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

  • ID: 3517275
  • Drug Pipelines
  • December 2015
  • Region: Global
  • 65 Pages
  • GBI Research
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Ovarian Cancer Treatment Pipeline Offers Promising Alternatives to Chemotherapy
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 of the report:

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?

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.
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1 Table of Contents
1.1 List of Tables
1.2 List of Figures

2 Executive Summary
2.1 Significant Unmet Needs in the Ovarian Cancer Market
2.2 High Proportion of First-in-Class Innovation offers Promise in Ovarian Cancer
2.3 Deal Activity Varies with First-in-Class Status

3 The Case for Innovation
3.1 Growing Opportunities for Biologic Products
3.2 Diversification of Molecular Targets
3.3 Innovative First-in-Class Product Developments Remain Attractive
3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation
3.5 Sustained Innovation
3.6 Report Guidance

4 Clinical and Commercial Landscape
4.1 Disease Overview
4.2 Disease Symptoms
4.3 Epidemiology and Etiology
4.4 Pathophysiology
4.4.1 High-Grade Serous Subtype
4.4.2 Low-Grade Serous Subtype
4.4.3 Mucinous Carcinoma Subtype
4.4.4 Endometrioid Carcinoma Subtype
4.4.5 Clear Cell Carcinoma Subtype
4.5 Diagnosis
4.6 Prognosis
4.7 Treatment Algorithm
4.7.1 Surgery
4.7.2 First-Line Therapy
4.7.3 Maintenance Therapy
4.7.4 Recurrent Disease and Second-Line Therapy
4.8 Overview of Marketed Products in Ovarian Cancer
4.8.1 Molecule Type and Target Analysis
4.8.2 Innovative Products in Ovarian Cancer Market
4.8.3 Unmet Needs

5 Assessment of Pipeline Product Innovation
5.1 Ovarian Cancer Pipeline by Molecule Type, Phase and Therapeutic Target
5.2 Comparative Distribution of Programs between Ovarian Cancer Market and Pipeline by Therapeutic Target Family
5.3 First-in-Class Pipeline Programs Targeting Novel Molecular Targets

6 Signaling Network, Disease Causation and Innovation Alignment
6.1 Complexity of Signaling Networks in Oncology
6.2 Signaling Pathways and First-in-Class Molecular Target Integration
6.3 First-in-Class Matrix Assessment

7 First-in-Class Target Evaluation
7.1 Pipeline Programs Targeting Mucin 16 and Mucin 1
7.2 Pipeline Programs Targeting Notch
7.3 Pipeline Programs Targeting 3-Phosphoinositide-Dependent Protein Kinase 1
7.4 Pipeline Programs Targeting G2/Mitotic-Specific Cyclin B1
7.5 Pipeline Programs Targeting Cell Division Cycle 7-Related Protein Kinase
7.6 Pipeline Programs Targeting X-Linked Inhibitor of Apoptosis Protein
7.7 Pipeline Programs Targeting Cyclin-Dependent Kinase 2
7.8 Pipeline Programs Targeting PIK3CA
7.9 Pipeline Products Targeting HDAC 10, 4, 5 and 7
7.10 Conclusion

8 Deals and Strategic Consolidations
8.1 Industry-Wide First-in-Class Deals
8.2 Licensing Deals
8.2.1 Licensing Deals by Molecule Type
8.2.2 Licensing Deals by Molecular Target
8.2.3 Conclusion
8.3 Co-development Deals
8.3.1 Co-development Deals by Molecule Type
8.3.2 Co-development Deals by Molecular Target
8.3.3 Conclusion
8.4 First-in-Class Programs Not Involved in Licensing or Co-development Deals

9 Appendix
9.1 References
9.2 Abbreviations
9.3 Research Methodology
9.4 Secondary Research
9.4.1 Marketed Product Heatmaps and Treatment Algorithm
9.4.2 Pipeline Analysis
9.4.3 First-in-Class Matrix Assessment
9.4.4 First-in-Class Target Profiles
9.4.5 Licensing and Co-Development Deals
9.5 Contact Us
9.6 Disclaimer

1.1 List of Tables

Table 1: Ovarian Cancer Therapeutics, Histological Subtypes and Associated Genetic Mutations
Table 2: Ovarian Cancer Therapeutics, Ovarian Cancer Disease Staging
Table 3: Key Features and Pipeline Activity of Mucin 1
Table 4: Key Features and Pipeline Activity of Mucin 16
Table 5: Notch Profile
Table 6: PDPK1 Profile
Table 7: CCNB1 Profile
Table 8: CDC7 Profile
Table 9: XIAP Profile
Table 10: CDK2 Profile
Table 11: PIK3CA Profile
Table 12: HDAC Profile
Table 13: List of Abbreviations (Part 1)
Table 14: List of Abbreviations (Part 2)

