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Ovarian Cancer Therapeutics in Major Developed Markets to 2020 - Late-Stage Pipeline Focuses on Improved Progression Free-Surival and Targeted Therapies

Summary

GBI Research, has released the pharma report -"Ovarian Cancer Therapeutics in Major Developed Markets to 2020 - Late-Stage Pipeline Focuses on Improved Progression Free-Surival and Targeted Therapies". The current Ovarian cancer therapeutics market is dominated by the use of generics – predominately carboplatin and paclitaxel, which are used in combination for the treatment of platinum-sensitive disease (both first-line and recurrent). Initial treatment with platinum-based therapy is usually effective, with approximately 70% of patients entering remission. However, even with extended progression free-survival of 24 months, almost all patients relapse, and after successive periods of remission and relapse either die or progress to platinum-resistant disease, for which the prognosis is poor. There is a clear gap in the market for maintenance therapies to extend the initial high rates of remission, and hopefully stimulate long-term remission in patients. As well as a gap for more effective treatment options in platinum-resistant or refractory patients.

The current developmental pipeline addresses these gaps in the market, with five of the 10 late stage pipeline molecules indicated as maintenance therapies, and three of the 10 indicated in platinum-resistant disease. However, efficacy with these late stage drugs has been poor, at best demonstrating minimal improvements in PFS. In the EU, both Avastin and Yondelis have been approved on the basis of improvements in PFS alone. It is expected therefore, that those pipeline drugs that have demonstrated the most significant improvements in PFS – olaparib, Vynfinit and trebananib, will be approved in this territory. However even on approval, the lack of an overwhelming improvement in clinical benefit with these drugs, and their expected high cost will limit their sales. In the US, the improvement in PFS observed with Yondelis and Avastin, in the absence of any other clinical benefit with either drug, resulted in neither drug being approved by the FDA. In line with these rejections, the improvements in PFS alone, observed with the current late stage pipeline drugs, is expected to result in the failure of any drug to be approved in the US within the forecast period.

As a result the global market is expected not be driven by new drug approvals, but primarily inflation, and the increase in the prevalence of pancreatic cancer. Global market revenues are forecast to rise at a limited CAGR of 3.4% to $1.9billion in 2020.

Despite the poor results obtained with late stage pipeline drugs there is evidence of continued interest in the ovarian cancer market, with a high number of drug candidates in the current developmental pipeline, particularly at the Preclinical Phase. There is a wide range of novel molecular targets distributed amongst these drug candidates, including growth factors, serine/threonine protein kinases and tumor associated antigens. This suggests a continued interest in introducing more targeted therapies into the treatment of OC, the use of which in this indication lags significantly behind that in other indications in oncology.

Scope

The report analyzes treatment usage patterns, drug types available and pipeline and market forecasts across indications for pancreatic cancer. The report covers and includes -
- A brief introduction to ovarian cancer, including the disease’s pathogenesis, risk factors and diagnosis.
- In-depth analysis of the drug combinations used in the treatment of ovarian cancer, including analyses of their safety, efficacy, and place in the disease treatment algorithm. This includes a heat map comparing the drug combination in terms of safety and efficacy.
- Comprehensive review of the pipeline for ovarian cancer therapies, including individual analysis of a number of late-stage pipeline drugs that have the potential to enter the market in the forecast period. The pipeline is analyzed on the basis of phase distribution, molecule types and molecular targets, as well as administration routes.
- Additional in-depth analysis of pipeline drug clinical trials by phase, molecule type, trial size, trial duration and program failure rate analyses for each molecule type and mechanism of action.
- Multi-scenario forecast data of the market to 2020, taking into account how it will be affected by the introduction of new drugs, the expiry of key patents on current drugs and the changes in disease epidemiology across the key developed markets including the US, Canada, Japan, Germany, the UK, France, Italy and Spain.
- Discussion of the drivers and barriers for market growth.
- An in-depth analysis of licensing and co-development deals involving drugs indicated in ovarian cancer, including an in-depth outline of the key deals.

