Report: Cancer Drug Discoveries: what the future holds TOC

EXECUTIVE SUMMARY

Figure 1.1 Global Cancer Drug Sales (including supportive care) in 2006 (US$47 billion)
Figure 1.2 The Global Cancer Drug Sales - Regional Sales Split (2006)
Figure 1.3. The Global Oncology Market - Cancer Sub-Type Sales Split (2006)
Competitor Ratio Analysis - Drugs
- Figure 1.4: Drugs Analysed for Launch by 2012 - Therapeutic Category
Competitor Ratio Analysis - Companies
- Figure 1.5: Drugs Analysed for Launch by 2012 - Pharma and Specialist Pharma Companies
- Figure 1.6: Drugs Analysed for Launch by 2012 -Biotechnology and Biopharmaceutical Companies

BREAST CANCER

EXECUTIVE SUMMARY

THE FACTS

What is BC and How Does it Affect Patients?
- Figure 2.1: Schematic of the Breast
- Risk Factors
- Diagnosis
- Stages of the Disease
- Table 2.1: TMN Classification in BC

PATIENT STATISTICS

Incidence, diagnosis rates & treatment; now and in the future
Table 2.2: US prevalence of BC
Figure 2.2: Cancer Incidence Rates and Cancer Death Rates for Women in the US
Table 2.3: European prevalence of BC
Table 2.4: Japanese prevalence of BC

PATIENT MODEL

The prevalence of people living with BC will increase by 20% by 2012
Figure 2.3: BC Market Opportunities
Table 2.5: Summary of Patient Population Forecasts in the Top 7 Countries (2005-2012E)
DRUG GROWTH DRIVERS
- Figure 2.4: Impact of biomarker identification on BC patients
- Figure 2.5: Impact of biomarker identification on dose selection studies in BC patients
DRUG GROWTH RISKS/DAMPENERS

THE MARKET

GLOBAL CANCER MARKET

Figure 2.6: Global Cancer Drug Sales (including Supportive Care) in 2006 (US$47.2 billion)
Figure 2.7: Global Cancer Sales Forecasts 2004-2012

THE BREAST CANCER MARKET

GLOBAL BC SALES SPLIT
- Figure 2.8: Global Sales Split (2006)
- Figure 2.9: Global BC Market by Therapy Class (2006)
- Figure 2.10: Global BC Market by Region (2012E)
- Figure 2.11: Global BC Market by Therapy Class (2012E)
US market
- Figure 2.12: BC US Drugs Sales Split (2006)
European market
- Figure 2.13: BC European Drugs Sales Split (2006)
Japanese market
- Figure 2.14: BC Japanese Drugs Sales Split (2006)
THE PLAYERS
- Figure 2.15: Market Share of BC Players by Sales (2006)
Players and Products in 2006
- Figure 2.16: Global Market Share of BC Players by Sales (Dec 2012E)
Players and products in 2012

CURRENT TREATMENTS

Figure 2.17: Schematic of Treatment Options in BC
SURGERY
RADIATION
HORMONAL THERAPY
- Figure 2.18: Hormones Affecting BC
- Table 2.6: Current Hormonal Therapies
- Table 2.7: Comparison of Leading Hormonal Therapies
Current Products' Patent Exposure
- Table 2.8: Patent Exposure of Leading Brands
ANALYSIS OF LEADING BRANDS
- Hormonal Therapies
  - Based on the analysis, we have forecast 2005 and 2012E global sales
Anti-Oestrogen Drugs
- Figure 2.19: Mode of Action of Anti-Oestrogens
Nolvadex (AstraZeneca)
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor Ratio Analysis
Faslodex (AstraZeneca)
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Figure 2.20: EFECT Trial Design - Fasoldex vs Aromasin
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor Ratio Analysis
Aromatase inhibitors
- Figure 2.21: Mode of Action of Aromatase Inhibitors
Arimidex (AstraZeneca)
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor Ratio Analysis
Femara (Novartis)
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor Ratio Analysis
Aromasin (Pfizer)
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Figure 2.22: Pfizer' s pipeline addresses over 70% of tumour types
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
  - Filings and approval
- Sales forecasts and assumptions
- Competitor Ratio Analysis
LHRH Agonists
- Zoladex (AstraZeneca)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis

CHEMOTHERAPY

Table 2.9: Chemotherapy Combinations Currently Prescribed in Stage I-III BC
Leading Brands
Current Products Patent Exposure
- Table 2.10: Patent Exposure of Leading Brands
ANALYSIS OF LEADING BRANDS
- Chemotherapies
Taxanes
- Taxotere (sanofi-aventis)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Taxol (Bristol-Myers Squibb)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Figure 2.23: BMS' oncology pipeline
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Abraxane (AstraZeneca/Abraxis BioScience)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
Cytotoxic Agents
- Ellence (Pfizer)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
Antimetabolites
- Xeloda (Roche)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Competition within the marketplace/gaining share of voice
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Gemzar (Eli Lilly)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Figure 2.24: a) Time-to-disease progression and b) overall response rate of metastatic BC to Gemzar treatment
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis

