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Ovarian Cancer Therapeutics to 2020 - Late-Stage Pipeline Focuses on Improved Progression Free Survival and Targeted Therapies

Published By :

GBI Research

Published Date : May 2014

Category :

Ovarian Cancer

No. of Pages : N/A

“Ovarian Cancer Therapeutics to 2020 - Late-Stage Pipeline Focuses on Improved Progression Free Survival 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

 

1 Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

 

2 Introduction

2.1 Disease Pathophysiology

2.1.1 Ovarian Cancer – A Group of Distinct Diseases

2.1.2 Ovarian Cancer is Highly Heterogenic, with Multiple Mutations and Affected Signaling Pathways

2.2 Symptoms and Diagnosis

2.3 Risk Factors

2.3.1 Age

2.3.2 Inherited Genetic Mutations

2.3.3 Greater Number of Lifetime Ovulations

2.3.4 Weight

2.3.5 Previous Medical Conditions

2.4 Treatment Algorithm

2.4.1 Surgery

2.4.2 First-Line Chemotherapy

2.4.3 Maintenance Therapy

2.5 Recurrent Disease

 

3 Marketed Products

3.1 Carboplatin

3.2 Paclitaxel

3.3 Gemcitabine

3.4 Topotecan

3.5 Pegylated Liposomal Doxorubicin

3.6 Yondelis

3.7 Avastin

 

4 Product Pipeline

4.1 Overview of Pipeline by Phase and Route of Administration

4.2 Overview of Pipeline by Molecule Type, Mechanism of Action and Molecular Target

4.2.1 Molecular Targets in the Developmental Pipeline

4.3 Clinical Trials

4.3.1 Clinical Trial Duration

4.3.2 Clinical Trial Size

4.3.3 Failure Rate

4.3.4 Discussion

 

5 Late-Stage Drugs in Developmental Pipeline

5.1 Profiles

5.1.1 Niraparib

5.1.2 Olaparib

5.1.3 Abagovomab

5.1.4 Vargatef

5.1.5 Trebananib

5.1.6 Farletuzumab

5.1.7 Vynfinit

5.1.8 Telcyta

5.1.9 Karenitecin

5.2 Discussion

 

6 Market Forecast

6.1 Global Market

6.1.1 Overview

6.1.2 Treatment Patterns and Revenues in Top Eight Markets

6.2 North America

6.2.1 Treatment Usage Patterns

6.2.2 Annual Cost of Therapy

6.2.3 Market Revenues

6.3 Top Five European Markets

6.3.1 Treatment Usage Patterns

6.3.2 Annual Cost of Therapy

6.3.3 Market Forecasts

6.4 Japan

6.4.1 Treatment Usage Patterns

6.4.2 Annual Cost of Therapy

6.4.3 Market Forecast

 

7 Drivers and Barriers

7.1 Drivers

7.1.1 High Number of Candidates in Drug Development

7.1.2 High Unmet Clinical Need

7.1.3 Incentives for Orphan Drug Development

7.1.4 Potential Changes to Clinical Trial Design

7.2 Barriers

7.2.1 Decreasing Incidence Rates

7.2.2 Lack of Cell Lines

7.2.3 High Heterogeneity of the Disease

7.2.4 High Cost of Novel Drugs

 

8 Deals

8.1 Licensing Deals

8.1.1 Clovis Oncology Enters into Licensing Agreement with Pfizer for PF-01367338

8.1.2 PharmaMar Enters into Licensing Agreement with Janssen for Yondelis

8.1.3 Hana Enters into Licensing Agreement with Tekmira

8.1.4 AstraZeneca Enters into Licensing Agreement with Merck for MK-1775

8.1.5 Tesaro Enters into Licensing Agreement with Merck Sharp & Dohme for Cancer Drug

8.1.6 Oasmia Enters into Licensing Agreement with Medison for Paclical

8.1.7 Orion Enters into Agreement with Oasmia

8.1.8 Ohio University Enters into Licensing Agreement with Phosplatin

8.1.9 Genta Enters into Licensing Agreement with Daiichi Sankyo

8.1.10 Celldex Enters into Licensing Agreement with the Ludwig Institute for Cancer Research

8.1.11 NanoCarrier Enters into Licensing Agreement with Kowa for NC-6300

8.2 Co-Development Deals

8.2.1 Merck Enters into Co-Development Agreement with Endocyte for Cancer Drug

8.2.2 Pfizer Enters into Research Agreement with BC Cancer Agency and Vancouver Prostate Centre

8.2.3 Almac Discovery Enters into an Agreement with Queen’s University Belfast for Drug Discovery

 

