Frontier Pharma: Women’s Health – An Expanding Therapy Area, with Endometriosis Therapies Prominent among the First-in-Class Pipeline

The women’s health therapy area covers medical disorders that affect females only, primarily disorders of the female reproductive system, including those associated with menstruation, conception, pregnancy, childbirth and menopause. Many of these disorders are highly prevalent among the female population.

Despite this, the women’s health market is relatively small. This reflects diagnostic barriers and high levels of non-treatment for women’s health disorders, as well as high levels of genericization and relatively limited innovation within recent decades.

Consequently, there is strong rationale for continued R&D investment in women’s health therapeutics due to high levels of unmet need across many indications.

This report assesses first-in-class innovation across the women’s health therapy area, with a particular focus on three key indications: endometriosis, polycystic ovarian syndrome (PCOS) and cervical intraepithelial neoplasia (CIN).

Scope

– Many women’s health disorders are highly prevalent. How do epidemiology trends vary for endometriosis, PCOS and CIN?

– Innovation within women’s health has been relatively limited over recent decades. What are the most prominent unmet needs across this therapy area?

– There are 261 pipeline programs in active development for women’s health. What proportion of these products are first-in-class? How does first-in-class innovation vary by indication, development stage and molecular target class?

– Although the first-in-class pipeline is relatively modest in size it is considerably diverse with eight distinct molecular target classes represented. Which first-in-class targets have been identified as most promising for women’s health conditions?

– Over 200 licensing deals relating to women’s health have been completed since 2006. Do women’s health products typically attract high deal values? Which first-in-class products have prior deal involvement?

Reasons to buy

- Understand the current clinical and commercial landscape. This includes a comprehensive study of symptoms, epidemiology, etiology, pathophysiology, co-morbidities and complications, diagnosis and treatment options.

- Visualize the composition of the women’s health market in terms of dominant molecule types and molecular targets, highlighting what the current unmet needs are and how they can be addressed. This knowledge allows a competitive understanding of gaps in the current market.

- Analyze the women’s health pipeline and stratify by stage of development, molecule type and molecular target.

- 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 first-in-class targets have been reviewed in greater detail.

- Recognize commercial opportunities in the women’s health deals landscape by analyzing trends in licensing and co-development deals, and identifying women’s health therapies that have not yet been involved in deals and may offer potential investment opportunities.

Table of Contents

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 Expanding Pipeline Has Potential to Address Unmet Needs of Large Prevalence Population 6

2.2 First-in-Class Innovation Concentrated Across Endometriosis, Polycystic Ovarian Syndrome and Cervical Intraepithelial Neoplasia 6

2.3 Despite High Licensing Deal Activity, Most First-in-Class Products Have No Prior Deal Involvement 6

3 The Case for Innovation 7

3.1 Growing Opportunities for Biologic Products 8

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 Product Innovation 9

3.5 Sustained Innovation in Women’s Health 9

3.6 GBI Research Report Guidance 10

4 Clinical and Commercial Landscape 11

4.1 Therapy Area Overview 11

4.2 Disease Overview and Symptoms 11

4.2.1 Endometriosis 11

4.2.2 Polycystic Ovarian Syndrome 12

4.2.3 Cervical Intraepithelial Neoplasia 12

4.3 Diagnosis 13

4.3.1 Endometriosis 13

4.3.2 Polycystic Ovarian Syndrome 13

4.3.3 Cervical Intraepithelial Neoplasia 14

4.4 Epidemiology and Etiology 14

4.4.1 Endometriosis 14

4.4.2 Polycystic Ovarian Syndrome 15

4.4.3 Cervical Intraepithelial Neoplasia 16

4.5 Pathophysiology 16

4.5.1 Endometriosis 16

4.5.2 Polycystic Ovarian Syndrome 17

4.5.3 Cervical Intraepithelial Neoplasia 18

4.6 Co-morbidities and Complications 18

4.6.1 Endometriosis 18

4.6.2 Polycystic Ovarian Syndrome 19

4.6.3 Cervical Intraepithelial Neoplasia 19

4.7 Treatment 19

4.7.1 Treatment Options 19

4.7.2 Treatment Algorithms 23

4.8 Overview of Marketed Products within Women’s Health 24

5 Pipeline Assessment 26

5.1 Overview 26

5.2 Pipeline by Stage of Development and Molecule Type 26

5.3 Pipeline by Molecular Target 29

5.4 Comparative Distribution of Programs between the Market and Pipeline by Molecular Target Class 32

5.5 First-in-Class Programs Targeting Novel Molecular Targets 33

5.6 Ratio of First-in-Class Products to First-in-Class Targets 35

5.7 List of All Pipeline Products 36

6 Signalling Network, Disease Causation and Innovation Alignment 46

6.1 Complexity of Signaling Networks 46

6.2 Signaling Pathways and First-in-Class Molecular Target Integration 46

6.3 First-in-Class Matrix Assessments 46

7 First-in-Class Target Evaluation 50

7.1 First-in-Class Programs Targeting Prostaglandin E2 Receptor EP4 Subtype (PTGER4) for Endometriosis 50

7.2 First-in-Class Programs Targeting Patatin-Like Phospholipase Domain Containing Protein 2 (PNPLA2) for Endometriosis, PCOS and Ovarian Hyperstimulation Syndrome 51

