Contents:

25+ BUSINESS DEVELOPMENT & INNOVATION OPPORTUNITIES IN CANCER MEDICINE – 2001 SUMMARY TABLE OF CONTENTS EXECUTIVE SUMMARY.........................................................................................................................................I SECTION 1 INTRODUCTION TO CANCER AND ITS THERAPY................................................................... 1 1.1 SCOPE AND OBJECTIVES OF RESEARCH INVESTIGATION........................................................... 1 1.2 METHODOLOGY OF INVESTIGATION................................................................................................ 1 1.3 LIMITATIONS OF INVESTIGATION ..................................................................................................... 2 1.4 INTRODUCTION TO CANCER AND ITS THERAPY ........................................................................... 3 1.5 TECHNOLOGY PLATFORMS............................................................................................................... 28 1.6 GLOSSARY OF CANCER TERMS ........................................................................................................ 35 SECTION 2 DELPHI PANEL AND THOUGHT LEADER INTERVIEWS: DISCUSSION AND SUMMARY OF CANCER THERAPY INNOVATION........................................................... 39 2.1 INTRODUCTION ................................................................................................................................... 39 2.2 CURRENT APPROACHES ..................................................................................................................... 39 2.3 THE ROLE OF GENOMICS IN CANCER DRUG DEVELOPMENT................................................... 40 2.4 CANCER VACCINES: DREAM OR REALITY - ELITE CANCER TREATMENT OR GLOBAL CANCER PREVENTIVE........................................................................................................................ 41 2.5 THE NEED FOR NEW ENDPOINTS IN CANCER CLINICAL RESEARCH...................................... 41 2.6 CANCER THERAPY – 10 YEARS FROM NOW .................................................................................. 41 2.7 RESULTS OF DELPHI PANEL INTERVIEWS..................................................................................... 42 2.8 DELPHI SUMMARY.............................................................................................................................. 61 SECTION 3 BRAIN CANCER BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITIES..... 65 3.1 INTRODUCTION TO BRAIN CANCER................................................................................................ 65 3.2 EVALUATION OF INNOVATION ACTIVITIES UNDER WAY......................................................... 66 3.3 PRODUCT TECHNOLOGY ANALYSIS ............................................................................................... 66 3.4 MARKET ANALYSIS AND FORECAST .............................................................................................. 70 3.5 BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITY IDENTIFICATION ................ 70 SECTION 4 BREAST CANCER BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITIES.. 77 4.1 INTRODUCTION TO BREAST CANCER............................................................................................. 77 4.2 EVALUATION OF INNOVATION ACTIVITIES UNDER WAY......................................................... 78 4.3 PRODUCT TECHNOLOGY ANALYSIS FOR BREAST CANCER ..................................................... 80 4.4 MARKET ANALYSIS AND FORECAST .............................................................................................. 85 4.5 BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITY IDENTIFICATION ................ 85 SECTION 5 COLORECTAL CANCER BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITIES...................................................................................................................... 97 5.1 INTRODUCTION TO COLORECTAL CANCER..................................................................................97 5.2 EVALUATION OF INNOVATION ACTIVITIES UNDER WAY......................................................... 98 5.3 PRODUCT TECHNOLOGY EVALUATION FOR COLORECTAL CANCER.................................. 100 5.4 MARKET ANALYSIS AND FORECAST ............................................................................................ 104 5.5 BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITY IDENTIFICATION .............. 105 SECTION 6 HEAD AND NECK CANCER BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITIES.................................................................................................................... 113 6.1 INTRODUCTION TO HEAD AND NECK CANCER.......................................................................... 113 6.2 EVALUATION OF INNOVATION ACTIVITIES UNDER WAY....................................................... 113 6.3 PRODUCT EVALUATION FOR HEAD AND NECK CANCER........................................................ 114 6.4 MARKET ANALYSIS AND FORECAST ............................................................................................ 117 6.5 BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITY IDENTIFICATION .............. 118 SECTION 7 LEUKEMIA BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITIES............ 123 7.1 INTRODUCTION TO LEUKEMIA ...................................................................................................... 123 7.2 EVALUATION OF INNOVATION ACTIVITIES UNDER WAY....................................................... 124 7.3 PRODUCT TECHNOLOGY EVALUATION FOR LEUKEMIA......................................................... 125 7.4 MARKET ANALYSIS AND FORECAST ............................................................................................ 130 7.5 BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITY IDENTIFICATION .............. 131 SECTION 8 LUNG CANCER BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITIES .... 137 8.1 INTRODUCTION TO LUNG CANCER............................................................................................... 137 8.2 EVALUATION OF INNOVATION ACTIVITIES UNDER WAY....................................................... 138 8.3 PRODUCT TECHNOLOGY EVALUATION FOR LUNG CANCER ................................................. 141 8.4 MARKET ANALYSIS AND FORECAST ............................................................................................ 145 8.5 BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITY IDENTIFICATION .............. 146 SECTION 9 LYMPHOMA BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITIES ......... 155 9.1 INTRODUCTION TO LYMPHOMA.................................................................................................... 155 9.2 EVALUATION OF INNOVATION ACTIVITIES UNDER WAY....................................................... 156 9.3 PRODUCT TECHNOLOGY EVALUATION FOR LYMPHOMA...................................................... 157 9.4 MARKET ANALYSIS AND FORECAST ............................................................................................ 161 9.5 BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITY IDENTIFICATION .............. 162 SECTION 10 MELANOMA BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITIES ....... 169 10.1 INTRODUCTION TO MELANOMA.................................................................................................... 169 10.2 EVALUATION OF INNOVATION ACTIVITIES UNDER WAY....................................................... 169 10.3 PRODUCT TECHNOLOGY EVALUATION FOR MELANOMA...................................................... 170 10.4 MARKET ANALYSIS AND FORECAST ............................................................................................ 174 10.5 BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITY IDENTIFICATION .............. 175 SECTION 11 OVARIAN CANCER BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITIES ..................................................................................................................................................... 181 11.1 INTRODUCTION TO OVARIAN CANCER........................................................................................181 11.2 EVALUATION OF INNOVATION ACTIVITIES UNDER WAY....................................................... 181 11.3 PRODUCT TECHNOLOGY EVALUATION FOR OVARIAN CANCER.......................................... 182 11.4 MARKET ANALYSIS AND FORECAST ............................................................................................ 