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A Datamonitor report Pipeline/Commercial Insight: Molecular Targeted Cancer Therapies – More Drugs on the Market, More Targets in the Pipeline Providing you with: Published: Sep-06 Product Code: DMHC2224 • Seven major pharmaceutical market sales forecasts from 2005 to 2015 for approved molecular targeted therapies and key pipeline candidates • Review of the current targeted therapies market, including profiles, product-specific assumptions and events over the forecasted period • Research and analysis of the targeted therapies pipeline with in-depth clinical and Use this report to... Acquire a detailed appreciation and impartial perspective of the targeted cancer therapies market as a whole commercial assessment of Phase III candidates, plus expert opinion • Examination of product pipeline by phase, mode of action, indication, drug class and developer, plus two commercial impact case studies Pipeline/Commercial Insight: Molecular Targeted Cancer Therapies – More Drugs on the Market, More Targets in the Pipeline DMHC2224 Introduction Cancer treatment continues to embrace the inclusion of molecular targeted therapies (MTT) into standard treatment regimens. With an increasing number of candidates gaining approval, and with a dynamic developmental pipeline, further clinical, commercial and strategic challenges are continuing to emerge. Since late 2005, four more MTTs have been launched. Both Nexavar (Bayer AG/Onyx) and Sutent (Pfizer) have gained approval for kidney cancer with Sutent receiving approval in an additional tumor type. Sprycel (Bristol-Myers Squibb), has been approved for Gleevec-resistant CML patients and Amgen's fully-humanized monoclonal antibody, Vectibix has very recently joined Erbitux and Avastin in the metastatic colorectal cancer market. These new agents are all expected to perform well over the forecast period with an aggregate level of sales reaching $2.77 billion in 2015. Key findings and highlights • In 2005, the MTT market was worth $7.5 billion and the forecast sales of already marketed drugs in this class are expected to grow to $25.2 billion by 2015, at a CAGR of 12.9 per cent. This growth will be driven mainly by Genentech/Roche's Rituxan, Herceptin and Avastin as well as Novartis' Gleevec, all of which have already reached blockbuster status. • 274 different pipeline MTTs have been identified. The introduction of current late-phase candidates, including the pre-registered agents Tykerb (lapatinib; GlaxoSmithKline) and Zolinza (vorinostat; Merck), will further increase the market's total value by $3.8 billion, enabling the targeted therapies market to reach $29.1 billion in 2015. • The rise in cost of cancer treatment is unsustainable with growing pharmacoeconomic pressures challenging healthcare payers globally. To counter these hurdles, developers must become more effective at communicating the value of their products. To this end, a comprehensive understanding of the targeted therapies market and pipeline is critical. Reasons to buy • Acquire a detailed appreciation and impartial perspective of the targeted cancer therapies market as a whole • Consider and react to the specific events influencing the future potential of marketed and pipeline targeted therapies • Gain an insight into the emerging clinical, developmental and commercial challenges and opportunities facing key developmental and marketed MTT drugs Sample pages from the report Pipeline Single-Target Signal Transduction Inhibitors Analysis & Forecasts Not Known Not Known Temsirolimus Zalutumumab Wyeth Research Genmab mTOR inhibitor EGFR inhibitor (hMAb) Mantle cell lymphoma and RCC MM, melanoma, glioma, NSCLC and endometrial cancer Head and neck cancer III II III *Vectibix was approved by the FDA for relapsed/refractory metastatic colorectal cancer on September 27, 2006 See Abbreviations; Source: R&D Focus, IMS Health, April 2006, Copyright ©, reprinted with permission; IDdb3, July 2006, Copyright Thomson Scientific; BioSpace; ClinicalTrials.gov DATAMONITOR Phase II pipeline single-target signal transduction Pipelineinhibitors, Angiogenesis 