Contents:

Table of Contents 1 Executive Summary 3 2 Methodology 5 3 Table of Contents 7 3.1 List of Boxes 8 3.2 List of Tables 9 4 Prostate Cancer 11 4.1.1 Introduction 11 4.1.2 Disease Definitions 12 4.1.3 Etiology & Pathophysiology 14 4.1.4 Epidemiology 16 4.1.5 Prognosis 17 4.2 Current Treatment Strategies . 18 4.2.1 Localized Disease . 18 4.2.1.1 Locally Advanced Prostate Cancer 18 4.2.2 Metastatic Prostate Cancer 18 4.2.2.1 Hormone-Sensitive Metastatic Prostate Cancer 19 4.2.2.2 Hormone-Refractory or Recurrent Metastatic Prostate Cancer 20 4.3 Progress in Current Treatment Strategies 25 4.3.1 Hormone Modulators 25 4.3.2 Chemotherapy 34 4.4 Key Therapeutic Strategies for Future Therapies 45 4.4.1 Therapeutic Type, Targets & Mechanisms 46 4.5 Competitive Landscape in Drug Development: The Late Stage Pipeline 58 4.5.1 Hormone Modulators 58 4.5.2 Protein Kinase Inhibitors 59 4.5.3 Apoptotic Inducers 63 4.5.4 Immunotherapy 67 4.5.5 DNA Binding 72 4.5.6 Other 74 4.6 Current Drug Development: The Early Stage Pipeline 77 4.6.1 Epothilones 77 4.6.2 Protein Kinse Inhibitors 78 4.6.3 Other 81 4.6.4 Chemotherapy 82 5 Breast Cancer 95 5.1 Introduction 95 5.1.1 Disease Definitions 95 5.1.2 Etiology 96 5.1.3 Epidemiology 97 5.1.4 Prognosis 98 5.2 Current Treatment Strategies 99 5.2.1 Localized Disease 100 5.2.2 Advanced Disease 101 5.3 Progress in Current Treatment Strategies 106 5.3.1 Hormone Based Therapies 107 5.3.2 Antibodies 122 5.3.3 Chemotherapy 126 5.4 Key Therapeutic Strategies for Future Therapies 131 5.4.1 Therapeutic Type, Targets & Mechanisms 131 5.5 Competitive Landscape in Drug Development: The Late Stage Pipeline 147 5.5.1 The Epothilones 147 5.5.2 Cell Cycle & Apoptosis 150 5.5.3 Protein Kinase Inhibitors 156 5.5.4 Immunotherapy 167 5.6 Current Drug Development: The Early Stage Pipeline 171 5.6.1 DNA Targeting 176 5.6.2 FTIs 178 5.6.3 Antisense 181 5.6.4 New Hormone Modulators 182 5.6.5 Other 183 5.7 Disclaimer 187 5.7.1 Liability 187 5.7.2 Completeness 187 6 Drug Index 188 7 Company Index 191 3.1 List of Boxes Box 1: The Eastern Cooperative Oncology Group Study 19 Box 2: Southwest Oncology Group Study 99-16 Design 41 Box 3: TAX 327 Study Design 41 Box 4: Quick Facts - Toremifene 58 Box 5: Quick Facts - Bevacizumab 60 Box 6: Quick Facts - Genasense 61 Box 7: Quick Facts - R-flurbiprofen 63 Box 8: Quick Facts - Exisulind 64 Box 9: Quick Facts - Provenge 67 Box 10: Quick Facts - GVAX 69 Box 11: Quick Facts - Satraplatin 72 Box 12: Quick Facts - Vapreotide 74 Box 13: Quick Facts - DCVax 75 Box 14: Ongoing Phase III Studies Anastrozole 111 Box 15: Ongoing Phase III Studies Letrozole 114 Box 16: Ongoing Phase III Studies Exemestane 115 Box 17: Ongoing Phase III Studies Goserelin 120 Box 18: Ongoing Phase III Studies Fulvestrant 122 Box 19: Ongoing Phase III Studies Trastuzumab 126 Box 20: Quick Facts - BMS-247550 147 Box 21: Quick Facts - Temsirolimus 150 Box 22: Quick Facts - SDX-105 153 Box 23: Quick Facts - 4HPR 154 Box 24: Quick Facts - Lapatinib 157 Box 25: Quick Facts - Bevacizumab 161 Box 26: Quick Facts - Theratope 168 Box 27: Erlotinib 172 Box 28: Gefitinib 174 Box 29: Imatinib 176 Box 30: Pemetrexed 177 Box 31: NX473 178 Box 32: Lonafarnib 180 Box 33: Tipifarnib 181 Box 34: Bortezomib 182 Box 35: Arzoxifene 182 Box 36: Patupilone 183 Box 37: KOS-862 184 3.2 List of Tables Table 1: The TNM System 13 Table 2: Lifestyle factors 15 Table 3: Historical Summary of Clinical Studies on Patients with Late Stage Disease 24 Table 4: Short Facts Bicalutamide 28 Table 5: Short Facts Flutamide 29 Table 6: Short Facts Goserelin 30 Table 7: Short Facts Histrelin 31 Table 8: Short Facts Lanreotide 32 Table 9: Short Facts Leuprolide 33 Table 10: Short Facts Nilutamide 34 Table 11: Short Facts Abarelix 35 Table 12: Short Facts Mitoxantrone 37 Table 13: Short Facts Carboplatin 38 Table 14: Short Facts Docetaxel 40 Table 15: Short Facts Estramustine 42 Table 16: Summary of Recent Clinical Studies on Patients with Late Stage Disease 43 Table 17: Ongoing Late Stage Clinical Studies 44 Table 18: Cancer Immunotherapy Strategies 52 Table 19: Near Term Progress Toremifene 59 Table 20: Near Term Progress Bevacizumab 61 Table 21: Near Term Progress Oblimersen 63 Table 22: Near Term Progress R-flurbiprofen 64 Table 23: Near Term Progress Exisulind 66 Table 24: Near Term Progress APC8015 69 Table 25: Near Term Progress GVAX 72 Table 26: Near Term Progress Satraplatin 74 Table 27: Summary of Prostate Cancer Late Stage Pipeline 76 Table 28: Epothilone 77 Table 29: Ixabepilone 78 Table 30: PTK/ZK 78 Table 31: Imatinib 79 Table 32: Bortezomib 80 Table 33: Sorafenib 81 Table 34: Arsenic trioxide 81 Table 35: Retinoic Acid 82 Table 36: Paclitaxel 82 Table 37: Doxorubicin 83 Table 38: Summary of Prostate Cancer Early Stage Pipeline 94 Accounts 22

Companies Mentioned

Some of the companies included in this analysis: Antigenics, AstraZeneca, Bayer, Baxter International, Biomira, Bristol Myers-Squibb, Cell Genesys, Cephalon, Debiopharm, Dendreon, Eli Lilly, Encore Pharmaceuticals, Genentech, GlaxoSmithKline, Genta, GTx, Isis Pharmaceuticals, Johnson and Johnson, Kosan Biosciences, Lorus Therapeutics, Merck, Millennium Pharmaceutical, Northwest Biotherapeutics, Novartis, Orion Pharma, OSI Pharmaceuticals, NeoRx, Novartis Pharmaceuticals, Pfizer, Roche, Salmedix, Schering-Plough, Wyeth, YM BioSciences