ABOUT DATAMONITOR HEALTHCARE
- About the oncology pharmaceutical analysis team
CHAPTER 1 KEY FINDINGS
- Datamonitor insight into the innovative market
- Key metrics
- Summary of research/clinical and commercial attractiveness of molecular
-targeted treatments in clinical development
CHAPTER 2 CANCER OVERVIEW
- Cancer treatment
- Cancer epidemiology
- Incidence
- Prevalence
- Unmet need in cancer
- Long-term control of advanced tumors
- Decreased relapse for early-stage patients
- Less toxic therapies
- Improved diagnostics and prognostic analysis
- Enhanced preventative strategies
- Segmentation of cancer
- Incident patients/year
- Patient split (metastatic/non-metastatic)
- Screening
- Surgical viability
- Usefulness of pharmacotherapy
- Appeal as target drug market
CHAPTER 3 R&D APPROACH
- Classification of pipeline products
- Development of targeted therapies
- Angiogenesis inhibitors
- Angiogenesis
- THE PROCESS OF TUMOR ANGIOGENESIS
- SIGNALING INHIBITORS
- ENDOTHELIAL CELL INHIBITORS
- MATRIX BREAKDOWN INHIBITORS
- OTHERS
- Apoptosis stimulators
- Signal transduction inhibitors
- Cell cycle inhibitors
- Histone deacetylase inhibitors (HDAC-Is)
- Monoclonal antibodies
- Unprecedented molecular targets
- Summary of molecular-targeted drugs in the developmental pipeline
CHAPTER 4 STRATEGIES FOR COMMERCIALIZATION: THE GENENTECH EXAMPLE
- Established, respected oncology franchise
- Strengths and weaknesses of a highly innovative portfolio
- Reliance on out-licensing and royalty payments
CHAPTER 5 APOPTOSIS STIMULATORS LATE-STAGE DRUG ANALYSIS & FORECASTS
- Overview of apoptosis stimulators
- Pipeline summary
- Genasense (oblimersen sodium)
- Profile
- Drug overview
- Clinical trial data
- MALIGNANT MELANOMA
- MULTIPLE MYELOMA
- CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)
- NSCLC
- SCLC
- PROSTATE CANCER
- OTHER TRIALS
- Datamonitor comments
- Marketing factors
- Genasense forecast to 2012
- Datamonitor drug assessment summary
- Affinitak (aprinocarsen, ISIS-3521, LY-900003)
- Profile
- Drug overview
- Clinical trial data
- NSCLC
- NHL
- BREAST CANCER
- Datamonitor comments
- Marketing factors
- Affinitak forecasts to 2012
- Datamonitor drug assessment summary
- LDI-200
- Profile
- Drug overview
- Clinical trial data
- MYELODYSPLATIC SYNDROME (MDS)
- ACUTE MYELOID LEUKEMIA (AML)
- PROSTATE CANCER
- Datamonitor comments
- Aptosyn (exisulind)
- Profile
- Drug overview
- Clinical trial data
- FAMILIAL ADENOMATOUS POLYPOSIS (FAP)
- NON-SMALL-CELL LUNG CANCER
- PROSTATE CANCER
- BREAST CANCER
- Datamonitor comments
- Marketing factors
- Aptosyn forecasts to 2012
- Datamonitor drug assessment summary
- Summary of research/clinical and commercial attractiveness of apoptosis
stimulators
CHAPTER 6 ANGIOGENESIS INHIBITORS LATE-STAGE DRUG ANALYSIS AND FORECASTS
- Overview for angiogenesis inhibitors
- Pipeline summary
- Neovastat (AE-941)
- Profile
- Drug overview
- Clinical trial data
- NSCLC
- RENAL CELL CARCINOMA
- Datamonitor comments
- Marketing factors
- Neovastat forecasts to 2012
- Datamonitor drug assessment summary
- Avastin (bevacizumab)
- Profile
- Drug overview
- Clinical trial data
- BREAST CANCER
- NSCLC
- RENAL CELL CANCER
- PROSTATE CANCER
- PANCREATIC CANCER
- MELANOMA
- Datamonitor comments
- Marketing factors
- Avastin sales forecasts to 2012
- Datamonitor drug assessment summary
- CAI (L-651582)
- Profile
- Drug overview
- Clinical trial data
- NSCLC
- RENAL CALL CANCER
- OVARIAN CANCER
- Datamonitor comments
- Marketing factors
- Datamonitor drug assessment summary
