Acute Myeloid Leukemia Therapeutics Market to 2020

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1 Brochure More information from Acute Myeloid Leukemia Therapeutics Market to 2020 Description: Summary: Treatment and prognosis in AML is strongly influenced by a patient s age, and their cytogenetic profile. In the majority of cases these two prognostic influences are linked, with a higher frequency of unfavorable cytogenetic abnormalities observed in the elderly. Survival in this cohort of elderly patients is very poor, with a five year overall survival of 3 8% (Luger, 2010). Despite a relatively advanced understanding of genetic abnormalities associated with AML, the introduction of targeted therapies is lagging in this indication in comparison to other cancers such as breast and lung cancer, with no approved targeted therapies. Such slow development may be a reflection of AMLs status as an orphan indication. Intensive treatment in eligible patients (younger patients, and approximately 50% of diagnosed elderly patients) is typically the combination of the two chemotherapeutic agents cytarabine and daunorubicin, both of which were approved in the 1960s. In patients ineligible for intensive first-line chemotherapy, options are very poor, with the more recently approved Vidaza and Dacogen as the treatment options, which both offer unsatisfactory survival. Across all newly diagnosed patients that obtain complete remission, a stem cell transplant offers the highest chance of long-term survival. However, this procedure is risky, with a higher rate of treatment related mortality in the absence of better techniques to reduce the risk of graftversus-host disease. The majority of patients experience disease relapse, which is almost always fatal. Treatment options in these patients typically involve the off-label use of chemotherapeutic agents, whether in combination or as monotherapies. There are clear gaps in the market for therapies to meet several unmet needs by increasing the initial length of remission; improving treatment options for newly-diagnosed patients, ineligible for relapsed disease treatments; improving the success of and reducing the side effects of stem cell transplantation; and improving survival, safety and quality of life in patients with relapsed disease. The current developmental pipeline addresses these gaps in the market, along with the significant lack of targeted therapies. Five of the eight pipeline products are under development as non-intensive therapies for the elderly, and six of the eight products are being investigated in relapsed disease. Results so far have been mixed, with several drugs offering no overwhelming clinical benefit in Phase I and II clinical trials. Some drugs have demonstrated encouraging results namely CPX-351, quizartinib, StemEx, treosulfan and midostaurin. All of these drugs are forecast to be approved within the forecast period, a result of clinical trial data that suggest these drugs can offer improved survival in comparison to the currently marketed products. It is important to note however, that these improvements and the subsequent approval of these products is restricted to small patient cohorts including patients with secondary AML, those with internal tandem repeats in Fms-like tyrosine kinase, and patients eligible for a stem cell transplant, but for whom a matched donor cannot be found. This fragmentation in the treatment algorithm is a reflection of the heterogeneity of AML, with continued fractionation likely to be essential for further effective treatments to be developed. This is reflected in the current developmental pipeline, with drugs targeting a high variety of molecule types and molecular targets currently under investigation in this disease. The small patient cohorts the pipeline drugs are expected to be approved in will result in each having a minimal effect on any growth in market revenues over the forecast period. They will nevertheless stimulate market growth. An increase in prevalence and treatment populations, driven by aging populations across each territory will also have a positive effect on market revenues. However, as an orphan indication, the effect of population growth is also expected to have a minor effect. As a result, the global market revenues are forecast to rise at a limited CAGR of 4.8% from $632.4m in to $878.2m in Scope: The report analyzes treatment usage patterns, marketed and pipeline drugs, and market forecasts across indications for AML.The report covers and includes - - A brief introduction to AML, including the disease s pathogenesis, risk factors and diagnosis - An in-depth analysis of the drug combinations used in the treatment of AML, including analyses of their

