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CANCER DRUG DISCOVERIES NON-SMALL CELL LUNG CANCER CONTENTS
BACKGROUND TO NSCLC.............................................................................................................2
What is NSCLC and how does it affect patients? ........................................................................2 Stages of the disease.................................................................................................................................3
Patient statistics..............................................................................................................................4 Incidence, diagnosis rates & treatment; now and in the future ............................................................4
Patient growth drivers ....................................................................................................................5 The addressable NSCLC market will increase by 17% by 2012 ............................................................5
CURRENT TREATMENTS ...............................................................................................................9
CHEMOTHERAPY..........................................................................................................................10 SWOT analysis of chemotherapy ...........................................................................................................12
Sales forecast of current NSCLC drugs......................................................................................33
RESEARCH & DEVELOPMENT OF NSCLC DRUGS...................................................................36
Phase II / III drugs of interest .......................................................................................................38
New cytotoxics..............................................................................................................................40 Eloxatin (sanofi-aventis) - Phase III .........................................................................................................40
Telcyta (Telik) - Phase II / III ....................................................................................................................42 Scientific rationale .............................................................................................................................42 Strengths ...........................................................................................................................................44 Weaknesses......................................................................................................................................44 Opportunities .....................................................................................................................................44 Threats ..............................................................................................................................................44 Probability of success and sales forecast .........................................................................................44
Satraplatin (Spectrum Pharmaceuticals/GPC Biotech) - Phase II...........................................................45 Scientific rationale .............................................................................................................................45 Strengths ...........................................................................................................................................45 Weaknesses......................................................................................................................................45 Opportunities .....................................................................................................................................46 Threats ..............................................................................................................................................46 Probability of success and sales forecast .........................................................................................46
Novel therapies..............................................................................................................................47 Erbitux (BMS/Merck KGaA/ImClone) - Phase III .....................................................................................47
Neovastat (AEterna Zentaris) - Phase III.................................................................................................54 Strengths ...........................................................................................................................................55 Weaknesses......................................................................................................................................55 Opportunities .....................................................................................................................................55 Threats ..............................................................................................................................................55 Probability of success and sales forecast .........................................................................................56
Epidermal growth factor inhibitors.........................................................................................................56 Panitumumab (Amgen) - Phase III ..........................................................................................................56
Filing and sales forecasts..................................................................................................................57 Matuzumab (Merck KGaA) - Phase II......................................................................................................58
Filing and sales forecasts..................................................................................................................58 DNA synthesis inhibitor...........................................................................................................................59
Cancer vaccines .......................................................................................................................................61
NON-SMALL CELL LUNG CANCER CONTENTS CANCER DRUG DISCOVERIES
KRX-0401 (Keryx/AEterna Zentaris) - Phase II .......................................................................................69 Strengths ...........................................................................................................................................69 Weaknesses ......................................................................................................................................69 Opportunities .....................................................................................................................................69 Threats ..............................................................................................................................................70 Probability of success and sales forecasts .......................................................................................70
EP-2101 (Epimmune) - Phase I / II ..........................................................................................................70 Strengths ...........................................................................................................................................70 Probability of success and sales forecasts .......................................................................................71
Alternative approaches............................................................................................................................72 Velcade (J&J/Millennium Pharmaceuticals) - Phase II ............................................................................72
Scientific rationale .............................................................................................................................72 Strengths ...........................................................................................................................................73 Weaknesses ......................................................................................................................................73 Opportunities .....................................................................................................................................73 Threats ..............................................................................................................................................74 Probability of success and sales forecasts .......................................................................................74