2006 Analysis & Forecasts Table 42: Brand Drug Company Mode of action Indication Certican Omnitarg Everolimus Pertuzumab Novartis AG Genentech Inc mTOR inhibitor Solid tumors Her2 (ErbB2) NSCLC, prostate, breast inhibitor (hMAb) and ovarian cancers Tracleer Bosentan Roche AG Melanoma Not Known AP-23573 ARIAD Pharmaceuticals Inc Endothelin ET-A receptor inhibitor mTOR inhibitor Not Known Not Known CP-751871 Pfizer Inc Various cancers HKI-272 Wyeth Research IGFR1 inhibitor (hMAb) Her2 (ErbB2) TK inhibitor Not Known Not Known Not Known Matuzumab (EMD72000) PEP-005 Merck KGaA ZD-4054 AstraZeneca Peplin Ltd EGFR inhibitor (hMAb) PKC inhibitor Endothelin ETA receptor inhibitor See Abbreviations Source: R&D Focus, IMS Health, April 2006, Copyright ©, reprinted with permission; IDdb3, July 2006, Copyright Thomson Scientific; BioSpace; ClinicalTrials.gov Table 32: © Datamonitor (Published 09/2006) Phase II pipeline angiogenesis inhibitors, 2006 Glioma, sarcoma, Brand leukemia, Drug endometrioid , lymphoma and prostate cancer Plitidepsin Aplidin Evizon Squalamine NSCLC and breast cancer Vitaxin, MEDI-522 Gastric, pancreatic, Abegrin cervical and ovarian cancers Basal cell Not carcinomaABT-510 Known Prostate cancer Not Angiostatin Known Not Axitinib Known (AG-13736) Not CDP-791 Known D A T A M OCilengitide NITOR Not Known Not Known Pipeline/Commercial Insight: Molecular Targeted Cancer Therapies Inhibitors Combretastatin CP-547632 Not KnownDMHC2224 Not Endostatin Known Page 164 This report is a licensed product and is not to be photocopied Not Known Not Known UK-356202 Not Known WX-UK1 Volociximab Company Mode of action Indication PharmaMar SA VEGFR1 inhibitor SCLC, AML, ALL, MM, melanoma, NHL, prostate, bladder and thyroid cancers NSCLC, ovarian and prostate cancers CRC, Sarcoma, Melanoma, prostate cancer Genaera Corp VEGF and Integrin receptor inhibitor Scripps Research Angiogenesis Institute inhibitor (Integrin hMAb) Abbott Thrombospondin-1 NSCLC, RCC, sarcoma, Laboratories ligand, coagulation lymphoma promoter and angiogenesis Pipeline Overview inhibitor EntreMed Inc Angiogenesis NSCLC inhibitor Pfizer Inc VEGF, CSF-1, & NSCLC, MDS, AML, RCC, PDGF TK inhibitor melanoma and breast cancer Celltech Group VEGFR2 TK NSCLC plc inhibitor Merck KGaA Integrin receptor TK NSCLC, Kaposi’s sarcoma, inhibitor CRC, glioma, andmolecular targeted therapies by class of drug, 2006 Figure 2: melanoma Pipeline pancreatic and breast cancers CRC, lung, prostate, thyroid, OXiGENE Cadherin-5 cervical, ovarian and head & antagonist and Immunomodulatory or vascular damaging neck cancers Immunoconjugated Angiogenesis inhibitors agent therapeutics 44 (16%) OSI VEGF inhibitor NSCLC and ovarian cancer 57 (21%) Pharmaceuticals Single-target signal Children’s Angiogenesis Neuroendocrine tumors and transduction inhibitors Hospital of inhibitor melanoma 32 (12%) Boston Epigenetic modulators Pfizer Inc uPA inhibitor Various cancers 16 (6%) Eos Biotechnology Inc Wilex Angiogenesis inhibitor (Integrin MAb) uPA inhibitor See Abbreviations Source: R&D Focus, IMS Health, April 2006, Copyright ©, reprinted with permission; IDdb3, July 2006, NSCLC, RCC, melanoma and pancreatic cancer Solid tumors Cell cycle and apoptosis targeted agents 78 (28%) Multi-targeted inhibitors 47 (17%) Copyright Thomson Scientific; BioSpace; ClinicalTrials.gov Pipeline/Commercial Insight: Molecular Targeted Cancer Therapies © Datamonitor (Published 09/2006) This report is a licensed product and is not to be photocopied DATAMONITOR Source: Datamonitor DATAMONITOR The cell cycle and apoptosis targeted agents make up the largest number of molecular targeted therapies (MTTs) in the developmental pipeline with 78 candidates inDMHC2224 all. This is largely due to the number of products from this class in Phase I and Phase II. While Millennium Pharmaceuticals’ Velcade is an apoptosis Page 134 stimulator that has reached the market and achieved success in the treatment of multiple myeloma, another product in this class, Genta’s Genasense, has suffered significant setbacks in its commercialization. As evidenced here, although Genasense