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

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


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Executive Summary

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

Obesity is a major growing health concern around the world. In most markets, a person is considered obese if their Body Mass Index (BMI) exceeds 30 kilograms per square meter (kg/m2), calculated by dividing body mass in kilograms by height in meters squared. With the global prevalence continuing to rise, the disease has placed significant burden on healthcare expenditure, as it is also a major risk factor for cardiovascular diseases, diabetes and cancer.

Anti-obesity pharmacotherapy can be used as an adjunct lifestyle modification to improve weight loss in order to significantly reduce obesity-associated health risks in obese patients. However, the use of currently available anti-obesity drugs is largely limited by poor long-term safety and a modest weight loss effect. Despite substantial clinical and regulatory challenges, the early-stage obesity pipeline remains robust, containing a high level of first-in-class innovation that has the potential to be translated into effective and safe weight loss treatments.

Scope

Historically, the obesity market has suffered from long-term safety concerns and modest efficacy with current treatments, both of which contribute to the low prescription rate and limited widespread use.

-What are the main safety concerns that lead to significant challenges in gaining drug approval in obesity?

-Why is sustainable weight loss difficult to achieve, and what is the implication for future drug development?

Analysis reveals a high level of innovation and diversity in the pipeline, with 75 first-in-class programs identified to act on 60 unique molecular targets.

-What is the dominant target family across these first-in-class pipeline products?

-How well do they align with the underlying signaling pathways governing the central and peripheral regulation of food intake, and energy expenditure?

Some first-in-class targets are deemed more likely to be developed into marketable treatments than others, having demonstrated substantial body weight reduction in Preclinical studies and addressing multiple mechanisms underpinning the development of obesity.

-What is the scientific rationale behind these targets? How are they likely to surpass existing treatment?

-Apart from body weight change, what other parameters are commonly used to measure the effect of investigational therapies?

Deals involving first-in-class obesity products are more likely to be made in earlier stages of development than non-first-in-class deals, supported by industry-wide analysis.

-What is the dominant molecular target in the obesity deals landscape?

-What are the promising first-in-class products still available for future licensing?

Reasons To Buy

This report will allow you to

Understand the current clinical and commercial landscape by considering disease pathogenesis, diagnosis, prognosis, and the available treatment options and their limitations in terms of safety and efficacy.

Visualize the composition of the obesity market to highlight the current unmet needs in order to gain a competitive understanding of the key opportunities.

Analyze the obesity pipeline and stratify by stage of development, molecule type, and molecular target; the diversity of molecular targets in the pipeline is extremely encouraging as obesity is characterized by the complex interplay between central and peripheral mechanisms.

Assess the therapeutic potential of first-in-class targets using a proprietary matrix that assesses and ranks first-in-class products according to clinical potential.

Target the most promising and innovative obesity products for early-stage investment by analyzing trends in licensing and co-development deals and accessing a curated list of first-in-class therapies potentially open to deal-making opportunities.

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 3

1.2 List of Figures 3

2 Executive Summary 4

2.1 High Unmet Need Remains in the Obesity Market 4

2.2 Highly Innovative and Diverse Pipeline 4

2.3 Deals Landscape Presents Substantial Investment Opportunities 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 Developments Remain Attractive 6