186 11.5 BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITY IDENTIFICATION .............. 186 SECTION 12 PROSTATE CANCER BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITIES.................................................................................................................... 193 12.1 INTRODUCTION TO PROSTATE CANCER...................................................................................... 193 12.2 EVALUATION OF INNOVATION ACTIVITIES UNDER WAY....................................................... 194 12.3 PRODUCT TECHNOLOGY ANALYSIS ............................................................................................. 196 12.4 MARKET ANALYSIS AND FORECAST ............................................................................................ 200 12.5 BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITY IDENTIFICATION .............. 200 SECTION 13 TECHNOLOGY PLATFORMS.................................................................................................... 209 13.1 CONVENTIONAL CHEMOTHERAPY................................................................................................ 210 13.2 HORMONE THERAPY........................................................................................................................ 213 13.3 IMMUNOTHERAPY ............................................................................................................................. 215 13.4 CELL CYCLE REGULATORS ............................................................................................................. 235 13.5 MOLECULAR THERAPY .................................................................................................................... 245 13.6 OTHER TECHNOLOGIES................................................................................................................... 261 SECTION 14 COMPANY PROFILES OF INNOVATIVE FIRMS REPRESENTING ACQUISITIONS, LICENSING, AND COMARKETING OPPORTUNITIES IN CANCER THERAPY....... 271 14.1 AETERNA LABORATORIES............................................................................................................... 271 14.2 ALTAREX CORPORATION................................................................................................................. 271 14.3 ANTIGENICS........................................................................................................................................ 272 14.4 ANTISOMA........................................................................................................................................... 273 14.5 ARGONEX............................................................................................................................................ 274 14.6 AVAX TECHNOLOGIES..................................................................................................................... 275 14.7 BIOMIRA .............................................................................................................................................. 275 14.8 CANTAB ............................................................................................................................................... 276 14.9 CELL GENESYS................................................................................................................................... 276 14.10 CELL PATHWAYS............................................................................................................................... 277 14.11 CELL THERAPEUTICS ........................................................................................................................ 278 14.12 CHIMERIC THERAPIES...................................................................................................................... 278 14.13 COBRA THERAPEUTICS .................................................................................................................... 279 14.14 CORIXA ................................................................................................................................................ 279 14.15 CRV LIMITED...................................................................................................................................... 281 14.16 CYTRAN............................................................................................................................................... 281 14.17 DENDREON.......................................................................................................................................... 282 14.18 DUKE UNIVERSITY............................................................................................................................ 282 14.19 ELAN ..................................................................................................................................................... 282 14.20 ENTREMED.......................................................................................................................................... 283 14.21 GLORY PHARMACEUTICALS ........................................................................................................... 284 14.22 HUGHES INSTITUTE.......................................................................................................................... 284 14.23 ILEX ONCOLOGY ............................................................................................................................... 285 14.24 IMCLONE SYSTEMS........................................................................................................................... 285 14.25 IMMUNE RESPONSE.......................................................................................................................... 286 14.26 IMMUNEX............................................................................................................................................ 286 14.27 IMMUNO-DESIGNED MOLECULES (IDM) ...................................................................................... 287 14.28 IMMUNOMEDICS................................................................................................................................ 287 14.29 JENNER BIOTHERAPIES .................................................................................................................... 288 14.30 JOHN WAYNE CANCER INSTITUTE ................................................................................................ 288 14.31 JOHNS HOPKINS UNIVERSITY......................................................................................................... 289 14.32 LIGAND ................................................................................................................................................ 289 14.33 MEDAREX............................................................................................................................................ 290 14.34 MEDIGENE AG.................................................................................................................................... 290 14.35 MSKCC.................................................................................................................................................. 290 14.36 MYRIAD GENETICS ............................................................................................................................ 291 14.37 NEOPHARM......................................................................................................................................... 291 14.38 NEUROCRINE BIOSCIENCES ............................................................................................................ 292 14.39 NIH ..................................................................................................................................................... 292 14.40 NORTHWEST BIOTHERAPEUTICS................................................................................................... 293 14.41 NOVOGEN............................................................................................................................................ 294 14.42 PEPTECH .............................................................................................................................................. 294 14.43 PEREGRINE PHARMACEUTICALS................................................................................................... 294 14.44 PROTEIN DESIGN LABS..................................................................................................................... 295 14.45 SELECTIVE GENETICS ....................................................................................................................... 