2 safety, efficacy, and place in the disease treatment algorithm. This includes a heat map comparing the drug combinations in terms of safety and efficacy - A comprehensive review of the pipeline for AML therapies, including individual analysis of a number of latestage pipeline drugs that have the potential to enter the market during the forecast period. The pipeline is analyzed on the basis of Phase distribution, molecule types and molecular targets, as well as administration routes - An additional in-depth analysis of pipeline drug clinical trials by phase, trial size, trial duration and program failure rate analyses for each molecule type and molecular target - A multi-scenario forecast data for the market to 2020, taking into account how it will be affected by the introduction of new drugs, the expiry of key patents on current drugs and the changes in disease epidemiology across the key developed markets including the US, Canada, Japan, Germany, the UK, France, Italy and Spain - A discussion of the drivers and barriers for market growth - An in-depth analysis of licensing and co-development deals involving drugs indicated in AML, including an in-depth outline of the key deals Reasons to Purchase: The report will assist business development and enable marketing executives to strategize their product launches, by allowing them to - - Understand the efficacy and safety of the current monotherapies and drug combinations used in the treatment of AML, with in-depth analysis of the disease treatment algorithm - Understand the key signaling pathways and molecular targets currently under investigation in drug development for AML - Understand the vast scope of the pipeline, including which molecule types and molecular targets are most prominent - Observe the trends in clinical trial duration and size by clinical phase and molecule type, and use the clinical trial failure rate analysis to assess the risk profiles of current and/or future developmental programs for AML cancer therapeutics - Assess the potential clinical and commercial impact of current late-stage pipeline molecules in the AML therapeutics market - Assess the location of involved companies, and the value of both licensing and co-development deals involving drugs under investigation for the treatment of AML Contents: 1.1 List of Tables 1.2 List of Figures 2 Introduction 2.1 Disease Introduction 2.2 Epidemiology 2.3 Symptoms 2.4 Risk Factors Age Gender Smoking Chemotherapy or Radiation Therapy Benzene Previous Myelodysplastic Syndrome Chromosomal Disorders or Genetic Mutations 2.5 Diagnostic Techniques Blood Tests and Immunophenotyping Flow-Cytometry Cytogenetic Analysis Molecular Diagnostics 2.6 Pathophysiology 2.7 Diagnostic Criteria 2.8 Prognosis and Survival 3 Treatment Algorithm 3.1 Treatment of Acute Promyelocytic (M3) Leukemia is Effective, with High Cure Rates 3.2 Clinical Trial Response Criteria 3.3 Remission Induction Therapy

3 3.3.1 Intensive Remission Induction Therapy Non-intensive Remission Induction Therapy 3.4 Consolidation Therapy High- or Low-dose Cytarabine-based Therapy Stem Cell Transplantation 3.5 Remission Re-induction in Relapsed Disease Salvage Chemotherapy HSCT in Relapsed Disease 4 Commercial and Clinical Prospects of Marketed Products 4.1 Cytarabine 4.2 Daunorubicin 4.3 Idarubicin 4.4 Vidaza 4.5 Dacogen 4.6 Mitoxantrone 4.7 Etoposide 4.8 Fludarabine 4.9 Busulfan 4.10 Cyclophosphamide 4.11 Conclusion 5 Pipeline for Acute Myeloid Leukemia Therapeutics 5.1 Overview by Phase and Route of Administration 5.2 Overview by Molecule Type and Molecular Target 5.3 Key Molecular Targets in the Developmental Pipeline DNA Machinery Targets Targeted Therapies CD CD Wilm s Tumor Fms-Like Tyrosine Kinase 3 and its Downstream Pathway Components Discussion 5.4 Clinical Trials Clinical Trial Duration Clinical Trial Size Clinical Trial Failure Rates Discussion 5.5 Promising Drugs in AML Developmental Pipeline New Formulations Nucleoside analogues Stem Cell Therapy Conclusions 6 Market Forecasts 6.1 Global Treatment Usage Patterns Market Forecasts 6.2 North America US Canada 6.3 Top Five European Markets Epidemiology and Treatment Usage Patterns Annual Cost of Therapy Market Revenues 6.4 Japan Epidemiology and Treatment Usage Patterns Annual Cost of Therapy Market Forecast 7 Drivers and Barriers 7.1 Market Drivers High Level of Understanding of Genetic and Epigenetic Factors Underlying AML