7.3 First-in-Class Programs Targeting Glutamyl Aminopeptidase (ENPEP) for Endometriosis 53

7.4 First-in-Class Programs Targeting Prostaglandin E Synthase (PTGES) for Endometriosis 54

7.5 First-in-Class Programs Targeting Kiss 1 Receptor (KISS1R) for Endometriosis, PCOS and Infertility 55

7.6 First-in-Class Programs Targeting Interleukin-1 Receptor Associated Kinase 4 (IRAK4) for Endometriosis 57

7.7 First-in-Class Programs Targeting Type 2 Angiotensin II Receptor (AGTR2) for PCOS 58

7.8 First-in-Class Programs Targeting Neuromedin K Receptor (TACR3) for PCOS, Endometriosis, Uterine Fibroids and Vasomotor Symptoms of Menopause 59

7.9 First-in-Class Programs Targeting Eukaryotic Translation Initiation Factor 2 Alpha Kinase 3 (EIF2AK3) for CIN 61

7.10 First-in-Class Programs Targeting Human Papillomavirus Protein E6 (E6) and Human Papillomavirus Protein E7 for CIN 62

8 Strategic Consolidations 65

8.1 First-in-Class Products with and without Prior Deal Involvement in Licensing and Co-development Deals 65

8.1.1 Industry-Wide First-in-Class Deals 65

8.2 Licensing Deals 67

8.2.1 Deals by Region, Value and Year 67

8.2.2 Deals by Stage of Development and Value 68

8.2.3 Deals by Molecule Type, Molecular Target and Value 68

8.2.4 List of Deals with Disclosed Deal Values 69

8.3 Co-Development Deals 71

8.3.1 Deals by Region, Value and Year 71

8.3.2 Deals by Stage of Development and Molecule Type 72

8.3.3 Deals by Molecule Type, Molecular Target and Aggregate Deal value 73

8.3.4 List of Deals with Disclosed Deal Values 74

8.4 First-in-Class Programs with and without Prior Deal Involvement 74

9 Appendix 77

9.1 References 77

9.2 Abbreviations 83

9.3 Pipeline Disease List 84

9.4 Research Methodology 84

9.4.1 Data integrity 84

9.4.2 Innovative and meaningful analytical techniques and frameworks 84

9.4.3 Evidence based analysis and insight 84

9.5 Secondary Research 85

9.5.1 Market Analysis 85

9.5.2 Pipeline Analysis 85

9.5.3 Licensing and Co-development Deals 86

9.6 Contact Us 86

9.7 Disclaimer 86

List of Tables

1.1 List of Tables

Table 1: Women’s Health, Global, Classification of CIN, 2018 12

Table 2: Women’s Health, Global, PCOS Diagnostic Criteria for NIH, Rotterdam and AE-PCOS Classification Systems, 2018 14

Table 3: Women’s Health, Global, Types of Female Contraceptives, 2018 20

Table 4: Women’s Health, Global, Key Details of Prostaglandin E2 Receptor EP4 Subtype (PTGER4), 2018 51

Table 5: Women’s Health, Global, Pipeline Programs Targeting Prostaglandin E2 Receptor EP4 Subtype (PTGER4), 2018 51

Table 6: Women’s Health, Global, Key Details of Patatin-Like Phospholipase Domain Containing Protein 2 (PNPLA2), 2018 52

Table 7: Women’s Health, Global, Women’s Health, Global, Pipeline Programs Patatin-like Phospholipase Domain Containing Protein 2 (PNPLA2), 2018 52

Table 8: Women’s Health, Global, Key Details of Glutamyl Aminopeptidase (ENPEP), 2018 53

Table 9: Women’s Health, Global, Pipeline Programs Targeting Glutamyl Aminopeptidase (ENPEP), 2018 53

Table 10: Women’s Health, Global, Key Details of Prostaglandin E synthase (PTGES), 2018 55

Table 11: Women’s Health, Global, Pipeline Programs Targeting Prostaglandin E synthase (PTGES), 2018 55

List of Figures

1.2 List of Figures

Figure 1: Women’s Health, US, Innovation Trends in Product Approvals, 1987-2014 7