Ispinesib (GlaxoSmithKline) - Phase II ....................................................................................................74
CANCER DRUG DISCOVERIES NON-SMALL CELL LUNG CANCER CONTENTS
Strengths ...........................................................................................................................................74 Weaknesses......................................................................................................................................74 Opportunities .....................................................................................................................................75 Threats ..............................................................................................................................................75 Probability of success and sales forecasts .......................................................................................76
Talabostat (Point Therapeutics) - Phase II ..............................................................................................76 Probability of success and sales forecasts .......................................................................................78
Talotrexin (Hana Biosciences) - Phase I / II ............................................................................................78 Scientific rationale .............................................................................................................................78 Strengths ...........................................................................................................................................79 Weaknesses......................................................................................................................................79 Opportunities .....................................................................................................................................79 Threats ..............................................................................................................................................79 Probability of success and sales forecasts .......................................................................................80
Targretin (Ligand Pharmaceuticals) - Phase III .......................................................................................80 Strengths ...........................................................................................................................................80 Weaknesses......................................................................................................................................80 Opportunities .....................................................................................................................................81 Threats ..............................................................................................................................................81 Probability of success and sales forecasts .......................................................................................81
TRAIL-R1 MAb (Human Genome Sciences Inc/Cambridge Antibody Technology) - Phase I / II ...........82 Scientific rationale .............................................................................................................................82 Strengths ...........................................................................................................................................82 Weaknesses......................................................................................................................................83 Opportunities .....................................................................................................................................83 Threats ..............................................................................................................................................84 Probability of success and sales forecasts .......................................................................................84
New formulations .....................................................................................................................................84 Xyotax (Cell Therapeutics / Chugai / Roche) - Phase III .........................................................................84
Scientific rationale .............................................................................................................................85 Strengths ...........................................................................................................................................87 Weaknesses......................................................................................................................................87 Opportunities .....................................................................................................................................87 Threats ..............................................................................................................................................88 Probability of success and sales forecast .........................................................................................88
DN-101 (Novacea) - Phase I/II ................................................................................................................88 Scientific rationale .............................................................................................................................88 Strengths ...........................................................................................................................................88 Weaknesses......................................................................................................................................88 Opportunities .....................................................................................................................................89 Threats ..............................................................................................................................................89 Probability of success and sales forecast .........................................................................................89
NON-SMALL CELL LUNG CANCER CONTENTS CANCER DRUG DISCOVERIES
DISCONTINUATION OF NSCLC DRUGS .....................................................................................93
THE MARKET - CURRENT AND FUTURE ...................................................................................94
GLOBAL CANCER MARKET ........................................................................................................94
GLOBAL NSCLC MARKET ...........................................................................................................96
Key companies in the global NSCLC market .............................................................................98 AstraZeneca.............................................................................................................................................98 Bristol-Myers Squibb ................................................................................................................................99 sanofi-aventis .........................................................................................................................................102
Leading NSCLC companies in 2012E...................................................................................................104
Figure 1: Schematic of the lung...........................................................................................................2 Figure 2: Estimated US cancer deaths (2004) ....................................................................................4 Figure 3: a) Tobaccco use in the US b) trends in cigarette smoking prevalence in the US................5 Figure 4: a) Time to disease progression and b) Overall response rate of NSCLC to Gemzar + cisplatin treatment vs cisplatin alone.................................................................................................17 Figure 5: a) Time to disease progression and b) Overall response rate of NSCLC to Gemzar + cisplatin treatment vs etoposide + cisplatin.......................................................................................18 Figure 6: Angiogenesis is the formation of new blood vessels .........................................................22 Figure 7: Agents targeting the VEGF pathway..................................................................................23 Figure 8: EGFr signal transduction in tumour cells ...........................................................................24 Figure 9: Expected US launch times for new NSCLC products........................................................32 Figure 10: Avastin strong US launch.................................................................................................53 Figure 11: Proposed target enzyme of talabostat .............................................................................76 Figure 12: Mechanism of action of talabostat ...................................................................................77 Figure 13: Global oncology market - US$24 billion (2004) ...............................................................94 Figure 14: Key players in the oncology market (2004)......................................................................95 Figure 15: Global NSCLC market by region 2004 - US$2.8 billion ...................................................96 Figure 16: Global NSCLC market by region 2012 - US$12.7 billion .................................................96 Figure 17: Global NSCLC market by therapy class 2004 - US$2.8 billion........................................97 Figure 18: Global NSCLC market by therapy class 2012 - US$12.7 billion......................................97 Figure 19: Market share of NSCLC players by sales (2004A) ..........................................................98 Figure 20: Market share of NSCLC players by sales (2012E) ........................................................104