3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation 7

3.5 Sustained Innovation 7

3.6 GBI Research Report Guidance 8

4 Clinical and Commercial Landscape 9

4.1 Disease Overview 9

4.2 Disease Etiology 9

4.2.1 Genetics 9

4.3 Disease Pathophysiology 10

4.3.1 Central Regulation of Energy Homeostasis 10

4.3.2 Endocrine Regulation in Energy Balance 11

4.3.3 Adipose Tissue and Regulation of Energy Expenditure 11

4.3.4 Dysregulation of Adipokines and Contribution to Obesity and Related Metabolic Disorders 12

4.4 Epidemiology 13

4.5 Classification and Diagnosis 13

4.6 Co-morbidities 14

4.6.1 Type 2 Diabetes 14

4.6.2 Hypertension 14

4.6.3 Dyslipidemia and Cardiovascular Diseases 14

4.6.4 Respiratory Complications 14

4.6.5 Osteoarthritis 14

4.6.6 Cancer Risk 14

4.7 Prognosis 15

4.8 Treatment Algorithm and Options 15

4.8.1 Lifestyle and Behavioral Modification 15

4.8.2 Bariatric Surgery 15

4.8.3 Pharmacotherapy 16

4.9 Overview of Marketed Products 18

4.9.1 Molecule Type and Target Analysis 19

4.9.2 Major Drug Withdrawals in the Obesity Market 20

4.9.3 Significant Challenges with Reimbursement in the Obesity Market 20

4.10 Current Unmet Needs 21

5 Assessment of Pipeline Product Innovation 22

5.1 Obesity Pipeline by Molecule Type, Phase and Therapeutic Target 22

5.2 Comparative Distribution of Programs between Obesity Market and Pipeline by Therapeutic Target Family 26

5.3 First-in-Class Pipeline Programs Targeting Novel Molecular Targets 27

6 Signaling Pathways, Genetics and Innovation Alignment 31

6.1 The Complexity of Signaling Networks in Obesity 31

6.2 Signaling Pathways, Genetic Risk Factors and First-in-Class Molecular Target Integration 32

6.3 First-in-Class Target Matrix Assessment 34

7 First-in-Class Target Evaluation 37

7.1 Pipeline Programs Targeting Growth Hormone Secretagogue Receptor 1a and Ghrelin 37

7.2 Pipeline Programs Targeting Neuropeptide Y Receptor 2 40

7.3 Pipeline Programs Targeting Neuropeptide Y Receptor 1 43

7.4 Pipeline Programs Targeting Adipocyte Fatty Acid Binding Protein 4 45

7.5 Pipeline Programs Targeting Sterol Regulatory Element-Binding Protein 1 and 2 47

7.6 Pipeline Programs Targeting Glycoprotein 130 Receptor 49

7.7 Pipeline Programs Targeting Bombesin Receptor Subtype 3 52

7.8 Pipeline Programs Targeting Acetyl-CoA Carboxylase 1 and 2 54

7.9 Pipeline Programs Targeting Stearoyl-CoA Desaturase 1 56

7.10 Pipeline Programs Targeting Bone Morphogenetic Protein-7 59

7.11 Conclusion 62

8 Deals and Strategic Consolidations 63

8.1 Industry-Wide First-in-Class Deals 63

8.2 Licensing Deals 65

8.3 Co-development Deals 72

8.4 First-in-Class Programs Not Involved in Licensing or Co-Development Deals 77

9 Appendix 79

9.1 Abbreviations 79

9.2 References 80

9.3 Methodology 87

9.4 Secondary Research 87

9.5 Contact Us 87

9.6 Disclaimer 87

1.1 List of Tables

Table 1: The International Classification of Underweight, Overweight and Obesity in Adults 13

Table 2: Treatment Options Dependent on Body Mass Index 15

1.2 List of Figures

Figure 1: Innovation Trends in Product Approvals, 1987-2013 5

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

Figure 3: Molecular Targets of Marketed Products, 2015 19

Figure 4: Developmental Pipeline Overview 23

Figure 5: Players in the Obesity Pipeline 24

Figure 6: Developmental Pipeline Overview 25

Figure 7: Molecular Target Category Comparison, Pipeline and Marketed Products 26

Figure 8: Molecular Target Category Comparison, Pipeline First-in-Class and Established Molecular Targets 28

Figure 9: Obesity, Global, First-in-Class Pipeline Products 29

Figure 10: Signaling Networks of Functional Families in Obesity 33

Figure 11: Location of Key First-in-Class Targets within the Signaling Matrix 34

Figure 12: First-in-Class Molecular Target Analysis Matrix 36

Figure 13: Data and Evidence for Growth Hormone Secretagogue Receptor 1a as a Therapeutic Target 39

Figure 14: Pipeline Programs Targeting Growth Hormone Secretagogue Receptor 1a and Ghrelin 40

Figure 15: Data and Evidence for Neuropeptide Y Receptor 2 as a Therapeutic Target 42

Figure 16: Pipeline Programs Targeting Neuropeptide Y Receptor 2 42

Figure 17: Data and Evidence for Neuropeptide Y Receptor 1 as a Therapeutic Target 44

Figure 18: Pipeline Programs Targeting Neuropeptide Y Receptor 1 44

Figure 19: Data and Evidence for Adipocyte Fatty Acid Binding Protein 4as a Therapeutic Target 46

Figure 20: Pipeline Programs Targeting Adipocyte Fatty Acid Binding Protein 4 46

Figure 21: Data and Evidence for Sterol Regulatory Element-Binding Protein 1 and 2 as a Therapeutic Target 48

Figure 22: Pipeline Programs Targeting Sterol Regulatory Element-Binding Protein 1 and 2 49

Figure 23: Data and Evidence for Glycoprotein 130 Receptor as a Therapeutic Target 51

Figure 24: Pipeline Programs Targeting Glycoprotein 130 Receptor 52

Figure 25: Data and Evidence for Bombesin Receptor Subtype 3 as a Therapeutic Target 53

Figure 26: Pipeline Programs Targeting Bombesin Receptor Subtype 3 53

Figure 27: Data and Evidence for Acetyl-CoA Carboxylase 1 and 2 as a Therapeutic Target 55

Figure 28: Pipeline Programs Targeting Acetyl-CoA Carboxylase 1 and 2 56

Figure 29: Data and Evidence for Stearoyl-CoA Desaturase 1 as a Therapeutic Target 58

Figure 30: Pipeline Programs Targeting Stearoyl-CoA Desaturase 1 58

Figure 31: Data and Evidence for Bone Morphogenetic Protein-7 as a Therapeutic Target 61

Figure 32: Pipeline Programs Targeting Bone Morphogenetic Protein-7 62

Figure 33: Industry-Wide Deals by Stage of Development, 2006-2014 63

Figure 34: Industry-Wide Deals by Stage of Development, 2006-2014 64

Figure 35: Licensing Deals in Obesity, 2006-2015 66

Figure 36: Licensing Deals, Global Distribution, 2006-2015 67

Figure 37: Licensing Deals by Molecule Type and Value, 2006-2015 68

Figure 38: Licensing Deals by Molecular Target, 2006-2015 70

Figure 39: Summary of Licensing Deals in Obesity, 2006-2015 71

Figure 40: Co-development Deals in Obesity, 2006-2015 73

Figure 41: Co-development Deals Global Distribution, 2006-2015 74

Figure 42: Co-development Deals by Molecule Type, 2006-2015 75

Figure 43: Co-development Deals by Molecular Target, 2006-2015 75

Figure 44: Summary of Co-Development Deals in Obesity, 2006-2015 76

Figure 45: First-in-Class Programs with No Recorded Prior Deal Involvement, 2006-2015 78

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