- Vatalanib (PTK787, ZK222582)
- Profile
- Drug overview
- Clinical trial data
- COLORECTAL CANCER
- OTHER TUMORS
- Datamonitor comments
- Marketing factors
- Vatalanib forecasts to 2012
- Datamonitor drug assessment summary
- Selected angiogenesis targets in early-stage development
- Selective MMP inhibitors
- BMS-275291
- Datamonitor comments:
- Integrin inhibition
- Vitaxin
- Cilengitide (EMD-121974)
- Datamonitor comments
- VEGF trap
- Summary of research/clinical and commercial attractiveness of apoptosis
stimulators
CHAPTER 7 HISTONE DEACETYLASE INHIBITORS DRUG ANALYSIS AND FORECASTS
- Overview of histone deacetylase inhibitors (HDAC-Is)
- Pipeline summary
- FK-228 (depsipeptide, FR-901228)
- Profile
- Drug overview
- Clinical trial data
- Datamonitor comments
- Marketing factors
- FK-228 forecasts to 2012
- Datamonitor drug assessment summary
- Suberanilohydroxyamic acid (SAHA)
- Profile
- Drug overview
- Clinical trial data
- Datamonitor comments
- SAHA forecasts to 2012
- Datamonitor drug assessment summary
- Pivanex (AN-9)
- Profile
- Drug overview
- Clinical trial data
- Datamonitor comments
- Marketing factors
- Datamonitor drug assessment summary
- Summary of research/clinical and commercial attractiveness of HDAC
inhibitors
CHAPTER 8 SIGNAL TRANSDUCTION INHIBITORS
- Overview of signal transduction inhibitors
- Pipeline summary
- Erbitux (cetuximab)
- Profile
- Drug overview
- Clinical trial data
- COLORECTAL CANCER
- NSCLC
- HEAD AND NECK CANCER
- PANCREATIC CANCER
- Datamonitor comments
- Marketing factors
- PROHIBITIVE COST?
- Erbitux forecast to 2012
- Datamonitor drug assessment
- Iressa (gefitinib)
- Profile
- Drug overview
- Clinical trial data
- NSCLC
- BREAST CANCER
- HEAD AND NECK CANCER
- COLORECTAL CANCER
- PROSTATE CANCER
- Datamonitor comments
- Marketing factors
- Iressa forecast to 2012
- Datamonitor drug assessment
- Tarceva (erlotinib)
- Profile
- Drug overview
- Clinical trial data
- NSCLC
- PANCREATIC CANCER
- GLIOBLASTOMA
- BREAST CANCER
- OTHER TUMOR TYPES
- TOXICITY
- Datamonitor comments
- Marketing factors
- Tarceva forecasts to 2012
- Datamonitor drug assessment summary
- ABX-EGF (panitumumab)
- Profile
- Drug overview
- Clinical trial data
- COLORECTAL CANCER
- RENAL CELL CARCINOMA
- NON-SMALL -CELL LUNG CANCER
- PROSTATE CANCER
- Datamonitor comments
- Marketing factors
- ABX-EGF forecasts to 2012
- Datamonitor drug assessment summary
- Lapatinib (GW-572016)
- Profile
- Drug overview
- BREAST CANCER
- NON-SMALL-CELL LUNG CANCER
- COLORECTAL CANCER
- UROTHELIAL TUMORS
- Datamonitor comments
- Marketing factors
- Lapatinib forecasts to 2012
- Datamonitor drug assessment summary
- SU11248
- Profile
- Drug overview
- Clinical trial data
- GIST
- RENAL CELL CARCINOMA
- Datamonitor comments
- SU22148 forecasts to 2012
- Datamonitor drug assessment summary
- BAY 43-9006
- Profile
- Drug overview
- Clinical trial data
- MALIGNANT MELANOMA
- RENAL CELL CARCINOMA (RCC)
- OTHER TUMOR TYPES
- Datamonitor comments
- Sales forecast for BAY 43-9006
- Datamonitor drug assessment summary
- Zarnestra (tipifarnib)
- Profile
- Drug overview
- Clinical trial data
- PHASE I TRIALS
- PANCREATIC CANCER
- COLORECTAL CANCER
- BREAST CANCER
- PROSTATE CANCER
- SMALL -CELL LUNG CANCER (SCLC)
- NON-SMALL-CELL LUNG CANCER (NSCLC)
- GLIOMAS
- ACUTE MYELOID LEUKEMIA (AML)
- OTHER TRIALS
- Datamonitor comments
- Marketing factors
- Zarnestra sales forecasts to 2012
- Datamonitor drug assessment summary
- Sarasar (lonafarnib)
- Profile
- Drug overview
- Clinical trial data
- PHASE I TRIALS
- NSCLC