has been at an advanced stage of development for several years, its numerous setbacks have not deterred other developers from pursuing a similar anticancer drug development strategy. It is also important to note that while, for the purposes of this report, multi-targeted agents have been classified as a separate subclass of MTTs, their mode of action is largely through inhibition of signal transduction or angiogenesis drivers. In light of this, the number of MTTs in development that are classified as single-target signal transduction inhibitors (32, 12%), angiogenesis inhibitors (44, 16%) and multitargeted inhibitors (47, 17%) must be appreciated in context. Pipeline/Commercial Insight: Molecular Targeted Cancer Therapies © Datamonitor (Published 09/2006) DMHC2224 Page 27 This report is a licensed product and is not to be photocopied “...We've got to figure out a way to know if we've actually hit the target. There's got to be some blood tests that you can push and say OK, we've maximally inhibited VEGF and then assume that's going to be the most efficacious dose and move forward...” US opinion leader, Pipeline/Commercial Insight: Molecular Targeted Cancer Therapies – More Drugs on the Market, More Targets in the Pipeline Pipeline/Commercial Insight: Molecular Targeted Cancer Therapies – More Drugs on the Market, More Targets in the Pipeline DMHC2224 Table of contents ABOUT DATAMONITOR HEALTHCARE • About the Oncology pharmaceutical analysis team EXECUTIVE SUMMARY • Scope of analysis • Datamonitor insight into the targeted therapies market PIPELINE OVERVIEW • Pipeline overview • Pipeline by developmental phase and class of drug - The cell cycle and apoptosis targeted agents make up the largest number of MTTs in the pipeline - Segmentation of drugs by developmental phase reflects attrition rate of drug development in the oncology market • Pipeline by indication - MTTs are being investigated in 29 different cancers • Pipeline by mode of action - Pipeline MTTs are being directed against a huge variety and combination of molecular targets - The VEGF/VEGFR family remains the focus of development for MTTs • Pipeline by company - There are over 150 different companies developing targeted therapies - Top three companies in terms of number of pipeline MTT products are Pfizer, Novartis and GlaxoSmithKline • Key metrics • Datamonitor pipeline assessment summary PIPELINE DYNAMICS • A diverse range of disease subtypes • Genetic basis of cancer evolution - Tumorigenesis is the result of co-operative accumulated mutations • Existing pharmacotherapy approaches provide limited treatment benefit - Cytotoxic drugs lack specificity - Hormonal or endocrine therapy provides incremental benefit in selected tumors - Optimizing current treatment strategies is paramount • The emergence of targeted treatment heralds a revolution in cancer pharmacotherapy • Dynamic cancer market offers significant commercial opportunity - Ongoing sales growth drives the market - Intensive R&D produces a rich developmental pipeline - Growing patient population and significant unmet needs propel innovation in the cancer market • Clinical and strategic threats to the commercialization of cancer drugs - Progressively rising R&D costs threaten industry productivity - Pharmacoeconomic pressures drive payers to implement restrictive pricing and reimbursement policies - Therapeutic and generic competition reduces periods of market exclusivity - Segmentation of market will require changes in clinical trial methodology MARKET DEFINITION & PIPELINE CLASSIFICATION • Targeted therapies overview - The development of molecular targeted therapies • Market definition - L1X3 - Antineoplastic monoclonal antibodies - L1X9 - All other antineoplastics • Classification of pipeline products - Angiogenesis inhibitors - Single-target signal transduction inhibitors - Multi-targeted inhibitors - Cell cycle and apoptosis targeted inhibitors - Epigenetic modulators - Immunomodulatory and immunoconjugated therapeutics • Pipeline comparator • Current market situation MARKETED PRODUCTS FORECAST ANALYSIS • Country-specific assumptions and effects - Effect of Medicare Modernization Act in the US - Biennial price cuts in Japan - National Institute of Clinical Excellence in the UK - Generic erosion assumptions • Product assumptions and effects - Angiogenesis inhibitors - Single-target signal transduction inhibitors - Multi-targeted inhibitors - Cell cycle and apoptosis targeted agents - Immunomodulatory and immunoconjugated therapeutics • Forecasts PIPELINE ANGIOGENESIS INHIBITORS ANALYSIS & FORECASTS • Pipeline overview • AstraZeneca's AZD2171 - Drug Profile - Clinical Trial Data - Datamonitor Comments • GlaxoSmithKline's Pazopanib (GW 786034) - Drug Profile - Clinical Trial Data - Datamonitor Comments • Novartis/Schering AG's Vatalanib (PTK-787) - Drug Profile - Clinical Trial Data - Datamonitor Comments • Sanofi Aventis/Regeneron's VEGF-Trap - Drug Profile - Clinical Trial Data - Datamonitor Comments • Forecasts • Datamonitor drug assessment summary PIPELINE SINGLE-TARGET SIGNAL TRANSDUCTION INHIBITORS ANALYSIS & FORECASTS • Pipeline overview • Amgen's Vectibix (panitumumab; ABX-EGF) - Drug Profile - Clinical Trial Data - Datamonitor Comments • Schering-Plough's Sarasar (Lonafarnib) - Drug Profile - Clinical Trial Data - Datamonitor Comments • Abbott Laboratories' Xinlay (atrasentan) - Drug Profile - Clinical Trial Data - Datamonitor Comments • Wyeth's Temsirolimus (CCI-779) - Drug Profile - Clinical Trial Data - Datamonitor Comments • Janssen/Johnson & Johnson's Zarnestra (tipifarnib) - Drug Profile - Clinical Trial Data - Datamonitor Comments • YM Bioscience's TheraCIM (Theraloc; Nimotuzumab) - Drug Profile - Clinical Trial Data - Datamonitor Comments • Forecasts • Datamonitor drug assessment summary PIPELINE MULTI-TARGETED INHIBITORS ANALYSIS & FORECASTS • Pipeline overview • GlaxoSmithKline's Tykerb/Tycerb (Lapatinib) - Drug Profile - Clinical Trial Data - Datamonitor Comments • ChemGenex Pharmaceuticals' Ceflatonin (CGX635, Myelostat) - Drug Profile - Clinical Trial Data - Datamonitor Comments • Ipsen's Somatuline (Lanreotide) - Drug Profile - Clinical Trial Data - Datamonitor Comments • Novartis's Tasigna (Nilotinib, AMN-107) - Drug Profile - Clinical Trial Data - Datamonitor Comments • AstraZeneca's Zactima (Vandetanib; ZD6474) - Drug Profile - Clinical Trial Data - Datamonitor Comments • Eli Lilly's Enzastaurin (LY317615) - Drug Profile - Clinical Trial Data - Datamonitor Comments • Cephalon's Lestaurtinib (CEP-701) - Drug Profile - Clinical Trial Data - Datamonitor Comments • Forecasts • Datamonitor drug assessment summary PIPELINE CELL CYCLE AND APOPTOSIS TARGETED AGENTS ANALYSIS & FORECASTS • Pipeline overview • Genta's Genasense (Oblimersen) - Drug Profile - Clinical Trial Data - Datamonitor Comments • Telik's Telcyta (TLK286) - Drug Profile - Clinical Trial Data Pipeline/Commercial Insight: Molecular Targeted Cancer Therapies – More Drugs on the Market, More Targets in the Pipeline DMHC2224 - Datamonitor Comments • Celtic Pharma/Xenova's TransMID (XR-311) - Drug Profile - Clinical Trial Data - Datamonitor Comments • Sanofi-Aventis's Alvocidib (Flavopiridol) - Drug Profile - Clinical Trial Data - Datamonitor Comments • Novogen's Phenoxodiol - Drug Profile - Clinical Trial Data - Datamonitor Comments • Forecasts • Datamonitor drug assessment summary - Clinical, developmental and commercial challenges to combining molecular targeted therapies • Case study two - Comparing marketed and pipeline MTTs: The evolving trends APPENDIX TABLES Table 1: Table 2: Table 3: PIPELINE EPIGENETIC MODULATORS ANALYSIS & FORECASTS • Pipeline overview • Merck's Zolinza (Vorinostat, SAHA) - Drug Profile - Clinical Trial Data - Datamonitor Comments • Gloucester Pharmaceuticals' Romidepsin (FK-228, depsipeptide) - Drug Profile - Clinical Trial Data - Datamonitor Comments • Forecasts • Datamonitor drug assessment summary PIPELINE IMMUNOMODULATORY AND IMMUNOCONJUGATED THERAPEUTICS ANALYSIS & FORECASTS • Pipeline overview • Wilex's Rencarex (WX-G250) - Drug Profile - Clinical Trial Data - Datamonitor Comments • Genmab's Ofatumumab (HuMax-CD20) - Drug Profile - Clinical Trial Data - Datamonitor Comments • Forecasts • Datamonitor