Frontier Pharma: Type 2 Diabetes Mellitus – Therapies Targeting GPCRs and Protein Kinases Dominate Pipeline, with Strong Repositioning Opportunities into Associated Areas, Including Obesity and Cardiovascular Disease

Type 2 diabetes mellitus (T2DM) is a major metabolic disease and one of the leading causes of death worldwide. The prevalence is on the rise, alongside increases in obesity due to lifestyle changes in the 21st century.

Type 2 diabetes is characterized by insulin resistance leading to dysregulation of glucose control and chronic hyperglycemia. This leads to several co-morbidities and complications, some of which are associated with damage to blood vessels as a result of elevated blood glucose levels.

The disease is progressive: patients’ standard of living deteriorate over time and the symptoms worsen, meaning more complex treatment regimens are required over time.

The complexity of the treatment means there is a high diversity of marketed products. In recent years new drug types have been great commercial successes and reached blockbuster status.

This alongside the financial cost of type 2 diabetes to healthcare providers has led to significant investment in R&D on therapeutics in this area.

Scope

– Requirement for new types of therapeutics to add to already complex treatment algorithms for severe T2DM

– What are the most important etiological risk factors and pathophysiological processes implicated in T2DM?

– What is the current treatment algorithm?

– How effective are current therapies for these indications, and how does this impact prognosis? What are the side effects associated with these treatments?

– The T2DM pipeline is dominated by G-protein-coupled receptors (GPCRs) and protein kinases

– Which molecule types and molecular targets are most prominent in the T2DM pipeline?

– Which first-in-class targets are most promising?

– How does the level of first-in-class innovation change within different target classes?

– How does first-in-class target diversity differ by stage of development and molecular target class?

– The deals landscape is active and dominated by products that target GPCRS and protein kinases

– Which molecular types/molecular target groups attract the highest deal values?

– How has deal activity fluctuated over the past decade?

– Which first-in-class pipeline products have no prior involvement in licensing or co-development deals?

Reasons to buy

- Appreciate the current clinical and commercial landscapes by considering disease pathogenesis, etiology, epidemiology, symptoms, and diagnosis and treatment options.

- Identify leading products and key unmet needs within the market.

- Recognize innovative pipeline trends by analyzing therapies by stage of development, molecule type and molecular target.

- Assess the therapeutic potential of first-in-class targets. Using proprietary matrix assessments, first-in-class targets in the pipeline have been assessed and ranked according to clinical potential. Individual matrix assessments are provided for targets identified in the pipeline for T2DM. Promising early-stage first-in-class targets are reviewed in greater detail.

- Consider first-in-class pipeline products with no prior involvement in licensing and co-development deals that may represent potential investment opportunities.

