Targeted Cancer Therapies: Innovative drugs and their impact on the future of oncology

Table of Contents

Acknowledgements

Executive summary

Beyond the blockbuster model

Emerging therapies

Therapy area analysis

Case studies

Conclusions

Chapter 1 Beyond the blockbuster model

Summary

Introduction

Beyond blockbusters - the development of targeted therapies

Declining R&D success rates

R&D spend in Europe and the US

No economies of scale in pharmaceutical R&D

The performance gap in R&D

Mergers as a driver of productivity gains

R&D pipeline and drug discovery trends

Therapeutic focus of clinical pipeline activity

Projects by therapeutic focus

Drug discovery deals

Implications of the move away from the blockbuster model

Chapter 2 Emerging therapies

Summary

IntroductionCurrent therapies

An overview of cancer treatment

The basis for targeted therapies

A promising therapeutic field

Molecularly targeted therapies

Regulatory risk-benefit evaluation vs. the use of surrogate endpoints for clinical efficacy

Efficacy criteria

Targeted therapies as a means to improving survival rates

Current treatments by type

Global analysis

Hormonal therapies

Cytotoxics

Innovative cancer therapies

Angiogenesis inhibitors

Immunostimulators

Tumor-targeted agents

Adjunct therapies

Advances in diagnosis

Introduction

Genetic counseling

OncoAssist

CeMines

Xantos Biomedicine

Advances in treatment

Pursuing biological therapies or small molecule inhibitors

From cytotoxic to cytostatic

Angiogenesis - a promising new approach to cancer treatment-

Differentiation therapy - developing HDAC inhibitors as anti-cancer drugs

Progress in oncogenics

Regional differences in access to healthcare

Chapter 3 Therapy area analysis

Summary

Introduction

Epidemiology

Current treatments

Current therapeutics

A new biologic approach for the treatment of metastatic breast cancer

Showing promise in the treatment of breast cancer

Profile: Cancer treatment in the UK

New treatments in breast cancer: predictions

Unmet needs

Key players in breast cancerColorectal cancer

Epidemiology

Current treatments

Current therapeutics

Treatment preferences in US and Europe

Unmet needs

Key players in colorectal cancer

Lung cancer

Epidemiology

Current treatments

NSCLC

SCLC

Malignant mesothelioma

Current therapeutics

Unmet needs

Key players in lung cancer

Prostate cancer

Epidemiology

Current treatments

Unmet needs

Key players in prostate cancer

Chapter 4 Case studies

Summary

Introduction

Sanofi-Aventis

Sanofi-Synthelabo

Eloxatin

Sales forecast

Aventis: development of oncology as a blockbuster franchise

Aventis?f cancer portfolio and R&D pipeline

Taxotere

Core strategies for growth

Recent and expected approvals

Taxotere as a specialty blockbuster

Roche

Introduction

R&D alliances, partnerships and acquisitions

Roche?fs cancer portfolio and R&D pipeline

Focus on new technologies and diagnostics

Tarceva

Sales forecast

Genentech

AvastinSales forecast

AstraZeneca

Iressa

Physician rating of Iressa

Sales forecast

Brief profiles

Bristol-Myers Squibb

Eli Lilly

GlaxoSmithKline

Merck KGaA

Novartis

Pfizer

Schering AG

Chapter 5 Conclusions

Challenges for development of targeted cancer therapies

Diagnostics are integral to targeted therapies

European companies will dominate targeted cancer therapies

The future of oncology

Beyond targeted medicines

Index

List of Figures

Figure 1.1: Global oncology players, 2002

Figure 1.2: From therapy to health maintenance busters

Figure 1.3: Forecast growth by blockbuster therapy area, 2002-08

Figure 1.4: Declining R&D rates

Figure 1.5: R&D spend in Europe and the US

Figure 1.6: No economies of scale in pharmaceutical R&D

Figure 1.7: Performance gap in R&D

Figure 1.8: Shareholder returns of merged and non-merged companies

Figure 1.9: Breakdown of projects by clinical phase and source of drug

Figure 1.10: Therapeutic focus of clinical pipeline activity

Figure 1.11: Breakdown of deals by therapeutic focus (September 2002 - March 2004)

Figure 1.12: Therapeutic focus of drug technology deals across the top 15 pharmaceutical

companies (September 2002 - March 2004)

Figure 1.13: The importance of specialty products in the market

Figure 1.14: Growth rates of primary care blockbuster drugs vs. specialty care drugs

Figure 2.15: 5-year survival rates in the US (1974-1999)

Figure 2.16: The global cancer market, 1998-2002

Figure 2.17: Chronology of the various cytotoxic classes

Figure 2.18: 5-year survival rate from breast cancer in various geographies

Figure 2.19: Reduction in deaths from testicular cancer

Figure 3.20: Breast cancer market opportunities

Figure 3.21: Improved quality of life by combination vs. monotherapy

Figure 3.22: Superior survival with Xeloda/Taxotere

Figure 3.23: Therapeutic strategies in prostate cancer

Figure 4.24: Recent and expected Taxotere approvals

Figure 4.25: Taxotere as a specialty blockbuster - a nichebuster

Figure 4.26: Roche?fs changing product portfolio

Figure 4.27: Roche?fs R&D ?euniverse?f

Figure 4.28: Roches business model: focus on innovation and diagnostics

List of Tables

Table 2.1: Examples of future therapies

Table 2.2: Late stage developments in cancer therapeutics (selection as at 12/03)

Table 2.3: Molecules that block angiogenesis via vEGF

Table 2.4: Angiogenesis products (other than vEGF targeting) in development

Table 3.5: Breast cancer patient epidemiology statistics, 2004

Table 3.6: Colorectal cancer patient epidemiology statistics, 2004

Table 3.7: Standard therapeutic approaches in various stages of colorectal cancer

Table 3.8: Protocols in treatment of metastatic colorectal cancer

Table 3.9: NCSLC patient epidemiology statistics, 2004

Table 3.10: SCLC patient epidemiology statistics, 2004

Table 3.11: Prostate cancer patient epidemiology statistics, 2004

Table 4.12: Eloxatin sales forecast ($m), 2005-2009

Table 4.13: Marketed cancer products for Aventis

Table 4.14: Aventis?fs oncology R&D pipeline, 2003

Table 4.15: Roche: early stage development alliances (selected)

Table 4.16: Marketed cancer products for Roche

Table 4.17: Roche?fs oncology R&D pipeline, 2003

Table 4.18: Tarceva sales forecast ($m), 2005-2009

Table 4.19: Avastin?fs clinical development program

Table 4.20: Avastin sales forecast ($m), 2005-2009

Table 4.21: Physician rating of Iressa

Table 4.22: Iressa sales forecast ($m), 2005-2009