295 14.46 STANFORD ROOK ............................................................................................................................... 296 14.47 TARGETED GENETICS ....................................................................................................................... 296 14.48 TELIK.................................................................................................................................................... 297 14.49 TITAN PHARMACEUTICALS............................................................................................................. 297 14.50 TRANSGENE........................................................................................................................................ 298 14.51 VICAL ................................................................................................................................................... 298 14.52 VION PHARMACEUTICALS............................................................................................................... 299 14.53 VIVENTIA BIOTECH ........................................................................................................................... 299 14.54 XOMA ................................................................................................................................................... 300 14.55 YM BIOSCIENCES............................................................................................................................... 300 DETAILED TABLE OF CONTENTS EXECUTIVE SUMMARY...............................................................................................................................................i Current Therapeutic Regimens.........................................................................................................................................x Future Treatments.............................................................................................................................................................x Cancer Vaccines..............................................................................................................................................................xi Section 1 INTRODUCTION TO CANCER AND ITS THERAPY ........................................................................ 1 1.1 SCOPE AND OBJECTIVES OF RESEARCH INVESTIGATION........................................................... 1 1.2 METHODOLOGY OF INVESTIGATION................................................................................................ 1 1.3 LIMITATIONS OF INVESTIGATION ..................................................................................................... 2 1.4 INTRODUCTION TO CANCER AND ITS THERAPY ........................................................................... 3 1.4.1 General Description of Cancer Pathogenesis .................................................................................. 3 Genetic Basis of Cancer: Protooncogenes and Oncogenes................................................................................................5 Growth Factors.................................................................................................................................................................7 Metastasis.........................................................................................................................................................................7 Causes of Cancer ..............................................................................................................................................................8 1.4.2 Cell Cycle Regulation and Its Role in the Development of Cancer.................................................. 9 Cell Cycle Phases ...........................................................................................................................................................10 Role of the Cyclins and Cyclin-Dependent Kinases........................................................................................................11 Signal Transduction Pathways........................................................................................................................................12 Checkpoints of the Cell Cycle ........................................................................................................................................14 Viral Interference with Cell Cycle Checkpoints..............................................................................................................15 Apoptosis........................................................................................................................................................................15 1.4.3 Diagnosis and Staging of Cancer................................................................................................... 16 Identification ..................................................................................................................................................................18 Staging............................................................................................................................................................................18 Location..........................................................................................................................................................................19 Screening........................................................................................................................................................................19 1.4.4 Therapy of Cancer......................................................................................................................... 19 Surgery ...........................................................................................................................................................................19 Cryosurgery....................................................................................................................................................................20 Radiation Therapy ..........................................................................................................................................................20 Chemotherapy ................................................................................................................................................................21 Biologic Therapy............................................................................................................................................................22 1.4.5 Description and Treatment of Various Cancers............................................................................. 22 1.4.6 Problems With Current Cancer Therapies ..................................................................................... 23 1.4.7 Rational Drug Design and the Emergence of New Approaches to Cancer Therapy...................... 25 Screening of Compounds from Biological and Synthesized Sources ..............................................................................27 Rational Drug Design.....................................................................................................................................................28 Definition of Terminology Used in This Report..............................................................................................................28 1.5 TECHNOLOGY PLATFORMS............................................................................................................... 