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Pipeline Insight: Leukemias Underserved patient populations offer potential for market growth

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IntroductionDespite major advances in treatment in the last decade, a considerable percentage of the leukemia population still has high unmet needs. Some key oncology companies have entered the ...

IntroductionDespite major advances in treatment in the last decade, a considerable percentage of the leukemia population still has high unmet needs. Some key oncology companies have entered the leukemias market fairly recently while others are pursuing late-phase development in this indication, hoping to exploit the commercial potential of patient subgroups underserved by existing treatment options.Scope*Forecast sales of the drugs in late-phase development for leukemia in the seven major markets over the period 2010 to 2019*In-depth analysis for all leukemia drugs in late-phase development, including trial data, SWOT analysis and clinical and commercial potential*Segmentation and analysis of the leukemia pipeline by developmental phase, class and indication*Insight and analysis of leukemia market potential including epidemiology, patient segmentation, unmet needs and target product profilesHighlightsDespite high cure rates in some forms of leukemia, certain groups of patients still have high unmet needs. Drug developers are targeting increasingly defined subsets of patients with high unmet need in order to establish a market for their products. Examples include elderly patients and patients with certain genetic characteristics.Chronic lymphocytic leukemia (CLL) offers the greatest potential. Datamonitor forecasts the three drugs in late-phase development to achieve total sales of $938m in 2019. This stems from the large size of the target patient populations and a lack of effective treatment options in these patient subgroups, which will drive high market penetration.A number of late-phase drugs will have a notable impact on the leukemia market as they go some way towards addressing some of the remaining unmet needs. These agents include Revlimid (lenalidomide; Celgene), RG7159 (obinutuzumab; Glycart/Roche/Genentech/Biogen Idec/Chugai) and bosutinib (PF-5208763; Pfizer).Reasons to Purchase*Justify go/no-go decisions on the basis of potential return on investment*Identifying licensing opportunities based on company portfolio and market needs*Use product profiles to aid pricing and reimbursement decisions

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    Pipeline Insight: Leukemias  Underserved patient populations offer potential for market growth Pipeline Insight: Leukemias Underserved patient populations offer potential for market growth Document Transcript

    • Find Industry reports, Company profilesReportLinker and Market Statistics >> Get this Report Now by email!Pipeline Insight: Leukemias Underserved patient populations offerpotential for market growthPublished on March 2010 Report SummaryIntroductionDespite major advances in treatment in the last decade, a considerable percentage of the leukemia population still has high unmetneeds. Some key oncology companies have entered the leukemias market fairly recently while others are pursuing late-phasedevelopment in this indication, hoping to exploit the commercial potential of patient subgroups underserved by existing treatmentoptions.Scope*Forecast sales of the drugs in late-phase development for leukemia in the seven major markets over the period 2010 to 2019*In-depth analysis for all leukemia drugs in late-phase development, including trial data, SWOT analysis and clinical and commercialpotential*Segmentation and analysis of the leukemia pipeline by developmental phase, class and indication*Insight and analysis of leukemia market potential including epidemiology, patient segmentation, unmet needs and target productprofilesHighlightsDespite high cure rates in some forms of leukemia, certain groups of patients still have high unmet needs. Drug developers aretargeting increasingly defined subsets of patients with high unmet need in order to