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Frontier Pharma: Ovarian Cancer-Identifying and Commercializing First-in-Class Innovation

Frontier Pharma: Ovarian Cancer-Identifying and Commercializing First-in-Class Innovation


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Executive Summary

Frontier Pharma: Ovarian Cancer-Identifying and Commercializing First-in-Class Innovation

Ovarian cancer is the sixth most common cancer in females and it also has the highest mortality rate of gynecological cancers. The five-year survival rate is approximately 45%, although the disease is ultimately fatal in the majority of patients due to a high rate of recurrence. Surgery is generally considered an effective treatment for localized tumors, however the management of recurrent and later-stage disease is largely reliant on cytotoxic chemotherapy regimens.

A highly active ovarian cancer pipeline contains an array of diverse molecule types and molecular targets, in contrast to the market. With the diversity in the pipeline, there is hope that innovative products can make it to market to provide patients with greater therapeutic options, while meeting unmet needs within ovarian cancer. There are 179 ovarian cancer pipeline products associated with a first-in-class molecular target representing 52% of the total pancreatic cancer pipeline products that have a disclosed molecular target. Such a diverse and innovative pipeline implies that approaches to ovarian cancer treatment are changing and first-in-class development is playing a significant role in this.

Scope

Chemotherapy based regimens continue to dominate the market, which has seen few new entrants over the past decade. Lynparza (olaparib) is a key new entrant; however it is only effective in a small patient subset.

-What survival benefits do current therapies provide?

-What are the current unmet needs that the pipeline needs to address?

The pipeline places increased focus on targeted therapies, including a large number of therapies targeting common oncogenic pathways and signaling intermediates such as PI3K/Akt.

-What potential do mAbs have in ovarian cancer treatment?

-Will pipeline diversity translate to clinically and commercially successful therapies?

-How are common target families, such as intracellular signal transduction associated with pathophysiology?

52% of pipeline products act on a first-in-class target, which is higher than the oncology and industry averages.

-Do first-in-class products show strong progression into the later stages?

-Why is the greatest number of first-in-class products seen in signal transduction?

First-in-class products differ substantially in their clinical potential, based on their alignment to disease causing pathways

-How well are first-in-class targets, such as Notch, aligned to known disease causing pathways?

-Which targets are specifically found in early-stage development?

-What is the industry-wide interest in these targets?

Co-development deals for first-in-class products are typically higher value than non-first-in-class counterparts.

-To what extent does first-in-class status influence deal value and phase?

-Can biologics command a greater deal value than other molecule types?

Reasons To Buy

This report will allow you to

Understand the current clinical and commercial landscape. This includes a comprehensive study of disease pathogenesis, diagnosis, prognosis and the available treatment options available at each stage of diagnosis.

Visualize the composition of the ovarian cancer market in terms of dominant molecule types and 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 ovarian cancer pipeline, and stratify by stage of development, molecule type and molecular target. There are promising signs in the pipeline that the industry is seeking novel approaches the treating ovarian cancer.

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 early-stage targets have been further reviewed in greater detail.

Identify commercial opportunities in the ovarian cancer deals landscape by analyzing trends in licensing and co-development deals and producing a curated list of ovarian cancer therapies that are not yet involved in deals and may be potential investment 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 Significant Unmet Needs in the Ovarian Cancer Market 4