Table of Contents

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 4

1.2 List of Figures 4

2 Executive Summary 6

2.1 Competitive Market Landscape Driven by Rising Prevalence 6

2.2 Large and Diverse Pipeline Dominated by Products Acting on G Protein Coupled Receptors (GPCR) and Protein Kinases 6

2.3 Strong Opportunities for Investment in First-in-Class Products 6

3 The Case for Innovation 7

3.1 Growing Opportunities for Biologic Products 7

3.2 Diversification of Molecular Targets 8

3.3 Innovative First-in-Class Product Developments Remain Attractive 8

3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Innovation 9

3.5 Sustained Innovation in Type 2 Diabetes Mellitus 9

4 Clinical and Commercial Landscape 10

4.1 Overview of Type 2 Diabetes Mellitus 10

4.2 Disease Classification 10

4.2.1 Type 1 Diabetes Mellitus 10

4.2.2 Type 2 Diabetes Mellitus 11

4.2.3 Type 3 Diabetes Mellitus 11

4.2.4 LADA 11

4.2.5 MODY 11

4.2.6 Gestational 11

4.2.7 Pancreatic diabetes 11

4.2.8 Prediabetes 11

4.3 Symptoms 11

4.4 Diagnosis 12

4.5 Etiology 12

4.6 Pathophysiology 13

4.7 Comorbidities and Complications 14

4.8 Epidemiology 15

4.9 Treatment 16

4.9.1 Non-Insulin T2DM Therapies 17

4.9.2 Insulin-Based T2DM Therapies 19

4.10 Overview of Marketed Products 20

4.11 Unmet Need and Commercial Opportunities in T2DM 22

5 Assessment of Pipeline Product Innovation 23

5.1 Overview 23

5.2 Pipeline by Stage of Development and Molecule Type 23

5.3 Pipeline by Molecular Target 24

5.4 Comparative Distribution of Programs between the Market and Pipeline by Molecular Target Class 26

5.5 Comparative Distribution of First-in-Class and Non-First-in-Class Pipeline Programs by Molecular Target Class 27

5.6 Ratio of First-in-Class Programs to First-in-Class Molecular Targets within the Pipeline 28

5.7 List of All First-in-Class Pipeline Programs 30

6 Signaling Network, Disease Causation and Innovation Alignment 39

6.1 Complexity of Signaling Networks in Type 2 Diabetes Mellitus 39

6.2 Signaling Pathways, Disease-Causing Mutations and First-in-Class Molecular Target Integration 39

6.3 First-in-Class Molecular Target Matrix Assessment 39

7 First-in-Class Molecular Target Evaluation 44

7.1 Pipeline Programs Targeting G Protein Coupled Receptor Kinase 5 (GRK5) 44

7.2 Pipeline Programs Targeting Gastric Inhibitory Polypeptide Receptors (GIPR) 45

7.3 Pipeline Programs Targeting Bone Morphogenetic Protein Receptor Type 1A (BMPR1A), Bone Morphogenetic Protein Receptor Type 1B (BMPR1B) and Bone Morphogenetic Protein Receptor Type 2 (BMPR2) 46

7.4 Pipeline Programs Targeting Solute Carrier Family 13 Member 5 (SLC13A5) 48

7.5 Pipeline Programs Targeting N Formyl Peptide Receptor 3 (FPR3) and N Formyl Peptide Receptor 2 (FPR2) 49

7.6 Pipeline Programs Targeting Neuromedin U receptor 2 (NMUR2) and Neuromedin U receptor 1 (NMUR1) 50

7.7 Pipeline Programs Targeting Peptide YY (PYY) 51

7.8 Pipeline Programs Targeting Apelin Receptor (APLNR) 52

7.9 Pipeline Programs Targeting Insulin Receptor Substrate (IRS1) and Insulin Receptor Substrate (IRS2) 53

7.10 Conclusion 56

8 Strategic Consolidations 57

8.1 Industry-Wide First-in-Class Deals 57

8.2 Licensing Deals 58

8.2.1 Deals by Region, Value and Year 58

8.2.2 Deals by Stage of Development and Value 59

8.2.3 Deals by Molecule Type and Molecular Target 59

8.2.4 List of Deals with Disclosed Deal Values 60

8.3 Co-development Deals 62

8.3.1 Deals by Region, Value and Year 62

8.3.2 Deals by Stage of Development and Value 62

8.3.3 Deals by Molecule Type and Molecular Target 63

8.3.4 List of Deals with Disclosed Deal Values 64

8.4 First-in-Class Programs with and without Prior Licensing or Co-development Deal Involvement 65

9 Appendix 69

9.1 References 69

9.2 Abbreviations 74

9.3 Methodology 75

9.3.1 Data Integrity 75

9.3.2 Innovative and Meaningful Analytical Techniques and Frameworks 75

9.3.3 Evidence Based Analysis and Insight 75

9.4 Secondary Research 75

9.4.1 Market Analysis 76

9.4.2 Pipeline Analysis 76

9.4.3 Licensing and Co-development Deals 77

9.5 Contact Us 77

9.6 Disclaimer 77

List of Tables

1.1 List of Tables

Table 1: Type 2 Diabetes Mellitus, Global, Related Indications of T2DM First-in-Class Products, 2018 40

Table 2: Type 2 Diabetes Mellitus, Global, Key Features of G Protein Coupled Receptor Kinase 5 (GRK5), 2018 44

Table 3: Type 2 Diabetes Mellitus, Global, Pipeline Programs Targeting G Protein Coupled Receptor Kinase 5 (GRK5), 2018 44

Table 4: Type 2 Diabetes Mellitus, Global, Key Features of Gastric Inhibitory Polypeptide Receptor (GIPR), 2018 45

Table 5: Type 2 Diabetes Mellitus, Global, Pipeline Programs Targeting Gastric Inhibitory Polypeptide Receptor (GIPR), 2018 46

Table 6: Type 2 Diabetes Mellitus, Global, Key Features of Bone Morphogenetic Protein Receptor Type 1A (BMPR1A), 2018 47

Table 7: Type 2 Diabetes Mellitus, Global, Key Features of Bone Morphogenetic Protein Receptor Type 1B (BMPR1B), 2018 47