establish a market for their products. Examplesinclude elderly patients and patients with certain genetic characteristics.Chronic lymphocytic leukemia (CLL) offers the greatest potential. Datamonitor forecasts the three drugs in late-phase development toachieve total sales of $938m in 2019. This stems from the large size of the target patient populations and a lack of effective treatmentoptions in these patient subgroups, which will drive high market penetration.A number of late-phase drugs will have a notable impact on the leukemia market as they go some way towards addressing some ofthe remaining unmet needs. These agents include Revlimid (lenalidomide; Celgene), RG7159 (obinutuzumab;Glycart/Roche/Genentech/Biogen Idec/Chugai) and bosutinib (PF-5208763; Pfizer).Reasons to Purchase*Justify go/no-go decisions on the basis of potential return on investment*Identifying licensing opportunities based on company portfolio and market needsPipeline Insight: Leukemias Underserved patient populations offer potential for market growth Page 1/15
    • Find Industry reports, Company profilesReportLinker and Market Statistics*Use product profiles to aid pricing and reimbursement decisions Table of ContentOverview 1Catalyst 1Summary 1ABOUT DATAMONITOR HEALTHCARE 2About the Oncology pharmaceutical analysis team 2Executive Summary 3Strategic scoping and focus 3Datamonitor insight into the disease market 3Contributing experts 5Related reports 5Upcoming related reports 5TABLE OF CONTENTS 61. Pipeline Overview and Dynamics 7Key findings 7Pipeline overview 8Pipeline summary 8Acute myeloid leukemia is the form of leukemia most targeted by drug developers 9Targeted therapies account for over half of leukemia drugs in clinical development 11Comparative forecasts 12Drugs in late-phase development for leukemias will achieve combined sales of $1.9 billion by 2019 12Key companies involved in the leukemias pipeline 14Novartis 14Roche 15Key R&D company strategies 16Drug developers are targeting increasingly defined subsets of patients 162. R&D Approach 17Key findings 17Clinical trial design in leukemia 17Patient selection 17Increasingly significant in the era of targeted treatment 17Clinical trial duration 18Sufficient follow-up is necessary to establish true clinical benefit 18The advent of novel therapies 18Diversity of targeted therapies will require an evolution in clinical trial design 18Clinical trial endpoints in leukemia 18Most oncology clinical trials designate multiple endpoints 18Survival 19Quality of life 19Response rates 19Toxicity 19Time to progression 193. Acute lymphoblastic leukemia 21Key findings 21Pipeline Insight: Leukemias Underserved patient populations offer potential for market growth Page 2/15
    • Find Industry reports, Company profilesReportLinker and Market StatisticsDisease overview - market potential 22Definition of acute lymphoblastic leukemia (ALL) 22ALL is a group of disorders that result from aberrant proliferation and differentiation of lymphoblasts 22Genetic alterations provide insight into the pathogenesis of ALL 22Non-specific syndromes are common in ALL 23Patient segmentation 23The classification of ALL is still evolving 23Patients are stratified according to risk 24Response to therapy: minimal residual disease is a critical prognostic factor 25Epidemiology 25Incidence of ALL will reach over 11,000 in the seven major markets by 2019 25Current treatment options 27Remission-induction 31Consolidation treatment 32Maintenance treatment 32Current comparator therapies 33Unmet need in ALL 33More effective therapies are required for adult ALL, particularly for relapse 33Philadelphia chromosome-positive patients remain a patient subset with high unmet need despite new therapies 34More research is needed for elderly ALL patients 34Prognostic markers are required for risk-adapted therapeutic strategies 35Target product profiles versus current level of attainment 35Induction therapy 35Relapse therapy 36Pipeline analysis and forecasts 38Pipeline summary 38Comparative forecasts 40Graspa (erythrocyte-encapsulated L-asparaginase; ERYtech) 42Drug overview 42Drug profile 42Key historical events 43Clinical