Reasons to buy

The report will assist business development and enable marketing executives to strategize their product launches, by allowing them to -
- Understanding the efficacy and safety of the current monotherapies and drug combinations used in the treatment of ovarian cancer, with an in-depth analysis of the disease treatment algorithm.
- Understand the key signalling pathways and molecular targets currently inder investigation in drug development for ovarian cancer
- Understand the vast scope of the pipeline, including which molecule types and mechanisms of action are prominent.
- Observe the trends in clinical trial duration and size amongst clinical phases and molecule types, and use the clinical trial failure rate analysis to assess the risk profiles of current and/or future developmental programs for pancreatic cancer therapeutics.
- Assess the potential clinical and commercial impact of current late-stage pipeline molecules in the ovarian cancer therapeutics market.

Table Of Contents

Ovarian Cancer Therapeutics in Major Developed Markets to 2020 - Late-Stage Pipeline Focuses on Improved Progression Free-Surival and Targeted Therapies
1 Table of Contents
1 Table of Contents 3
1.1 List of Tables 6
1.2 List of Figures 7
2 Introduction 9
2.1 Disease Pathophysiology 9
2.1.1 Ovarian Cancer - A Group of Distinct Diseases 9
2.1.2 Ovarian Cancer is Highly Heterogenic, with Multiple Mutations and Affected Signaling Pathways 10
2.2 Symptoms and Diagnosis 12
2.3 Risk Factors 13
2.3.1 Age 13
2.3.2 Inherited Genetic Mutations 13
2.3.3 Greater Number of Lifetime Ovulations 14
2.3.4 Weight 14
2.3.5 Previous Medical Conditions 14
2.4 Treatment Algorithm 14
2.4.1 Surgery 14
2.4.2 First-Line Chemotherapy 14
2.4.3 Maintenance Therapy 18
2.5 Recurrent Disease 20
3 Marketed Products 36
3.1 Carboplatin 36
3.2 Paclitaxel 37
3.3 Gemcitabine 38
3.4 Topotecan 40
3.5 Pegylated Liposomal Doxorubicin 41
3.6 Yondelis 42
3.7 Avastin 43
4 Product Pipeline 45
4.1 Overview of Pipeline by Phase and Route of Administration 45
4.2 Overview of Pipeline by Molecule Type, Mechanism of Action and Molecular Target 47
4.2.1 Molecular Targets in the Developmental Pipeline 48
4.3 Clinical Trials 53
4.3.1 Clinical Trial Duration 53
4.3.2 Clinical Trial Size 54
4.3.3 Failure Rate 57
4.3.4 Discussion 59
5 Late-Stage Drugs in Developmental Pipeline 61
5.1 Profiles 61
5.1.1 Niraparib 61
5.1.2 Olaparib 62
5.1.3 Abagovomab 64
5.1.4 Vargatef 65
5.1.5 Trebananib 66
5.1.6 Farletuzumab 70
5.1.7 Vynfinit 71
5.1.8 Telcyta 73
5.1.9 Karenitecin 75
5.2 Discussion 83
6 Market Forecast 84
6.1 Global Market 84
6.1.1 Overview 84
6.1.2 Treatment Patterns and Revenues in Top Eight Markets 85
6.2 North America 88
6.2.1 Treatment Usage Patterns 88
6.2.2 Annual Cost of Therapy 90
6.2.3 Market Revenues 92
6.3 Top Five European Markets 94
6.3.1 Treatment Usage Patterns 94
6.3.2 Annual Cost of Therapy 96
6.3.3 Market Forecasts 97
6.4 Japan 100
6.4.1 Treatment Usage Patterns 100
6.4.2 Annual Cost of Therapy 101
6.4.3 Market Forecast 102
7 Drivers and Barriers 104
7.1 Drivers 104
7.1.1 High Number of Candidates in Drug Development 104
7.1.2 High Unmet Clinical Need 104
7.1.3 Incentives for Orphan Drug Development 104