BACKGROUND TO PC................................................................................................................116
What is PC and how does it affect patients?............................................................................116
Patient statistics..........................................................................................................................118 Incidence, diagnosis rates & treatment; now and in the future ........................................................118
Patient growth drivers ................................................................................................................119 US.............................................................................................................................................................120 Europe .....................................................................................................................................................120 Japan .......................................................................................................................................................121
CURRENT TREATMENTS ...........................................................................................................122 SWOT analysis of radiotherapy treatments.........................................................................................125
Sales forecast..................................................................................................................................143 Sales forecast of current PC drugs ...........................................................................................144
RESEARCH & DEVELOPMENT OF PC DRUGS ........................................................................149 5-alpha reductase inhibitors .................................................................................................................149
Phase II / III drugs of interest .....................................................................................................152 Immunotherapy.......................................................................................................................................153 Vaccines ..................................................................................................................................................153
Strengths .........................................................................................................................................154 Weaknesses....................................................................................................................................155 Opportunities ...................................................................................................................................155 Threats ............................................................................................................................................155 Probability of success and sales forecast .......................................................................................155
GVAX (Cell Genesys) - Phase III...........................................................................................................156 Strengths .........................................................................................................................................156 Weaknesses....................................................................................................................................157 Opportunities ...................................................................................................................................157 Threats ............................................................................................................................................157 Probability of success and sales forecast .......................................................................................157
MLN 2704 (Millennium Pharmaceuticals) - Phase II / III .......................................................................158 Probability of success and sales forecast .......................................................................................158
MDX-010 (Medarex) - Phase II..............................................................................................................158 Probability of success and sales forecast .......................................................................................159
Thalidomid (Celgene) - Phase III ...........................................................................................................159 Strengths .........................................................................................................................................160 Weaknesses....................................................................................................................................160 Opportunities ...................................................................................................................................160 Threats ............................................................................................................................................160 Probability of success and sales forecast .......................................................................................160
Actimid (CC4047; Celgene Corporation) - Phase II...............................................................................160 Probability of success and sales forecast .......................................................................................161
Satraplatin (GPC Biotech/Spectrum Pharmaceuticals) - Phase III ........................................................164 Scientific rationale ...........................................................................................................................164 Strengths .........................................................................................................................................164 Weaknesses ....................................................................................................................................165 Opportunities ...................................................................................................................................165 Threats ............................................................................................................................................165 Probability of success and sales forecast .......................................................................................165
Vitamin D analogues ..............................................................................................................................165 Scientific rationale ...........................................................................................................................165
DN-101 (Novacea) - Phase II.................................................................................................................165 Probability of success and sales forecast .......................................................................................165
Hectorol (Bone Care International) - Phase II........................................................................................166 Epothilone analogues ............................................................................................................................166
