Triple Analysis: Decoding Big Pharma's R&D Strategy In Oncology and Special Focus on Breast and Prostate Cancer

Published by: BioSeeker Group AB

Published: Sep. 14, 2007 - 445+ Pages

Table of Contents

1 Executive Summary

2 Methodologies

3 Table of Contents

3.1 List of Tables

3.2 List of Boxes

4 Big Pharma’s R&D Position and Strategy in Oncology: A Summary

4.1 Bristol-Myers Squibb

4.2 GlaxoSmithKline

4.3 Hoffmann-La Roche

4.4 Novartis

4.5 Sanofi-Aventis

5 Last Five Years of Deals and Alliances in Oncology

5.1 Bristol Myers Squibb

5.1.1 Discovery and Lead Molecule Improvements

5.1.2 Adding Image Analysis to Support Clinical Trials and Early Diagnosis

5.1.3 Bladder Cancer and Melanoma Registration Filings are Emminent

5.1.4 The Human Kinome and Cell Cycle Inhibitors

5.1.5 Strategic Priorities in Pipeline Development Leads to Divestments

5.1.6 Erbitux Expansion is Set to Challenge Avastin

5.2 GlaxoSmithKline

5.2.1 The Biopharmaceutical Strategy at GSK

5.2.2 Out Goes Classes of Small Molecule Inhibitors

5.2.3 Marketing and Manufacturing Collaborations

5.2.4 Patient Selectionfo r GSK’s Targeted Cancer Therapies

5.2.5 GSK Taping Into Knowledge Databases

5.2.6 Increasing the Oral Bioavailability Cytotoxic Oncology Drugs

5.2.7 Oxford University Helps GSK in India

5.2.8 GSK is Set to Improve Medical Imaging

5.3 Hoffmann-La Roche

5.3.1 Roche Builds Center of Excellence for RNAi Therapeutics Discovery

5.3.2 A New Delivery Route for Avastin?

5.3.3 Improving Antibody Drugs

5.3.4 Roche Strengthens Presence in Genomics Research Market

5.3.5 Target Validation

5.3.6 Drug Discovery Collaborations

5.3.7 Marketing

5.3.8 Outlicensing

5.3.9 Size Doesn’t Matter: Genentech's Goal of Aggressively Pursuing Novel and Innovative Therapies 67

5.4 Novartis

5.4.1 Novartis Acquisition of Chiron: A Major Biopharmaceutical Investment

5.4.2 Protein Kinase Inhibitors

5.4.3 Next Generation Oral Topoisomerase Inhibitor and Telomerase Promotors

5.4.4 Novartis Sells of World-Wide Rights

5.4.5 Biomarker and Proteomics Research

5.5 Sanofi-Aventis

5.5.1 Target Screening and Validation

5.5.2 Biologicals

5.5.3 A Short Cut to Success?

5.5.4 Aventis Divests Interest

5.5.5 Recombine My Molecule

6 Competitive R&D Comparison on Oncology Drug Target Level

6.1 Target Overview

6.2 Head to Head Target Comparison by Molecular Function and Cancer Type

6.2.1 Transmembrane Receptor Protein Tyrosine Kinase Activity Targets

6.2.2 Receptor Activity Targets

6.2.3 G-protein Coupled Receptor Activity Targets

6.2.4 Protein Serine/Threonine Kinase Activity Targets

6.2.5 Transcription Factor Activity Targets

6.2.6 Transmembrane Receptor Activity Targets

6.2.7 Catalytic Activity Targets

6.2.8 Cytokine Activity Targets

6.2.9 Protein-Tyrosine Kinase Activity Targets

6.2.10 Kinase Activity Targets

6.2.11 DNA Topoisomerase Activity Targets

6.2.12 Growth Factor Activity Targets

6.2.13 Ligase Activity Targets

6.2.14 Motor Activity Targets

6.2.15 Structural Constituent of Cytoskeleton Targets

6.2.16 Transporter Activity Targets

6.2.17 Targets According to Miscellaneous Molecular Function Groups

6.2.18 Unclassified or Unknown Molecular Function of Targets

6.3 Drug Targets by Target Localization and Compound Type

6.4 Targets, Drugs and Cancer Indications Linked to Signaling Pathways

6.4.1 Alpha6 Beta4 Integrin Signaling Pathway

6.4.2 Androgen Receptor Signaling Pathway