Figure 2: Women’s Health, US, Sales Performance of First-in-Class and Non-First-in-Class Products Post Marketing Approval, 2006-2013 9

Figure 3: Women’s Health, Global, Market by Molecule Type, 2018 24

Figure 4: Women’s Health, Global, Market by Molecular Target, 2018 25

Figure 5: Women’s Health, Global, Overall Pharmaceutical Industry Pipeline by Therapy Area, 2018 26

Figure 6: Women’s Health, Global, Pipeline by Stage of Development and Molecule Type, 2018 27

Figure 7: Women’s Health, Global, Key Indications by Stage of Development, 2018 28

Figure 8: Women’s Health, Global, Key Indications by Molecule Type, 2018 29

Figure 9: Women’s Health, Global, Pipeline by Molecular Target, 2018 30

Figure 10: Women’s Health, Global, Breakdown of Key Molecular Target Classes, 2018 31

Figure 11: Women’s Health, Global, Key Indications by Molecular Target Class, 2018 32

Figure 12: Women’s Health, Global, Pipeline and Marketed Products by Molecular Target Class, 2018 33

Figure 13: Women’s Health, Global, Pipeline by Molecular Target Class, First-in-Class Status and Stage of Development, 2018 34

Figure 14: Women’s Health, Global, Percentage Distribution of First-in-Class and Non-First-in-Class Products by Stage of Development and Molecular Target Class, 2018 35

Figure 15: Women’s Health, Global, Ratio of First-in-Class Products to First-in-Class Targets by Stage of Development and Molecular Target Class, 2018 36

Figure 16: Women’s Health, Global, List of All Pipeline Products, 2018 (part 1) 37

Figure 17: Women’s Health, Global, List of All Pipeline Products, 2018 (part 2) 38

Figure 18: Women’s Health, Global, List of All Pipeline Products, 2018 (part 3) 39

Figure 19: Women’s Health, Global, List of All Pipeline Products, 2018 (part 4) 40

Figure 20: Women’s Health, Global, List of All Pipeline Products, 2018 (part 5) 41

Figure 21: Women’s Health, Global, List of All Pipeline Products, 2018 (part 6) 42

Figure 22: Women’s Health, Global, List of All Pipeline Products, 2018 (part 7) 43

Figure 23: Women’s Health, Global, List of All Pipeline Products, 2018 (part 8) 44

Figure 24: Women’s Health, Global, List of All Pipeline Products, 2018 (part 9) 44

Figure 25: Women’s Health, Global, List of All Pipeline Products, 2018 (part 10) 45

Figure 26: Women’s Health, Global, First-in-Class Matrix Assessment for Endometriosis, 2018 48

Figure 27: Women’s Health, Global, First-in-Class Matrix Assessment for PCOS, 2018 48

Figure 28: Women’s Health, Global, First-in-Class Matrix Assessment for CIN (Human Proteins), 2018 48

Figure 29: Women’s Health, Global, First-in-Class Matrix Assessment for CIN (Viral Proteins), 2018 49

Figure 30: Women’s Health, Global, All First-in-Class Molecular Targets Across the Women’s Health Pipeline, 2018 49

Figure 31: Women’s Health, Global, Industry-Wide Licensing Deals by Stage of Development and First-in-Class Product Status, 2006-2015 65

Figure 32: Women’s Health, Global, Industry-Wide Licensing Deals by Deal Value, Upfront Payment Value, Stage of Development and First-in-Class Product Status ($m), 2006-2015 66

Figure 33: Women’s Health, Global, Licensing Deals by Region, Value and Year, 2018 67

Figure 34: Women’s Health, Global, Licensing Deals by Stage of Development, Deal Value and Upfront Payment Value, 2018 68

Figure 35: Women’s Health, Global, Licensing Deals by Molecule Type, Molecular Target and Aggregate Deal Value, 2018 69

Figure 36: Women’s Health, Global, Licensing Deals with Disclosed Deal Values, 2018 (part 1) 70

Figure 37: Women’s Health, Global, Licensing Deals with Disclosed Deal Values, 2018 (part 2) 71

Figure 38: Women’s Health, Global, Co-development Deals by Region, Value and Year, 2018 72

Figure 39: Women’s Health, Global, Licensing Deals by Region, Value and Year, 2018 73

Figure 40: Women’s Health, Global, Licensing Deals by Region, Value and Year, 2018 73

Figure 41: Women’s Health, Global, Co-development with Disclosed Deal Values, 2018 74

Figure 42: Women’s Health, Global, First-in-Class Products with and without Prior Involvement in Licensing and Co-development Deals, 2018 (part 1) 75

Figure 43: Women’s Health, Global, First-in-Class Products with and without Prior Involvement in Licensing and Co-development Deals, 2018 (part 2) 76

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