9 Appendix

9.1 All Pipeline Drugs by Phase

9.1.1 Discovery

9.1.2 Preclinical

9.1.3 IND/CTA-Filed

9.1.4 Phase I

9.1.5 Phase II

9.1.6 Phase III

9.1.7 Pre-Registration

9.2 Market Forecasts to 2020

9.2.1 Global

9.2.2 The US

9.2.3 Canada

9.2.4 UK

9.2.5 France

9.2.6 Germany

9.2.7 Italy

9.2.8 Spain

9.2.9 Japan

9.3 Abbreviations

9.4 Bibliography

9.5 Methodology

9.6 Secondary Research

9.7 Contact Us

9.8 Disclaimer

List of Table

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

Table 2: Ovarian Cancer Therapeutics, Affected Signaling Pathways in Ovarian Cancer, Associated Mutations and Effects on Cancer Development

Table 3: Ovarian Cancer Therapeutics, Ovarian Cancer Disease Staging

Table 4: Ovarian Cancer Therapeutics, Eastern Cooperative Oncology Group Performance Status Scores and Description

Table 5: Ovarian Cancer Therapeutics, Common Endpoints in Ovarian Cancer and Details of Criteria

Table 6: Ovarian Cancer Therapeutics, Rates of Sensory and Motor Neuropathy with Pegylated Liposomal Doxorubicin and Paclitaxel in Combination with Carboplatin (%), 2010

Table 7: Ovarian Cancer Therapeutics, Yondelis Phase III Clinical Trial, Stratification of patients by Platinum-Free Interval (%), 2010

Table 8: Ovarian Cancer Therapeutics, Poly ADP Ribose Polymerase Inhibitors Under Development, 2013

Table 9: Ovarian Cancer Therapeutics, Epidermal Growth Factor Receptor Inhibitors Under Development, 2013

Table 10: Ovarian Cancer Therapeutics, Mucin Inhibitors Under Development, 2013

Table 11: Ovarian Cancer Therapeutics, Aurora Kinase Inhibitors Under Development, 2013

Table 12: Ovarian Cancer Therapeutics, Average Clinical Trial Duration across Each Phase for Ovarian Cancer, across Oncology and across Entire Industry (months), 2013

Table 13: Ovarian Cancer Therapeutics, Global, Patient Demographics of a Phase III Clinical Trial of Trebananib (%), 2011

Table 14: Ovarian Cancer Therapeutics, Efficacy Results of Phase III Clinical Trial, Telcyta, 2010

Table 15: Ovarian Cancer Therapeutics, Results of Phase III Clinical Trial, Telcyta, 2007

Table 16: Ovarian Cancer Therapeutics, Top Five European Union Markets, Incidence Rates (per 100,000), 2008–2012

Table 17: Ovarian Cancer Therapeutics, Global, Developmental Pipeline, Discovery Phase, 2013

Table 18: Ovarian Cancer Therapeutics, Global, Developmental Pipeline, Preclinical Phase, 2013

Table 19: Ovarian Cancer Therapeutics, Global, Developmental Pipeline, IND/CTA Filed, 2013

Table 20: Ovarian Cancer Therapeutics, Global, Developmental Pipeline, Phase I, 2013

Table 21: Ovarian Cancer Therapeutics, Global, Developmental Pipeline, Phase II, 2013

Table 22: Ovarian Cancer Therapeutics, Global, Developmental Pipeline, Phase III, 2013

Table 23: Ovarian Cancer Therapeutics, Global, Developmental Pipeline, Pre-Registration, 2013

Table 24: Ovarian Cancer Therapeutics, Global, Market Forecast, 2013–2020

Table 25: Ovarian Cancer Therapeutics, The US, Market Forecast, 2013–2020

Table 26: Ovarian Cancer Therapeutics, Canada, Market Forecast, 2013–2020

Table 27: Ovarian Cancer Therapeutics, UK, Market Forecast, 2013–2020

Table 28: Ovarian Cancer Therapeutics, France, Market Forecast, 2013–2020

Table 29: Ovarian Cancer Therapeutics, Germany, Market Forecast, 2013–2020

Table 30: Ovarian Cancer Therapeutics, Italy, Market Forecast, 2013–2020

Table 31: Ovarian Cancer Therapeutics, Spain, Market Forecast, 2013–2020

Table 32: Ovarian Cancer Therapeutics, Japan, Market Forecast, 2013–2020

Table 33: Abbreviations

List of Chart

Figure 1: Ovarian Cancer Therapeutics, Efficacy Results for Key Parameters – Marketed Products, First-Line and Maintenance Therapies

Figure 2: Ovarian Cancer Therapeutics, Safety Results for Key Parameters – Marketed Products, First-Line and Maintenance Therapies

Figure 3: Ovarian Cancer Therapeutics, Efficacy Results for Key Parameters – Marketed Products, Recurrent Disease: All Patients

Figure 4: Ovarian Cancer Therapeutics, Safety Results for Key Parameters – Marketed Products, Recurrent Disease: All Patients