Ixabepilone (BMS-247550; Bristol-Myers Squibb) - Phase III ...............................................................166 Strengths .........................................................................................................................................166 Weaknesses ....................................................................................................................................166 Opportunities ...................................................................................................................................166 Threats ............................................................................................................................................167 Probability of success and sales forecast .......................................................................................167
Sales forecast of new PC drugs.................................................................................................169
DISCONTINUATION OF DRUGS.................................................................................................171
THE MARKET - CURRENT AND FUTURE..................................................................................173
GLOBAL CANCER MARKET ......................................................................................................173
GLOBAL PC MARKET.................................................................................................................174
Key companies in the PC market...............................................................................................177 AstraZeneca...........................................................................................................................................177 Abbott Laboratories................................................................................................................................177 sanofi-aventis.........................................................................................................................................178
Leading PC companies in 2012E ..........................................................................................................178
PROSTATE CANCER INDEX OF TABLES Table 1: TNM classification in prostate cancer ...............................................................................117 Table 2: Prostate cancer management ...........................................................................................117 Table 3: Current hormonal treatments ............................................................................................128 Table 4: Average wholesale price of LHRH agonists/antagonists ..................................................136 Table 5: Global PC sales of new products 2004A-2012E (US$ millions) .......................................148 Table 6: Current PC drugs in clinical development .........................................................................150 Table 7: Sales forecasts of new developmental drugs (2004A-2012E) ..........................................169 Table 8: Potential candidates for prostate cancer discontinued from development .......................171
CANCER DRUG DISCOVERIES PROSTATE CANCER INDEX OF CHARTS
PROSTATE CANCER INDEX OF CHARTS Figure 1: Increase in elderly as a % of populations ........................................................................119 Figure 2: Cancer incidence rates for men - US 1975-2001 ............................................................120 Figure 3: Prostate cancer treatment algorithm................................................................................123 Figure 4: Docetaxel combinations currently in research for HRPC ................................................140 Figure 5: Docetaxel combinations in androgen-dependent prostate cancer ..................................141 Figure 6: Expected US launch timescales for prostate cancer therapeutics ..................................147 Figure 7: Provenge mode of action.................................................................................................154 Figure 8: MDX-010 mechanism of action........................................................................................159 Figure 9: Global oncology market 2004 - US$24 billion..................................................................173 Figure 10: Global PC market by region 2004A - US$2.7 billion......................................................174 Figure 11: Global PC market by region 2012E - US$8.6 billion......................................................175 Figure 12: Global PC market by therapy class 2004 - US$2.7 billion.............................................176 Figure 13: Global PC market by therapy class 2012 - US$8.6 billion.............................................176 Figure 14: Market share of top five PC players by sales (2004A) ..................................................177 Figure 15: Market share of top 6 PC players by sales (2012E) ......................................................178
PROSTATE CANCER INDEX OF CHARTS CANCER DRUG DISCOVERIES
BACKGROUND TO BC................................................................................................................190
What is BC and how does it affect patients?............................................................................190 Risk factors .............................................................................................................................................191 Diagnosis ................................................................................................................................................191 Stages of the disease.............................................................................................................................191
Patient statistics..........................................................................................................................193 Incidence, diagnosis rates & treatment; now and in the future ........................................................193
Patient growth drivers ................................................................................................................194 The prevalence of people living with BC will increase by 20% by 2012...........................................194
Drug growth drivers ....................................................................................................................198
CURRENT TREATMENTS ...........................................................................................................199
HORMONAL THERAPY...............................................................................................................201 SWOT analysis of hormonal therapies.................................................................................................204
Sales forecast of current BC drugs ...........................................................................................241
RESEARCH & DEVELOPMENT OF BC DRUGS ........................................................................245
Phase II / III drugs of interest .....................................................................................................248 Selective oestrogen receptor modulators ...........................................................................................248
Evista (Eli Lilly) - Phase III .....................................................................................................................249 Strengths .........................................................................................................................................250 Weaknesses....................................................................................................................................250 Opportunities ...................................................................................................................................250 Threats ............................................................................................................................................250
Sales forecasts ................................................................................................................................251 Arzoxifene (Eli Lilly) - Phase III ..............................................................................................................251 Oporia (Pfizer) - Phase III ......................................................................................................................251
New aromatase inhibitors......................................................................................................................251 Atamestane (Intarcia Therapeutics) - Phase II ......................................................................................251