6.4.3 B Cell Receptor Signaling Pathway

6.4.4 EGFR1 Signaling Pathway

6.4.5 Hedgehog Signaling Pathway

6.4.6 ID Signaling Pathway

6.4.7 IL-1 Signaling Pathway

6.4.8 IL-2 Signaling Pathway

6.4.9 IL-3 Signaling Pathway

6.4.10 IL-4 Signaling Pathway

6.4.11 IL-5 Signaling Pathway

6.4.12 IL-6 Signaling Pathway

6.4.13 IL-9 Signaling Pathway

6.4.14 Kit Receptor Signaling Pathway

6.4.15 Notch Signaling Pathway

6.4.16 T Cell Receptor Signaling Pathway

6.4.17 TGF-beta Receptor Signaling Pathway

6.4.18 TNF-alpha Signaling Pathway

6.4.19 Wnt Signaling Pathway

7 Drug Compound Type Analysis

7.1 Deployment of Biological Based Compounds by Cancer Indications

7.2 Deployment of Chemical Based Compounds by Cancer Indications

7.3 Deployment of Natural Product Compounds by Cancer Indications

8 Drug Development in Oncology by Major Targeted Therapy Areas

8.1 Angiogenesis

8.2 Antibodies

8.3 Apoptosis

8.4 Protein Kinase Inhibitors

8.5 Vaccines

9 Cancer Indication Focus Analysis

9.1 Preclinical Stage Pipeline

9.2 Phase I Clinical Stage Pipeline

9.3 Phase II Clinical Stage Pipeline

9.4 Phase III Clinical Stage Pipeline

9.5 Drugs Soon to be on the Market

9.6 Approved Drugs

10 Breast Cancer: An Introduction

10.1 Disease Definitions

10.2 Etiology

10.3 Epidemiology

10.4 Prognosis

11 Current Treatment Strategies of Breast cancer

11.1 Localized Disease

11.2 Advanced Disease

12 Progress in Current Breast Cancer Treatment Strategies

12.1 Hormone Based Therapies

12.2 Antibodies

12.3 Chemotherapy

12.4 Chemotherapy

13 Key Therapeutic Strategies for Future Breast Cancer Therapies

13.1 Therapeutic Type, Targets & Mechanisms

14 Competitive Landscape in Breast Cancer Drug Development: The Late Stage Pipeline

14.1 The Epothilones

14.2 Cell Cycle & Apoptosis

14.3 Protein Kinase Inhibitors

14.4 Immunotherapy

15 Current Drug Development for Breast Cancer: The Early Stage Pipeline

15.1 DNA Targeting

15.2 FTIs

15.3 Antisense

15.4 New Hormone Modulators

15.5 Other

16 Prostate Cancer: An Introduction

16.1 Disease Definitions

16.2 Etiology & Pathophysiology

16.3 Epidemiology

16.4 Prognosis

17 Current Prostate Cancer Treatment Strategies

17.1 Localized Disease

17.1.1 Locally Advanced Prostate Cancer

17.2 Metastatic Prostate Cancer

17.2.1 Hormone-Sensitive Metastatic Prostate Cancer

17.2.2 Hormone-Refractory or Recurrent Metastatic Prostate Cancer

18 Progress in Current Prostate Cancer Treatment Strategies

18.1 Long-Term Follow-up Data not yet Been Published

18.2 Significant Reduced Risk of Distant Metastases

18.3 Adverse Events

18.4 No Difference in Overall Survival

18.5 Cross-over Design an Optimal Option?

18.6 Death due to Liver Failure

18.7 Survival Benefit

18.8 Subdermal Implant

18.9 No FDA Approval

18.10 No Improvement in 5-year Disease-Free Survival

18.11 Effective Secondary Hormonal Therapy?

18.12 Synery in Combination

19 Key Therapeutic Strategies for Future Prostate Cancer Therapies

19.1 Therapeutic Type, Targets & Mechanisms

20 Competitive Landscape in Prostate Cancer Drug Development: The Late Stage Pipeline

20.1 Reduced Prostate Cancer Risk

20.2 High Activity in Metastatic AIPC Patients

20.3 Absence of Severe Toxicities

20.4 Waiting for Data

20.5 Probability of Regulatory Approval?

20.6 Co-development and License Agreement

20.7 Improves Predicted Survival?

20.8 Slow Progress & Development Partners

20.9 Exclusive License Agreement

