Contents:

Overview Catalyst Summary Executive Summary Strategic scoping and focus Datamonitor insight into the colorectal cancer market Datamonitor pipeline assessment summary Related reports Upcoming related reports 1. Pipeline Overview and dynamics Key findings Pipeline overview Pipeline summary Novel molecular targeted therapies dominate the current late-phase colorectal cancer pipeline Comparative forecasts Datamonitor pipeline assessment summary Key companies involved in the colorectal cancer (CRC) pipeline Amgen AstraZeneca Roche Key R&D company strategies Ongoing shift towards molecular targeted therapies in colorectal cancer Line extensions of already marketed drugs 2. Colorectal cancer - Market Potential Key findings Definition Introduction Colorectal cancer is one of the 'big four' tumors and numbers are set to rise over the next decade Histology Risk factors CRC is predominantly a disease of the elderly People with CRC in the family have a high risk of developing the disease Western style diets contribute to CRC incidence Rise of CRC in the migrant population Symptoms Screening and diagnosis Fecal occult blood test is the most commonly used screening method Endoscopic methods are not ideal for CRC screening CRC screening remains fragmented between countries Patient segmentation Proper staging is essential to the design of treatment plans Epidemiology Seven major markets CRC cases are expected to rise in line with the aging world population Low detection in the early stages of the disease results in a high mortality rate Rest of the world Current treatment options Surgery remains the primary treatment choice for early-stage CRC Adjuvant therapy extends disease-free survival in Stage III patients Combination chemotherapy is the standard of care in metastatic disease Avastin is used predominantly in the US in the first-line setting Erbitux is indicated for use in patients with wild-type KRAS status Vectibix has limited uptake in the treatment of the disease Current comparator therapy Eloxatin (oxaliplatin; Sanofi-aventis) Unmet need in colorectal cancer (CRC) Better screening approaches needed to decrease mortality rates There is a need for more effective therapies in both early-stage and advanced disease Biomarkers and the selection of patients may help improve outcomes Target product profile versus current level of attainment 3. R&D Approach Key findings Clinical trial design in colorectal cancer (CRC) Patient selection Clinical trial endpoints in oncology Overall survival Disease-free survival Overall response rates Progression-free survival Disease control Toxicity 4. Pipeline Analysis & Forecasts: Molecular Targeted Therapies Key findings Overview of the molecular targeted therapies Pipeline summary Comparative forecasts Aflibercept (VEGF-Trap; Regeneron/Sanofi-aventis) Drug overview Drug profile Key historical events SWOT analysis Clinical trial data Phase II studies show aflibercept to be well tolerated in metastatic CRC Clinical attractiveness Commercial attractiveness Datamonitor drug assessment summary Satisfaction of unmet needs Forecasts to 2018 Brivanib (Bristol-Myers Squibb) Drug overview Drug profile Key historical events SWOT analysis Clinical trial data The combination of brivanib with Erbitux is tolerable and shows signs of clinical activity Retrospective study shows that efficacy of brivanib with Erbitux is driven by wild-type KRAS patients Clinical attractiveness Commercial attractiveness Datamonitor drug assessment summary Satisfaction of unmet needs Forecasts to 2018 Recentin (cediranib; AstraZeneca) Drug overview Drug profile Key historical events SWOT analysis Clinical trial data Recentin shows disappointing results in a Phase II head-to-head trial against Avastin Clinical attractiveness Commercial attractiveness Datamonitor drug assessment summary Satisfaction of unmet needs Forecasts to 2018 MK-0646 (Merck/Pierre Fabre) Drug overview Drug profile Key historical events SWOT analysis Clinical trial data Phase II shows MK-0646 to be tolerable in metastatic patients with wild-type KRAS Clinical attractiveness Commercial attractiveness Datamonitor drug assessment summary Satisfaction of unmet needs Forecasts to 2018 5. Innovative Early-Stage Approaches Key findings Overview of early-stage innovative projects TRAIL Insulin-like growth factor receptor (IGFR) MAP kinase pathway The future of treatment of colorectal cancer (CRC) Molecular markers will become an important part of therapy for patient selection The future will see more combination therapies to target multiple pathways Increased understanding of cancer evolution should result in a large range of potential drug targets Bibliography Journals Websites APPENDIX Methodology Epidemiology forecasts Product forecasts Datamonitor drug assessment scorecard Contributing experts About Datamonitor About Datamonitor Healthcare About the Oncology analysis team Datamonitor consulting Disclaimer List of Tables Table 1: Sales forecasts for late-phase colorectal cancer (CRC) pipeline products in the seven major markets ($m), 2009-2018 Table 2: Drugs in late-phase development for colorectal cancer (CRC), 2009 Table 3: Sales forecasts for late-stage colorectal cancer (CRC) pipeline products in the seven major markets ($m), 