trial data 43Phase II data suggest that Graspa is better tolerated than native L-asparaginase, while inducing similar asparagine depletion 44SWOT analysis 45Clinical and commercial attractiveness 45Limited evidence of clinical efficacy makes it difficult to comment on Graspas clinical potential 45A favorable toxicity profile alone may not be sufficient for Graspa to capture significant market share 45Forecasts to 2019 46Marqibo (liposomal vincristine; Hana Biosciences) 47Drug overview 47Drug profile 47Key historical events 48Clinical trial data 49Marqibo shows promising evidence of efficacy in heavily pretreated ALL 50SWOT analysis 52Datamonitors drug assessment summary for Marqibo 53Clinical and commercial attractiveness 53Marqibo will only partially address the need for more effective salvage regimens in ALL 53Data from a small single-arm study may be insufficient to support approval and drive uptake of Marqibo 54Forecasts to 2019 54Pipeline Insight: Leukemias Underserved patient populations offer potential for market growth Page 3/15
    • Find Industry reports, Company profilesReportLinker and Market StatisticsRituxan/MabThera (rituximab; Biogen Idec/Roche/Genentech/Zenyaku Kogyo/Chugai) 55Drug overview 55Drug profile 56Key historical events 57Clinical trial data 58Rituxan/MabThera plus HyperCVAD shows promising evidence of efficacy in younger patients with CD20-positive ALL 58Rituxan/MabThera plus HyperCVAD also shows promising efficacy in Burkitt-type ALL, particularly in elderly patients 59SWOT analysis 61Datamonitor drug assessment summary for Rituxan 62Clinical and commercial attractiveness 62Phase II data point to Rituxan/MabTheras promising potential in ALL, but provoke several questions 62The use of Rituxan/MabThera in ALL may remain off-label for the foreseeable future 63Forecasts to 2019 644. Acute myeloid leukemia 65Key findings 65Disease overview - market potential 66Definition of acute myeloid leukemia (AML) 66AML is a disease of older age 66Symptoms can vary for AML patients 66Patient segmentation 66Two classification systems are used in AML 66Cytogenetics is the most important prognostic factor 67Age is a major determinant of survival 68Secondary AML patients have particularly poor prognosis 69Epidemiology 69Incidence of AML will reach over 31,000 in the seven major markets by 2019, driven by population aging 69Current treatment options 71Induction treatment 73Post-induction treatment 73Consolidation treatment 74Relapse treatment 74Current comparator therapies 74Unmet need in AML 75More effective and tolerable therapies are required for AML, particularly in older patients 75HSCT remains an underutilized procedure 76Molecular markers may help improve risk-adapted therapeutic strategies 76Target product profiles versus current level of attainment 76Induction therapy 77Consolidation therapy 77Relapse therapy 78Pipeline analysis and forecasts 80Pipeline summary 80Comparative forecasts 81AS1413 (amonafide; Antisoma) 85Drug overview 85Drug profile 85Key historical events 86Clinical trial data 87Antisoma has amended the primary endpoint in AS1413s pivotal Phase III study 87Phase II study shows encouraging evidence of activity in secondary AML 88Pipeline Insight: Leukemias Underserved patient populations offer potential for market growth Page 4/15
    • Find Industry reports, Company profilesReportLinker and Market StatisticsSWOT analysis 89Datamonitor drug assessment summary for AS1413 90Clinical and commercial attractiveness 90AS1413 has the potential to address unmet need in a difficult-to-treat patient population 90AS1413s potential in the wider AML population is uncertain 91Forecasts to 2019 91Clolar/Evoltra (clofarabine; Genzyme) 92Drug overview 92Drug profile 93Key historical events 94Clinical trial data 95Phase II data in newly diagnosed elderly AML insufficient to support label extension for Clolar 97Phase II data show potential of Clolar in combination with low-dose cytarabine 98SWOT analysis 99Datamonitor drug assessment summary for Clolar/Evoltra 100Clinical and commercial attractiveness 100Clolars unsuccessful bid for accelerated approval in AML is a double blow to Genzyme 