4 7.1.2 High Number of Candidates in Drug Development Aging Population Orphan Designation High Degree of Clinical Trial Participation 7.2 Market Barriers Increasing Rates of Stem Cell Transplant High Heterogeneity of the Disease Lack of Standardized Treatment Market Heavily Dominated by Generics 8 Strategic Consolidations 8.1 Co-development Deals Ambit Biosciences Enters Co-development Agreement with Astellas Equity Financing of BioTheryX by Leukemia and Lymphoma Society Leukemia and Lymphoma Society Provide Funding for Celator s CPX Ascenta Therapeutics Enter Agreement with Leukemia and Lymphoma Society Stemline Therapeutics and MD Anderson Cancer Centre Enter Collaboration 8.2 Licensing Deals EpiCept Sells European Rights of Ceplene to Meda Biokine Therapeutics Out-License Development of BL-8040 to BioLineRx Tolero In-License alvocidib from Sanofi Bristol-Myers Squibb Enter Licensing Agreement with Innate Pharma for Lirilumab Cell Therapeutics Enters Licensing Agreement with Chroma Erytech Pharma Enters Licensing Agreement with Orphan Europe for Graspa 9 Appendix 9.1 All Pipeline Drugs by Phase Discovery Preclinical IND/CTA-Filed Phase I Phase II Phase III 9.2 Market Forecasts to Global The US Canada The UK France Germany Italy Spain Japan 9.3 References 9.4 Abbreviations 9.5 Research Methodology Secondary Research Marketed Product Profiles Late-Stage Pipeline Candidates Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products Product Competitiveness Framework Pipeline Analysis Forecasting Model Deals Data Analysis 9.6 Contact Us 9.7 Disclaimer 1.1 List of Tables Table 1: Acute Myeloid Leukemia Therapeutics, French-American-British Classification, Incidence (%) and Prognosis, Table 2: Acute Myeloid Leukemia Therapeutics, World Health Organization Classification, 2008 Table 3: Acute Myeloid Leukemia Therapeutics, Cytogenetic and Molecular Genetic Alterations and their Implications in Disease Prognosis

5 Table 4: Acute Myeloid Leukemia Therapeutics, Response Criteria (Remission or Treatment Failure) Table 5: Acute Myeloid Leukemia Therapeutics, Survival and Relapse Rates by Risk Category, Prognosis Table 6: Acute Myeloid Leukemia Therapeutics, Dosing Regimens of Conventional Care Regimes of Comparator Arm of One Phase III Clinical Trial of Vidaza, 2010 Table 7: Acute Myeloid Leukemia Therapeutics, Hazard Ratio for Allogeneic Stem Cell Transplants vs Chemotherapy and Autologous Stem Cell Transplant in Patients in First Remission, 2009 Table 8: Acute Myeloid Leukemia Therapeutics, Therapies Targeting CD123 in the Developmental Pipeline, Table 9: Acute Myeloid Leukemia Therapeutics, Therapies Targeting CD33 in the Developmental Pipeline, Table 10: Acute Myeloid Leukemia Therapeutics, Therapies Targeting Wilm s Tumor 1 in Developmental Pipeline, Table 11: Acute Myeloid Leukemia Therapeutics, Upstream and Downstream Pathway Components of FLT3, Table 12: Acute Myeloid Leukemia Therapeutics, Therapies Targeting FLT3 in Developmental Pipeline, Table 13: AML Therapeutics, Combination Therapies* in Current Developmental Pipeline Table 14: Acute Myeloid Leukemia Therapeutics, Dosing Schedules in One Phase II Trial of Qinprezo, 2010 Table 15: Acute Myeloid Leukemia Therapeutics, Results of a Phase II Clinical Trial of Midostaurin, 2009 Table 16: Acute Myeloid Leukemia Therapeutics, Therapies Targeting CD123 in the Developmental Pipeline, Table 17: Acute Myeloid Leukemia Therapeutics, Top Five European Markets, Annual Cost of Therapy, ($), 2020 Table 18: Market for AML, Global, Developmental Pipeline, Discovery, Table 19: Market for AML, Global, Developmental Pipeline, Preclinical, Table 20: Market for AML, Global, Developmental Pipeline, IND/CTA-Filed, Table 21: Market for AML, Global, Developmental Pipeline, Phase I, Table 22: Market for AML, Global, Developmental Pipeline, Phase II, Table 23: Market for AML, Global, Developmental Pipeline, Phase III, Table 24: Acute Myeloid Leukemia Market, Global, Market Forecasts, 2020 Table 25: Acute Myeloid Leukemia Market, US, Market Forecasts, 2020 Table 26: Acute Myeloid Leukemia Market, Canada, Market Forecasts, 2020 Table 27: Acute Myeloid Leukemia Market, UK, Market Forecasts, 2020 Table 28: Acute Myeloid Leukemia Market, France, Market Forecasts, 2020 Table 29: Acute Myeloid Leukemia Market, Germany, Market Forecasts, 2020 Table 30: Acute Myeloid Leukemia Market, Italy, Market Forecasts, 2020 Table 31: Acute Myeloid Leukemia Market, Spain, Market Forecasts, 2020 Table 32: Acute Myeloid Leukemia Market, Japan, Market Forecasts, List of Figures Figure 1: Acute Myeloid Leukemia Therapeutics, Efficacy Results for Key Parameters Marketed Products, Intensive Remission Induction Therapy Figure 2: Acute Myeloid Leukemia Therapeutics, Efficacy Results for Key Parameters Marketed Products, Non-Intensive Remission Induction Therapy Figure 3: Acute Myeloid Leukemia Therapeutics, Efficacy Results for Key Parameters Marketed Products, Salvage Therapy in Relapsed Disease Figure 4: Acute Myeloid Leukemia Therapeutics, Treatment Algorithm Figure 5: Acute Myeloid Leukemia Therapeutics, Global, Pipeline Distribution by Stage, Program Type and Route of Administration, Figure 6: Acute Myeloid Leukemia Therapeutics, Global, Pipeline by Molecule Type and Molecular Target, Figure 7: Acute Myeloid Leukemia Therapeutics, Global, Molecular Targets of Developmental Pipeline, Figure 8: Acute Myeloid Leukemia Therapeutics, Global, Clinical Trial Duration (Months), 2006 Figure 9: AML Therapeutics, Global, Clinical Trial Size (Participants), 2006 Figure 10: AML Therapeutics, Global, Clinical Trial Failure Rate and Reasons for Failure, 2006 Figure 11: Acute Myeloid Leukemia Therapeutics, Clinical Trial Heat Map Figure 12: Acute Myeloid Leukemia Therapeutics, Global, Forecast Revenues of CPX-351 ($m), Figure 13: Acute Myeloid Leukemia Therapeutics, Global, Forecast Revenues of Midostaurin ($m), Figure 14: Acute Myeloid Leukemia Therapeutics, Global, Forecast Revenues of Quizartinib ($m), Figure 15: Acute Myeloid Leukemia Therapeutics, Global, Forecast Revenues of StemEx ($m), Figure 16: Acute Myeloid Leukemia Therapeutics, Efficacy Results for Key Parameters Pipeline (Blue) and Marketed Products Comparison. Intensive Remission Induction Figure 17: Acute Myeloid Leukemia Therapeutics, Efficacy Results for Key Parameters Pipeline (Blue) and Marketed Products Comparison. Non-Intensive Remission Induction