TARGETED THERAPY

Avastin (Roche/Genentech/Chugai)
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Table 2.11: Proposed Filing of New Indication for Avastin
- Sales forecasts and assumptions
- Competitor Ratio Analysis
Herceptin (Roche/Genentech)
- Novelty/rationale for mechanism of action
- Figure 2.25: Mechanism of Action of Herceptin
- Proof of concept/clinical data
- Table 2.12: Pivotal Clinical Trials With Herceptin
- Management/clinical expertise
- Figure 2.26: A) Herceptin Positive and Negative BC Patient Split and B) Marketing Opportunities for Herceptin in Chemotherapy Patients
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Figure 2.27: Herceptin Has a Comprehensive Clinical Trial Programme to Drive Future Sales Growth
- Table 2.13: Registration Programme for Herceptin
- Sales forecasts and assumptions
- Competitor Ratio Analysis
Tykerb (GlaxoSmithKline)
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Figure 2.28: GSK to Target a Broad BC Population With Tykerb
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor Ratio Analysis
Sales Forecast of Current BC Drugs
- Table 2.14: Global Sales of Leading BC Drugs 2005-2012E (US$ millions)

RESEARCH & DEVELOPMENT OF BC DRUGS

Figure 2.29: 2006 Survey: Medicines in Development for Cancer
Table 2.15: Products in Clinical Development for the Treatment of BC
ANALYSIS OF PHASE III DRUGS
- Table 2.16: New Drugs in Phase III Development to Treat BC
- Arzoxifene (Eli Lilly)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Atamestane (Intarcia Therapeutics)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Evista (Eli Lilly/Chugai Pharmaceutical/Daichii Sankyo)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Figure 2.30: Evista - Invasive BC Incidence - STAR Trial
  - Figure 2.31: Evista - Invasive BC Placebo Trials
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Ixabepilone (Bristol-Myers Squibb)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Oporia (Pfizer)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Patupilone (Novartis)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Tesmilifene (YM BioSciences)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Figure 2.32: Pivotal Phase III DEC Study Status
  - Table 2.18: YM BioSciences Product Pipeline
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis

GLOBAL SALES FORECASTS OF PHASE III BC DRUGS 2006E - 2012E

Table 2.19: Sales Forecasts of Phase III Developmental BC Drugs (US$ million)
Model assumptions

ANALYSIS OF PHASE II DRUGS

Table 2.20: New Drugs in Phase II Development to Treat BC
- Iressa (AstraZeneca)
  - Novelty/rationale for mechanism of action
  - Figure 2.34: Mechanism of Iressa' s action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Omnitarg (Roche/Genentech)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- ZK-EPO (Bayer Schering Pharma)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
Other Drugs of Interest
- AE37 (Generex)
- Axitinib (Pfizer)
- HER2/neu vaccine (GlaxoSmithKline)
- IMC-11F8 (ImClone Systems)
- INGN 241 (Introgen Therapeutics)
  - Recombinant human insulin-like growth factor binding protein-3 (Insmed)
- Sprycel (Bristol-Myers Squibb)
- XRP6258 (sanofi-aventis)
GLOBAL SALES FORECASTS OF PHASE II BC DRUGS 2006E - 2012E
- Table 2.21: Sales Forecasts of Phase II Developmental BC Drugs (US$ million)
- Model assumptions
Sales Forecast of New BC Drugs
- Table 2.22: Sales Forecasts of New Developmental BC Drugs US$ millions (2005-2012E)

COMPETITOR RATIO ANALYSIS - PRODUCTS

Table 2.23: Rating Score for Clinical Rating
Figure 2.37: CR Analysis of BC Agents Approved by 2012 - Based on Drug Class

COMPETITOR RATIO ANALYSIS - COMPANIES

Figure 2.38: CR Analysis of BC Agents Approved by 2012 - Based on Company
WINNERS & LOSERS
- Table 2.24: Summary of Key Companies and Drugs in the BC Market by 2012
- Winners (alphabetical)
- Losers

DISCONTINUATION OF DRUGS

Table 2.25: BC Drugs Discontinued During Development

APPENDIX 1

Diagnostic Assays
- HER2 diagnostics
  - HER2/neu diagnostic testing
  - Fluorescence in situ hybridisation (FISH)
  - Chromogenic in situ hybridisation (CISH)
  - InSite HER2/neu kit
  - “Virtual Cancer Patient” technology - Optimata
New diagnostic tests
- Future advances in diagnostics

APPENDIX 2

Patient Model
- Table 2.26: Summary of US BC Patient Population Forecasts

APPENDIX 3

Patient Model
- Table 2.27: Summary of Europe (Top 5) BC Patient Population Forecasts

APPENDIX 4

Patient Model
- Table 2.28: Summary of Japan BC Patient Population Forecasts

APPENDIX 5

Table 2.29: Global BC Drugs Sales 2005-2012E

APPENDIX 6

Phase transition probability
- Table 2.30: Probability of Launch

APPENDIX 7

Competitor Ratio Analysis Criteria
- Table 2.31: Key BC Drugs on the Market by 2012

GLOSSARY

BIBLIOGRAPHY

WEBSITE REFERENCES

ACRONYMS

COLORECTAL CANCER

EXECUTIVE SUMMARY

THE FACTS

What is CRC and how does it affect patients?
- Figure 3.1: Schematic of the Lower Gastrointestinal Tract
Stages of the disease
- Table 3.1: Classification of CRC
- Figure 3.2: Incidence of CRC in US and Western Europe
PATIENT STATISTICS
- Incidence, diagnosis rates and treatment; now and in the future
- Figure 3.3: Estimated US Cancer Deaths (2006)
- Figure 3.4: Incidence of CRC in Men and Women in the US
- Table 3.2: European prevalence of BC
- Table 3.3: Japanese prevalence of BC
PATIENT MODEL
- The addressable CRC market will increase by 12.5% by 2012
- Table 3.4: Summary of Global CRC Patient Population Forecasts in Top 7 Countries (2005A-2012E)
DRUG GROWTH DRIVERS
DRUG GROWTH RISKS/DAMPENERS