100Clolar could receive off-label use in the absence of label expansion 101Forecasts to 2019 102Dacogen (decitabine; Eisai) 103Drug overview 103Drug profile 104Key historical events 105Clinical trial data 106Dacogen has shown promising evidence of efficacy in previously untreated elderly AML patients 107SWOT analysis 109Datamonitor drug assessment summary for Dacogen 110Clinical and commercial attractiveness 110Dacogens low toxicity could be a major driver of uptake 110Vidaza will be Dacogens principal competitor in the AML market 111Forecasts to 2019 112Midostaurin (PKC412; Novartis) 113Drug overview 113Drug profile 113Key historical events 114Clinical trial data 115Midostaurin shows promising evidence of efficacy in AML patients with wild-type and mutant Flt-3 116SWOT analysis 117Datamonitor drug assessment summary for midostaurin 118Clinical and commercial attractiveness 118Targeting younger AML patients offers lower commercial potential for midostaurin 118Novartiss capabilities in niche hematological indications will boost midostaurins commercial potential 119Forecasts to 2019 120PR1 peptide antigen vaccine (The Vaccine Company) 121Drug overview 121Drug profile 122Key historical events 122Clinical trial data 123PR1 peptide antigen induced immune and clinical responses in patients with myeloid hematological malignancies in Phase I/II trial124Pipeline Insight: Leukemias Underserved patient populations offer potential for market growth Page 5/15
    • Find Industry reports, Company profilesReportLinker and Market StatisticsSWOT analysis 125Datamonitor drug assessment summary for PR1 peptide antigen 126Clinical and commercial attractiveness 126PR1 peptide antigen could fulfill the unmet need for more tolerable treatment options in elderly AML patients 126As a therapeutic vaccine, PR-1 peptide antigen will face particular barriers to successful commercialization 127Forecasts to 2019 1275. Chronic lymphocytic leukemia 128Key findings 128Disease overview - market potential 129Definition of chronic lymphocytic leukemia (CLL) 129CLL is an incurable disease characterized by an accumulation of mature B-lymphocytes 129The definition of CLL has recently changed 130The etiology of CLL is poorly understood 130Patient segmentation 131Rai and Binet staging systems are used to stage CLL 131Molecular markers are used to identify high-risk patients 132Epidemiology 133CLL will remain the most commonly diagnosed leukemia in the seven major markets through to 2019 133Current treatment options 136Physicians commonly initiate first-line treatment after a period of observation 137First-line treatment 138Second- and third-line treatment 138Current comparator therapy 138Rituxan/MabThera (rituximab; Biogen Idec/Genentech/Roche/Chugai/Zenyaku Kogyo) 138Unmet need in CLL 140More effective therapies are needed for relapsed and refractory CLL 140CLL still lacks curative treatment options for the majority of patients 141More tolerable treatment options are needed for elderly patients 141Target product profiles versus current level of attainment 142First-line therapy 142Second-line therapy 143Pipeline analysis and forecasts 144Pipeline summary 144Comparative forecasts 145Alvocidib (flavopiridol; Sanofi-Aventis) 148Drug overview 148Drug profile 148Key historical events 149Clinical trial data 150Optimization of alvocidibs dosing schedule has reawakened interest in the drug 150Single-agent alvocidib induces responses in heavily pretreated CLL patients with unfavorable cytogenetics 150Alvocidib has also shown promise in early stages studies in combination with fludarabine and Rituxan 152SWOT analysis 153Datamonitor drug assessment summary for alvocidib 154Clinical and commercial attractiveness 154Alvocidib has shown encouraging signs of activity in difficult-to-treat patients 154Sanofi-Aventis will have to overturn negative perceptions of alvocidibs clinical development in CLL 155Arzerra could prove to be a major competitor for alvocidib, given its more favorable toxicity profile 155Forecasts to 2019 156Revlimid (lenalidomide; Celgene) 157Pipeline Insight: Leukemias Underserved patient populations offer potential for market growth Page 6/15