28 Conventional Chemotherapeutic Agents .........................................................................................................................29 Topoisomerase Inhibitors ...............................................................................................................................................29 Microtubulin Inhibitors ..................................................................................................................................................29 Hormones .......................................................................................................................................................................29 Cytokines........................................................................................................................................................................29 Immunomodulators ........................................................................................................................................................30 Vaccines .........................................................................................................................................................................30 Ligand Fusion Toxins.....................................................................................................................................................30 Extracellular Matrix (ECM) Therapy (Cell Adhesion Molecular Targets)......................................................................30 Olgionucleotides (Antisense/Ribozymes).......................................................................................................................30 Cell Therapy...................................................................................................................................................................30 Gene Therapy .................................................................................................................................................................31 Sensitizers ......................................................................................................................................................................31 Cell Cycle Regulation ....................................................................................................................................................31 Others .............................................................................................................................................................................31 Antimetastatic therapy....................................................................................................................................................32 Antiangiogenesis therapy ...............................................................................................................................................32 Antisense therapy ...........................................................................................................................................................32 Apoptosis induction........................................................................................................................................................32 Cell therapy ....................................................................................................................................................................32 Cell adhesion molecule therapy......................................................................................................................................33 Differentiation therapy ...................................................................................................................................................33 Enzyme inhibition therapy .............................................................................................................................................33 Gene therapy ..................................................................................................................................................................33 Hormone therapy............................................................................................................................................................33 Immunotherapy ..............................................................................................................................................................33 Ligand therapy................................................................................................................................................................33 MAb and immunoconjugate therapy ...............................................................................................................................34 Multidrug resistance modulation ....................................................................................................................................34 Oncogene therapy...........................................................................................................................................................34 Photo and radio-directed therapy....................................................................................................................................34 Recombinant protein and peptides (e.g., cytokine) therapy.............................................................................................34 Signal transduction/transcriptional regulation therapy ....................................................................................................34 Traditional chemotherapy...............................................................................................................................................34 Vaccine therapy..............................................................................................................................................................35 1.6 GLOSSARY OF CANCER TERMS ........................................................................................................ 35 SECTION 2 DELPHI PANEL AND THOUGHT LEADER INTERVIEWS: DISCUSSION AND SUMMARY OF CANCER THERAPY INNOVATION........................................................... 39 2.1 INTRODUCTION ................................................................................................................................... 39 2.2 CURRENT APPROACHES ..................................................................................................................... 39 2.3 THE ROLE OF GENOMICS IN CANCER DRUG DEVELOPMENT................................................... 40 2.4 CANCER VACCINES: DREAM OR REALITY - ELITE CANCER TREATMENT OR GLOBAL CANCER PREVENTIVE........................................................................................................................ 41 2.5 THE NEED FOR NEW ENDPOINTS IN CANCER CLINICAL RESEARCH...................................... 41 2.6 CANCER THERAPY – 10 YEARS FROM NOW .................................................................................. 41 2.7 RESULTS OF DELPHI PANEL INTERVIEWS..................................................................................... 42 2.8 DELPHI SUMMARY.............................................................................................................................. 61 Current Therapeutic Regimens.......................................................................................................................................62 Future Treatments...........................................................................................................................................................62 Cancer Vaccines.............................................................................................................................................................62 SECTION 3 BRAIN CANCER BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITIES..... 65 3.1 INTRODUCTION TO BRAIN CANCER................................................................................................ 65 3.2 EVALUATION OF INNOVATION ACTIVITIES UNDER WAY......................................................... 66 3.3 PRODUCT TECHNOLOGY ANALYSIS ............................................................................................... 66 3.4 MARKET ANALYSIS AND FORECAST .............................................................................................. 70 3.5 BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITY IDENTIFICATION ................ 70 SECTION 4 BREAST CANCER BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITIES.. 77 4.1 INTRODUCTION TO BREAST CANCER............................................................................................. 77 4.2 EVALUATION OF INNOVATION ACTIVITIES UNDER WAY......................................................... 78 4.3 PRODUCT TECHNOLOGY ANALYSIS FOR BREAST CANCER ..................................................... 80 4.4 MARKET ANALYSIS AND FORECAST .............................................................................................. 85 4.5 BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITY IDENTIFICATION ................ 85 SECTION 5 COLORECTAL CANCER BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITIES...................................................................................................................... 