GLOBAL CANCER MARKET

Figure 3.5: Global Cancer Drug Sales (including Supportive Care) in 2006 (US$47 billion)
Figure 3.6: Global Cancer Sales Forecasts 2004-2012

THE CRC MARKET

GLOBAL CRC SALES SPLIT
- Figure 3.7: Global CRC Market by Region (2006)
- Figure 3.8: Global CRC Market by Therapy Class (2006)
- Figure 3.9: Global CRC Market by Region (2012E)
- Figure 3.10: Global CRC Market by Therapy Class (2012E)
US market
- Figure 3.11: CRC US Drugs Sales Split (2006)
European market
- Figure 3.12: CRC European Drugs Sales Split (2006)
Japanese market
The major players
- Figure 3.13: Market Share of CRC Players by Sales (Dec 2006)
Players and Products in 2006
Players and products in 2012
- Figure 3.14: Global Market Share of CRC Players by Sales (Dec 2012E)

CURRENT TREATMENTS

CHEMOTHERAPY

Leading Brands
Table 3.5: Comparison of Leading CRC Agents
Current Products' Patent Exposure
- Table 3.6: Patent Exposure of Leading Brands
ANALYSIS OF LEADING BRANDS
- Cytotoxics
- Antimetabolite
- Camptosar (Pfizer)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Eloxatin (sanofi-aventis)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Xeloda (Roche)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Table 3.7: Xeloda Clinical Trial Programme
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
    - Competitor Ratio Analysis Score = 43/50

IMMUNOTHERAPY

Targeting VEGF
Figure 3.15: Angiogenesis is the Formation of New Blood Vessels
Figure 3.16: Agents Targeting the VEGF Pathway
Targeting EGFR
Current Products Patent Exposure
ANALYSIS OF LEADING BRANDS
- Avastin (Roche/Genentech/Chugai)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Figure 3.17: Expanding Avastin in Adjuvant Setting in CRC
  - Management/clinical expertise
  - Table 3.8: Ranking of specialist oncologist sales forces
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Table 3.9: Proposed Filing of New Indication for Avastin
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Erbitux (Bristol-Myers Squibb/Merck Serono/ImClone Systems)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Table 3.10: Clinical trial programme for Erbitux
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Vectibix (Amgen)
  - Novelty/rationale for mechanism of action
  - Figure 3.18: Schematic of EGFr inhibition in tumourgenesis
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
GLOBAL SALES FORECASTS OF CURRENT TREATMENTS 2005A-2012E
- Table 3.11: Sales Forecasts of Current Leading CRC Drugs (US$ millions)
- Model assumptions

RESEARCH & DEVELOPMENT OF CRC DRUGS

Figure 3.19: 2006 Survey - Medicines in Development for Cancer
Table 3.12: Products in Clinical Development for the Treatment of CRC
ANALYSIS OF PHASE III DRUGS
- Table 3.13: New Drugs in Phase III Development to Treat CRC
Novel Therapy
- Recentin (AstraZeneca)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Figure 3.20: Efficacy and Pharmacokinetic Profile of Recentin Compared to Avastin
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Vatalanib (Bayer Schering Pharma/Novartis)
  - Novelty/rationale for mechanism of action
  - Figure 3.21: Schematic of VEGF Receptors
  - Proof of concept/clinical data
  - Figure 3.22: Results of the CONFIRM 1 Trial - PFS
  - Figure 3.23: Results of the CONFIRM 1 Trial - LDH
  - Figure 3.24: Results of the CONFIRM 1 Trial - PFS in High LDH Patients
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Figure 3.25: Results of the CONFIRM 1 Trial - AEs
  - Filings and approval
  - and assumptions
  - Competitor Ratio Analysis
Drug Enhancer
- CoFactor (ADVENTRX Pharmaceuticals)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Davanat (Pro-Pharmaceuticals)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
Vaccine
- OncoVAX (Intracel Resources)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- TroVax (Oxford BioMedica/sanofi-aventis)
  - Novelty/rationale for mechanism of action
  - Figure 3.26: TroVax
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis

GLOBAL SALES FORECASTS OF PHASE III CRC DRUGS 2006A - 2012 E

Table 3.14: Sales Forecasts of Phase III Developmental CRC Drugs (US$ millions)
Model assumptions