    • Find Industry reports, Company profilesReportLinker and Market StatisticsDrug overview 157Drug profile 158Key historical events 159Clinical trial data 160Celgene has initiated an extensive clinical development program for Revlimid in CLL 160Low dose single-agent Revlimid shows promising activity and tolerability in heavily pretreated CLL 161Early Phase II data show that single-agent Revlimid has favorable toxicity profile in previously untreated elderly CLL 162Revlimid may be more effective when combined with Rituxan 163SWOT analysis 164Datamonitor drug assessment summary for Revlimid 165Clinical and commercial attractiveness 165Revlimid has the potential to fill a niche in the CLL market 165Revlimids favorable toxicity profile could be an important attribute in the maintenance setting 166Potential for long-term use could boost Revlimids commercial potential in CLL 167Forecasts to 2019 168RG7159 (obinutuzumab; Glycart/Roche/Genentech/Biogen Idec/Chugai) 169Drug overview 169Drug profile 170Key historical events 171Clinical trial data 172There is currently minimal reported evidence of RG7159s clinical efficacy 172SWOT analysis 173Datamonitor drug assessment summary for RG7159 174Clinical and commercial attractiveness 174Roche has avoided the risk of cannibalizing Rituxans market share in CLL 174The design of RG7159s pivotal trial is high-risk, but necessary in order to drive notable uptake 175Forecasts to 2019 1766. Chronic myeloid leukemia 177Key findings 177Disease overview - market potential 178Definition of chronic myeloid leukemia (CML) 178CML is characterized by a single genetic aberration 178CML patients are commonly asymptomatic at presentation 178CML has an unknown etiology 178Patient segmentation 179CML has a triphasic or biphasic disease course 179Epidemiology 181Annual CML incidence will rise to nearly 13,000 in the seven major markets by 2019 181Improving treatment outcomes will drive significant increases in the prevalence of CML 183The market potential for newly-diagnosed CML will grow markedly between 2010 and 2019 186Current treatment options 187Small molecule Bcr-Abl tyrosine kinase inhibitors dominate the treatment of CML 187Treatment of newly-diagnosed CML 188Gleevec-refractory CML 188Current comparator therapy 188Gleevec/Glivec (imatinib; Novartis) 188Unmet need in CML 190Resistance to Bcr-Abl tyrosine kinase inhibitors is an area of high unmet need 190Blast crisis lacks effective treatment options but is not a commercially attractive indication 192Despite good treatment outcomes for the majority of chronic phase patients, there is room for improvement 192Pipeline Insight: Leukemias Underserved patient populations offer potential for market growth Page 7/15
    • Find Industry reports, Company profilesReportLinker and Market StatisticsTarget product profiles versus current level of attainment 192Newly diagnosed CML 192Gleevec refractory/intolerant CML 193Pipeline analysis and forecasts 195Pipeline summary 195Comparative forecasts 197Bosutinib (PF-5208763; Pfizer) 199Drug overview 199Drug profile 200Key historical events 201Clinical trial data 201Bosutinib has shown promising activity and a favorable toxicity profile in Gleevec-resistant/intolerant CML 202SWOT analysis 204Datamonitor drug assessment summary for bosutinib 205Clinical and commercial attractiveness 205Bosutinib could struggle to penetrate a crowded first-line market ... 205...although its promising safety profile could allow Pfizer to position it effectively in the CML market 206Forecasts to 2019 207Omapro (omacetaxine mepesuccinate; ChemGenex/Hospira) 209Drug overview 209Drug profile 210Key historical events 211Clinical trial data 212Omapro shows promising activity in Gleevec-resistant patients with the T315I mutation but ODAC vote could delay approval 213Omapro also shows activity in patients refractory/intolerant to at least two tyrosine kinase inhibitors 214SWOT analysis 215Datamonitor drug assessment summary for Omapro 216Clinical and commercial attractiveness 216Omapro may address one of the largest remaining areas of unmet in CML in the Gleevec era 216Prospects of approval remain uncertain for Omapro 217Advances in first-line therapy could threaten Omapros commercial potential 217Forecasts to 2019 218Bibliography 219Journals 219Websites 229Datamonitor reports 232Other 232APPENDIX 233Methodology 233Datamonitor forecast methodology 233Epidemiology forecasts 233Product forecasts 233Datamonitor drug assessment scorecard 234Contributing experts 235About Datamonitor 235About Datamonitor Healthcare 235About the Disease analysis team 236Datamonitor consulting 236Disclaimer 238List of TablesPipeline Insight: Leukemias Underserved patient populations offer potential for market growth Page 8/15