21 Current Prostate Cancer Drug Development: The Early Stage Pipeline

21.1 New Data?

21.2 Terminated Study

21.3 More Than 50% PSA decline

21.4 Safety and Tolerability

21.5 Terminated?

21.6 Marker of Drug Effect

21.7 Preliminary Results for a Tyrosine Kinase Inhibitor

21.8 No Activity in Monotherapy

21.9 Dramatic Disappearance of Bone Metastatic Lesions

21.10 PSA Response - Anthracycline

22 Disclaimer

23 Drug Index

24 Company Index

List of Tables

Table 1: How to Navigate the Report

Table 2: Number of Pursued Oncology Drugs Targets by Company

Table 3: Pursued Oncology Drugs Targets by Molecular Function

Table 4: Drug Target Expression Profiles in Humans

Table 5: Identified Targets By Cancer Indications

Table 6: Head to Head Comparison of Drugs with Transmembrane Receptor Protein Tyrosine Kinase Activity Targets

Table 7: Head to Head Comparison of Drugs with Receptor Activity Targets

Table 8: Head to Head Comparison of Drugs with G-protein Coupled Receptor Activity

Table 9: Head to Head Comparison of Drugs with Protein Serine/Threonine Kinase Activity

Table 10: Head to Head Comparison of Drugs with Transcription Factor Activity Targets

Table 11: Head to Head Comparison of Drugs with Transmembrane Receptor Activity Targets

Table 12: Head to Head Comparison of Drugs with Catalytic Activity Targets

Table 13: Head to Head Comparison of Drugs with Cytokine Activity Targets

Table 14: Head to Head Comparison of Drugs with Protein-Tyrosine Kinase Activity Targets

Table 15: Head to Head Comparison of Drugs with Kinase Activity Targets

Table 16: Head to Head Comparison of Drugs with DNA Topoisomerase Activity Targets

Table 17: Head to Head Comparison of Drugs with Growth Factor Activity Targets

Table 18: Head to Head Comparison of Drugs with Ligase Activity Targets

Table 19: Head to Head Comparison of Drugs with Motor Activity Targets

Table 20: Head to Head Comparison of Drugs with Structural Constituent of Cytoskeleton Targets

Table 21: Head to Head Comparison of Drugs with Transporter Activity Targets

Table 22: Head to Head Comparison of Drugs with Targets According to Miscellaneous Molecular Function Groups

Table 23: Head to Head Comparison of Drugs with Unclassified or Unknown Molecular Function Targets

Table 24: Drug Target Comparison by Target Localization and Compound Type

Table 25: Targeting Signaling Pathways: An Overview

Table 26: Targeted Signaling Pathway Profiles of Big Pharma

Table 27: Targets, Drugs and Cancer Indications Linked to the Alpha6 Beta4 Integrin Signaling Pathway

Table 28: Targets, Drugs and Cancer Indications Linked to the Androgen Receptor Signaling Pathway

Table 29: Targets, Drugs and Cancer Indications Linked to the B Cell Receptor Signaling Pathway

Table 30: Targets, Drugs and Cancer Indications Linked to the EGFR1 Signaling Pathway

Table 31: Targets, Drugs and Cancer Indications Linked to the Hedgehog Signaling Pathway

Table 32: Targets, Drugs and Cancer Indications Linked to the ID Signaling Pathway

Table 33: Targets, Drugs and Cancer Indications Linked to the IL-1 Signaling Pathway

Table 34: Targets, Drugs and Cancer Indications Linked to the IL-3 Signaling Pathway

Table 35: Targets, Drugs and Cancer Indications Linked to the IL-4 Signaling Pathway

Table 36: Targets, Drugs and Cancer Indications Linked to the IL-5 Signaling Pathway

Table 37: Targets, Drugs and Cancer Indications Linked to the IL-6 Signaling Pathway