ANALYSIS OF PHASE II DRUGS

Table 3.15: New Drugs in Phase II Development to Treat CRC
Alimta (Eli Lilly)
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
  - A Phase II Trial of ALIMTA (Pemetrexed) Plus Irinotecan in Patients Who Have Been Previously Treated For Metastatic Colorectal Cancer
    - A Phase II Trial of ALIMTA (LY231514, Pemetrexed) Plus Oxaliplatin Administered Every 21 Days for First-Line Treatment of Patients With Advanced Colorectal Cancer
  - A Phase II Study of Pemetrexed and Folic Acid Given Before Surgery (Neoadjuvant Treatment) to Patients With Rectal Cancer
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor Ratio Analysis
- New Drug Formulations
HyCAMP (Alchemia )
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor Ratio Analysis
Other Phase II Drugs of Interest
- ABT-751 (Abbott)
- Avicine (AVI BioPharma/SuperGen)
- Enzastaurin (Eli Lilly)
- EP-2101 (IDM Pharma)
- Ispinesib (GlaxoSmithKline/Cytokinetics)
- LE-SN38 (NeoPharm)
- Mapatumumab (GlaxoSmithKline/Human Genome Sciences)
- Nexavar (Bayer Schering Pharma/Onyx Pharmaceuticals)
- Rh-Apo2L (Aida Pharmaceuticals)
- rNAPc2 (Nuvelo)
- Sutent (Pfizer)
- Symadex (Xanthus)
- VQD-002 (VioQuest)
- VX-680/MK-0457 (Vertex/Merck & Co)
GLOBAL SALES FORECASTS OF PHASE II CRC DRUGS 2006A - 2012E
- Table 3.16: Sales Forecasts of Phase II Developmental CRC Drugs (US$ million)
- Model assumptions
Sales Forecast of New CRC Drugs
- Table 3.17: Global CRC Sales of New Products 2006A-2012E (US$ millions)

COMPETITOR RATIO ANALYSIS - PRODUCTS

Figure 3.27: CR Analysis of CRC Agents Approved by 2012 - Based on Drug Class

COMPETITOR RATIO ANALYSIS - COMPANIES

Figure 3.28: CR Analysis of CRC Agents Approved by 2012 - Based on Company
WINNERS & LOSERS
- Table: 3.18: Summary of Key Companies and Drugs in the CRC Market by 2012
- Winners (alphabetical)
- Winner/Loser
- Losers

DISCONTINUATION OF DRUGS

Table 3.19: CRC Drugs Discontinued During Development

APPENDIX 1

Patient Model
- Table 3.20: Summary of US CRC Patient Population Forecasts

APPENDIX 2

Patient Model
- Table 3.21: Summary of Europe (Top 5) CRC Patient Population Forecasts

APPENDIX 3

Patient Model
- Table 3.22: Summary of Japan CRC Patient Population Forecasts

APPENDIX 4

Table 3.23: Global CRC Drugs Sales 2005A-20012E

APPENDIX 5

Phase transition probability
- Probability of launch

APPENDIX 6

Competitor Ratio Analysis Criteria
- Table 3.24: Key CRC Drugs on the Market by 2012

Glosary

Bibliography

ACRONYMS

Volume2

NON-SMALL CELL LUNG CANCER

EXECUTIVE SUMMARY

THE FACTS

What is NSCLC and how does it affect patients?
- Figure 4.1: Schematic of the Lung
Stages of the disease
- Table 4.1: Stages of NSCLC and Survival Rates
PATIENT STATISTICS
- Incidence, diagnosis rates and treatment; now and in the future
- Figure 4.2: Estimates New Cancer Deaths (2006E)*
- Table 4.2: European prevalence of NSCLC
- Table 4.3: Japanese prevalence of NSCLC
PATIENT MODEL
- The addressable NSCLC market will increase by 15% by 2012
- Table 4.4: Summary of Global NSCLC Patient Population Forecasts In Top 7 Countries (2005A-2012E)
- Figure 4.3: Tobacco Use in the US 1900-2002
DRUG GROWTH DRIVERS
DRUG GROWTH RISKS/DAMPENERS

GLOBAL CANCER MARKET

Figure 4.6: Global Cancer Drug Sales (including Supportive Care) in 2006 (US$47.2 billion)
Figure 4.7: Global Cancer Sales 2004A-2012E

THE NSCLC MARKET

GLOBAL NSCLC SALES SPLIT
- Figure 4.8: Global NSCLC Market By Region (2006)
- Figure 4.9: Global NSCLC Market By Therapy Class (2006)
- Figure 4.10: Global NSCLC Market by Region (2012E)
- Figure 4.11: Global NSCLC Market by Therapy Class (2012E)
US market
- Figure 4.12: NSCLC US Drugs Sales Split (2006)
European market
- Figure 4.13: NSCLC European Drugs Sales Split (2006)
Japanese market
- Figure 4.14: NSCLC Japanese Drugs Sales Split (2006)
THE PLAYERS
- Figure 4.15: Market Share of NSCLC Players By Sales (2006)
- Players and Products in 2006
- Players and products in 2012
CURRENT TREATMENTS
- SURGERY
- RADIATION
- CHEMOTHERAPY
  - Table 4.5: Standard NSCLC therapy
  - Table 4.6: Platinum-Based Regimens
  - Table 4.7: FDA-Approved Regimens for Advanced NSCLC
  - Table 4.8: Doublet Regimens
  - Leading Brands
- Current Products' Patent Exposure
  - Table 4.9: Patent Exposure of Leading Brands
ANALYSIS OF LEADING BRANDS
- Chemotherapies
- Taxotere (sanofi-aventis)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Figure 4.17: Summary of pivotal clinical trial data with Taxotere
  - Figure 4.18: TAX317 Survival Kaplan-Meier Curves - Taxotere 75mg/m2 vs Best Supportive Care
  - Figure 4.19: TAX320 Survival Kaplan-Meier Curves - Taxotere 75mg/m2 vs Vinorelbine or Ifosfamide Control
  - Figure 4.20: Taxotere-treated patients as % of patient potential (Top 7)
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Taxol (Bristol-Myers Squibb)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Figure 4.20: Efficacy Parameters in Phase III Trials
  - Management/clinical expertise
  - Figure 4.21: BMS Developmental Product Pipeline
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Navelbine (GlaxoSmithKline)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Gemzar (Eli Lilly)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Alimta (Eli Lilly)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Novel Targeted Therapies
  - Targeting EGFR
  - Figure 4.24: EGFR Signal Transduction in Tumour Cells
  - Table 4.10: EGFR Expression In Solid Tumours
  - Targeting VEGF
  - Figure 4.25: Angiogenesis is the Formation of New Blood Vessels
  - Figure 4.26: Agents Targeting the VEGF Pathway
  - Current Products Patent Exposure
  - Table 4.11: Patent Exposure of Leading Brands
ANALYSIS OF LEADING BRANDS
- Novel targeted therapies
- Iressa (AstraZeneca)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Table 4.12: Clinical Development of Iressa
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Tarceva (Roche/Genentech/OSI Pharmaceuticals)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Figure 4.27: Tarceva Lung Cancer Development Programme
  - Figure 4.28: Key Combination Targeted Therapy Programmes
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Table 4.13: Tarceva Filings and Indications
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Avastin (Roche/Genentech/Chugai)
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Figure 4.29: Avastin Lung Cancer Development Programme
- Figure 4.30: Key Combination Targeted Therapy Programmes
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Table 4.14: Proposed Filing of New Indication for Avastin
- Sales forecasts and assumptions
- Competitor Ratio Analysis
Sales Forecast of Current NSCLC Drugs
- Table 4.15: Global NSCLC Sales of New Products 2005A-2012E (US$ millions)