2009-2018 Table 4: Amgen's marketed and pipeline oncology portfolio, 2009 Table 5: AstraZeneca's marketed and pipeline oncology portfolio, 2009 Table 6: Roche's marketed and pipeline oncology portfolio, 2009 Table 7: Forecast incidence of colorectal cancer (CRC) in the seven major pharmaceutical markets, 2009-2018 Table 8: Molecular targeted therapies (MTTs) approved for use in metastatic colorectal cancer (CRC), 2009 Table 9: Eloxatin (oxaliplatin) - drug profile, 2009 Table 10: Ability of Eloxatin to meet unmet needs in the first-line treatment of metastatic colorectal cancer (CRC), 2009 Table 11: Ability of Eloxatin to meet unmet needs in the second-line treatment of metastatic colorectal cancer (CRC), 2009 Table 12: Drugs in late-phase development for colorectal cancer (CRC) , 2009 Table 15: Sales forecasts for late-phase colorectal cancer (CRC) pipeline products in the seven major markets ($m), 2009-2018 Table 16: Aflibercept - drug profile, 2009 Table 17: Aflibercept: key historical events Table 18: Clinical development of aflibercept in colorectal cancer (CRC), 2009 Table 19: Ability of aflibercept to meet unmet needs in colorectal cancer (CRC), 2009 Table 20: Sales forecast for aflibercept in colorectal cancer (CRC) across the seven major markets ($m), 2009-2018 Table 21: Brivanib - drug profile, 2009 Table 22: Brivanib: key historical events Table 23: Clinical development of brivanib in colorectal cancer (CRC), 2009 Table 24: Phase I results investigating a second-line or higher combination of Erbitux and brivanib in advanced gastrointestinal malignancies Table 25: Ability of brivanib to meet unmet needs in colorectal cancer (CRC), 2009 Table 26: Sales forecast for brivanib in colorectal cancer (CRC) across the seven major markets($m), 2009-2018 Table 27: Recentin (cediranib) - drug profile, 2009 Table 28: Recentin: key historical events Table 29: Clinical development of Recentin in colorectal cancer (CRC), 2009 Table 30: Ability of Recentin to meet unmet needs in colorectal cancer (CRC), 2009 Table 31: Sales forecast for Recentin in colorectal cancer (CRC) across the seven major markets ($m), 2009-2018 Table 32: MK-0646 - drug profile, 2009 Table 33: MK-0646: key historical events Table 34: Clinical development of MK-0646 in colorectal cancer (CRC), 2009 Table 35: Ability of MK-0646 to meet unmet needs in colorectal cancer (CRC), 2009 Table 36: Sales forecast for MK-0646 in colorectal cancer (CRC) across the seven major markets, 2009-2018 ($m) Table 37: Top 10 early-stage colorectal cancer (CRC) drug targets, 2009 Table 38: Datamonitor drug assessment parameters List of Figures Figure 1: Datamonitor drug assessment summary for molecular targeted therapies (MTTs) in development for colorectal cancer (CRC), 2009 Figure 2: Colorectal cancer (CRC) pipeline split by development phase and drug class, 2009 Figure 3: Datamonitor drug assessment summary for molecular targeted therapies (MTTs) in development for colorectal cancer (CRC), 2009 Figure 4: Incidence and mortality from colorectal cancer (CRC) in the seven major pharmaceutical markets, 2009 and 2018 Figure 5: Incidence of colorectal cancer (CRC) in the rest of the world, 2009 and 2019 Figure 6: Datamonitor drug assessment summary for molecular targeted therapies in development for colorectal cancer (CRC), 2009 Table 13: Forecast assumptions for molecular targeted therapy colorectal cancer (CRC) pipeline products across the seven major markets, 2009 Table 14: Forecast assumptions for molecular targeted therapy colorectal cancer (CRC) pipeline products across the seven major markets, 2009 Figure 7: SWOT analysis for aflibercept, 2009 Figure 8: Phase II data on the second-line treatment of aflibercept in recurrent metastatic colorectal cancer (CRC) patients following failure of standard therapy Figure 9: Datamonitor drug assessment summary for aflibercept in colorectal cancer (CRC), 2009 Figure 10: Brivanib SWOT analysis, 2009 Figure 11: Retrospective analysis evaluating correlation between KRAS status and efficacy from a Phase I/II study of brivanib in combination with Erbitux in patients with advanced or metastatic colorectal cancer (CRC) Figure 12: Datamonitor drug assessment summary for brivanib in colorectal cancer (CRC), 2009 Figure 13: SWOT analysis for Recentin, 2009 Figure 14: Phase II results for second-line FOLFOX + Recentin versus FOLFOX + Avastin in metastatic colorectal cancer (CRC) (HORIZON I) Figure 15: Datamonitor drug assessment summary for Recentin in colorectal cancer (CRC), 2009 Figure 16: SWOT analysis for MK-0646, 2009 Figure 17: Phase II study of MK-0646 in second-line or higher metastatic colorectal cancer (CRC) patients with wild-type KRAS Figure 18: Datamonitor drug assessment summary for MK-0646 in colorectal cancer (CRC), 2009 Figure 19: Early-stage colorectal cancer pipeline (CRC) split by drug class, 2009 Figure 20: Datamonitor drug assessment summary for molecular targeted therapies in development for colorectal cancer (CRC), 2009

Companies Mentioned

- AstraZeneca PLC - Biogen Idec, Inc. - Boehringer Ingelheim GmbH - Bristol-Myers Squibb Company - Eli Lilly and Company - Genentech, Inc. - Human Genome Sciences, Inc. - IMS Health - Keryx Biopharmaceuticals, Inc. - Merck KGaA - Schering-Plough Corporation