    • Find Industry reports, Company profilesReportLinker and Market StatisticsTable 1: Drugs in late-phase clinical development for leukemia in the seven major pharmaceutical markets, 2010 9Table 2: Sales forecasts for drugs in late-phase clinical development for leukemia across the seven major markets, 2010-19 ($m) 12Table 3: Novartiss portfolio of marketed and pipeline leukemia drugs, 2010 14Table 4: Roches portfolio or marketed and pipeline leukemia drugs, 2010 15Table 5: The French-American-British system for the classification of acute lymphoblastic leukemia (ALL) 23Table 6: Crude incidence rates of acute lymphoblastic leukemia (ALL) per 100,000 population in the seven major pharmaceuticalmarkets, 2002 26Table 7: Forecast incidence of acute lymphoblastic leukemia (ALL) in the seven major pharmaceutical markets, 2002-2019 26Table 8: Leading agents for acute lymphocytic leukemia (ALL), 2010 29Table 9: Minimum acceptable product profile (MAPP) and target product profile (TPP) for first-line treatment of adult acutelymphoblastic leukemia (ALL), 2010 36Table 10: Minimum acceptable product profile (MAPP) and target product profile (TPP) for the treatment of relapsed adult acutelymphoblastic leukemia (ALL), 2010 37Table 11: Drugs in late-phase clinical development for acute lymphoblastic leukemia (ALL), 2010 38Table 12: Forecast assumptions for drugs in late-phase clinical development for acute lymphoblastic leukemia (ALL) across the sevenmajor markets, 2010 40Table 13: Sales forecasts for drugs in late-phase clinical development for acute lymphoblastic leukemia across the seven majormarkets, 2010-19 ($m) 41Table 14: Graspa - drug profile, 2010 42Table 15: Graspa: key historical events, 2004-2010 43Table 16: Clinical development of Graspa in acute lymphoblastic leukemia (ALL), 2010 43Table 17: Marqibo - drug profile, 2010 47Table 18: Marqibo: key historical events, 2000-2010 48Table 19: Clinical development of Marqibo in acute lymphoblastic leukemia (ALL), 2010 49Table 20: Sales forecast for Marqibo in acute lymphoblastic leukemia (ALL) across the seven major markets, 2010-19 ($m) 54Table 21: Rituxan/MabThera - drug profile, 2010 56Table 22: Rituxan/MabThera: key historical events, 1997-2010 57Table 23: Clinical development of Rituxan/MabThera in acute lymphoblastic leukemia (ALL), 2010 58Table 24: Sales forecast for Rituxan in acute lymphoblastic leukemia (ALL) across the seven major markets, 2010-19 ($m) 64Table 25: French-American-British classification of acute myeloid leukemia (AML) 67Table 26: Crude incidence rates of acute myeloid leukemia (AML) per 100,000 population in the seven major pharmaceutical markets,2002 69Table 27: Forecast incidence of acute myeloid leukemia (AML) in the seven major pharmaceutical markets, 2002-2019 70Table 28: Leading agents for acute myeloid leukemia (AML), 2010 72Table 29: Minimum acceptable product profile (MAPP) and target product profile (TPP) for first-line treatment of adult acute myeloidleukemia (AML), 2010 77Table 30: Minimum acceptable product profile (MAPP) and target product profile (TPP) for consolidation treatment of adult acutemyeloid leukemia (AML) in first remission, 2010 78Table 31: Minimum acceptable product profile (MAPP) and target product profile (TPP) for first-line treatment of adult acute myeloidleukemia (AML), 2010 79Table 32: Drugs in late-phase clinical development for acute myeloid leukemia (AML), 2010 80Table 33: Forecast assumptions for drugs in late-phase clinical development for acute myeloid leukemia (AML) across the sevenmajor markets, 2010 (1 of 2) 82Table 34: Forecast assumptions for drugs in late-phase clinical development for acute myeloid leukemia (AML) across the sevenmajor markets, 2010 (2 of 2) 83Table 35: Sales forecasts for drugs in late-phase clinical development for acute myeloid leukemia across the seven major markets,2010-19 ($m) 84Table 36: AS1413 - drug profile, 2010 85Table 37: AS1413: key historical events, 2003-2010 86Table 38: Clinical development of AS1413 in acute myeloid leukemia, 2010 87Pipeline Insight: Leukemias Underserved patient populations offer potential for market growth Page 9/15