Strengths .........................................................................................................................................253 Weaknesses ....................................................................................................................................254 Opportunities ...................................................................................................................................254 Threats ............................................................................................................................................254 Probability of success and sales forecast .......................................................................................254
Other epothilone analogues in clinical development include............................................................254 R1492 (Roche and Kosan Biosciences) - Phase II................................................................................254 EPO906 (Novartis) - Phase II ................................................................................................................255
Lapatinib (GlaxoSmithKline) - Phase II ..................................................................................................258 Scientific rationale ...........................................................................................................................259 Probability of success and sales forecasts .....................................................................................259
Iressa (AstraZeneca) - Phase II .............................................................................................................260 Mechanism of action........................................................................................................................260 Strengths .........................................................................................................................................260 Weaknesses ....................................................................................................................................260 Opportunities ...................................................................................................................................261 Threats ............................................................................................................................................261 Sales forecasts ................................................................................................................................261
Omnitarg (Roche/Genentech) - Phase II ...............................................................................................262 Probability of success and sales forecasts .....................................................................................262
ZD6474 (AstraZeneca) - Phase II ..........................................................................................................262 CI-1033 (Pfizer) - Phase II .....................................................................................................................263
IMC-111F8 (ImClone Systems) - Phase I..............................................................................................263 Alternative targeted approaches to angiogenesis..............................................................................263
INGN 241 (Introgen Therapeutics) - Phase II ........................................................................................263 Scientific rationale ...........................................................................................................................263 Probability of success and sales forecasts .....................................................................................264
Recombinant human insulin-like growth factor binding protein-3..........................................................264 Probability of success and sales forecasts .....................................................................................264
Cancer vaccines .....................................................................................................................................264 IGN101 (Aphton) - Phase III ..................................................................................................................265
Probability of success and sales forecasts .....................................................................................266 HER2 Protein AutoVac (Pharmexa / GlaxoSmithKline) - Phase II ........................................................266 HER2/neu vaccine (GlaxoSmithKline / Corixa) .....................................................................................267
Probability of success and sales forecasts .....................................................................................267 Alternative approaches to BC treatment...................................................................................268 Multi-drug resistant inhibitors (MDRIs) .....................................................................................................268
Tesmilifene (YM Biosciences) - Phase III ..............................................................................................269 Probability of success and sales forecasts .....................................................................................270
MS-209 (Schering AG) - Phase III .........................................................................................................270 Elacridar (GlaxoSmithKline) - Phase I ...................................................................................................270
Genasense (Genta) ...............................................................................................................................271 Strengths .........................................................................................................................................271 Weaknesses....................................................................................................................................271 Opportunities ...................................................................................................................................271 Threats ............................................................................................................................................272 Probability of success and sales forecast .......................................................................................272
Sales forecast of new BC drugs ................................................................................................273 Diagnostic assays .......................................................................................................................................275 HER2 diagnostics ........................................................................................................................................276
HER2/neu diagnostic testing .................................................................................................................276 Fluorescence in situ hybridisation (FISH) ..............................................................................................276 Chromogenic in situ hybridisation (CISH) .............................................................................................276 InSite HER2/neu kit................................................................................................................................276 “Virtual Cancer Patient” technology - Optimata .....................................................................................277
Future advances in diagnostics............................................................................................................277
DISCONTINUATION OF DRUGS.................................................................................................278
THE MARKET - CURRENT AND FUTURE..................................................................................280
GLOBAL CANCER MARKET ......................................................................................................280
GLOBAL BC MARKET ................................................................................................................282
Key companies in the global BC market...................................................................................285 AstraZeneca...........................................................................................................................................285 Roche.....................................................................................................................................................286 sanofi-aventis .........................................................................................................................................286 Bristol-Myers Squibb ..............................................................................................................................288