97 5.1 INTRODUCTION TO COLORECTAL CANCER..................................................................................97 5.2 EVALUATION OF INNOVATION ACTIVITIES UNDER WAY......................................................... 98 5.3 PRODUCT TECHNOLOGY EVALUATION FOR COLORECTAL CANCER.................................. 100 5.4 MARKET ANALYSIS AND FORECAST ............................................................................................ 104 5.5 BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITY IDENTIFICATION .............. 105 SECTION 6 HEAD AND NECK CANCER BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITIES.................................................................................................................... 113 6.1 INTRODUCTION TO HEAD AND NECK CANCER.......................................................................... 113 6.2 EVALUATION OF INNOVATION ACTIVITIES UNDER WAY....................................................... 113 6.3 PRODUCT EVALUATION FOR HEAD AND NECK CANCER........................................................ 114 6.4 MARKET ANALYSIS AND FORECAST ............................................................................................ 117 6.5 BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITY IDENTIFICATION .............. 118 SECTION 7 LEUKEMIA BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITIES............ 123 7.1 INTRODUCTION TO LEUKEMIA ...................................................................................................... 123 7.2 EVALUATION OF INNOVATION ACTIVITIES UNDER WAY....................................................... 124 7.3 PRODUCT TECHNOLOGY EVALUATION FOR LEUKEMIA......................................................... 125 7.4 MARKET ANALYSIS AND FORECAST ............................................................................................ 130 7.5 BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITY IDENTIFICATION .............. 131 SECTION 8 LUNG CANCER BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITIES .... 137 8.1 INTRODUCTION TO LUNG CANCER............................................................................................... 137 8.2 EVALUATION OF INNOVATION ACTIVITIES UNDER WAY....................................................... 138 8.3 PRODUCT TECHNOLOGY EVALUATION FOR LUNG CANCER ................................................. 141 8.4 MARKET ANALYSIS AND FORECAST ............................................................................................ 145 8.5 BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITY IDENTIFICATION .............. 146 SECTION 9 LYMPHOMA BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITIES ......... 155 9.1 INTRODUCTION TO LYMPHOMA.................................................................................................... 155 9.2 EVALUATION OF INNOVATION ACTIVITIES UNDER WAY....................................................... 156 9.3 PRODUCT TECHNOLOGY EVALUATION FOR LYMPHOMA...................................................... 157 9.4 MARKET ANALYSIS AND FORECAST ............................................................................................ 161 9.5 BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITY IDENTIFICATION .............. 162 SECTION 10 MELANOMA BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITIES ....... 169 10.1 INTRODUCTION TO MELANOMA.................................................................................................... 169 10.2 EVALUATION OF INNOVATION ACTIVITIES UNDER WAY....................................................... 169 10.3 PRODUCT TECHNOLOGY EVALUATION FOR MELANOMA...................................................... 170 10.4 MARKET ANALYSIS AND FORECAST ............................................................................................ 174 10.5 BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITY IDENTIFICATION .............. 175 SECTION 11 OVARIAN CANCER BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITIES ..................................................................................................................................................... 181 11.1 INTRODUCTION TO OVARIAN CANCER........................................................................................181 11.2 EVALUATION OF INNOVATION ACTIVITIES UNDER WAY....................................................... 181 11.3 PRODUCT TECHNOLOGY EVALUATION FOR OVARIAN CANCER.......................................... 182 11.4 MARKET ANALYSIS AND FORECAST ............................................................................................ 186 11.5 BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITY IDENTIFICATION .............. 186 SECTION 12 PROSTATE CANCER BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITIES.................................................................................................................... 193 12.1 INTRODUCTION TO PROSTATE CANCER...................................................................................... 193 12.2 EVALUATION OF INNOVATION ACTIVITIES UNDER WAY....................................................... 194 12.3 PRODUCT TECHNOLOGY ANALYSIS ............................................................................................. 196 12.4 MARKET ANALYSIS AND FORECAST ............................................................................................ 200 12.5 BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITY IDENTIFICATION .............. 200 SECTION 13 TECHNOLOGY PLATFORMS.................................................................................................... 209 Key Assumption Structure ...........................................................................................................................................209 13.1 CONVENTIONAL CHEMOTHERAPY................................................................................................ 210 Traditional Chemotherapy – Cytotoxic Drugs, Alkylating Agents, Microtubule Inhibitors, Antimetabolites, and Topoisomerase Inhibitors .............................................................................................................................................210 Overview of Product Development/Technology Platforms...........................................................................................210 Strengths and Shortcomings .........................................................................................................................................213 Forecast Role of Traditional Cytotoxic Chemotherapy .................................................................................................213 13.2 HORMONE THERAPY........................................................................................................................ 213 Overview of Product Development ...............................................................................................................................214 Strengths and Shortcomings .........................................................................................................................................215 Forecast Role of Hormone Therapy ..............................................................................................................................215 13.3 IMMUNOTHERAPY ............................................................................................................................. 215 13.3.1 Cytokine and Cytokine Blockers................................................................................................... 215 Overview of Product Development/Technology Platforms...........................................................................................216 Interferons ....................................................................................................................................................................216 Interleukins...................................................................................................................................................................217 Strengths and Shortcomings of Cytokines.....................................................................................................................222 Forecast Role of Cytokines ..........................................................................................................................................223 13.3.2 Monoclonal Antibody and Immunoconjugate Therapy ................................................................ 