Ovarian Cancer Therapeutics in Major Developed

Markets to 2020 - Late-Stage Pipeline Focuses on

Improved Progression Free-Surival and Targeted
Therapies
Published: May 2014

No. of Pages: 148

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 diseases 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.

Detailed report at: http://www.reportsandintelligence.com/chagasdisease-american-trypanosomiasis-global-clinical-trials-review-h22014-market

Table of Content
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 PF01367338 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 & 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 Queens 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 148

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