Leading BC companies in 2012E ..........................................................................................................289
BREAST CANCER INDEX OF TABLES Table 1: TMN classification in BC ...................................................................................................192 Table 2: Summary of patient population forecasts (2003A-2012E) ................................................195 Table 3: Current hormonal therapies ..............................................................................................202 Table 4: Key characteristics of the leading hormonal therapies .....................................................203 Table 5: Patent expiration of leading BC hormonal therapies ........................................................205 Table 6: Chemotherapy combinations currently prescribed in Stage I-III BC.................................221 Table 7: Xeloda clinical trial programme.........................................................................................232 Table 8: Pivotal clinical trials with Herceptin ...................................................................................239 Table 9: Global BC sales 2003A-2012E (US$ millions)..................................................................243 Table 10: Products in clinical development for the treatment of BC ...............................................245 Table 11: SORMs in clinical development for BC ...........................................................................248 Table 12: Angiogenesis drugs in clinical development for BC targeting growth factors .................256 Table 13: Ongoing Avastin clinical trials .........................................................................................257 Table 14: Clinical development of Iressa ........................................................................................261 Table 15: BC vaccines in clinical development...............................................................................265 Table 16: Sales forecasts of new developmental BC drugs US$ millions (2005E-2012E).............273 Table 16: BC drugs discontinued during development ...................................................................278 Table 17: sanofi-aventis oncology franchise...................................................................................287 Table 18: sanofi-aventis oncology pipeline .....................................................................................287 Table 19: BMS oncology franchise .................................................................................................288 Table 20: BMS oncology pipeline....................................................................................................289
BREAST CANCER INDEX OF TABLES CANCER DRUG DISCOVERIES
Figure 1: Schematic of the breast ...................................................................................................190 Figure 2a) and 2b): Cancer incidence rates and cancer death rates for women in the US............193 Figure 3: BC market opportunities...................................................................................................194 Figure 4: Schematic of treatment options in BC..............................................................................199 Figure 5: Hormones affecting BC....................................................................................................201 Figure 6: Mode of action of anti-oestrogens....................................................................................206 Figure 7: Mode of action of aromatase inhibitors ............................................................................210 Figure 8: Clinical trial data drives growth of BC products ...............................................................211 Figure 9: Market potential for Femara in extended adjuvant setting...............................................216 Figure 10: a) Time to disease progression and b) overall response rate of MBC to Gemzar treatment .........................................................................................................................................233 Figure 11: Mechanism of action of Herceptin..................................................................................236 Figure 12: A) Herceptin positive and negative BC patient split and B) Marketing opportunities for Herceptin in chemotherapy patients................................................................................................238 Figure 13: Herceptin has a comprehensive clinical trial programme to drive future sales growth..238 Figure 14: Expected US launch times for BC therapeutics .............................................................242 Figure 15: Avastin strong US launch...............................................................................................258 Figure 16: Mechanism of action of IGN101.....................................................................................265 Figure 17: Schematic of multidrug resistant inhibitors (MDRIs) blockade. .....................................268 Figure 18: Global oncology market - US$24 billion (2004) .............................................................280 Figure 19: Key players in the oncology market (2004)....................................................................281 Figure 20: Global BC market by region 2004 - US$6.0 billion ........................................................282 Figure 21: Global BC market by therapy class 2004 - US$6.0 billion .............................................283 Figure 22: Global BC market by region 2012E - US$8.9 billion......................................................284 Figure 23: Global BC market by therapy class 2012 - US$8.9 billion .............................................284 Figure 24: Market share of BC players by sales (2004A) ...............................................................285 Figure 25: Market share of BC players by sales (2012E) ...............................................................290
CANCER DRUG DISCOVERIES COLORECTAL CANCER CONTENTS
BACKGROUND TO CRC .............................................................................................................304
What is CRC and how does it affect patients? .........................................................................304
Patient statistics..........................................................................................................................306 Incidence, diagnosis rates & treatment; now and in the future ........................................................306
Patient growth drivers ................................................................................................................308 The prevalence of people living with CRC will increase by 14% by 2012 ........................................308
Drug growth drivers ....................................................................................................................309
CURRENT TREATMENTS ...........................................................................................................310
CHEMOTHERAPY........................................................................................................................311 SWOT analysis of individual chemotherapy treatments....................................................................313
SWOT analysis of individual immunotherapies ..................................................................................324 Rationale for targeting the epidermal growth factor pathway in colorectal cancer ........................324
Opportunities ...................................................................................................................................356 Threats ............................................................................................................................................356 Filing and sales forecasts................................................................................................................356
Alternative targeted approaches ..........................................................................................................357 Ispinesib (GlaxoSmithKline) - Phase II ..................................................................................................357