- UROTHELIAL TRACT CARCINOMA
- PANCREATIC CANCER
- COLORECTAL CANCER
- HEAD AND NECK CANCER
- MYELODYSPLASTIC SYNDROME & CHRONIC MYELOID LEUKEMIA
- OTHER TRIALS
- Datamonitor comments
- Marketing factors
- Datamonitor drug assessment summary
- Summary of research/clinical and commercial attractiveness of signal
transduction inhibitors
CHAPTER 9 CELL CYCLE REGULATORS
- Overview of the cyclin dependent kinase inhibitors
- Pipeline summary
- CYC-202 (R-roscovitine)
- Clinical data
- Indisulam (E-7070)
- Clinical data
- UCN-01
- Clinical data
- Datamonitor comments
CHAPTER 10 MONOCLONAL ANTIBODIES TARGETING UNPRECEDENTED RECEPTORS
- Overview of monoclonal antibodies
- Pipeline summary
- MLN2704
- Profile
- Drug overview
- Clinical data
- Datamonitor comments
- Marketing factors
- TRIAL-R1 and -R2 MoAb
- Profile
- Clinical data
- Datamonitor comments
- Marketing factors
CHAPTER 11 INNOVATIVE EARLY-STAGE PROJECTS
- Pipeline summary
- Efaproxiral (efaproxyn, revaproxyn)
- Patrin (lomeguatrib)
- AQ4N
CHAPTER 12 SUMMARY ASSESSMENT OF MOLECULAR-TARGETED TREATMENTS IN ONCOLOGY
APPENDIX A
- Methodology
- Datamonitor forecast methodology
- Datamonitor drug assessment summary
- List of tables
- List of figures
- Contributing experts
- Bibliography
- Apoptosis Stimulators
- Angiogenesis Inhibitors
- Histone deacetylase inhibitors
- Signal-transduction inhibitors
- Cyclin dependent kinases
- Report methodology
APPENDIX B
- About Datamonitor
- About Datamonitor Healthcare
- Datamonitor Healthcare's research and analysis methodologies
- Datamonitor Healthcare's therapy area capabilities
- About the Oncology analysis team
- Key therapy team members
- Nish Saini, Senior Oncology Analyst
- Disclaimer
List of Tables
- Table 1: Incidence of cancer in the seven major pharmaceutical markets,
2004-12
- Table 2: Sales forecasts for key molecular-targeted therapies in clinical
development ($m), 2004-12
- Table 3: Drug assessment summary of molecular -targeted treatments in
clinical devlopmentdevelopment
- Table 4: Common mutations involved in tumor development
- Table 5: Summary of key indications for innovative therapies in the
oncology market
- Table 6: Screening definitions
- Table 7: Surgical viability definitions
- Table 8: Usefulness of pharmacotherapy definitions
- Table 9: Examples of naturally occurring angiogenesis stimulators
- Table 10: Molecular targeted drugs in development, 2004
- Table 11: Apoptosis stimulators in clinical development, 2004
- Table 12: Assumptions and factors influencing Genasense's sales forecast
- Table 13: Research/clinical and commercial attractiveness of Genasense
- Table 14: Research/clinical and commercial attractiveness of Affinitak
- Table 15: Assumptions and factors influencing Aptosyn sales forecast
- Table 16: Research/clinical and commercial attractiveness of Aptosyn
- Table 17: Summary of research/clinical and commercial attractiveness of
apoptosis stimulators
- Table 19: Assumptions and factors influencing Neovastat sales forecast
- Table 20: Research/clinical and commercial attractiveness of Neovastat
- Table 21: Assumptions and factors influencing Avastin sales forecast
- Table 22: Research/clinical and commercial attractiveness of Avastin
- Table 23: Research/clinical and commercial attractiveness of CAI
- Table 24: Assumptions and factors influencing vatalanib sales forecast
- Table 25: Research/clinical and commercial attractiveness of vatalanib
- Table 26: Research/clinical and commercial attractiveness of BMS-275291
- Table 27: Summary of research/clinical and commercial attractiveness of