223 Overview of Product Development/Technology Platforms...........................................................................................224 Strengths and Weaknesses of Monoclonal Antibodies and Immunoconjugates ............................................................228 Forecast Role of Monoclonal Antibodies and Immunoconjugates ................................................................................229 13.3.3 Therapeutic Vaccines ................................................................................................................... 230 Overview of Product Development/Technology Platforms...........................................................................................230 Strengths and Shortcomings of Vaccines ......................................................................................................................231 Forecast Role of Therapeutic Vaccines .........................................................................................................................231 13.3.4 Ligand Fusion and Other Targeted Therapy................................................................................ 232 Overview of Product Development/Technology Platforms...........................................................................................232 Strengths and Weaknesses of Ligand Therapy ..............................................................................................................233 Forecast Role of Ligand Therapy .................................................................................................................................233 13.3.5 Immunomodulators...................................................................................................................... 233 Overview of Product Development/Technology Platforms...........................................................................................234 Strengths and Shortcomings of Immunomodulators......................................................................................................234 Forecast Role of Immunomodulators ............................................................................................................................234 13.4 CELL CYCLE REGULATORS ............................................................................................................. 235 13.4.1 Signal Transduction/ Transcription Regulation ........................................................................... 235 Overview of Product Development/Technology Platforms...........................................................................................235 13.4.2 Transcription Regulation.............................................................................................................. 237 Strengths and Shortcomings of Signal Transduction/Transcription Factor Modulators ................................................240 Forecast Role of Signal Transduction/Transcription Factor Modulators.......................................................................241 13.4.3 Apoptosis Agonists ....................................................................................................................... 241 Strengths and Shortcomings of Apoptosis Agonists......................................................................................................244 Forecast Role of Apoptosis Agonists ............................................................................................................................244 13.4.4 Differentiating Agents .................................................................................................................. 244 13.5 MOLECULAR THERAPY .................................................................................................................... 245 13.5.1 Oligonucleotide-based Therapy: Antisense/Ribozymes................................................................ 245 Overview of Product Development/Technology Platforms...........................................................................................245 13.5.2 Ribozymes.................................................................................................................................... 249 Strengths and Weaknesses of Antisense/Ribozymes .....................................................................................................250 13.5.3 Cell Therapy................................................................................................................................ 253 Overview of Product Development/Technology Platforms...........................................................................................253 Strengths and Weaknesses of Cell Therapy...................................................................................................................254 Forecast Role of Cell Therapy......................................................................................................................................254 13.5.4 Gene Therapy, Genetic Vaccines, Gene Delivery......................................................................... 255 Overview of Product Development/Technology Platforms...........................................................................................255 Strengths and Weaknesses of Gene Therapy.................................................................................................................259 Forecast Role of Gene Therapy ....................................................................................................................................259 13.6 OTHER TECHNOLOGIES................................................................................................................... 261 13.6.1 Angiogenesis Inhibitors................................................................................................................ 261 Overview of Product Development/Technology Platforms...........................................................................................261 Strengths and Shortcomings of Anti-Angiogenic Therapy...........................................................................................262 Forecast Role of Antiangiogenic Compounds ...............................................................................................................262 13.6.2 Multidrug Resistance (MDR) ....................................................................................................... 263 Overview of Product Development/Technology Platforms...........................................................................................263 Strengths and Shortcomings of MDR Regulators..........................................................................................................264 Forecast Role of MDR Regulators ...............................................................................................................................264 13.6.3 Extracellular Matrix (ECM) and Cell Adhesion Molecules (CAMs)............................................ 265 Overview of Product Development/Technology Platforms...........................................................................................265 Strengths and Shortcomings of ECM/CAMs.................................................................................................................268 Forecast Role of ECM/CAMs ......................................................................................................................................269 13.6.4 Minor Technologies: .................................................................................................................... 269 SECTION 14 COMPANY PROFILES OF INNOVATIVE FIRMS REPRESENTING ACQUISITIONS, LICENSING, AND COMARKETING OPPORTUNITIES IN CANCER THERAPY....... 271 14.1 AETERNA LABORATORIES............................................................................................................... 271 14.2 ALTAREX CORPORATION................................................................................................................. 271 14.2.1 ALZA ........................................................................................................................................... 272 14.3 ANTIGENICS........................................................................................................................................ 272 14.4 ANTISOMA........................................................................................................................................... 273 14.5 ARGONEX............................................................................................................................................ 274 14.6 AVAX TECHNOLOGIES..................................................................................................................... 