Strengths .........................................................................................................................................358 Weaknesses....................................................................................................................................358 Opportunities ...................................................................................................................................358 Threats ............................................................................................................................................359 Probability of success and sales forecasts .....................................................................................359
TNFerade (GenVec) - Phase II..............................................................................................................360 Strengths .........................................................................................................................................360 Weaknesses....................................................................................................................................360 Opportunities ...................................................................................................................................361 Threats ............................................................................................................................................362 Probability of success and sales forecasts .....................................................................................362
Velcade (Millennium Pharmaceuticals / Johnson & Johnson) - Phase III .............................................362 Scientific rationale ...........................................................................................................................362 Strengths .........................................................................................................................................362 Weaknesses....................................................................................................................................363 Opportunities ...................................................................................................................................363 Threats ............................................................................................................................................363 Probability of success and sales forecasts .....................................................................................363
Cotara (Peregrine Pharmaceuticals / Medipharm Biotech) - Phase III..................................................364 Scientific rationale ...........................................................................................................................364 Strengths .........................................................................................................................................364 Weaknesses....................................................................................................................................364 Opportunities ...................................................................................................................................365 Threats ............................................................................................................................................366 Probability of success and sales forecasts .....................................................................................366
Cancer vaccines .....................................................................................................................................366 TroVax (Oxford BioMedica) - Phase II...................................................................................................366
Strengths .........................................................................................................................................366 Weaknesses....................................................................................................................................367 Opportunities ...................................................................................................................................367 Threats ............................................................................................................................................367 Probability of success and sales forecasts .....................................................................................367
IGN101 (Aphton Corporation) - Phase II ...............................................................................................368 Strengths .........................................................................................................................................368 Weaknesses....................................................................................................................................369 Opportunities ...................................................................................................................................369 Threats ............................................................................................................................................369 Probability of success and sales forecasts .....................................................................................370
EP-2101 (Epimmune) - Phase II ............................................................................................................372 Strengths .........................................................................................................................................372 Weaknesses ....................................................................................................................................373 Opportunities ...................................................................................................................................373 Threats ............................................................................................................................................374 Probability of success and sales forecasts .....................................................................................374
Avicine (AVI BioPharma) Phase II ........................................................................................................374 Strengths .........................................................................................................................................374 Weaknesses ....................................................................................................................................375 Opportunities ...................................................................................................................................375 Threats ............................................................................................................................................375 Probability of success and sales forecasts .....................................................................................375
Theratope (Biomira) - Phase II...............................................................................................................376 Strengths .........................................................................................................................................376 Weaknesses ....................................................................................................................................376 Opportunities ...................................................................................................................................377 Threats ............................................................................................................................................377 Probability of success and sales forecasts .....................................................................................377
Chemotherapy drug enhancer ..............................................................................................................377 CoFactor (ADVENTRX Pharmaceuticals) - Phase II .............................................................................377
Strengths .........................................................................................................................................377 Weaknesses ....................................................................................................................................379 Opportunities ...................................................................................................................................379 Threats ............................................................................................................................................379 Probability of success and sales forecasts .....................................................................................379