apoptosis stimulators
- Table 28: Histone deacetylase inhibitors in R&D pipeline, 2004
- Table 29: Assumptions and factors influencing FK-228 sales forecast
- Table 30: Research/ clinical and commercial attractiveness of FK-228
- Table 31: Assumptions and factors influencing SAHA sales forecast
- Table 32: Research/ clinical and commercial attractiveness of SAHA
- Table 33: Research/ clinical and commercial attractiveness of Pivanex
- Table 34: Summary of research/clinical and commercial attractiveness of
HDAC inhibitors
- Table 35: Signal transduction inhibitors in R&D, 2004
- Table 36: Early-phase trial results of Erbitux
- Table 37: BOND trial summary results
- Table 38: Preliminary safety analysis of Erbitux with or without FOLFOX in
second line
- Table 39: Current Phase III trials of Erbitux
- Table 40: Clinical trial results of Erbitux for NSCLC
- Table 41: Assumptions and factors influencing Erbitux's sales forecast
- Table 42: Research/clinical and commercial attractiveness of Erbitux
- Table 43: Summary of key results in the INTACT 1 trial
- Table 44: Summary of key results in the INTACT 2 trial
- Table 45: Subset analysis of patients with adenocarcinoma who received 90
days or more chemotherapy
- Table 46: Phase II clinical trial results for single-agent Iressa in
breast cancer
- Table 47: Current Iressa Phase II clinical trials
- Table 48: Phase II trials of Iressa in SCCHN
- Table 49: Results of Phase II trial of Iressa in colorectal cancer
- Table 50: Assumptions and factors influencing the sales forecast for
Iressa
- Table 51: Research/clinical and commercial attractiveness of Iressa
- Table 52: Phase III trials of Tarceva in NSCLC
- Table 53: Phase II trials of Tarceva in malignant gliomas (MG)
- Table 54: Current Tarceva Phase II breast cancer trials
- Table 55: Assumptions and factors influencing Tarceva sales forecast
- Table 56: Research/ clinical and commercial attractiveness of Tarceva
- Table 57: Assumptions and factors influencing ABX-EGF sales forecast
- Table 58: Research/ clinical and commercial attractiveness of ABX-EGF
- Table 59: Ongoing Phase II and Phase III trials for lapatinib
- Table 60: Assumptions and factors influencing lapatinib sales forecast
- Table 61: Research/clinical and commercial attractiveness of lapatinib
- Table 62: Assumptions and factors influencing SU11248 sales forecast
- Table 63: Research/ clinical and commercial attractiveness of SU11248
- Table 64: Assumptions and factors influencing BAY 43-9006 sales forecast
- Table 65: Research/ clinical and commercial attractiveness of BAY 43-9006
- Table 66: Assumptions and factors influencing Zarnestra sales forecast
- Table 67: Research/ clinical and commercial attractiveness of Zarnestra
- Table 68: Research/clinical and commercial attractiveness of Sarasar
- Table 69: Summary of research/clinical and commercial attractiveness of
signal transduction inhibitors
- Table 70: Cell cycle regulators in the R&D pipeline, 2004
- Table 71: Conjugated MoAbs in clinical development
- Table 72: Naked MoAbs in clinical development
- Table 73: Innovative drugs in early-stage clinical development
- Table 74: Datamonitor drug assessment parameters
List of Figures
- Figure 1: Sales forecasts for key molecular-targeted therapies in clinical
development, 2004-12
- Figure 2: Datamonitor drug assessment summary
- Figure 3: Datamonitor drug assessment summary by drug class
- Figure 4: Increasing combined incidence for breast, lung, prostate and
colorectal cancer with increasing age
