Contents:

NON-SMALL CELL LUNG CANCER EXECUTIVE SUMMARY THE FACTS What is NSCLC and how does it affect patients? Figure 41: Schematic of the Lung Stages of the disease Table 41: Stages of NSCLC and Survival Rates PATIENT STATISTICS Incidence, diagnosis rates and treatment; now and in the future Figure 42: Estimates New Cancer Deaths (2006E)* Table 42: European prevalence of NSCLC Table 43: Japanese prevalence of NSCLC PATIENT MODEL The addressable NSCLC market will increase by 15% by 2012 Table 44: Summary of Global NSCLC Patient Population Forecasts In Top 7 Countries (2005A-2012E) Figure 43: Tobacco Use in the US 1900-2002 DRUG GROWTH DRIVERS DRUG GROWTH RISKS/DAMPENERS GLOBAL CANCER MARKET Figure 46: Global Cancer Drug Sales (including Supportive Care) in 2006 (US$472 billion) Figure 47: Global Cancer Sales 2004A-2012E THE NSCLC MARKET GLOBAL NSCLC SALES SPLIT Figure 48: Global NSCLC Market By Region (2006) Figure 49: Global NSCLC Market By Therapy Class (2006) Figure 410: Global NSCLC Market by Region (2012E) Figure 411: Global NSCLC Market by Therapy Class (2012E) US market Figure 412: NSCLC US Drugs Sales Split (2006) European market Figure 413: NSCLC European Drugs Sales Split (2006) Japanese market Figure 414: NSCLC Japanese Drugs Sales Split (2006) THE PLAYERS Figure 415: Market Share of NSCLC Players By Sales (2006) Players and Products in 2006 Players and products in 2012 CURRENT TREATMENTS SURGERY RADIATION CHEMOTHERAPY Table 45: Standard NSCLC therapy Table 46: Platinum-Based Regimens Table 47: FDA-Approved Regimens for Advanced NSCLC Table 48: Doublet Regimens Leading Brands Current Products’ Patent Exposure Table 49: 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 417: Summary of pivotal clinical trial data with Taxotere Figure 418: TAX317 Survival Kaplan-Meier Curves – Taxotere 75mg/m2 vs Best Supportive Care Figure 419: TAX320 Survival Kaplan-Meier Curves – Taxotere 75mg/m2 vs Vinorelbine or Ifosfamide Control Figure 420: 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 420: Efficacy Parameters in Phase III Trials Management/clinical expertise Figure 421: 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 424: EGFR Signal Transduction in Tumour Cells Table 410: EGFR Expression In Solid Tumours Targeting VEGF Figure 425: Angiogenesis is the Formation of New Blood Vessels Figure 426: Agents Targeting the VEGF Pathway Current Products Patent Exposure Table 411: 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 412: 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 427: Tarceva Lung Cancer Development Programme Figure 428: 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 413: 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 429: Avastin Lung Cancer Development Programme Figure 430: 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 414: Proposed Filing of New Indication for Avastin Sales forecasts and assumptions Competitor Ratio Analysis Sales Forecast of Current NSCLC Drugs Table 415: Global NSCLC Sales of New Products 2005A-2012E (US$ millions) RESEARCH & DEVELOPMENT OF NSCLC DRUGS Figure 431: 2006 Survey: Medicines in Development for Cancer Table 415: Products in Clinical Development for the Treatment of NSCLC ANALYSIS OF PHASE III DRUGS Table 416: 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 417: 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 432: PF-3,512,676 Mechanism of Action Through TLR Modulation Proof of concept/clinical data Figure 433: 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 434: Schematic of Talabostat’s mechanism of action Proof of concept/clinical data Figure 435: 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 436: 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 437: 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 418: Sales Forecasts of Phase III Developmental NSCLC Drugs (US$ million) Model assumptions ANALYSIS OF PHASE II DRUGS Table 419: 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 438: 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 439: 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 440: 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 420: Sales Forecasts of Phase II Developmental NSCLC Drugs (US$ millions) Model assumptions Sales Forecast of New NSCLC Drugs Table 421: Global NSCLC Sales of New Products 2006A-2012E (US$ millions) COMPETITOR RATIO ANALYSIS - PRODUCTS Table 422: Rating Score for Clinical Rating Figure 441: CR Analysis of NSCLC Agents Approved by 2012 – Based on Drug Class COMPETITOR RATIO ANALYSIS - COMPANIES Figure 442: CR Analysis of NSCLC Agents Approved by 2012 – Based on Company WINNERS & LOSERS Table 423: Summary of Key Companies and Drugs in the NSCLC Market by 2012 Winners (alphabetical) Losers DISCONTINUATION OF NSCLC DRUGS Table 424: NSCLC Drugs Discontinued During Development Appendix 1 Patient Model Table 425: Summary of US NSCLC Patient Population Forecasts Appendix 2 Patient Model Table 426: Summary of Europe (Top 5) NSCLC Patient Population Forecasts Appendix 3 Patient Model Table 427: Summary of Japan NSCLC Patient Population Forecasts Appendix 41 Table 428: Global NSCLC Drugs Sales 2005A-20012E APPENDIX 5 Phase transition probability Table 429: Probability of Launch Appendix 6 Competitor Ratio Analysis Criteria Table 430: Key NSCLC Drugs on the Market by 2012 BIBLIOGRAPHY GLOSSARY Acronyms Table of Contents

Summary:

Lung cancer affects more than 1.2 million patients a year, with around 1.1 million deaths annually and 500,000 in the US, Europe and Japan. Find out more about market developments in this chapter of Cancer Drug Discoveries.