6 Figure 18: Acute Myeloid Leukemia Therapeutics, Efficacy Results for Key Parameters Pipeline (Blue) and Marketed Products Comparison. Salvage Therapy for Relapsed Disease Figure 19: Acute Myeloid Leukemia Therapeutics, Global, Treatment Usage Patterns ( 000) and Market Revenues ($m), 2020 Figure 20: Acute Myeloid Leukemia Therapeutics, US, Treatment Usage Patterns ( 000) and Annual Cost of Therapy ($), 2020 Figure 21: Acute Myeloid Leukemia Therapeutics, US, Market Revenues ($m), 2020 Figure 22: Acute Myeloid Leukemia Therapeutics, Canada, Treatment Usage Patterns and ACoT ( 000; $), 2020 Figure 23: Acute Myeloid Leukemia Therapeutics, Canada, Market Revenues ($m), 2020 Figure 24: Acute Myeloid Leukemia Therapeutics, Top Five European Markets, Treatment Usage Patterns ( 000), 2020 Figure 25: Acute Myeloid Leukemia Therapeutics, Top Five European Markets, Annual Cost of Therapy ($), 2020 Figure 26: Acute Myeloid Leukemia Therapeutics,Top Five European Markets, Market Revenues ($m), 2020 Figure 27: Acute Myeloid Leukemia Therapeutics, Japan, Treatment Usage Patterns and Annual Cost of Therapy ( 000; $), 2020 Figure 28: Acute Myeloid Leukemia Therapeutics, Japan, Market Revenues ($m), 2020 Figure 29: Acute Myeloid Leukemia Therapeutics, Global, Co-development Deals, 2006 Figure 30: Acute Myeloid Leukemia Therapeutics, Global, Co-development Deals (Molecule Type and Mechanism of Action), 2006 Figure 31: Acute Myeloid Leukemia Therapeutics, Global, Licensing Deals by Region, 2006 Figure 32: Acute Myeloid Leukemia Therapeutics, Global, Licensing Deals by Value and Year, 2006 Figure 33: Acute Myeloid Leukemia Therapeutics, Global, Licensing Deals by Molecule Type and Mechanism of Action, Ordering: Order Online - Order by Fax - using the form below Order by Post - print the order form below and send to Research and Markets, Guinness Centre, Taylors Lane, Dublin 8, Ireland.

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