RESEARCH & DEVELOPMENT OF NSCLC DRUGS

Figure 4.31: 2006 Survey: Medicines in Development for Cancer
Table 4.15: Products in Clinical Development for the Treatment of NSCLC
ANALYSIS OF PHASE III DRUGS
- Table 4.16: New Drugs in Phase III Development to Treat NSCLC
- Recentin (AstraZeneca)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Eloxatin (sanofi-aventis)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Erbitux (Bristol-Myers Squibb/Merck Serono/ImClone Systems)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Table 4.17: Clnical developmental programme for Erbitux
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- PF-3,512,676 (Pfizer/Coley Pharmaceutical)
  - Novelty/rationale for mechanism of action
  - Figure 4.32: PF-3,512,676 Mechanism of Action Through TLR Modulation
  - Proof of concept/clinical data
  - Figure 4.33: Survival benefit of TLR-9 monotherapy in NSCLC
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Stimuvax (Merck Serono/Biomira)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Talabostat (Point Therapeutics)
  - Novelty/rationale for mechanism of action
  - Figure 4.34: Schematic of Talabostat' s mechanism of action
  - Proof of concept/clinical data
  - Figure 4.35: Point Therapeutics Pipeline December 2006
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Xyotax (Novartis/Chugai/Cell Therapeutics)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Zactima (AstraZeneca)
  - Novelty/rationale for mechanism of action
  - Figure 4.36: Zactima' s Triple Mechanism of Action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Figure 4.37: Schematic of Zactima' s Pivotal Trial Programme 2006-2008
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
Another Phase III drug of interest
- Telcyta (Telik)
GLOBAL SALES FORECASTS OF PHASE III NSCLC DRUGS 2006E - 2012E
- Table 4.18: Sales Forecasts of Phase III Developmental NSCLC Drugs (US$ million)
- Model assumptions
ANALYSIS OF PHASE II DRUGS
- Table 4.19: New Drugs in Phase II Development to Treat NSCLC
- Abraxane (AstraZeneca/Abraxis BioScience)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- EP-2101 (IDM Pharma)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Matuzumab (Merck Serono/Takeda)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Onconase (Alfacell)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Satraplatin (GPC Biotech/Pharmion/Spectrum Pharmaceuticals)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Talvesta (Hana Biosciences)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Figure 4.38: Talvesta' s Developmental Status
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions numbers are the same as last time
  - Competitor Ratio Analysis
- TG 4010 (Transgene)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Figure 4.39: Transgene Product Pipeline
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Figure 4.40: TG 4010 Development Timeline
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Velcade (Johnson & Johnson/Millennium Pharmaceuticals)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Other Interesting Phase II Drugs
  - Asentar (sanofi-aventis/Novacea)
    - Phase I/II
  - Axitinib (Pfizer)
  - HGS-ETR2 (Human Genome Sciences Inc/Cambridge Antibody Technology)
    - Phase I/II
  - Ispinesib (Cytokinetics/GlaxoSmithKline)
  - KRX-0401 (Keryx Oncology/AEterna Zentaris)
    - Phase I/II
  - LEP-ETU (NeoPharm)
  - MAGE-A3 vaccine (GlaxoSmithKline)
  - Nexavar (Bayer Schering Pharma/Onyx Pharmaceuticals)
    - Phase I/II
  - Omnitarg (Roche/Genentech/Chugai Pharmaceutical)
  - Triapine (Vion Pharmaceuticals)
    - Phase I/II
  - Targretin (Ligand Pharmaceuticals)
  - Torisel (Wyeth)
GLOBAL SALES FORECASTS OF PHASE II NSCLC DRUGS 2006A - 2012E
- Table 4.20: Sales Forecasts of Phase II Developmental NSCLC Drugs (US$ millions)
- Model assumptions
Sales Forecast of New NSCLC Drugs
- Table 4.21: Global NSCLC Sales of New Products 2006A-2012E (US$ millions)