Figure 5: Ovarian Cancer Therapeutics, Efficacy Results for Key Parameters – Marketed Products, Recurrent Disease: Platinum-Sensitive

Figure 6: Ovarian Cancer Therapeutics, Safety Results for Key Parameters – Marketed Products, Recurrent Disease: Platinum-Sensitive

Figure 7: Ovarian Cancer Therapeutics, Efficacy Results for Key Parameters – Marketed Products, Recurrent Disease: Platinum-Resistant

Figure 8: Ovarian Cancer Therapeutics, Safety Results for Key Parameters – Marketed Products, Recurrent Disease: Platinum-Resistant

Figure 9: Ovarian Cancer Therapeutics, Global, Pipeline Distribution by Stage, Program Type and Route of Administration, 2013

Figure 10: Ovarian Cancer Therapeutics: Global, Pipeline by Molecule Type and Mechanism of Action, 2013

Figure 11: Ovarian Cancer Therapeutics, Global, Molecular Targets of the Developmental Pipeline, 2013

Figure 12: Ovarian Cancer Therapeutics, Global, Clinical Trial Duration (months), 2006–2013

Figure 13: Ovarian Cancer Therapeutics, Global, Clinical Trial Size (participants), 2006–2013

Figure 14: Ovarian Cancer Therapeutics, Global, Clinical Trial Failure Rate and Reasons for Failure (%), 2006–2013

Figure 15: Ovarian Cancer Therapeutics, Global, Overview of Clinical Trial Failure Rate, Duration and Size by Phase and Molecule Type, 2006–2013

Figure 16: Ovarian Cancer Therapeutics, Global, Forecast Revenues of Olaparib ($m), 2014–2020

Figure 17: Ovarian Cancer Therapeutics, Global, Forecast Revenues of Trebananib ($m), 2016–2020

Figure 18: Ovarian Cancer Therapeutics, Global, Forecast Revenues of Vynfinit ($m), 2016–2020

Figure 19: Ovarian Cancer Therapeutics, Efficacy Results for Key Parameters – Pipeline (blue) and Marketed Products Comparison. Recurrent Disease: All Patients

Figure 20: Ovarian Cancer Therapeutics, Safety Results for Key Parameters – Pipeline (blue) and Marketed Products Comparison. Recurrent Disease: All Patients

Figure 21: Ovarian Cancer Therapeutics, Efficacy Results for Key Parameters – Pipeline (blue) and Marketed Products Comparison. Recurrent Disease: Platinum-Sensitive

Figure 22: Ovarian Cancer Therapeutics, Safety Results for Key Parameters – Pipeline (blue) and Marketed Products Comparison. Recurrent Disease: Platinum-Sensitive

Figure 23: Ovarian Cancer Therapeutics, Efficacy Results for Key Parameters – Pipeline (blue) and Marketed Products Comparison. Recurrent Disease: Platinum-Resistant

Figure 24: Ovarian Cancer Therapeutics, Efficacy Results for Key Parameters – Pipeline (blue) and Marketed Products Comparison. Recurrent Disease: Platinum-Resistant

Figure 25: Ovarian Cancer Therapeutics, Global, Treatment Usage Patterns and Market Revenues (‘000; $m), 2013–2020

Figure 26: Ovarian Cancer Therapeutics, US and Canada, Treatment Usage Patterns (‘000), 2013–2020

Figure 27: Ovarian Cancer Therapeutics, US and Canada, Annual Cost of Therapy ($), 2013–2020

Figure 28: Ovarian Cancer Therapeutics, US and Canada, Market Revenues ($m), 2013–2020

Figure 29: Ovarian Cancer Therapeutics, Top Five European Union Markets, Treatment Usage Patterns (‘000), 2013–2020

Figure 30: Ovarian Cancer Therapeutics, Top Five European Union Markets, Annual Cost of Therapy ($), 2013–2020

Figure 31: Ovarian Cancer Therapeutics, Top Five European Union Markets, Market Revenues ($m), 2013–2020

Figure 32: Ovarian Cancer Therapeutics, Japan, Treatment Usage Patterns (‘000), 2013–2020

Figure 33: Ovarian Cancer Therapeutics, Japan, Annual Cost of Therapy ($), 2013–2020

Figure 34: Ovarian Cancer Therapeutics: Japan, Market Revenues ($m), 2013–2020

Figure 35: Ovarian Cancer Therapeutics, Global, Licensing Deals by Location, Year and Value, 2006–2013

Figure 36: Ovarian Cancer Therapeutics, Global, Licensing Deals by Phase, Molecule Type and Mechanism of Action, 2006–2013

Figure 37: Ovarian Cancer Therapeutics, Global, Co-Development Deals by Location, Year and Value, 2006–2013

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