drug assessment summary Table 4: Table 5: Table 6: Table 7: Table 8: Table 9: Table 10: Table 11: Table 12: Table 13: Table 14: Table 15: Table 16: Table 17: Table 18: Table 19: COMMERCIAL IMPACT & LIFECYCLE MANAGEMENT: CASE STUDIES • Introduction • Case study one Table 20: Table 21: Table 22: Molecular targeted therapies in preregistration, 2006 Molecular targeted therapies in Phase III development, 2006 Pipeline molecular targeted therapies by development phase and class of drug, 2006 Pipeline molecular targeted therapies by indication, 2006 Specific target/targets with two candidates in the pipeline, 2006 Specific target/targets with three or more candidates in the pipeline, 2006 Number of products in the pipeline targeting key molecular drivers of cancer, 2006 Companies with two candidates in the molecular targeted therapies pipeline, 2006 Companies with three candidates in the molecular targeted therapies pipeline, 2006 Companies with four or more candidates in the molecular targeted therapies pipeline, 2006 Pfizer's marketed oncology portfolio, 2006 Pfizer's molecular targeted cancer therapies portfolio, 2006 Novartis' marketed oncology portfolio, 2006 Novartis' molecular targeted cancer therapies portfolio, 2006 GSK's marketed oncology portfolio, 2006 GSK's molecular targeted cancer therapies portfolio, 2006 Late-phase pipeline targeted therapies sales forecasts for the seven major markets ($m), 2006-2015 Datamonitor drug assessment summary for late-phase pipeline molecular targeted cancer therapies, 2006 Common mutations involved in tumor development Forecast incidence of cancer across the seven major markets, 2005-2013 Examples of naturally occurring angiogenesis stimulators Recently approved multi-targeted inhibitors, 2006 Table 23: Current targeted therapy marketed products, 2006 (1 of 2) Table 24: Current targeted therapy marketed products, 2006 (1 of 2) Table 25: Targeted therapies sales in the seven major markets, 2005 Table 26: Clinical pipeline for Nexavar, 2006 Table 27: Clinical pipeline for Sprycel, 2006 Table 28: Summary of Phase II Sprycel clinical trial results Table 29: Clinical pipeline for Sutent, 2006 Table 30: Approved indications for Rituxan in the US and EU, 2006 Table 31: Late-phase pipeline angiogenesis inhibitors, 2006 Table 32: Phase II pipeline angiogenesis inhibitors, 2006 Table 33: Phase I pipeline angiogenesis inhibitors, 2006 Table 34: Ongoing clinical trials involving AZD2171, 2006 Table 35: Ongoing clinical trials involving pazopanib, 2006 Table 36: Ongoing clinical trials involving vatalanib, 2006 Table 37: Ongoing clinical trials involving VEGF-Trap, 2006 Table 38: Forecasting assumptions for late-phase angiogenesis inhibitors, 2006 Table 39: Angiogenesis inhibitors sales forecasts ($m), 2006-2015 Table 40: Research/clinical and commercial attractiveness of pipeline angiogenesis inhibitors, 2006 Table 41: Late-phase pipeline single-target signal transduction inhibitors, 2006 Table 42: Phase II pipeline single-target signal transduction inhibitors, 2006 Table 43: Phase I pipeline single-target signal transduction inhibitors, 2006 Table 44: Ongoing clinical trials involving Vectibix, 2006 Table 45: Ongoing clinical trials involving Sarasar, 2006 Table 46: Ongoing clinical trials involving Xinlay, 2006 Table 47: Historical development of Xinlay, 1994-2005 Table 48: Ongoing Phase II/III trials involving temsirolimus, 2006 Table 49: Ongoing clinical trials involving Zarnestra, 2006 Table 50: Phase I/II trial involving Nexavar, Tarceva, Temsirolimus and Zarnestra, 2006 Table 51: Forecasting assumptions for late-stage pipeline single-target signal transduction inhibitors (1 of 2) Table 52: Forecasting assumptions for late-stage pipeline single-target signal transduction inhibitors (2 of 2) Table 53: Single-target signal transduction inhibitors sales forecasts ($m), 2006-2015 Table 54: Research/clinical and commercial attractiveness of pipeline single-target signal transduction inhibitors (1 of 2) Table 55: Research/clinical and commercial attractiveness of pipeline single-target signal transduction inhibitors (2 of 2) Table 56: Late-phase