.3 Licensing Deals 82

8.3.1 Molecule Type 84

8.3.2 Mechanism of Action 85

8.4 Co-development Deals 90

8.4.1 Molecule Type 91

8.4.2 Mechanism of Action 92

8.5 First-in-Class Programs Not Involved in Licensing or Co-Development Deals 96

9 Appendix 98

9.1 Abbreviations 98

9.2 References 99

9.3 Contact Us 106

9.4 Disclaimer 106

Figure 1: Innovation Trends in Product Approvals, 1987-2012 5

Figure 2: Sales Performance of First-in-Class and Non-First-in-Class Products Post Marketing Approval, 2006-2013 7

Figure 3: Sales Performance of Central Nervous System First-in-Class and Non-First-in-Class Products post Marketing Approval, 2006-2013 7

Figure 4: Treatment Algorithm 16

Figure 5: WHO Analgesic Ladder 17

Figure 6: Molecule Types in Marketed Products 19

Figure 7: Marketed Products, Part 2 21

Figure 8: Developmental Pipeline Overview 24

Figure 9: Developmental Pipeline Molecular Target Categories 26

Figure 10: Molecular Target Category Comparison, Pipeline and Marketed Products 28

Figure 11: Molecular Target Category Comparison, Pipeline First-in-Class and Established Molecular Targets 30

Figure 12: Total Pipeline Targets by Pain Subtype 31

Figure 13: First-in-Class Pipeline Targets by Pain Subtypes 32

Figure 14: First-in-Class Products in the Pipeline 33

Figure 15: Patent Families Filed and Granted by Year 35

Figure 16: Organizations Frequently Applying for Pain-Related Patent Families, (2008-2012) 35

Figure 17: Granted Patents by Mechanism of Action 36

Figure 18: Granted Patent Families by Molecular Target Family, 2009-2012 38

Figure 19: Molecular Targets Identified in Patents(Part 1), 2008-2012 39

Figure 20: Molecular Targets Identified in Patents(Part 2), 2008-2012 40

Figure 21: Molecular Targets Identified in Patents(Part 3), 2008-2012 41

Figure 22: Molecular Targets Identified in Patents(Part 4), 2008-2012 42

Figure 23: Data and Evidence for Fatty Acid Amide Hydrolase as a Therapeutic Target 44

Figure 24: Pipeline Programs Targeting FAAH 45

Figure 25: Data and Evidence for P2X3 as a Therapeutic Target 47

Figure 26: Pipeline Programs Targeting P2X3 48

Figure 27: Data and Evidence for P2X7 as a Therapeutic Target 49

Figure 28: Pipeline Programs Targeting P2X7 49

Figure 29: Pipeline Programs Targeting P2X4 51

Figure 30: Pipeline Programs Targeting Orexin Receptor Type 1 52

Figure 31: Pipeline Programs Targeting Orexin Receptor Type 1 53

Figure 32: Data and Evidence for Neuronal Nitric Oxide Synthase as a Therapeutic Target 55

Figure 33: Pipeline Programs Targeting Neuronal Nitric Oxide Synthase 55

Figure 34: Data and Evidence for Tropomyosin-Related Kinase A as a Therapeutic Target 58

Figure 35: Pipeline Programs Targeting Tropomyosin-Related Kinase A 59

Figure 36: Data and Evidence for C-C Chemokine Receptor 2 as a Therapeutic Target 60

Figure 37: Pipeline Programs Targeting C-C Chemokine Receptor 2 61

Figure 38: Data and Evidence for Endomorphin 2 as a Therapeutic Target 62

Figure 39: Pipeline Programs Targeting Endomorphin 2 62

Figure 40: Data and Evidence for Protein Kinase C ? as a Therapeutic Target 64

Figure 41: Pipeline Programs Targeting Protein Kinase C ? 64

Figure 42: Data and Evidence for Opioid Receptor-Like-1 Receptor as a Therapeutic Target (Part 1) 67

Figure 43: Data and Evidence for Opioid Receptor-Like-1 Receptor as a Therapeutic Target (Part 2) 68

Figure 44: Pipeline Programs Targeting Opioid Receptor-Like-1 Receptor 68

Figure 45: Data and Evidence for Bradykinin B1 Receptor as a Therapeutic Target (Part 1) 71

Figure 46: Data and Evidence for Bradykinin B1 Receptor as a Therapeutic Target (Part 2) 72

Figure 47: Data and Evidence for Bradykinin B1 Receptor as a Therapeutic Target (Part 3) 72

Figure 48: Pipeline Programs Targeting Bradykinin B1 Receptor 73

Figure 49: Data and Evidence for Galanin Receptor 2 as a Therapeutic Target 75

Figure 50: Pipeline Programs Targeting Galanin Receptor 2 76

Figure 51: Data and Evidence for Nerve Growth Factor as a Therapeutic Target 78

Figure 52: Pipeline Programs Targeting Nerve Growth Factor 79

Figure 53: Industry-wide Deals by Stage of Development, 2006-2014 80

Figure 54: Industry Licensing Deal Values by Stage of Development, 2006-2014 81

Figure 55: Licensing Deals, 2006-2015 83

Figure 56: Regional Network of Licensing Deals, 2006-2015 84

Figure 57: Licensing Deals by Molecule Type and Phase, 2006-2015 85

Figure 58: Licensing Deals by Target, 2006-2015 86

Figure 59: Summary of Licensing Deals, 2006-2015 (Part1) 87

Figure 60: Summary of Licensing Deals, 2006-2015 (Part 2) 88

Figure 61: Summary of Licensing Deals, 2006-2015 (Part 3) 89

Figure 62: Co-development Deals, 2006-2015 90

Figure 63: Regional Network of Co-development Deals, 2006-2015 91

Figure 64: Co-Development Deals by Molecule Type and Phase, 2006-2015 92

Figure 65: Co-Development Deals by Target, 2006-2015 93

Figure 66: Summary of Co-development Deals, 2006-2015 (Part 1) 94

Figure 67: Summary of Co-development Deals, 2006-2015 (Part 2) 95

Figure 68: First-in-Class Products not Involved in Prior Deals 97

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