7.1.4 Potential Changes to Clinical Trial Design 105
7.2 Barriers 105
7.2.1 Decreasing Incidence Rates 105
7.2.2 Lack of Cell Lines 105
7.2.3 High Heterogeneity of the Disease 105
7.2.4 High Cost of Novel Drugs 105
8 Deals 106
8.1 Licensing Deals 106
8.1.1 Clovis Oncology Enters into Licensing Agreement with Pfizer for PF-01367338 108
8.1.2 PharmaMar Enters into Licensing Agreement with Janssen for Yondelis 108
8.1.3 Hana Enters into Licensing Agreement with Tekmira 109
8.1.4 AstraZeneca Enters into Licensing Agreement with Merck for MK-1775 109
8.1.5 Tesaro Enters into Licensing Agreement with Merck Sharp and Dohme for Cancer Drug 109
8.1.6 Oasmia Enters into Licensing Agreement with Medison for Paclical 110
8.1.7 Orion Enters into Agreement with Oasmia 110
8.1.8 Ohio University Enters into Licensing Agreement with Phosplatin 110
8.1.9 Genta Enters into Licensing Agreement with Daiichi Sankyo 110
8.1.10 Celldex Enters into Licensing Agreement with the Ludwig Institute for Cancer Research 110
8.1.11 NanoCarrier Enters into Licensing Agreement with Kowa for NC-6300 111
8.2 Co-Development Deals 111
8.2.1 Merck Enters into Co-Development Agreement with Endocyte for Cancer Drug 112
8.2.2 Pfizer Enters into Research Agreement with BC Cancer Agency and Vancouver Prostate Centre 113
8.2.3 Almac Discovery Enters into an Agreement with Queen's University Belfast for Drug Discovery 113
9 Appendix 114
9.1 All Pipeline Drugs by Phase 114
9.1.1 Discovery 114
9.1.2 Preclinical 116
9.1.3 IND/CTA-Filed 122
9.1.4 Phase I 123
9.1.5 Phase II 128
9.1.6 Phase III 133
9.1.7 Pre-Registration 134
9.2 Market Forecasts to 2020 134
9.2.1 Global 134
9.2.2 The US 134
9.2.3 Canada 135
9.2.4 UK 135
9.2.5 France 136
9.2.6 Germany 136
9.2.7 Italy 137
9.2.8 Spain 137
9.2.9 Japan 138
9.3 Abbreviations 139
9.4 Bibliography 141
9.5 Methodology 147
9.6 Secondary Research 147
9.7 Contact Us 148
9.8 Disclaimer 1481.1 List of Tables
Table 1: Ovarian Cancer Therapeutics, Histological Subtypes and Associated Genetic Mutations 10
Table 2: Ovarian Cancer Therapeutics, Affected Signaling Pathways in Ovarian Cancer, Associated Mutations and Effects on Cancer Development 12
Table 3: Ovarian Cancer Therapeutics, Ovarian Cancer Disease Staging 13
Table 4: Ovarian Cancer Therapeutics, Eastern Cooperative Oncology Group Performance Status Scores and Description 15
Table 5: Ovarian Cancer Therapeutics, Common Endpoints in Ovarian Cancer and Details of Criteria 16
Table 6: Ovarian Cancer Therapeutics, Rates of Sensory and Motor Neuropathy with Pegylated Liposomal Doxorubicin and Paclitaxel in Combination with Carboplatin (%), 2010 23
Table 7: Ovarian Cancer Therapeutics, Yondelis Phase III Clinical Trial, Stratification of patients by Platinum-Free Interval (%), 2010 27
Table 8: Ovarian Cancer Therapeutics, Poly ADP Ribose Polymerase Inhibitors Under Development, 2013 49
Table 9: Ovarian Cancer Therapeutics, Epidermal Growth Factor Receptor Inhibitors Under Development, 2013 50
Table 10: Ovarian Cancer Therapeutics, Mucin Inhibitors Under Development, 2013 51
Table 11: Ovarian Cancer Therapeutics, Aurora Kinase Inhibitors Under Development, 2013 51
Table 12: Ovarian Cancer Therapeutics, Average Clinical Trial Duration across Each Phase for Ovarian Cancer, across Oncology and across Entire Industry (months), 2013 53