pipeline multi-targeted inhibitors, 2006 Table 57: Phase II pipeline multi-targeted inhibitors, 2006 Table 58: Phase I pipeline multi-targeted inhibitors, 2006 Table 59: Ongoing breast cancer clinical trials involving Tykerb, 2006 Table 60: Ongoing non-breast cancer clinical trials involving Tykerb, 2006 Table 61: Summary of key Tykerb breast cancer clinical trials, 2006 Table 62: Ongoing clinical trials involving Ceflatonin, 2006 Table 63: Ongoing trials involving Somatuline, 2006 Table 64: Ongoing clinical trials involving Tasigna, 2006 Table 65: Zactima's multiple anticancer targets Table 66: Ongoing clinical trials involving Zactima Table 67: Ongoing clinical trials involving enzastaurin, 2006 Table 68: Ongoing clinical trials involving lestaurtinib Table 69: Forecasting assumptions for late-stage pipeline multi-targeted inhibitors (1 of 2) Table 70: Forecasting assumptions for late-stage pipeline multi-targeted inhibitors (2 of 2) Table 71: Multi-targeted inhibitors sales forecasts ($m), 2006-2015 Table 72: Research/clinical and commercial attractiveness of pipeline multi-targeted inhibitors (1 of 2) Table 73: Research/clinical and commercial attractiveness of pipeline multi-targeted inhibitors (2 of 2) Table 74: Late-phase pipeline cell cycle and apoptosis targeted agents, 2006 Table 75: Phase II pipeline cell cycle and apoptosis targeted agents, 2006 Table 76: Phase I pipeline cell cycle and apoptosis targeted agents, 2006 Table 77: Ongoing clinical trials involving Genasense, 2006 Table 78: Ongoing clinical trials involving Telcyta, 2006 Table 79: NSCLC clinical trial data summary for Telcyta, 2006 Table 80: Key Phase III trials of Telcyta for ovarian cancer, 2006 Table 81: Ongoing clinical trials involving TransMID, 2006 Table 82: Ongoing clinical trials involving alvocidib, 2006 Table 83: Ongoing clinical trials involving phenoxodiol, 2006 “...I don't know what to tell the pharmaceutical companies… There's got to be a strategy they can come up with so that their targeted drugs are better justified to payers...” US opinion leader, Pipeline/Commercial Insight: Molecular Targeted Cancer Therapies – More Drugs on the Market, More Targets in the Pipeline Pipeline/Commercial Insight: Molecular Targeted Cancer Therapies – More Drugs on the Market, More Targets in the Pipeline DMHC2224 Table 84: Forecasting assumptions for late-stage pipeline cell cycle and apoptosis targeted agents (1 of 2) Table 85: Forecasting assumptions for late-stage pipeline cell cycle and apoptosis targeted agents (2 of 2) Table 86: Cell cycle and apoptosis targeted agents sales forecasts ($m), 2006-2015 Table 87: Research/clinical and commercial attractiveness of pipeline cell cycle and apoptosis targeted agents Table 88: Late-phase pipeline epigenetic modulators, 2006 Table 89: Phase II pipeline epigenetic modulators, 2006 Table 90: Phase I pipeline epigenetic modulators, 2006 Table 91: Ongoing clinical trials involving Zolinza, 2006 Table 92: Ongoing clinical trials involving romidepsin, 2006 Table 93: Zolinza forecasting assumptions Table 94: Zolinza sales forecasts ($m), 2006-2015 Table 95: Research/clinical and commercial attractiveness of Zolinza Table 96: Late-phase pipeline immunomodulatory and immunoconjugated therapeutics, 2006 Table 97: Phase II pipeline immunomodulatory and immunoconjugated therapeutics, 2006 Table 98: Phase I pipeline immunomodulatory and immunoconjugated therapeutics, 2006 Table 99: Ongoing clinical trial involving Rencarex, 2006 Table 100: Ongoing clinical trial involving ofatumumab, 2006 Table 101: Forecasting assumptions for late-phase immunomodulatory and immunoconjugated therapeutics Table 102: Late-phase immunomodulatory and immunoconjugated therapeutics sales forecasts ($m), 2006-2015 Table 103: Research/clinical and commercial attractiveness of the late-phase immunomodulatory and immunoconjugated therapeutics Table 104: Phase I/II trial involving Nexavar, Tarceva, Temsirolimus and Zarnestra in GBM or gliosarcoma patients, 2006 Table 105: Examples of combinatorial approaches of MAbs with chemotherapy Table 106: Comparative characteristics of small molecules