Big Pharmas R&D Strategy In Oncology & Breast & Prostate Cancer

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
• 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

List of Boxes

• Box 1: Ongoing Phase III Studies Anastrozole
• Box 2: Ongoing Phase III Studies Letrozole
• Box 3: Ongoing Phase III Studies Exemestane
• Box 4: Ongoing Phase III Studies Goserelin
• Box 5: Ongoing Phase III Studies Fulvestrant
• Box 6: Ongoing Phase III Studies Trastuzumab
• Box 7: The TRAIL Receptor family
• Box 8: The Bcl-2 family of proteins
• Box 9: Quick Facts - BMS-247550
• Box 10: Quick Facts - Temsirolimus
• Box 11: Quick Facts - SDX-105
• Box 12: Quick Facts - 4HPR
• Box 13: Quick Facts - Lapatinib
• Box 14: Quick Facts - Bevacizumab
• Box 15: Quick Facts - Theratope
• Box 16: Erlotinib
• Box 17: Gefitinib
• Box 18: Imatinib
• Box 19: Pemetrexed
• Box 20: NX473
• Box 21: Lonafarnib
• Box 22: Tipifarnib
• Box 23: Bortezomib
• Box 24: Arzoxifene
• Box 25: Patupilone
• Box 26: KOS-862
• Box 27: Southwest Oncology Group Study 99-16 Design
• Box 28: TAX 327 Study Design
• Box 29: The TRAIL Receptor family
• Box 30: The Bcl-2 family of proteins
• Box 31: Quick Facts - Toremifene
• Box 32: Quick Facts - Bevacizumab
• Box 33: Quick Facts - Genasense
• Box 34: Quick Facts - R-flurbiprofen
• Box 35: Quick Facts - Provenge
• Box 36: Quick Facts - Satraplatin
• Box 37: Quick Facts - GVAX
• Box 38: Quick Facts - Exisulind
• Box 39: Quick Facts - Vapreotide
• Box 40: Quick Facts - DCVax