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COLORECTAL CANCER EXECUTIVE SUMMARY THE FACTS What is CRC and how does it affect patients? Figure 31: Schematic of the Lower Gastrointestinal Tract Stages of the disease Table 31: Classification of CRC Figure 32: Incidence of CRC in US and Western Europe PATIENT STATISTICS Incidence, diagnosis rates and treatment; now and in the future Figure 33: Estimated US Cancer Deaths (2006) Figure 34: Incidence of CRC in Men and Women in the US Table 32: European prevalence of BC Table 33: Japanese prevalence of BC PATIENT MODEL The addressable CRC market will increase by 125% by 2012 Table 34: Summary of Global CRC Patient Population Forecasts in Top 7 Countries (2005A-2012E) DRUG GROWTH DRIVERS DRUG GROWTH RISKS/DAMPENERS GLOBAL CANCER MARKET Figure 35: Global Cancer Drug Sales (including Supportive Care) in 2006 (US$47 billion) Figure 36: Global Cancer Sales Forecasts 2004-2012 THE CRC MARKET GLOBAL CRC SALES SPLIT Figure 37: Global CRC Market by Region (2006) Figure 38: Global CRC Market by Therapy Class (2006) Figure 39: Global CRC Market by Region (2012E) Figure 310: Global CRC Market by Therapy Class (2012E) US market Figure 311: CRC US Drugs Sales Split (2006) European market Figure 312: CRC European Drugs Sales Split (2006) Japanese market The major players Figure 313: Market Share of CRC Players by Sales (Dec 2006) Players and Products in 2006 Players and products in 2012 Figure 314: Global Market Share of CRC Players by Sales (Dec 2012E) CURRENT TREATMENTS CHEMOTHERAPY Leading Brands Table 35: Comparison of Leading CRC Agents Current Products’ Patent Exposure Table 36: 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 37: 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 315: Angiogenesis is the Formation of New Blood Vessels Figure 316: 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 317: Expanding Avastin in Adjuvant Setting in CRC Management/clinical expertise Table 38: 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 39: 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 310: 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 318: 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 311: Sales Forecasts of Current Leading CRC Drugs (US$ millions) Model assumptions RESEARCH & DEVELOPMENT OF CRC DRUGS Figure 319: 2006 Survey - Medicines in Development for Cancer Table 312: Products in Clinical Development for the Treatment of CRC ANALYSIS OF PHASE III DRUGS Table 313: 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 320: 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 321: Schematic of VEGF Receptors Proof of concept/clinical data Figure 322: Results of the CONFIRM 1 Trial – PFS Figure 323: Results of the CONFIRM 1 Trial – LDH Figure 324: 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 325: 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 326: 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 314: Sales Forecasts of Phase III Developmental CRC Drugs (US$ millions) Model assumptions ANALYSIS OF PHASE II DRUGS Table 315: 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 316: Sales Forecasts of Phase II Developmental CRC Drugs (US$ million) Model assumptions Sales Forecast of New CRC Drugs Table 317: Global CRC Sales of New Products 2006A-2012E (US$ millions) COMPETITOR RATIO ANALYSIS - PRODUCTS Figure 327: CR Analysis of CRC Agents Approved by 2012 – Based on Drug Class COMPETITOR RATIO ANALYSIS - COMPANIES Figure 328: CR Analysis of CRC Agents Approved by 2012 – Based on Company WINNERS & LOSERS Table: 318: Summary of Key Companies and Drugs in the CRC Market by 2012 Winners (alphabetical) Winner/Loser Losers DISCONTINUATION OF DRUGS Table 319: CRC Drugs Discontinued During Development APPENDIX 1 Patient Model 1 Table 320: Summary of US CRC Patient Population Forecasts APPENDIX 2 Patient Model Table 321: Summary of Europe (Top 5) CRC Patient Population Forecasts APPENDIX 3 Patient Model Table 322: Summary of Japan CRC Patient Population Forecasts APPENDIX 4 Table 323: Global CRC Drugs Sales 2005A-20012E APPENDIX 5 Phase transition probability Probability of launch APPENDIX 6 Competitor Ratio Analysis Criteria Table 324: Key CRC Drugs on the Market by 2012 GLOSSARY BIBLIOGRAPHY ACRONYMS

Summary:

Colorectal cancer (CRC) is the third most common cancer in the US in both sexes and accounts for around 10% of all cancer deaths. Find out more about market developments in this chapter of Cancer Drug Discoveries.