and MAbs Table 107: Single agents versus multiple agents in combination Table 108: Marketed molecular targeted cancer therapies, 2006 Table 109: Rituxan: key facts Table 110: Herceptin: key facts Table Table Table Table Table Table Table Table Table Table Table Table Table Table Table Table 111: 112: 113: 114: 115: 116: 117: 118: 119: 120: 121: 122: 123: 124: 125: 126: Table 127: Table 128: Table 129: Table 130: Table 131: Table 132: Table 133: Table 134: Table 135: Table 136: Table 137: Campath: key facts Mylotarg: key facts Bexxar: key facts Avastin: key facts Erbitux: key facts Zevalin: key facts Gleevec: key facts Targretin: key facts Iressa: key facts Velcade: key facts Tarceva: key facts Sprycel: key facts Nexavar: key facts Sutent: key facts Ontak: key facts Forecasts for marketed targeted therapies for the US ($m), 2005-2015 Forecasts for marketed targeted therapies for Japan ($m), 2005-2015 Forecasts for marketed targeted therapies for France ($m), 2005-2015 Forecasts for marketed targeted therapies for Germany ($m), 2005-15 Forecasts for marketed targeted therapies for Italy ($m), 2005-15 Forecasts for marketed targeted therapies for Spain ($m), 2005-15 Forecasts for marketed targeted therapies in the UK ($m), 2005-15 Forecasts for marketed targeted therapies for the EU5 ($m), 2005-2015 Forecasts for marketed targeted therapies for the seven major markets ($m), 2005-2015 Datamonitor drug assessment parameters Abbreviations used in Pipeline/Commercial Insight: Molecular Targeted Cancer Therapies (1 of 2) Abbreviations used in Pipeline/Commercial Insight: Molecular Targeted Cancer Therapies (2 of 2) FIGURES Figure 1: Pipeline molecular targeted therapies by development phase and class of drug, 2006 Figure 2: Pipeline molecular targeted therapies by class of drug, 2006 Figure 3: Pipeline molecular targeted therapies by development phase, 2006 Figure 4: Angiogenesis inhibitors by developmental phase, 2006 Figure 5: Single-target signal transduction inhibitors by developmental phase, 2006 Figure 6: Multi-targeted inhibitors by developmental phase, 2006 Figure 7: Cell cycle and apoptosis targeted agents by developmental phase, 2006 Figure 8: Epigenetic inhibitors by developmental phase, 2006 Figure 9: Immunomodulatory and immunoconjugated therapeutics by developmental phase, 2006 Figure 10: Pipeline molecular targeted therapies by solid tumor indication, 2006 Figure 11: Pipeline molecular targeted therapies by hematological malignancy, 2006 Figure 12: Number of products in the pipeline targeting key molecular drivers of cancer, 2006 Figure 13: Companies with four or more candidates in the molecular targeted therapies pipeline, 2006 Figure 14: Pipeline angiogenesis inhibitors sales forecasts for the seven major markets ($m), 2006-2015 Figure 15: Pipeline single-target signal transduction inhibitors sales forecasts for the seven major markets ($m), 2006-2015 Figure 16: Pipeline multi-targeted inhibitors sales forecasts for the seven major markets ($m), 2006-2015 Figure 17: Pipeline cell cycle and apoptosis targeted agents sales forecasts for the seven major markets ($m), 2006-2015 Figure 18: Pipeline epigenetic modulators sales forecasts for the seven major markets ($m), 2006-2015 Figure 19: Pipeline immunomodulatory and immunoconjugated therapeutics sales forecasts for the seven major markets ($m), 2006-2015 Figure 20: Datamonitor drug assessment summary for pipeline angiogenesis inhibitors, 2006 Figure 21: Datamonitor drug assessment summary for pipeline single-target signal transduction inhibitors, 2006 Figure 22: Datamonitor drug assessment summary for pipeline multi-targeted inhibitors, 2006 Figure 23: Datamonitor drug assessment summary for pipeline cell cycle and apoptosis targeted agents, 2006 Figure 24: Datamonitor drug assessment summary for epigenetic modulators, 2006 Figure 25: Datamonitor drug assessment summary for immunomodulatory and immunoconjugated therapeutics, 2006 Figure 26: Global oncology sales ($m), 2002-09 Figure 27: Oncology pipeline including supportive care, 2006 Figure 28: Forecast incidence of cancer across the seven major markets, 