Table 38: Targets, Drugs and Cancer Indications Linked to the Kit Receptor Signaling Pathway

Table 39: Targets, Drugs and Cancer Indications Linked to the Notch Signaling Pathway

Table 40: Targets, Drugs and Cancer Indications Linked to the T Cell Receptor Signaling Pathway

Table 41: Targets, Drugs and Cancer Indications Linked to the TGF-beta Receptor Signaling Pathway

Table 42: Targets, Drugs and Cancer Indications Linked to the TNF-alpha Signaling Pathway

Table 43: Targets, Drugs and Cancer Indications Linked to the Wnt Signaling Pathway

Table 44: Deployment of Biological Based Compounds by Cancer Indications

Table 45: Deployment of Chemical Based Compounds by Cancer Indications

Table 46: Deployment of Natural Product Based Compounds by Cancer Indications

Table 47: Comparative Presentation of Targeted Therapy Areas in Oncology

Table 48: The Angiogenesis Pipeline by Cancer Type and Developmental Stage

Table 49: The Antibody Pipeline by Cancer Type and Developmental Stage

Table 50: The Apoptosis Pipeline by Cancer Type and Developmental Stage

Table 51: The Protein Kinase Inhibitor Pipeline by Cancer Type and Developmental Stage

Table 52: The Cancer Vaccine Pipeline by Cancer Type and Developmental Stage

Table 53: Summary of Big Pharma’s Preclinical Stage Pipeline

Table 54: Preclinical Stage Pipeline by Cancer Indications

Table 55: Summary of Big Pharma’s Phase I Clinical Stage Pipeline

Table 56: : Phase I Clinical Stage Pipeline by Cancer Indications

Table 57: Summary of Big Pharma’s Phase II Clinical Stage Pipeline

Table 58: Phase II Clinical Stage Pipeline by Cancer Indications

Table 59: Summary of Big Pharma’s Phase III Clinical Stage Pipeline

Table 60: Phase III Clinical Stage Pipeline by Cancer Indications

Table 61: Oncology Drugs Soon to be on the Market

Table 62: Summary of Big Pharma’s Approved Oncology Drugs

Table 63: Approved Drugs by Cancer Indications

Table 105: The Stage System

Table 106: Risk Factors

Table 107: List of Approved Drugs and Their Mechanisms of Action.

Table 108: Hormonal Treatment Strategies

Table 109: Adjuvant Systemic Treatment Options for Women With Axillary Node-Negative Breast Cancer

Table 110: Treatment Options for Women With Axillary Node-Positive Breast Cancer

Table 111: Chemotherapy Drugs and Regimen

Table 112: Summay of Drugs Involved in Breast Cancer Therapy

Table 113: Short Facts Tamoxifen

Table 114: Short Facts Anastrozole

Table 115: Short Facts Letrozole

Table 116: Short Facts Exemestane

Table 117: Short Facts Goserelin

Table 118: Short Facts Fulvestrant

Table 119: Short Facts Trastuzumab

Table 120 Cancer Immunotherapy Strategies

Table 121: Progress on Ixabepilone

Table 122: Progress on CCI-779

Table 123: Progress on Fenretinide

Table 124: Progress on Lapatinib

Table 125: Progress on Bevacizumab

Table 126: Progress on Theratope

Table 127: Summary of Mid-Stage to Late stage Investigational Agents Under Development

Table 128: Summary of Breast Cancer Early Stage Pipeline

Table 129: The TNM System

Table 130: Lifestyle factors

Table 131: Historical Summary of Clinical Studies on Patients with Late Stage Disease

Table 132: Short Facts Abarelix

Table 133: Short Facts Bicalutamide

Table 134: Short Facts Carboplatin

Table 135: Short Facts Docetaxel

Table 136: Short Facts Mitoxantrone

Table 137: Short Facts Flutamide

Table 138: Short Facts Goserelin

Table 139: Short Facts Histrelin

Table 140: Short Facts Lanreotide

Table 141: Short Facts Leuprolide

Table 142: Short Facts Nilutamide

Table 143: Short Facts Estramustine

Table 144: Summary of Recent Clinical Studies on Patients with Late Stage Disease

