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Imprime PGG (Colorectal Cancer) - Forecast and Market Analysis to 2023

Published By :

GlobalData

Published Date : Nov 2014

Category :

Cancer

No. of Pages : 71 Pages


GlobalData has released its new PharmaPoint Drug Evaluation report, Imprime PGG (Colorectal Cancer) Forecast and Market Analysis to 2023. Colorectal cancer (CRC) is the second leading cause of mortality among cancer patients in the world and is the third most diagnosed cancer globally, and thus represents a huge burden on healthcare systems. This report focuses on the current treatment landscape, unmet needs, current pipeline, and commercial opportunities in the colorectal cancer market, with coverage of multiple settings of the disease including neoadjuvant/adjuvant, first-, second-, third-line KRAS wild-type and mutation-positive, and fourth-line metastatic. In terms of targeted treatments, the metastatic CRC treatment landscape is mature, including the branded treatments Avastin (bevacizumab), Erbitux (cetuximab), and Vectibix (panitumumab), treatments that have extended the survival of metastatic patients compared to chemotherapy-only regimens. However, high unmet needs remain for the extension of survival of metastatic patients, and particularly those with KRAS mutation-positive disease, for whom the epidermal growth factor receptor (EGFR) inhibitors Erbitux and Vectibix are not recommended.

Biotheras Imprime PGG is an immunotherapy in Phase III development in the US and Europe for the treatment of chemotherapy-refractory KRAS wild-type metastatic CRC in combination with the EGFR inhibitor Erbitux. Its open-label pivotal study has an estimated enrollment of 795 patients, and these patients will be randomized (2:1) to either Imprime PGG and Erbitux or Erbitux alone. The trial has a primary endpoint of OS, with final data for this outcome expected in April 2016; the company is investigating the potential to apply for accelerated approval based on interim data when available.

Scope

  • Overview of Colorectal Cancer, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
  • Detailed information on Imprime PGG including product description, safety and efficacy profiles as well as a SWOT analysis.
  • Sales forecast for Imprime PGG for the top six countries from 2013 to 2023.
  • Sales information covered for the US, France, Germany, Italy, Spain and the UK.

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 Colorectal 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 Imprime PGG performance
  • Obtain sales forecast for Imprime PGG from 2013-2023 in top six countries (the US, France, Germany, Italy, Spain and the UK)

1 Table of Contents 5
1.1 List of Tables 8
1.2 List of Figures 8

2 Introduction 9
2.1 Catalyst 9
2.2 Related Reports 10
2.3 Upcoming Related Reports 11

3 Disease Overview 12
3.1 Etiology and Pathophysiology 12
3.1.1 Etiology 12
3.1.2 Pathophysiology 14
3.2 Clinical Staging 15
3.3 Symptoms 16

4 Disease Management 18
4.1 Diagnosis and Treatment Overview 18
4.1.1 Screening and Diagnosis 18
4.1.2 Treatment Guidelines and Leading Prescribed Drugs 21
4.1.3 Clinical Practice 25

5 Competitive Assessment 32
5.1 Overview 32

6 Unmet Need and Opportunity 34
6.1 Overview 34
6.2 Therapies That Provide Substantial Overall Survival Benefit for Metastatic Patients 35
6.2.1 Unmet Need 35
6.2.2 Gap Analysis 37
6.2.3 Opportunity 37
6.3 Targeted Treatments for KRAS and BRAF Mutaton-Positive Patients 39
6.3.1 Unmet Need 39
6.3.2 Gap Analysis 40
6.3.3 Opportunity 40
6.4 Effective Neoadjuvant/Adjuvant Therapies for High Risk Resectable Disease 41
6.4.1 Unmet Need 41
6.4.2 Gap Analysis 42
6.4.3 Opportunity 42
6.5 Tolerable Later-Line Therapies For Chemotherapy-Resistant Patients 43
6.5.1 Unmet Need 43
6.5.2 Gap Analysis 43
6.5.3 Opportunity 44

7 Pipeline Assessment 45
7.1 Overview 45
7.2 Promising Drugs in Clinical Development 46

8 Imprime PGG 48
8.1 Overview 48
8.2 Efficacy 49
8.3 Safety 50
8.4 Dosing and Formulation 50
8.5 Potential Clinical and Commercial Positioning 51
8.6 SWOT Analysis 52
8.7 Forecast 53

9 Appendix 54
9.1 Bibliography 54
9.2 Abbreviations 59
9.3 Methodology 63
9.4 Forecasting Methodology 63
9.4.1 Diagnosed Colorectal Cancer Patients 63
9.4.2 Percent Drug-Treated Patients 64
9.4.3 General Pricing Assumptions 64
9.4.4 Average Body Weight and Surface Area Across the 8MM 65
9.4.5 Generic Erosion 65
9.4.6 Pricing of Pipeline Agents 65
9.5 Primary Research - KOLs Interviewed for this Report 66
9.6 Primary Research - Prescriber Survey 67
9.7 About the Authors 68
9.7.1 Analyst 68
9.7.2 Global Head of Healthcare 69
9.8 About GlobalData 70
9.9 Disclaimer 70

List of Table


Table 1: TNM and Staging Classification System for CRC 16
Table 2: Symptoms of Colorectal Cancer 17
Table 3: Treatment Guidelines for CRC 22
Table 4: Most-Prescribed Neoadjuvant/Adjuvant Regimens for Early-Stage CRC in the Global Markets, 2013 23
Table 5: Most Prescribed Targeted Therapies for Metastatic CRC by Segment in the Global Markets, 2013 24
Table 6: Leading Treatments for CRC, 2014 33
Table 7: Unmet Need and Opportunity in CRC 35
Table 8: Product Profile - Imprime PGG 49
Table 9: Imprime PGG SWOT Analysis, 2014 52
Table 10: Global Sales Forecasts ($m) for Imprime PGG, 2013-2023 53
Table 11: Average Body Weight and Surface Area Across the 8MM 65
Table 12: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 67

List of Chart


Figure 1: CRC - Phase III Pipeline 46
Figure 2: Competitive Assessment of Late-Stage Pipeline Agents in CRC, 2013-2023 47
Figure 3: Clinical and Commercial Positioning of Imprime PGG 51

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