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
Figure 2: First-in-Class and Non-First-in-Class Products, Sales Performance after Marketing Approval ($m)
Figure 3: Heatmap for First-Line Marketed Products
Figure 4: Heatmap for Maintenance Marketed Products
Figure 5: Heatmap for Recurrent Disease Marketed Products
Figure 6: Overview of Marketed Products in Ovarian Cancer
Figure 7: Overview of Pipeline Products
Figure 8: Molecular Targets in Ovarian Cancer Pipeline
Figure 9: Pipeline by Molecular Targets and Stage of Development
Figure 10: Molecular Target Family Comparison, Pipeline and Marketed Products
Figure 11: Molecular Target Family Comparison, Pipeline First-in-Class and Established Molecular Targets
Figure 12: Percentage of First-in-Class Products within Ovarian Cancer Pipeline Molecular Target Families (%)
Figure 13: Percentage of First-in-Class Products within Ovarian Cancer Pipeline by Stage of Development (%)
Figure 14: First-in-Class Products in Ovarian Cancer Pipeline (Part 1)
Figure 15: First-in-Class Products in Ovarian Cancer Pipeline (Part 2)
Figure 16: First-in-Class Products in Ovarian Cancer Pipeline (Part 3)
Figure 17: Target Matrix Assessment (Part 1)
Figure 18: Target Matrix Assessment (Part 2)
Figure 19: Target Matrix Assessment (Part 3)
Figure 20: Programs Targeting Mucin 1
Figure 21: Products Targeting Mucin 16
Figure 22: Products Targeting Notch
Figure 23: Products Targeting 3-Phosphoinositide-Dependent Protein Kinase 1
Figure 24: Products Targeting G2/Mitotic-Specific Cyclin B1
Figure 25: Products Targeting Cell Division Cycle 7-Related Protein Kinase
Figure 26: Products Targeting X-Linked Inhibitor of Apoptosis Protein
Figure 27: CDK2 Targeting Products
Figure 28: PIK3CA Targeting Products
Figure 29: HDAC 10, 4, 5 and 7 Targeting Products
Figure 30: Industry-Wide Deals by Stage of Development, 2006-2014
Figure 31: Industry Licensing Deal Values by Stage of Development ($m), 2006-2014
Figure 32: Licensing Deal Value
Figure 33: Licensing Deals by Year, 2006-2015
Figure 34: Licensing Deals by Stage of Development
Figure 35: Licensing Deal Value by Stage of Development and Molecule Type
Figure 36: Licensing Deal Value by Molecular Target
Figure 37: Co-development Deal Value
Figure 38: Co-development Deals by Year, 2006-2015
Figure 39: Co-development Deals by Stage of Development
Figure 40: Co-development by Stage of Development and Molecule Type
Figure 41: Co-development by Stage of Development and Molecular Target
Figure 42: Ovarian Cancer First-in-Class Therapies Not Involved in Deals (Part 1)
Figure 43: Ovarian Cancer First-in-Class Therapies Not Involved in Deals (Part 2)
Figure 44: Ovarian Cancer First-in-Class Therapies Not Involved in Deals (Part 3)
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Ovarian Cancer Treatment Pipeline Offers Promising Alternatives to Chemotherapy

Despite the currently high level of unmet need in the ovarian cancer therapeutic market, a strong pipeline of 462 diverse and innovative products in active development signals significant potential for alternatives to chemotherapy, according to this latest research report. "Frontier Pharma: Ovarian Cancer - Identifying and Commercializing First-in-Class Innovation" states that as the market becomes more diverse, it will become less reliant on indiscriminate and highly cytotoxic chemotherapy regimens, which do not target specific proteins in aberrant pathways in ovarian cancer.

Joshua Libberton, one of the report analysts, says that despite limited therapeutic options for ovarian cancer patients at the moment, almost 52% of ovarian cancer products in active development in the pipeline are considered to be first-in-class, as they have a molecular target not associated with any marketed products.

Libberton explains: “As the current ovarian cancer market has a large generic presence, and relatively few novel active pharmaceutical ingredients, the market has stagnated, leaving a large portion of the ovarian cancer population with significant unmet needs. “Currently, ovarian cancer has the highest mortality rate of all gynaecological cancers and is fatal in a majority of patients, rendering it imperative that more effective therapies are developed.”

According to this research, the high proportion of first-in-class innovation implies that the industry is pursuing novel approaches to treatment and reducing the focus on established therapies. Although innovation to date has been slow, greater disease understanding and awareness has created an environment in which it will thrive.

Libberton continues: “In addition to the use of existing platinum-based chemotherapy, treatments such as anti-angiogenic treatments and Poly ADP Ribose Polymerase inhibitors are expected to have a positive impact on ovarian cancer survival in particular patient subsets. “The pipeline is showing clear signs of innovation in ovarian cancer treatment, with many products deviating away from standard chemotherapy targets, and a high proportion of first-in-class drugs.

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