Table 145: Ongoing Late Stage Clinical Studies

Table 146: Cancer Immunotherapy Strategies

Table 147: Near Term Progress Toremifene

Table 148: Near Term Progress Bevacizumab

Table 149: Near Term Progress Oblimersen

Table 150: Near Term Progress R-flurbiprofen

Table 151: Near Term Progress APC8015

Table 152: Near Term Progress Satraplatin

Table 153: Near Term Progress GVAX

Table 154: Near Term Progress Exisulind

Table 155: Summary of Prostate Cancer Late Stage Pipeline

Table 156: Paclitaxel

Table 157: Epothilone

Table 158: Ixabepilone

Table 159: PTK/ZK

Table 160: Arsenic trioxide

Table 161: Retinoic Acid

Table 162: Imatinib

Table 163: Bortezomib

Table 164: Sorafenib

Table 165: Doxorubicin

Table 166: Summary of Prostate Cancer Early Stage Pipeline

Abstract

Executive Summary

This is the report for professionals interested to grasp big pharma’s R&D strategy in oncology and at the same time have an extensive R&D overview of the breast- and prostate cancer field. This extensive 440+ pages report compiles and analyzes Deals and alliances, Drug targets, Compound types, Targeted therapy areas, and Selection of cancer indications among the five major pharmaceutical companies in the oncology arena: Bristol-Myers Squibb, GlaxoSmithKline, Hoffmann-La Roche, and Sanofi-Aventis. Between them and together with their respective partners they have more than 250 drugs for the treatment of cancer. In other words, their collective R&D capacity and presence is solid enough to set trends for the entire field of oncology drug development. Beyond trends, all five are fiercely defining their competitive edge and advantage in oncology and that is what this report is about.

The collective force of the above research and analysis ’decodes’ these five big pharma R&D efforts into strategy revealing and gap filing presentations. Enough to fuel and sustain comparative benchmarking, peer group surveillance, and partnership decisions.

The report further give an in depth analysis in two important key oncology areas; Breast- and Prostate cancer . And provide a framework but also a careful identification and evaluation of drug candidates, technologies and competitors.

Decoding Big Pharma’s R&D Strategy in Oncology in numbers:

• Includes references to more than 250 drugs and 600 clinical/preclinical trials
• Addresses the competitive situation on more than 80 different cancer indications, including supportive care indications
• Special focus on Angiogenesis-, Antibody-, Apoptosis-, Protein kinase inhibitor- and Vaccine drugs for the treatment of cancer
• The included competitive landscape between the five big pharma includes more than 200 companies related to cancer drug development
• Last five years of deals and alliances in oncology, including almost a hundred different key deals and alliances
• Target analysis of 119 drug targets in oncology, including molecular function of target, target localization, type of compound for targeting, targets affecting signaling pathways etc
• Drug compound analysis by cancer indications
  
  

In breast cancer we have identified 170 drug candidates in clinical stage of development and more than 100 companies are involved in the development of these drugs. As a treatment for breast cancer hormone modifying therapies together with different chemotherapeutic schedules have been of highest interest during the last years of progress. A vast amount of new clinical research data has emerged and several new clinical trials have been initiated and others generated new results. Protein kinase inhibitors and epothilones have generated substantial amount of new research data in this field. But, other strategies seem not successful and we are still waiting new information regarding their progress.

In prostate cancer we have identified 127 drug candidates in phase II or III stage of development and more than 85 companies are involved in the development of these drugs. Two of the most successful strategies are apoptosis inducers and cell based vaccines. Three out of 10 late stage candidates are apoptosis inducers. Cell based vaccines has been tried for some time but has so far failed to generate substantial improvements.

Breast and Prostate Cancer Highlights

• Thorough examination of status and impact of several novel drugs in development
• Discussion of the challenges in current and future treatment strategies
• Anticancer pipeline of most companies in the field

Key reasons to read this report

• This report serves as a serious reference for professionals interested in the development of oncology drug targets and selection/validation of targeting strategies.
• Explore the strengths and weaknesses associated with compounds in clinical development. Scientific rationale for most novel therapeutics in breast- and prostate cancer R&D, and the results of clinical trials to date
• Gain insight into the current challenges and commercial opportunities associated with breast- and prostate cancer therapy
  
  

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