Table 8: Type 2 Diabetes Mellitus, Global, Key Features of Bone Morphogenetic Protein Receptor Type 2 (BMPR2), 2018 47

Table 9: Type 2 Diabetes Mellitus, Global, Pipeline Programs Targeting Bone Morphogenetic Protein Receptor Type 1A (BMPR1A), Bone Morphogenetic Protein Receptor Type 1B (BMPR1B) and Bone Morphogenetic Protein Receptor Type 2 (BMPR2), 2018 48

Table 10: Type 2 Diabetes Mellitus, Global, Key Features of Solute Carrier Family 13 Member 5 (SLC13A5), 2018 48

Table 11: Type 2 Diabetes Mellitus, Global, Pipeline Programs Targeting Solute Carrier Family 13 Member 5 (SLC13A5), 2018 49

Table 12: Type 2 Diabetes Mellitus Drugs Market, Global, Pipeline Programs Targeting N-Formyl Peptide Receptor 2 (FPR2) and N-Formyl Peptide Receptor 3 (FPR3), 2018 49

Table 13: Type 2 Diabetes Mellitus Drugs Market, Global, Pipeline Programs Targeting N-Formyl Peptide Receptor 2 (FPR2) and N-Formyl Peptide Receptor 3 (FPR3) , 2018 50

Table 14: Type 2 Diabetes Mellitus, Global, Key Features of Neuromedin U Receptor 1 (NMUR1), 2018 51

Table 15: Type 2 Diabetes Mellitus, Global, Key Features of Neuromedin U Receptor 2 (NMUR2), 2018 51

Table 16: Type 2 Diabetes Mellitus, Global, Global, Pipeline Programs Targeting Neuromedin U Receptor 2 (NMUR2), 2018 51

Table 17: Type 2 Diabetes Mellitus Drugs Market, Global, Key Features of Targeting Peptide YY (PYY), 2018 52

Table 18: Type 2 Diabetes Mellitus Drugs Market, Global, Pipeline Programs Targeting Peptide YY (PYY), 2018 52

Table 19: Type 2 Diabetes Mellitus, Global, Key Features of Apelin Receptor (APLNR), 2018 53

Table 20: Type 2 Diabetes Mellitus, Global, Pipeline Programs Targeting Apelin Receptor (APLNR), 2018 53

Table 21: Type 2 Diabetes Mellitus, Global, Key Features of Insulin Receptor Substrate 1 (IRS1), 2018 54

Table 22: Type 2 Diabetes Mellitus, Global, Key Features of Insulin Receptor Substrate 2 (IRS2), 2018 55

Table 23: Type 2 Diabetes Mellitus, Global, Pipeline Programs Targeting Insulin Receptor Substrate 1 (IRS1), 2018 55

Table 24: Type 2 Diabetes Mellitus, Global, Pipeline Programs Targeting Insulin Receptor Substrate 2 (IRS2), 2018 55

List of Figures

1.2 List of Figures

Figure 1: Type 2 Diabetes Mellitus, Global, Innovation Trends in Product Approvals Across the Pharmaceutical Market, 1987-2014 7

Figure 2: Type 2 Diabetes Mellitus, Global, Post-Marketing-Approval Sales Performance of First-in-Class and Non-First-in-Class Products Across Pharmaceutical Industry ($m), 2006-2013 8

Figure 3: Type 2 Diabetes Mellitus, Global, Market by Molecule Type and Molecular Target, 2018 21

Figure 4: Type 2 Diabetes Mellitus, Global, Pipeline Size by Therapy Area, 2018 23

Figure 5: Type 2 Diabetes Mellitus, Global, Pipeline by Stage of Development and Molecule Type, 2018 24

Figure 6: Type 2 Diabetes Mellitus, Global Pipeline by Molecular Target and Stage of Development, 2018 25

Figure 7: Type 2 Diabetes Mellitus, Global, Pipeline Breakdown of GPCR and Protein Kinase Molecular Target Class, 2018 25

Figure 8: Type 2 Diabetes Mellitus, Global, Distribution of Pipeline and Marketed Products by Molecular Target Class, 2018 26

Figure 9: Type 2 Diabetes Mellitus, Global, Distribution of Pipeline Products by First-in-Class Status and Molecular Target Class, 2018 27

Figure 10: Type 2 Diabetes Mellitus, Global, Percentage Distribution of First-in-Class and Non-First-in-class Pipeline Programs by Stage of Development and Molecular Target Class, 2018 28