Table 13: Ovarian Cancer Therapeutics, Global, Patient Demographics of a Phase III Clinical Trial of Trebananib (%), 2011 67
Table 14: Ovarian Cancer Therapeutics, Efficacy Results of Phase III Clinical Trial, Telcyta, 2010 74
Table 15: Ovarian Cancer Therapeutics, Results of Phase III Clinical Trial, Telcyta, 2007 75
Table 16: Ovarian Cancer Therapeutics, Top Five European Union Markets, Incidence Rates (per 100,000), 2008-2012 95
Table 17: Ovarian Cancer Therapeutics, Global, Developmental Pipeline, Discovery Phase, 2013 114
Table 18: Ovarian Cancer Therapeutics, Global, Developmental Pipeline, Preclinical Phase, 2013 116
Table 19: Ovarian Cancer Therapeutics, Global, Developmental Pipeline, IND/CTA Filed, 2013 122
Table 20: Ovarian Cancer Therapeutics, Global, Developmental Pipeline, Phase I, 2013 123
Table 21: Ovarian Cancer Therapeutics, Global, Developmental Pipeline, Phase II, 2013 128
Table 22: Ovarian Cancer Therapeutics, Global, Developmental Pipeline, Phase III, 2013 133
Table 23: Ovarian Cancer Therapeutics, Global, Developmental Pipeline, Pre-Registration, 2013 134
Table 24: Ovarian Cancer Therapeutics, Global, Market Forecast, 2013-2020 134
Table 25: Ovarian Cancer Therapeutics, The US, Market Forecast, 2013-2020 134
Table 26: Ovarian Cancer Therapeutics, Canada, Market Forecast, 2013-2020 135
Table 27: Ovarian Cancer Therapeutics, UK, Market Forecast, 2013-2020 135
Table 28: Ovarian Cancer Therapeutics, France, Market Forecast, 2013-2020 136
Table 29: Ovarian Cancer Therapeutics, Germany, Market Forecast, 2013-2020 136
Table 30: Ovarian Cancer Therapeutics, Italy, Market Forecast, 2013-2020 137
Table 31: Ovarian Cancer Therapeutics, Spain, Market Forecast, 2013-2020 137
Table 32: Ovarian Cancer Therapeutics, Japan, Market Forecast, 2013-2020 138
Table 33: Abbreviations 1391.2 List of Figures
Figure 1: Ovarian Cancer Therapeutics, Efficacy Results for Key Parameters - Marketed Products, First-Line and Maintenance Therapies 30
Figure 2: Ovarian Cancer Therapeutics, Safety Results for Key Parameters - Marketed Products, First-Line and Maintenance Therapies 31
Figure 3: Ovarian Cancer Therapeutics, Efficacy Results for Key Parameters - Marketed Products, Recurrent Disease: All Patients 32
Figure 4: Ovarian Cancer Therapeutics, Safety Results for Key Parameters - Marketed Products, Recurrent Disease: All Patients 32
Figure 5: Ovarian Cancer Therapeutics, Efficacy Results for Key Parameters - Marketed Products, Recurrent Disease: Platinum-Sensitive 33
Figure 6: Ovarian Cancer Therapeutics, Safety Results for Key Parameters - Marketed Products, Recurrent Disease: Platinum-Sensitive 34
Figure 7: Ovarian Cancer Therapeutics, Efficacy Results for Key Parameters - Marketed Products, Recurrent Disease: Platinum-Resistant 35
Figure 8: Ovarian Cancer Therapeutics, Safety Results for Key Parameters - Marketed Products, Recurrent Disease: Platinum-Resistant 35
Figure 9: Ovarian Cancer Therapeutics, Global, Pipeline Distribution by Stage, Program Type and Route of Administration, 2013 46
Figure 10: Ovarian Cancer Therapeutics: Global, Pipeline by Molecule Type and Mechanism of Action, 2013 48