COMPETITOR RATIO ANALYSIS - PRODUCTS

Table 4.22: Rating Score for Clinical Rating
Figure 4.41: CR Analysis of NSCLC Agents Approved by 2012 - Based on Drug Class
COMPETITOR RATIO ANALYSIS - COMPANIES
- Figure 4.42: CR Analysis of NSCLC Agents Approved by 2012 - Based on Company
WINNERS & LOSERS
- Table 4.23: Summary of Key Companies and Drugs in the NSCLC Market by 2012
Winners (alphabetical)
Losers

DISCONTINUATION OF NSCLC DRUGS

Table 4.24: NSCLC Drugs Discontinued During Development

Appendix 1

Patient Model
- Table 4.25: Summary of US NSCLC Patient Population Forecasts

Appendix 2

Patient Model
- Table 4.26: Summary of Europe (Top 5) NSCLC Patient Population Forecasts

Appendix 3

Patient Model
- Table 4.27: Summary of Japan NSCLC Patient Population Forecasts

Appendix 4

Table 4.28: Global NSCLC Drugs Sales 2005A-20012E

APPENDIX 5

Phase transition probability
Table 4.29: Probability of Launch

Appendix 6

Competitor Ratio Analysis Criteria
- Table 4.30: Key NSCLC Drugs on the Market by 2012

BIBLIOGRAPHY

GLOSSARY

Acronyms

PROSTATE CANCER

EXECUTIVE SUMMARY

THE FACTS

What is PCA and why are we interested in it?
- Figure 5.1: Schematic of prostate gland
PATIENT STATISTICS
- Incidence, diagnosis rates and treatment; now and in the future
  - Figure 5.2: Incidence and mortality rates of PCA in selected countries (2002E)
PATIENT MODEL
- The number of patients with PCA will have a CAGR (2005A-2012E) of 4.8%
  - Table 5.1: Summary of Patient Population Forecasts
DRUG GROWTH DRIVERS
DRUG GROWTH RISKS/DAMPENERS

GLOBAL CANCER MARKET

Figure 5.3: Global Cancer Drug Sales (including Supportive Care) in 2006 (US$47.2 billion)
Figure 5.4: Global Cancer Sales 2004A-2012E
THE PCA MARKET
- Figure 5.5: Global Sales Split (2006)
US market
- Figure 5.6: PCA US Drugs Sales Split (2006)
European market
- Figure 5.7: PCA European Drugs Sales Split (2006)
Japanese market
The major players
- Figure 5.8: Market Share of PCA Players by Sales (Dec 2006)
Players and Products in 2006
Players and products in 2012
- Figure 5.9: Global Market Share of PCA Players by Sales (Dec 2012E)
CURRENT TREATMENTS
- Watchful waiting/active monitoring
- Surgery
- Radiotherapy
- Hormonal treatment
- Chemotherapy
- Leading Brands
  - Table 5.2: Comparison of Leading PCA Agents
- Current Products' Patent Exposure
  - Table 5.3: Patent Exposure of Leading Brands
ANALYSIS OF LEADING BRANDS
- LHRH analogues
- Anti-androgens
- Chemotherapy
LHRH Analogues
- Eligard (sanofi-aventis/Astellas Pharma)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Lupron (TAP Pharmaceutical Products)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Zoladex (AstraZeneca)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
Anti-Androgens
- Casodex (AstraZeneca)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
Chemotherapy
- Taxotere (sanofi-aventis)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
GLOBAL SALES FORECASTS OF CURRENT TREATMENTS 2005A-2012E
- Table 5.4: Sales Forecasts of Current Leading PCA Drugs (US$ millions)
- Model assumptions
NEW DRUGS IN R&D
- Table 5.5: Drugs in Development to Treat PCA
Drugs for PCA prevention
- 5-Alpha Reductase Inhibitors
  - Proscar (Merck & Co) and Avodart (GlaxoSmithKline)
- Non-Steroidal Selective Oestrogen Receptor Modulator (SORM)
  - Acapodene (GTx)
ANALYSIS OF PHASE III DRUGS
- Table 5.6: New Drugs in Phase III Development to Treat PCA
- Chemotherapy
- Hormone/Vitamin D therapies
- Targeted therapies
- Vaccines
Chemotherapy
- Satraplatin (GPC Biotech/Pharmion/Spectrum Pharmaceuticals)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
Hormone/Vitamin D therapies
- Asentar (Novacea)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Degarelix (Ferring/Astellas Pharma)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
Targeted Therapies
- Avastin (Roche/Genentech/Chugai)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Xinlay (Abbott Laboratories)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
Vaccines
- GVAX (Cell Genesys)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Provenge (Dendreon)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
GLOBAL SALES FORECASTS OF PHASE III PCA DRUGS 2006A-2012E
- Table 5.7: Sales Forecasts of Phase III Developmental PCA Drugs (US$ million)
- Model assumptions
ANALYSIS OF PHASE II DRUGS
- Table 5.8: New Drugs in Early Clinical Development to Treat PCA
- Angiogenesis inhibitors
- Gene therapy
- Hormonal therapies
- Monoclonal antibodies
Angiogenesis inhibitors
- AS1404 (Antisoma/Novartis)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- CC-4047 (Celgene)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- ZD4054 (AstraZeneca)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
Gene Therapy
- Genasense (Genta)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
Hormonal Therapies
- Ozarelix (AEterna Zentaris/Spectrum Pharmaceuticals)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
Monoclonal Antibodies
- Ipilimumab (Bristol-Myers Squibb/Medarex)
  - Novelty/rationale for mechanism of action
  - Figure 5.10: Schematic of MDX-010' s mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
Other Interesting Phase II Drugs
- Recentin (AstraZeneca)
- Gleevec/Glivec (Novartis)
- GTI-2040 (Lorus Therapeutics)
- Ixabepilone (Bristol-Myers Squibb)
- Zactima (AstraZeneca)
GLOBAL SALES FORECASTS OF PHASE II PCA DRUGS 2006A - 2012E
- Table 5.9: Sales Forecasts of Phase II Developmental PCA Drugs (US$ millions)
- Model assumptions