- Figure 5: Incidence increases, while the rate of cure and death reduces
disease prevalence
- Figure 6: Point prevalence for colorectal and lung cancer differs markedly
despite similar rates of incidence
- Figure 7: Unmet needs in cancer, 2004
- Figure 8: The process of tumor angiogenesis
- Figure 9: Summary of research/clinical and commercial attractiveness of
apoptosis stimulators
- Figure 10: Sales forecast for Genasense to 2012
- Figure 11: Research/clinical and commercial attractiveness of Genasense
- Figure 12: Research/clinical and commercial attractiveness of Affinitak
- Figure 13: Sales forecast for Aptosyn to 2012
- Figure 14: Research/clinical and commercial attractiveness of Aptosyn
- Figure 15: Summary of research/clinical and commercial attractiveness of
apoptosis stimulators
- Figure 16: Summary of research/clinical and commercial attractiveness of
apoptosis stimulators
- Figure 17: Sales forecast for Neovastat to 2012
- Figure 18: Research/clinical and commercial attractiveness of Neovastat
- Figure 19: Sales forecast for Avastin 2004-to 2012
- Figure 20: Research/clinical and commercial attractiveness of Avastin
- Figure 21: Research/clinical and commercial attractiveness of CAI
- Figure 22: Sales forecasts for vatalanib to 2012
- Figure 23: Research/clinical and commercial attractiveness of vatalanib
- Figure 24: Research/clinical and commercial attractiveness of BMS-275291
- Figure 25: Summary of research/clinical and commercial attractiveness of
apoptosis stimulators
- Figure 26: Summary of research/clinical and commercial attractiveness of
HDAC inhibitors
- Figure 27: Sales forecast for FK-228 to 2012
- Figure 28: Research/ clinical and commercial attractiveness of FK-228
- Figure 29: Sales forecast for SAHA to 2012
- Figure 30: Research/ clinical and commercial attractiveness of SAHA
- Figure 31: Research/ clinical and commercial attractiveness of Pivanex
- Figure 32: Summary of research/clinical and commercial attractiveness of
HDAC inhibitors
- Figure 33: Summary of research/clinical and commercial attractiveness of
signal transduction inhibitors
- Figure 34: BOND trial design
- Figure 40: Erbitux sales forecast to 2012
- Figure 35: Research/clinical and commercial attractiveness of Erbitux
- Figure 36: Iressa revenue forecasts to 2012
- Figure 37: Research/clinical and commercial attractiveness of Iressa
- Figure 38: Sales forecast for Tarceva to 2012
- Figure 39: Research/ clinical and commercial attractiveness of Tarceva
- Figure 40: Sales forecast for ABX-EGF to 2012
- Figure 41: Research/ clinical and commercial attractiveness of ABX-EGF
- Figure 42: Sales forecast for lapatinib to 2012
- Figure 43: Research/ clinical and commercial attractiveness of lapatinib
- Figure 44: Sales forecast for SU11248 to 2012
- Figure 45: Research/ clinical and commercial attractiveness of SU11248
- Figure 46: Sales forecast for BAY 43-9006 to 2012
- Figure 47: Research/ clinical and commercial attractiveness of BAY 43-9006
- Figure 48: Sales forecast for Zarnestra to 2012
- Figure 49: Research/ clinical and commercial attractiveness of Zarnestra
- Figure 50: Research/clinical and commercial attractiveness of Sarasar
- Figure 51: Summary of research/clinical and commercial attractiveness of
signal transduction inhibitors
- Figure 52: Summary of Datamonitor assessment by drug
- Figure 53: Summary of Datamonitor assessment by drug class
- Figure 54: Example of Datamonitor drug assessment scorecard
- Figure 55: Example of Datamonitor drug assessment graph
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