2.2 High Proportion of First-in-Class Innovation offers Promise in Ovarian Cancer 4

2.3 Deal Activity Varies with First-in-Class Status 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 Symptoms 9

4.3 Epidemiology and Etiology 9

4.4 Pathophysiology 10

4.4.1 High-Grade Serous Subtype 10

4.4.2 Low-Grade Serous Subtype 11

4.4.3 Mucinous Carcinoma Subtype 11

4.4.4 Endometrioid Carcinoma Subtype 11

4.4.5 Clear Cell Carcinoma Subtype 11

4.5 Diagnosis 12

4.6 Prognosis 12

4.7 Treatment Algorithm 12

4.7.1 Surgery 12

4.7.2 First-Line Therapy 12

4.7.3 Maintenance Therapy 14

4.7.4 Recurrent Disease and Second-Line Therapy 15

4.8 Overview of Marketed Products in Ovarian Cancer 18

4.8.1 Molecule Type and Target Analysis 18

4.8.2 Innovative Products in Ovarian Cancer Market 19

4.8.3 Unmet Needs 20

5 Assessment of Pipeline Product Innovation 21

5.1 Ovarian Cancer Pipeline by Molecule Type, Phase and Therapeutic Target 21

5.2 Comparative Distribution of Programs between Ovarian Cancer Market and Pipeline by Therapeutic Target Family 25

5.3 First-in-Class Pipeline Programs Targeting Novel Molecular Targets 26

6 Signaling Network, Disease Causation and Innovation Alignment 32

6.1 Complexity of Signaling Networks in Oncology 32

6.2 Signaling Pathways and First-in-Class Molecular Target Integration 33

6.3 First-in-Class Matrix Assessment 33

7 First-in-Class Target Evaluation 37

7.1 Pipeline Programs Targeting Mucin 16 and Mucin 1 37

7.2 Pipeline Programs Targeting Notch 38

7.3 Pipeline Programs Targeting 3-Phosphoinositide-Dependent Protein Kinase 1 39

7.4 Pipeline Programs Targeting G2/Mitotic-Specific Cyclin B1 40

7.5 Pipeline Programs Targeting Cell Division Cycle 7-Related Protein Kinase 40

7.6 Pipeline Programs Targeting X-Linked Inhibitor of Apoptosis Protein 41

7.7 Pipeline Programs Targeting Cyclin-Dependent Kinase 2 42

7.8 Pipeline Programs Targeting PIK3CA 43

7.9 Pipeline Products Targeting HDAC 10, 4, 5 and 7 44

7.10 Conclusion 45

8 Deals and Strategic Consolidations 46

8.1 Industry-Wide First-in-Class Deals 46

8.2 Licensing Deals 47

8.2.1 Licensing Deals by Molecule Type 51

8.2.2 Licensing Deals by Molecular Target 52

8.2.3 Conclusion 52

8.3 Co-development Deals 53

8.3.1 Co-development Deals by Molecule Type 55

8.3.2 Co-development Deals by Molecular Target 56

8.3.3 Conclusion 56

8.4 First-in-Class Programs Not Involved in Licensing or Co-development Deals 56

9 Appendix 60

9.1 References 60

9.2 Abbreviations 62

9.3 Research Methodology 63

9.4 Secondary Research 64

9.4.1 Marketed Product Heatmaps and Treatment Algorithm 64

9.4.2 Pipeline Analysis 64

9.4.3 First-in-Class Matrix Assessment 64

9.4.4 First-in-Class Target Profiles 65

9.4.5 Licensing and Co-Development Deals 65

9.5 Contact Us 65

9.6 Disclaimer 65

1.1 List of Tables

Table 1: Ovarian Cancer Therapeutics, Histological Subtypes and Associated Genetic Mutations 10

Table 2: Ovarian Cancer Therapeutics, Ovarian Cancer Disease Staging 12

Table 3: Key Features and Pipeline Activity of Mucin 1 37

Table 4: Key Features and Pipeline Activity of Mucin 16 37

Table 5: Notch Profile 39

Table 6: PDPK1 Profile 39

Table 7: CCNB1 Profile 40

Table 8: CDC7 Profile 41

Table 9: XIAP Profile 41

Table 10: CDK2 Profile 43

Table 11: PIK3CA Profile 44

Table 12: HDAC Profile 44

Table 13: List of Abbreviations (Part 1) 62

Table 14: List of Abbreviations (Part 2) 63

1.2 List of Figures

Figure 1: Innovation Trends in Product Approvals, Number of Product Approvals by FDA and Five-Year Moving Average of Products Approvals (%), 1987-2012 5

Figure 2: First-in-Class and Non-First-in-Class Products, Sales Performance after Marketing Approval (USD m) 7

Figure 3: Heatmap for First-Line Marketed Products 14

Figure 4: Heatmap for Maintenance Marketed Products 15

Figure 5: Heatmap for Recurrent Disease Marketed Products 17

Figure 6: Overview of Marketed Products in Ovarian Cancer 19

Figure 7: Overview of Pipeline Products 22

Figure 8: Molecular Targets in Ovarian Cancer Pipeline 24

Figure 9: Pipeline by Molecular Targets and Stage of Development 25

Figure 10: Molecular Target Family Comparison, Pipeline and Marketed Products 25

Figure 11: Molecular Target Family Comparison, Pipeline First-in-Class and Established Molecular Targets 27

Figure 12: Percentage of First-in-Class Products within Ovarian Cancer Pipeline Molecular Target Families (%) 28

Figure 13: Percentage of First-in-Class Products within Ovarian Cancer Pipeline by Stage of Development (%) 28

Figure 14: First-in-Class Products in Ovarian Cancer Pipeline (Part 1) 29

Figure 15: First-in-Class Products in Ovarian Cancer Pipeline (Part 2) 30

Figure 16: First-in-Class Products in Ovarian Cancer Pipeline (Part 3) 31

Figure 17: Target Matrix Assessment (Part 1) 34

Figure 18: Target Matrix Assessment (Part 2) 35

Figure 19: Target Matrix Assessment (Part 3) 36

Figure 20: Programs Targeting Mucin 1 38

Figure 21: Products Targeting Mucin 16 38

Figure 22: Products Targeting Notch 39

Figure 23: Products Targeting 3-Phosphoinositide-Dependent Protein Kinase 1 40

Figure 24: Products Targeting G2/Mitotic-Specific Cyclin B1 40

Figure 25: Products Targeting Cell Division Cycle 7-Related Protein Kinase 41

Figure 26: Products Targeting X-Linked Inhibitor of Apoptosis Protein 42

Figure 27: CDK2 Targeting Products 43

Figure 28: PIK3CA Targeting Products 44

Figure 29: HDAC 10, 4, 5 and 7 Targeting Products 44

Figure 30: Industry-Wide Deals by Stage of Development, 2006-2014 46

Figure 31: Industry Licensing Deal Values by Stage of Development (USD m), 2006-2014 47

Figure 32: Licensing Deal Value 48

Figure 33: Licensing Deals by Year, 2006-2015 49

Figure 34: Licensing Deals by Stage of Development 50

Figure 35: Licensing Deal Value by Stage of Development and Molecule Type 51

Figure 36: Licensing Deal Value by Molecular Target 52

Figure 37: Co-development Deal Value 53

Figure 38: Co-development Deals by Year, 2006-2015 54

Figure 39: Co-development Deals by Stage of Development 55

Figure 40: Co-development by Stage of Development and Molecule Type 56

Figure 41: Co-development by Stage of Development and Molecular Target 56

Figure 42: Ovarian Cancer First-in-Class Therapies Not Involved in Deals (Part 1) 57

Figure 43: Ovarian Cancer First-in-Class Therapies Not Involved in Deals (Part 2) 58

Figure 44: Ovarian Cancer First-in-Class Therapies Not Involved in Deals (Part 3) 59

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