275 14.7 BIOMIRA .............................................................................................................................................. 275 14.8 CANTAB ............................................................................................................................................... 276 14.9 CELL GENESYS................................................................................................................................... 276 14.10 CELL PATHWAYS............................................................................................................................... 277 14.11 CELL THERAPEUTICS ........................................................................................................................ 278 14.12 CHIMERIC THERAPIES...................................................................................................................... 278 14.13 COBRA THERAPEUTICS .................................................................................................................... 279 14.14 CORIXA ................................................................................................................................................ 279 14.15 CRV LIMITED...................................................................................................................................... 281 14.16 CYTRAN............................................................................................................................................... 281 14.17 DENDREON.......................................................................................................................................... 282 14.18 DUKE UNIVERSITY............................................................................................................................ 282 14.19 ELAN ..................................................................................................................................................... 282 14.20 ENTREMED.......................................................................................................................................... 283 14.21 GLORY PHARMACEUTICALS ........................................................................................................... 284 14.22 HUGHES INSTITUTE.......................................................................................................................... 284 14.23 ILEX ONCOLOGY ............................................................................................................................... 285 14.24 IMCLONE SYSTEMS........................................................................................................................... 285 14.25 IMMUNE RESPONSE.......................................................................................................................... 286 14.26 IMMUNEX............................................................................................................................................ 286 14.27 IMMUNO-DESIGNED MOLECULES (IDM) ...................................................................................... 287 14.28 IMMUNOMEDICS................................................................................................................................ 287 14.29 JENNER BIOTHERAPIES .................................................................................................................... 288 14.30 JOHN WAYNE CANCER INSTITUTE ................................................................................................ 288 14.31 JOHNS HOPKINS UNIVERSITY......................................................................................................... 289 14.32 LIGAND ................................................................................................................................................ 289 14.33 MEDAREX............................................................................................................................................ 290 14.34 MEDIGENE AG.................................................................................................................................... 290 14.35 MSKCC.................................................................................................................................................. 290 14.36 MYRIAD GENETICS ............................................................................................................................ 291 14.37 NEOPHARM......................................................................................................................................... 291 14.38 NEUROCRINE BIOSCIENCES ............................................................................................................ 292 14.39 NIH ..................................................................................................................................................... 292 14.40 NORTHWEST BIOTHERAPEUTICS................................................................................................... 293 14.41 NOVOGEN............................................................................................................................................ 294 14.42 PEPTECH .............................................................................................................................................. 294 14.43 PEREGRINE PHARMACEUTICALS................................................................................................... 294 14.44 PROTEIN DESIGN LABS..................................................................................................................... 295 14.45 SELECTIVE GENETICS ....................................................................................................................... 295 14.46 STANFORD ROOK ............................................................................................................................... 296 14.47 TARGETED GENETICS ....................................................................................................................... 296 14.48 TELIK.................................................................................................................................................... 297 14.49 TITAN PHARMACEUTICALS............................................................................................................. 297 14.50 TRANSGENE........................................................................................................................................ 298 14.51 VICAL ................................................................................................................................................... 298 14.52 VION PHARMACEUTICALS............................................................................................................... 299 14.53 VIVENTIA BIOTECH ........................................................................................................................... 299 14.54 XOMA ................................................................................................................................................... 300 14.55 YM BIOSCIENCES............................................................................................................................... 300 LIST OF FIGURES Figure ES 1 Product Development Activity in Cancer Therapy by Phase of Development...... vi Figure ES 2 Product Development Activity in Cancer Therapy by Disease State.................... vii Figure ES 3 Product Development Activity in Breast Cancer Therapy by Phase of Development ......................................................................................................... vii Figure ES 4 Active Development Programs in each Cancer Area by Phase of Development.viii Figure ES 5 Active Development Programs in each Phase of Development by Cancer Area.viii Figure ES 6 Unpartnered vs. Partnered Programs by Phase of Development ........................... ix Figure ES 7 Market Activity in 1997 by Disease State............................................................xiii Figure ES 8 Market Activity in 2000 by Disease State............................................................xiii Figure ES 9 Market Activity in 2010 by Disease State............................................................ xiv Figure 3.1 Market Impact Matrix for Technology Platforms in Brain Cancer Therapy ........ 68 Figure 3.2 WW Forecast for Brain Cancer Therapy by Technology Platform ...................... 