COMPETITOR RATIO ANALYSIS - PRODUCTS

Table 5.10: Rating Score for Clinical Rating
Figure 5.11: CR Analysis of PCA Agents Approved by 2012 - Based on Drug Class
COMPETITOR RATIO ANALYSIS - COMPANIES
- Figure 5.12: CR Analysis of PCA Agents Approved by 2012 - Based on Company
WINNERS & LOSERS
- Table 5.11: Summary of Key Companies and Drugs in the PCA Market by 2012
Winners (alphabetical)
Losers

DISCONTINUATION OF DRUGS

Table 5.12: Drugs Discontinued (or ‘on hold’) from Clinical Development in PCA

APPENDIX 1

Figure 5.13: TNM Staging System for PCA

APPENDIX 2

PCA Tumour Grading System - Gleason Score

APPENDIX 3

Phase transition probability
- Table 5.13: Probability of Launch

APPENDIX 4

Patient Model
- Table 5.14: Summary of US PCA Patient Population Forecasts
- Table 5.15: Summary of Europe (Top 5) PCA Patient Population Forecasts
- Table 16: Summary of Japan PCA Patient Population Forecasts

APPENDIX 5

Table 5.17: Global PCA Drugs Sales 2005A-20012E (US$ millions)

APPENDIX 6

Competitor Ratio Analysis Criteria
- Table 5.18: Key PCA Drugs on the Market by 2012

Glosary

REFERENCES

ACRONYMS

RENAL CELL CARCINOMA

EXECUTIVE SUMMARY

THE FACTS

What is RCC and why are we interested in it?
- Figure 6.1: Structure of the Kidney
PATIENT STATISTICS
- Incidence, diagnosis rates and treatment; now and in the future
  - Figure 6.2: World age-standardised incidence rates for kidney cancer, selected countries, 2002 estimates
PATIENT MODEL
- The number of patients with RCC will have a CAGR 2005A-2012E of 2.67%
  - Table 6.1: Summary of Patient Population Forecasts
DRUG GROWTH DRIVERS
DRUG GROWTH RISKS/DAMPENERS

THE MARKET

GLOBAL CANCER MARKET
- Figure 6.3: Global Cancer Drug Sales (including Supportive Care) in 2006 (US$47 billion)
- Figure 6.4: Global Cancer Sales 2004A-2012E
THE RCC MARKET
GLOBAL SALES SPLIT
- Figure 6.5: Global sales split (2006)
- US market
  - Figure 6.6: RCC US Drugs Sales Split (2006A)
- European market
  - Figure 6.7: RCC European Drugs Sales Split (2006A)
- Japanese market
- The major players
- Players and Products in 2006
- Players and products in 2012
  - Figure 6.9: Global Market share of RCC players by sales (Dec 2012E)
CURRENT TREATMENTS
- Leading Brands
  - Table 6.2: Comparison of Leading RCC Agents
- Current Products' Patent Exposure
  - Table 6.3: Patent Exposure of Leading Brands
ANALYSIS OF LEADING BRANDS
- Immunomodulating agents
Immunomodulating agents
- Interferon (IFN) alpha
- Intron A/PEG-Intron (Schering-Plough)
- Roferon-A/Pegasys (Roche)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Table 6.4: Sales forecasts for interferon products
  - Competitor Ratio Analysis
- Proleukin (Novartis/Chiron)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Nexavar (Bayer/Onyx Pharmaceuticals)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Sutent (Pfizer)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
GLOBAL SALES FORECASTS OF CURRENT TREATMENTS 2005A-2012E
- Table 6.5: Sales Forecasts of Current Leading RCC Drugs (US$ millions)
- Model assumptions
NEW DRUGS IN R&D
- Table 6.6: Drugs in Development to Treat RCC
ANALYSIS OF PHASE III DRUGS
- Table 6.7: New Drugs in Phase III Development to Treat RCC
- Avastin (Roche/Genentech/Chugai)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Everolimus (Novartis)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Pazopanib (GlaxoSmithKline)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Rencarex (Wilex)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Torisel (Wyeth)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- TroVax (Oxford BioMedica/sanofi-aventis)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Tykerb (GlaxoSmithKline)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
GLOBAL SALES FORECASTS OF PHASE III RCC DRUGS 2006E-2012E
- Table 6.8: Sales Forecasts of Phase III Developmental RCC Drugs (US$ million)
- Model assumptions
ANALYSIS OF PHASE II DRUGS
- Table 6.9: New Drugs in Early Clinical Development to Treat RCC
- Immunomodulators
- Angiogenic inhibitors
- Novel agents
Immunomodulators
- rIL-21 (ZymoGenetics/Novo Nordisk)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Revlimid (Celgene)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Talactoferrin (Agennix)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
Angiogenesis inhibitors
- ABT-510 (Abbott)
  - Novelty/rationale for mechanism of action
  - Proof of concept/clinical data
  - Management/clinical expertise
  - Competition within the marketplace/gaining share of voice
  - Risks associated with developing a drug within a therapeutic class
  - Filings and approval
  - Sales forecasts and assumptions
  - Competitor Ratio Analysis
- Novel agents
  - AS1411 (Antisoma)
    - Novelty/rationale for mechanism of action
    - Proof of concept/clinical data
    - Management/clinical expertise
    - Competition within the marketplace/gaining share of voice
    - Risks associated with developing a drug within a therapeutic class
    - Filings and approval
    - Sales forecasts and assumptions
    - Competitor Ratio Analysis
- Other Interesting Phase II Drugs
  - ABT-751 (Abbott)
  - Recentin (AstraZeneca)
  - GTI-2040 (Lorus Therapeutics)
  - Ipilimumab (Medarex/Bristol-Myers Squibb)
  - Ixabepilone (Bristol-Myers Squibb)
  - Vatalinib (Novartis/Bayer Schering Pharma)
  - Volociximab (PDL BioPharma/Biogen Idec)
  - XL880 (Exelixis)
GLOBAL SALES FORECASTS OF PHASE II RCC DRUGS 2006A - 2012E
- Table 6.10: Sales Forecasts of Phase II Developmental RCC Drugs (US$ million)
- Model assumptions

