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

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.

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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.

Scope

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

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Table of Content

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

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