New drug formulations...........................................................................................................................379 HyCAMP (Meditech Research) - Phase II .............................................................................................380
Technology ......................................................................................................................................380 Strengths .........................................................................................................................................381 Weaknesses ....................................................................................................................................381 Opportunities ...................................................................................................................................381 Threats ............................................................................................................................................382 Probability of success and sales forecasts .....................................................................................382
Threats ............................................................................................................................................384 Probability of success and sales forecasts .....................................................................................385
LE-SN38 (NeoPharm ) - Phase I / II ......................................................................................................385 Strengths .........................................................................................................................................385 Weaknesses....................................................................................................................................386 Opportunities ...................................................................................................................................386 Threats ............................................................................................................................................386 Probability of success and sales forecasts .....................................................................................386
AP5346 (Access Pharmaceuticals) - Phase I ........................................................................................387 Strengths .........................................................................................................................................387 Weaknesses....................................................................................................................................388 Opportunities ...................................................................................................................................388 Threats ............................................................................................................................................388 Probability of success and sales forecasts .....................................................................................388
Alternative approaches to colorectal cancer treatment ..........................................................389 Cholesterol-lowering agents or statins .....................................................................................................389
Probability of success .....................................................................................................................390 Cyclooxygenase-2 or Cox-2 inhibitors ......................................................................................................391
Scientific rationale ...........................................................................................................................391 Probability of success .....................................................................................................................392
DISCONTINUATION OF DRUGS.................................................................................................393
THE MARKET - CURRENT AND FUTURE..................................................................................394
GLOBAL CANCER MARKET ......................................................................................................394
GLOBAL CRC MARKET..............................................................................................................396
Key companies in the CRC market............................................................................................399 Bristol-Myers Squibb..............................................................................................................................399 Pfizer ......................................................................................................................................................401 Roche.....................................................................................................................................................403 sanofi-aventis.........................................................................................................................................403
Leading CRC companies in 2012E .......................................................................................................405
COLORECTAL CANCER INDEX OF CHARTS Figure 1: Incidence of CRC in US and Western Europe.................................................................305 Figure 2: Estimated US cancer deaths (2004)................................................................................306 Figure 3: Incidence of CRC in men and women in the US .............................................................307 Figure 4: Overexpression of EGFr correlates with increased metastasis, decreased survival and a poor prognosis.................................................................................................................................325 Figure 5: Inhibition of EGFr prevents tumour growth and dissemination as well as inducing cell death (apoptosis).............................................................................................................................325 Figure 6: US Market share of Erbitux versus its competitors..........................................................329 Figure 7: Avastin strong US launch.................................................................................................336 Figure 8: Expected US launch times for CRC therapeutics............................................................339 Figure 9: Schematic of VEGF receptors .........................................................................................349 Figure 10: Design of the CONFIRM 1 trial ......................................................................................350 Figure 11: Results of the CONFIRM 1 trial - PFS...........................................................................351 Figure 12: Results of the CONFIRM 1 trial - LDH...........................................................................351 Figure 13: Results of the CONFIRM 1 trial - AEs ...........................................................................352 Figure 14: Results of the CONFIRM 1 trial - PFS in high HDL patients .........................................354 Figure 15: Mechanism of action of IGN101 ....................................................................................368 Figure 16: Avicine cancer vaccine clinical development programme .............................................376 Figure 17: Schematic of a Carbosome............................................................................................382 Figure 18: Pro-Pharmaceuticals product pipeline ...........................................................................384 Figure 19: Global oncology market - US$24 billion (2004) .............................................................394 Figure 20: Key players in the oncology market (2004) ...................................................................395 Figure 21: Global CRC market by region 2004 - US$3.2 billion .....................................................396 Figure 22: Global CRC market by therapy class 2004 - US$3.2 billion ..........................................397 Figure 23: Global CRC market by therapy class 2012 - US$5.6 billion ..........................................397 Figure 24: Global CRC market by region 2012 - US$5.6 billion .....................................................398 Figure 25: Market share of CRC players by sales (2004A) ............................................................399 Figure 26: Market share of CRC players by sales (2012E) ............................................................406