69 Figure 4.1 Market Impact Matrix for Technology Platforms in Breast Cancer Therapy....... 83 Figure 4.2 WW Forecast for Breast Cancer Therapy by Technology Platform ..................... 84 Figure 5.1 Market Impact Matrix for Technology Platforms in Colorectal Cancer Therapy................................................................................................................ 102 Figure 5.2 WW Forecast for Colorectal Cancer Therapy by Technology Platform............. 103 Figure 6.1 Market Impact Matrix for Technology Platforms in Head and Neck Cancer..... 116 Figure 6.2 WW Forecast for Head and Neck Cancer Therapy by Technology Platform..... 117 Figure 7.1 Market Impact Matrix for Technology Platforms in Leukemia Therapy............ 127 Figure 7.2 WW Forecast for Leukemia Therapy by Technology Platform.......................... 128 Figure 8.1 Market Impact Matrix for Technology Platforms in Lung Cancer Therapy....... 143 Figure 8.2 WW Forecast for Lung Cancer Therapy by Technology Platform..................... 144 Figure 9.1 Market Impact Matrix for Technology Platforms in Lymphoma Therapy ......... 159 Figure 9.2 WW Forecast for Lymphoma Therapy by Technology Platform ....................... 160 Figure 10.1 Market Impact Matrix for Technology Platforms in Melanoma Therapy .......... 172 Figure 10.2 WW Forecast for Melanoma Therapy by Technology Platform......................... 173 Figure 11.1 Market Impact Matrix for Technology Platforms in Ovarian Cancer Therapy . 184 Figure 11.2 WW Forecast for Ovarian Cancer Therapy by Technology Platform ................ 185 Figure 12.1 Market Impact Matrix for Technology Platforms in Prostate Cancer Therapy . 198 Figure 12.2 WW Forecast for Prostate Cancer Therapy by Technology Platform ................ 199 LIST OF TABLES Table ES 1 Market Forecast for All 10 Cancer Therapies by Disease ....................................xii Table ES 2 Opportunity Sorting Matrix for All 10 Cancer Therapies by Final Score ........... xvi Table ES 3 Opportunity Sorting Matrix for All 10 Cancer Therapies by Disease ................xvii Table ES 4 Opportunity Sorting Matrix for All 10 Cancer Therapies by Company ............xviii Table 1.1 Oncogene Families and Genes ................................................................................ 6 Table 1.2 Cancers Associated with the Loss of a Tumor Suppressor Gene............................ 6 Table 1.3 Growth Factors With Cancer Pathogenesis............................................................. 7 Table 1.4 Environmental Risk Factors Associated With Cancer ............................................ 8 Table 1.5 Diagnostic Tests in Cancer Therapy Management ............................................... 17 Table 1.6 Tumor Markers...................................................................................................... 18 Table 1.7 Description of Various Carcinomas and Sarcomas............................................... 24 Table 1.8 Emerging Approaches in Cancer Therapy ............................................................ 26 Table 1.9 Technologies ......................................................................................................... 32 Table 3.1 Product Development Activity for Brain Cancer Therapy by Phase of Development ......................................................................................................... 67 Table 3.2 Market Forecast for Brain Cancer Therapy by Technology ................................ 71 Table 3.3 Opportunity Sorting Matrix for Brain Cancer Therapy ........................................ 72 Table 3.4 Product Development Activity for Brain Cancer Therapy.................................... 74 Table 4.1 Product Development Activity for Breast Cancer Therapy by Phase of Development ......................................................................................................... 81 Table 4.2 Market Forecast for Breast Cancer Therapy by Technology............................... 86 Table 4.3 Opportunity Sorting Matrix for Breast Cancer Therapy....................................... 87 Table 4.4 Product Development Activity for Breast Cancer Therapy .................................. 89 Table 5.1 Product Development Activity for Colorectal Cancer Therapy by Phase of Development ....................................................................................................... 101 Table 5.2 Market Forecast for Colorectal Cancer Therapy by Technology....................... 105 Table 5.3 Opportunity Sorting Matrix for Colorectal Cancer Therapy............................... 106 Table 5.4 Product Development Activity for Colorectal Therapy ...................................... 107 Table 6.1 Product Development Activity for Head and Neck Cancer Therapy by Phase of Development ................................................................................................... 115 Table 6.2 Market Forecast for Head and Neck Cancer Therapy by Technology............... 118 Table 6.3 Opportunity Sorting Matrix for Head and Neck Cancer Therapy....................... 119 Table 6.4 Product Development Activity for Head and Neck Cancer Therapy.................. 121 Table 7.1 Product Development Activity for Leukemia Cancer Therapy by Phase of Development ....................................................................................................... 126 Table 7.2 Market Forecast for Leukemia Therapy by Technology.................................... 130 Table 7.3 Opportunity Sorting Matrix for Leukemia Therapy............................................ 132 Table 7.4 Product Development Activity for Leukemia Therapy....................................... 133 Table 8.1 Product Development Activity for Lung Cancer Therapy by Phase of Development ....................................................................................................... 142 Table 8.2 Market Forecast for Lung Cancer Therapy by Technology............................... 146 Table 8.3 Opportunity Sorting Matrix for Lung Cancer Therapy....................................... 147 Table 8.4 Product Development Activity for Lung Cancer Therapy.................................. 149 Table 9.1 Product Development Activity for Lymphoma Cancer Therapy by Phase of Development ....................................................................................................... 158 Table 9.2 Market Forecast for Lymphoma Therapy by Technology ................................. 162 Table 9.3 Opportunity Sorting Matrix for Lymphoma Therapy ......................................... 163 Table 9.4 Product Development Activity for Lymphoma Therapy .................................... 165 Table 10.1 Product Development Activity for Melanoma Cancer Therapy by Phase of Development ....................................................................................................... 171 Table 10.2 Market Forecast for Melanoma Therapy by Technology................................... 174 Table 10.3 Opportunity Sorting Matrix for Melanoma Therapy .......................................... 176 Table 10.4 Product Development Activity for Melanoma Therapy...................................... 177 Table 11.1 Product Development Activity for Ovarian Cancer Therapy by Phase of Development ....................................................................................................... 183 Table 11.2 Market Forecast for Ovarian Cancer Therapy by Technology .......................... 186 Table 11.3 Opportunity Sorting Matrix for Ovarian Cancer Therapy .................................. 188 Table 11.4 Product Development Activity for Ovarian Cancer Therapy.............................. 189 Table 12.1 Product Development Activity for Prostate Cancer Therapy by Phase of Development ....................................................................................................... 197 Table 12.2 Market Forecast for Prostate Cancer Therapy by Technology .......................... 200 Table 12.3 Opportunity Sorting Matrix for Prostate Cancer Therapy .................................. 201 Table 12.4 Product Development Activity for Prostate Cancer Therapy.............................. 203

Summary:

This report is designed to provide a useful tool to professionals in research and development (R&D), marketing, business development, licensing, and strategic planning who are, or are anticipating, involvement in the discovery, development, licensing, and/or marketing of therapeutics for the treatment of: brain cancer, breast cancer, colorectal cancer, head and neck cancer, leukemia, lung cancer, lymphoma, melanoma, ovarian cancer or prostate cancer.