Figure 11: Ovarian Cancer Therapeutics, Global, Molecular Targets of the Developmental Pipeline, 2013 52
Figure 12: Ovarian Cancer Therapeutics, Global, Clinical Trial Duration (months), 2006-2013 54
Figure 13: Ovarian Cancer Therapeutics, Global, Clinical Trial Size (participants), 2006-2013 56
Figure 14: Ovarian Cancer Therapeutics, Global, Clinical Trial Failure Rate and Reasons for Failure (%), 2006-2013 58
Figure 15: Ovarian Cancer Therapeutics, Global, Overview of Clinical Trial Failure Rate, Duration and Size by Phase and Molecule Type, 2006-2013 60
Figure 16: Ovarian Cancer Therapeutics, Global, Forecast Revenues of Olaparib ($m), 2014-2020 64
Figure 17: Ovarian Cancer Therapeutics, Global, Forecast Revenues of Trebananib ($m), 2016-2020 70
Figure 18: Ovarian Cancer Therapeutics, Global, Forecast Revenues of Vynfinit ($m), 2016-2020 73
Figure 19: Ovarian Cancer Therapeutics, Efficacy Results for Key Parameters - Pipeline (blue) and Marketed Products Comparison. Recurrent Disease: All Patients 77
Figure 20: Ovarian Cancer Therapeutics, Safety Results for Key Parameters - Pipeline (blue) and Marketed Products Comparison. Recurrent Disease: All Patients 78
Figure 21: Ovarian Cancer Therapeutics, Efficacy Results for Key Parameters - Pipeline (blue) and Marketed Products Comparison. Recurrent Disease: Platinum-Sensitive 79
Figure 22: Ovarian Cancer Therapeutics, Safety Results for Key Parameters - Pipeline (blue) and Marketed Products Comparison. Recurrent Disease: Platinum-Sensitive 80
Figure 23: Ovarian Cancer Therapeutics, Efficacy Results for Key Parameters - Pipeline (blue) and Marketed Products Comparison. Recurrent Disease: Platinum-Resistant 81
Figure 24: Ovarian Cancer Therapeutics, Efficacy Results for Key Parameters - Pipeline (blue) and Marketed Products Comparison. Recurrent Disease: Platinum-Resistant 82
Figure 25: Ovarian Cancer Therapeutics, Global, Treatment Usage Patterns and Market Revenues (‘000; $m), 2013-2020 87
Figure 26: Ovarian Cancer Therapeutics, US and Canada, Treatment Usage Patterns (‘000), 2013-2020 89
Figure 27: Ovarian Cancer Therapeutics, US and Canada, Annual Cost of Therapy ($), 2013-2020 91
Figure 28: Ovarian Cancer Therapeutics, US and Canada, Market Revenues ($m), 2013-2020 94
Figure 29: Ovarian Cancer Therapeutics, Top Five European Union Markets, Treatment Usage Patterns (‘000), 2013-2020 96
Figure 30: Ovarian Cancer Therapeutics, Top Five European Union Markets, Annual Cost of Therapy ($), 2013-2020 97
Figure 31: Ovarian Cancer Therapeutics, Top Five European Union Markets, Market Revenues ($m), 2013-2020 100
Figure 32: Ovarian Cancer Therapeutics, Japan, Treatment Usage Patterns (‘000), 2013-2020 101
Figure 33: Ovarian Cancer Therapeutics, Japan, Annual Cost of Therapy ($), 2013-2020 102
Figure 34: Ovarian Cancer Therapeutics: Japan, Market Revenues ($m), 2013-2020 103
Figure 35: Ovarian Cancer Therapeutics, Global, Licensing Deals by Location, Year and Value, 2006-2013 107
Figure 36: Ovarian Cancer Therapeutics, Global, Licensing Deals by Phase, Molecule Type and Mechanism of Action, 2006-2013 108
Figure 37: Ovarian Cancer Therapeutics, Global, Co-Development Deals by Location, Year and Value, 2006-2013 112

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