2005-2013 Figure 29: Combined incidence for breast, lung, prostate and colorectal cancer rises with age in seven major markets, 2003 Figure 30: Incidence increases, while the rate of cure and death reduces disease prevalence Figure 31: Point prevalence for colorectal and lung cancer differs markedly despite similar rates of incidence Figure 32: Unmet needs in cancer, 2006 Figure 33: The process of tumor angiogenesis Figure 34: Approaches to inhibition of VEGF signaling Figure 35: Angiogenesis inhibitors sales forecasts ($m), 2006-2015 Figure 36: Research/clinical and commercial attractiveness of pipeline angiogenesis inhibitors, 2006 Figure 37: Single-target signal transduction inhibitors sales forecasts ($m), 2006-2015 Figure 38: Research/clinical and commercial attractiveness of pipeline single-target signal transduction inhibitors, 2006 Figure 39: Design of Phase III Tykerb plus capecitabine versus capecitabine alone trial Figure 40: Multi-targeted inhibitors sales forecasts ($m), 2006-2015 Figure 41: Research/clinical and commercial attractiveness of pipeline multi-targeted inhibitors Figure 42: Telcyta's mechanism of action Figure 43: TransMID's mode of action Figure 44: Cell cycle and apoptosis targeted agents sales forecasts ($m), 2006-2015 Figure 45: Research/clinical and commercial attractiveness of pipeline cell cycle and apoptosis targeted agents Figure 46: Zolinza sales forecasts ($m), 2006-2015 Figure 47: Research/clinical and commercial attractiveness of Zolinza Figure 48: Rencarex induced ADCC Figure 49: Rencarex Phase II results: median survival Figure 50: Late-phase immunomodulatory and immunoconjugated therapeutics sales forecasts ($m), 2006-2015 Figure 51: Research/clinical and commercial attractiveness of the late-phase immunomodulatory and immunoconjugated therapeutics, 2006 Figure 52: Number of marketed MAbs and small molecules, 2006 Figure 53: Number of late-phase MAbs and small molecules, 2006 Figure 54: Number of marketed molecular targeted therapies for solid tumors and hematological malignancies, 2006 Figure 55: Number of late-phase molecular targeted therapies for solid tumors and hematological malignancies, 2006 Pipeline/Commercial Insight: Molecular Targeted Cancer Therapies – More Drugs on the Market, More Targets in the Pipeline DMHC2224 Figure 56: Number of molecular targeted therapies approved in the 'big four' tumor types, 2006 Figure 57: Number of late-phase molecular targeted therapies in the 'big four' tumor types, 2006 Figure 58: Marketed molecular targeted therapies by indication, 2006 Figure 59: Phase I, II and III molecular targeted therapies by indication, 2006 Figure 60: Approval paths of the marketed molecular targeted therapies Figure 61: Advantages and disadvantages of developing an MTT in one of the 'Big Four' tumor types Figure 62: Advantages and disadvantages of developing an MTT in a niche tumor type Figure 63: Example of Datamonitor drug assessment scorecard Figure 64: Example of Datamonitor drug assessment graph Datamonitor: Your total information solution Datamonitor is a premium business information company helping 5,000 of 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Datamonitor’s Oncology portfolio features detailed analysis of development pipelines, current and future market dynamics, patient potential, treatment patterns, and strategic issues, to highlight latest market trends and new commercial opportunities. - Hormonal Therapies - Innovative Therapies - Cytotoxic Therapies - Key tumor types: breast, colorectal, lung, ovarian, prostate, niche Also available in this portfolio Stakeholder Insight: Non Small Cell Lung Cancer Treatment and physician persectives on NSCLC Published: Sep-06 Product code: DMHC2223 Commercial Insight: Top 20 Cancer Therapeutics – New treatment paradigms transforming market outlook Analysis of the current and future potential of the cancer market in terms of the Top 20 leading therapeutics. Includes in-depth profiles and sales forecasts to 2015 across the seven major markets in light of key events to influence product revenues. 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