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

Pages: 72 Published: November 01, 2014 Report Code: GDHC477DFR

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. Biothera’s 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)

Table of Contents

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1Catalyst

2.2Related Reports

2.3Upcoming Related Reports

3Disease Overview

3.1Etiology and Pathophysiology

3.1.1Etiology

3.1.2Pathophysiology

3.2Clinical Staging

3.3Symptoms

4Disease Management

4.1Diagnosis and Treatment Overview

4.1.1Screening and Diagnosis

4.1.2Treatment Guidelines and Leading Prescribed Drugs

4.1.3Clinical Practice

5Competitive Assessment

5.1Overview

6Unmet Need and Opportunity

6.1Overview

6.2Therapies That Provide Substantial Overall Survival Benefit for Metastatic Patients

6.2.1Unmet Need

6.2.2Gap Analysis

6.2.3Opportunity

6.3Targeted Treatments for KRAS and BRAF Mutaton-Positive Patients

6.3.1Unmet Need

6.3.2Gap Analysis

6.3.3Opportunity

6.4Effective Neoadjuvant/Adjuvant Therapies for High Risk Resectable Disease

6.4.1Unmet Need

6.4.2Gap Analysis

6.4.3Opportunity

6.5Tolerable Later-Line Therapies For Chemotherapy-Resistant Patients

6.5.1Unmet Need

6.5.2Gap Analysis

6.5.3Opportunity

7Pipeline Assessment

7.1Overview

7.2Promising Drugs in Clinical Development

8Imprime PGG

8.1Overview

8.2Efficacy

8.3Safety

8.4Dosing and Formulation

8.5Potential Clinical and Commercial Positioning

8.6SWOT Analysis

8.7Forecast

9Appendix

9.1Bibliography

9.2Abbreviations

9.3Methodology

9.4Forecasting Methodology

9.4.1Diagnosed Colorectal Cancer Patients

9.4.2Percent Drug-Treated Patients

9.4.3General Pricing Assumptions

9.4.4Average Body Weight and Surface Area Across the 8MM

9.4.5Generic Erosion

9.4.6Pricing of Pipeline Agents

9.5Primary Research – KOLs Interviewed for this Report

9.6Primary Research – Prescriber Survey

9.7About the Authors

9.7.1Analyst

9.7.2Global Head of Healthcare

9.8About GlobalData

9.9Disclaimer

List of Tables

Table 1: TNM and Staging Classification System for CRC

Table 2: Symptoms of Colorectal Cancer

Table 3: Treatment Guidelines for CRC

Table 4: Most-Prescribed Neoadjuvant/Adjuvant Regimens for Early-Stage CRC in the Global Markets, 2013

Table 5: Most Prescribed Targeted Therapies for Metastatic CRC by Segment in the Global Markets, 2013

Table 6: Leading Treatments for CRC, 2014

Table 7: Unmet Need and Opportunity in CRC

Table 8: Product Profile – Imprime PGG

Table 9: Imprime PGG SWOT Analysis, 2014

Table 10: Global Sales Forecasts ($m) for Imprime PGG, 2013-2023

Table 11: Average Body Weight and Surface Area Across the 8MM

Table 12: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

Figure 1: CRC – Phase III Pipeline

Figure 2: Competitive Assessment of Late-Stage Pipeline Agents in CRC, 2013-2023

Figure 3: Clinical and Commercial Positioning of Imprime PGG

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