COMPETITOR RATIO ANALYSIS - PRODUCTS

Table 6.11: Rating Score for Clinical Rating
Figure 6.11: CR Analysis of RCC Agents Approved by 2012 - Based on Drug Class
COMPETITOR RATIO ANALYSIS - COMPANIES
- Figure 6.12: CR Analysis of RCC Agents Approved by 2012 - Based on Company
WINNERS & LOSERS
- Table 6.12: Summary of Key Companies and Drugs in the RCC Market by 2012
- Winners (alphabetical)
- Losers

DISCONTINUATION OF DRUGS

Table 6.13: Drugs Discontinued (or ‘on hold’) from Clinical Development in RCC

APPENDIX 1

Figure 6.13: RCC Tumour Staging Systems
Tumour, Node, Metastasis (TNM) Staging of Renal Cell Carcinoma

APPENDIX 2

Phase Transition Probability
- Table 6.14: Probability of Launch

Appendix 3

Patient Model
- Table 6.15: Summary of US RCC Patient Population Forecasts
- Table 6.16: Summary of Europe (Top 5) RCC Patient Population Forecasts

Cancer Drug Discoveries: what the future holds

Table of Contents

EXECUTIVE SUMMARY

BREAST CANCER

THE FACTS

PATIENT STATISTICS

PATIENT MODEL

THE MARKET

GLOBAL CANCER MARKET

THE BREAST CANCER MARKET

CURRENT TREATMENTS

CHEMOTHERAPY

TARGETED THERAPY

RESEARCH & DEVELOPMENT OF BC DRUGS

GLOBAL SALES FORECASTS OF PHASE III BC DRUGS 2006E - 2012E

ANALYSIS OF PHASE II DRUGS

COMPETITOR RATIO ANALYSIS - PRODUCTS

COMPETITOR RATIO ANALYSIS - COMPANIES

DISCONTINUATION OF DRUGS

APPENDIX 1

APPENDIX 2

APPENDIX 3

APPENDIX 4

APPENDIX 5

APPENDIX 6

APPENDIX 7

GLOSSARY

BIBLIOGRAPHY

WEBSITE REFERENCES

ACRONYMS

COLORECTAL CANCER

THE FACTS

GLOBAL CANCER MARKET

THE CRC MARKET

CURRENT TREATMENTS

CHEMOTHERAPY

IMMUNOTHERAPY

RESEARCH & DEVELOPMENT OF CRC DRUGS

GLOBAL SALES FORECASTS OF PHASE III CRC DRUGS 2006A - 2012 E

ANALYSIS OF PHASE II DRUGS

COMPETITOR RATIO ANALYSIS - PRODUCTS

COMPETITOR RATIO ANALYSIS - COMPANIES

DISCONTINUATION OF DRUGS

APPENDIX 1

APPENDIX 2

APPENDIX 3

APPENDIX 4

APPENDIX 5

APPENDIX 6

Glosary

Bibliography

ACRONYMS

Volume2

NON-SMALL CELL LUNG CANCER

THE FACTS

GLOBAL CANCER MARKET

THE NSCLC MARKET

RESEARCH & DEVELOPMENT OF NSCLC DRUGS

COMPETITOR RATIO ANALYSIS - PRODUCTS

DISCONTINUATION OF NSCLC DRUGS

Appendix 1

Appendix 2

Appendix 3

Appendix 4

APPENDIX 5

Appendix 6

BIBLIOGRAPHY

GLOSSARY

Acronyms

PROSTATE CANCER

THE FACTS

GLOBAL CANCER MARKET

COMPETITOR RATIO ANALYSIS - PRODUCTS

DISCONTINUATION OF DRUGS

APPENDIX 1

APPENDIX 2

APPENDIX 3

APPENDIX 4

APPENDIX 5

APPENDIX 6