Figure 11: Type 2 Diabetes Mellitus, Global, Ratio of First-in-Class Products to First-in-Class Targets by Stage of Development and Molecular Target Class, 2018 29

Figure 12: Type 2 Diabetes Mellitus, Global, All First-in-Class Pipeline Programs, 2018 (part 1) 30

Figure 13: Type 2 Diabetes Mellitus, Global, All First-in-Class Pipeline Programs, 2018 (part 2) 31

Figure 14: Type 2 Diabetes Mellitus, Global, All First-in-Class Pipeline Programs, 2018 (part 3) 32

Figure 15: Type 2 Diabetes Mellitus, Global, All First-in-Class Pipeline Programs, 2018 (part 4) 33

Figure 16: Type 2 Diabetes Mellitus, Global, All First-in-Class Pipeline Programs, 2018 (part 5) 34

Figure 17: Type 2 Diabetes Mellitus, Global, All First-in-Class Pipeline Programs, 2018 (part 6) 34

Figure 18: Type 2 Diabetes Mellitus, Global, All First-in-Class Pipeline Programs, 2018 (part 7) 35

Figure 19: Type 2 Diabetes Mellitus, Global, All First-in-Class Pipeline Programs, 2018 (part 8) 35

Figure 20: Type 2 Diabetes Mellitus, Global, All First-in-Class Pipeline Programs, 2018 (part 9) 36

Figure 21: Type 2 Diabetes Mellitus, Global, All First-in-Class Pipeline Programs, 2018 (part 10) 36

Figure 22: Type 2 Diabetes Mellitus, Global, All First-in-Class Pipeline Programs, 2018 (part 11) 37

Figure 23: Type 2 Diabetes Mellitus, Global, All First-in-Class Pipeline Programs, 2018 (part 12) 38

Figure 24: Type 2 Diabetes Mellitus, Global, First-in-Class Molecular Target Matrix Assessment for Type 2 Diabetes Mellitus, 2018 (part 1) 41

Figure 25: Type 2 Diabetes Mellitus, Global, First-in-Class Molecular Target Matrix Assessment for Type 2 Diabetes Mellitus, 2018 (part 2) 42

Figure 26: Type 2 Diabetes Mellitus, Global, First-in-Class Molecular Target Matrix Assessment for Type 2 Diabetes Mellitus, 2018 (part 2) 43

Figure 27: Type 2 Diabetes Mellitus, Global, Industry-Wide Licensing Deals by First-in-Class Status and Stage of Development, 2006-2015 57

Figure 28: Type 2 Diabetes Mellitus, Global, Industry-Wide Licensing Deals by First-in-Class Status, Deal Value, Upfront Payment Value and Stage of Development, 2006-2014 58

Figure 29: Type 2 Diabetes Mellitus, Global Licensing Deals by Region, Value and Year 2006-2018 59

Figure 30: Type 2 Diabetes Mellitus, Global, Licensing Deals by Deal Value, Upfront Payment Value and Stage of Development, 2006-2018 59

Figure 31: Type 2 Diabetes Mellitus, Global, Number and Aggregate Deal Value of Licensing Deals by Molecule Type and Molecular Target Class, 2006-2018 60

Figure 32: Type 2 Diabetes Mellitus, Global, Licensing Deals with Disclosed Deal Values, 2006-2018 61

Figure 33: Type 2 Diabetes Mellitus, Global, Co-development Deals by Region, Value and Year 2006-2018 62

Figure 34: Type 2 Diabetes Mellitus, Global, Number and Aggregate Deal Value of Co-development Deals By Stage of Development and Year, 2006-2018 63

Figure 35: Type 2 Diabetes Mellitus, Global, Co-development Deals by Deal Value, Upfront Payment Value and Stage of Development, 2006-2018 64

Figure 36: Type 2 Diabetes Mellitus, Global, Co-development Deals with Disclosed Deal Values, 2006-2018 65

Figure 37: Type 2 Diabetes Mellitus, Global, First-in-Class Programs with and without Prior Involvement in Licensing or Co-development Deals, 2006-2018 (part 1) 66

Figure 38: Type 2 Diabetes Mellitus, Global, First-in-Class Programs with and without Prior Involvement in Licensing or Co-development Deals, 2006-2018 (part 2) 67

Figure 39: Type 2 Diabetes Mellitus, Global, First-in-Class Programs with and without Prior Involvement in Licensing or Co-development Deals, 2006-2018 (part 3) 68

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