Custirsen Sodium (Prostate Cancer) - Forecast and Market Analysis to 2022


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Custirsen Sodium (Prostate Cancer) - Forecast and Market Analysis to 2022

Summary

GlobalData has released its new PharmaPoint Drug Evaluation report, Custirsen Sodium (Prostate Cancer) - Forecast and Market Analysis to 2022. The recent approvals of second-line metastatic castration-resistant prostate cancer (mCRPC) therapies like J&J’s Zytiga (abiraterone acetate) and Medivation/Astellas’ Xtandi (enzalutamide) will drive strong market growth over the next decade. 

These safe and orally administered treatments will provide safety and convenience benefits over the current standard of care, chemotherapy with docetaxel, while prolonging the overall survival of patients with mCRPC. The December 12, 2012 FDA approval of Zytiga for the added indication of chemotherapy-naïve mCRPC marks the onset of a new treatment paradigm for the disease, in which chemotherapy is relegated to second-line therapy and beyond. 

For patients with earlier-stage prostate cancer, androgen deprivation therapy with LHRH agonists and first-generation antiandrogens remains the standard of care for suppressing testosterone levels and temporarily controlling the disease.

Custirsen (OGX-011) is an FIC drug in development for the first-line treatment of mCRPC in combination with docetaxel and prednisone. It is an mRNA antisense inhibitor of clusterin production that is administered intravenously on a weekly basis. Clusterin is a chaperone protein expressed at high levels in prostate cancer cells, and levels of the drug increase further after castration therapy and in castration-resistant tissues. 

Custirsen was discovered and initially developed by OncoGenex Pharmaceuticals and Isis Pharmaceuticals, and was licensed to Teva in 2009. The drug has been fast-tracked by the FDA, and the companies are currently sponsoring the Phase III Synergy trial under an FDA Special Protocol Assessment (SPA)

Scope
  • Overview of Prostate cancer, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
  • Detailed information on Custirsen including product description, safety and efficacy profiles as well as a SWOT analysis.
  • Sales forecast for Custirsen for the top nine countries from 2012 to 2022.
  • Sales information covered for the US, Japan, UK, France, Germany, Spain, Italy , Canada, and Australia 
Reasons to buy
  • Understand and capitalize by identifying products that are most likely to ensure a robust return
  • Stay ahead of the competition by understanding the changing competitive landscape for Prostate cancer
  • Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
  • Make more informed business decisions from insightful and in-depth analysis of Custirsen performance 
  • Obtain sales forecast for Custirsen from 2012-2022 in nine markets (US, Japan, UK, France, Germany, Spain, Italy , Canada, and Australia)
Table of Contents

1 Table of Contents 4
1.1 List of Tables 6
1.2 List of Figures 6

2 Introduction 7
2.1 Catalyst 7
2.2 Related Reports 7
2.3 Upcoming Related Reports 9

3 Disease Overview 10
3.1 Etiology and Pathophysiology 10
3.1.1 Etiology 10
3.1.2 Pathophysiology 10
3.1.3 Prognosis 11
3.1.4 Quality of Life 12
3.2 Symptoms 12

4 Disease Management 13
4.1 Diagnosis and Referral Overview 13
4.2 Treatment Overview 15
4.2.1 Conservative Management Strategies 19
4.2.2 Localized Treatments 20
4.2.3 Hormone Therapy 21
4.2.4 Drug Therapies 23

5 Competitive Assessment 25
5.1 Overview 25
5.2 Strategic Competitor Assessment 26

6 Opportunity and Unmet Need 29
6.1 Overview 29
6.2 Efficacy at Prolonging Overall Survival 30
6.3 Safety 30
6.4 Mitigation of Symptoms 31
6.5 Cost 31
6.6 Convenient Routes of Administration 31
6.7 Accurate Diagnostic Tests and Surveillance Tools 32
6.8 Unmet Needs Gap Analysis 32
6.9 Opportunity: Targeting Early-Stage, Hormone-Sensitive Prostate Cancer 33

7 Pipeline Assessment 34
7.1 Overview 34
7.2 Promising Drugs in Clinical Development 35

8 Custirsen Sodium 37
8.1 Overview 37
8.2 Efficacy 38
8.3 Safety 38
8.4 Dosing and Formulation 39
8.5 Potential Clinical Positioning 39
8.6 Potential Commercial Positioning 40
8.7 Pricing and Reimbursement 40
8.8 SWOT Analysis 41
8.9 Forecast 42

9 Appendix 43
9.1 Bibliography 43
9.2 Abbreviations 47
9.3 Methodology 48
9.4 Forecasting Methodology 48
9.4.1 Number of Prostate Cancer Patients Currently Seeking Treatment 49
9.4.2 Percent Drug-treated Patients 49
9.4.3 Percent Hormone Therapy-Treated Patients 49
9.4.4 General Pricing Assumptions 50
9.4.5 Individual Drug Assumptions 52
9.4.6 Generic Erosion 52
9.4.7 Pricing of Pipeline Agents 52
9.5 Physicians and Specialists Included in This Study 53
9.6 Survey of Prescribing Physicians 53
9.7 About the Authors 54
9.7.1 Authors 54
9.7.2 Global Head of Healthcare 54
9.8 About GlobalData 55
9.9 Contact Us 55
9.10 Disclaimer 55

Table 1: Stage Distribution of Prostate Cancer at Diagnosis in Selected Major Markets 11
Table 2: Global Variations in Recommendations on Routine PSA Screening 13
Table 3: Most Commonly Followed Treatment Guidelines for Prostate Cancer, 2012 16
Table 4: Most Commonly Prescribed Drugs for Prostate Cancer by Class in the Global Markets, 2012 18
Table 5: Leading Treatments for Prostate Cancer, 2012 28
Table 6: Overall Unmet Needs, Hormone-Sensitive Prostate Cancer - Current Level of Attainment 29
Table 7: Overall Unmet Needs, CRPC - Current Level of Attainment 30
Table 8: Clinical Unmet Needs - Gap Analysis, 2012 33
Table 9: Prostate Cancer - Phase III Pipeline, 2012 35
Table 10: Comparison of Therapeutic Classes in Development for Prostate Cancer, 2012 35
Table 11: Product Profile - Custirsen Sodium 37
Table 12: Custirsen Sodium SWOT Analysis, 2012 41
Table 13: Global Sales Forecasts ($m) for Custirsen Sodium, 2012-2022 42
Table 14: Physicians Surveyed, By Country 53
Figure 1: General Treatment Algorithm for Prostate Cancer, 2012 17
Figure 2: Competitive Assessment of Late-Stage Pipeline Agents in Prostate Cancer, 2012-2022 36