    • Find Industry reports, Company profilesReportLinker and Market StatisticsTable 39: Sales forecast for AS1413 in acute myeloid leukemia (AML) across the seven major markets, 2010-19 ($m) 91Table 40: Clolar/Evoltra - drug profile, 2010 93Table 41: Clolar/Evoltra: key historical events, 1998-2010 94Table 42: Clinical development of Clolar/Evoltra in acute myeloid leukemia (AML), 2010 95Table 43: Sales forecast for Clolar/Evoltra in acute myeloid leukemia across the seven major markets, 2010-19 ($m) 102Table 44: Dacogen - drug profile, 2010 104Table 45: Dacogen: key historical events, 1999-2010 105Table 46: Clinical development of Dacogen in acute myeloid leukemia (AML), 2010 106Table 47: Sales forecast for Dacogen in acute myeloid leukemia (AML) across the seven major markets, 2010-19 ($m) 112Table 48: Midostaurin - drug profile, 2010 113Table 49: Midostaurin: key historical events, 2002-2010 114Table 50: Clinical development of midostaurin in acute myeloid leukemia (AML), 2010 115Table 51: Sales forecast for midostaurin in acute myeloid leukemia (AML) across the seven major markets, 2010-19 ($m) 120Table 52: PR1 peptide antigen - drug profile, 2010 122Table 53: PR1 peptide antigen: key historical events, 1999-2010 122Table 54: Clinical development of PR1 peptide antigen, 2010 123Table 55: Sales forecast for PR1 peptide antigen vaccine in acute myeloid leukemia (AML) across the seven major markets, 2010-19($m) 127Table 56: The Rai staging system for chronic lymphocytic leukemia (CLL) 131Table 57: The Binet staging system for chronic lymphocytic leukemia (CLL) 131Table 58: Crude incidence rates of chronic lymphocytic leukemia (CLL) per 100,000 population in the seven major pharmaceuticalmarkets, 2002 133Table 59: Forecast incidence of chronic lymphocytic leukemia (CLL) in the seven major pharmaceutical markets, 2002-2019 134Table 60: Leading agents for chronic lymphocytic leukemia (CLL), 2010 136Table 61: Rituxan/MabThera (rituximab) - drug profile, 2010 139Table 62: Minimum acceptable product profile (MAPP) and target product profile (TPP) for first-line treatment of chronic lymphocyticleukemia (CLL), 2010 142Table 63: Minimum acceptable product profile (MAPP) and target product profile (TPP) for second-line treatment of chroniclymphocytic leukemia (CLL), 2010 143Table 64: Drugs in late-phase clinical development for chronic lymphocytic leukemia (CLL), 2010 144Table 65: Forecast assumptions for drugs in late-phase clinical development for chronic lymphocytic leukemia (CLL) across the sevenmajor markets, 2010 146Table 66: Sales forecasts for drugs in late-phase clinical development for chronic lymphocytic leukemia (CLL) across the seven majormarkets, 2010-19 ($m) 147Table 67: Alvocidib - drug profile, 2010 148Table 68: Alvocidib: key historical events, 2004-2010 149Table 69: Clinical development of alvocidib in chronic lymphocytic leukemia (CLL), 2010 150Table 70: Phase I dose-escalating study of alvocidib in combination with chemotherapy in patients with indolent B-cell non-Hodgkinslymphoma, chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL) 152Table 71: Sales forecast for alvocidib in chronic lymphocytic leukemia (CLL) across the seven major markets, 2010-19 ($m) 156Table 72: Revlimid - drug profile, 2010 158Table 73: Revlimid: key historical events, 2005-2010 159Table 74: Clinical development of Revlimid in chronic lymphocytic leukemia (CLL), 2010 160Table 75: Sales forecast for Revlimid in chronic lymphocytic leukemia (CLL) across the seven major markets, 2010-19 ($m) 168Table 76: RG7159 - drug profile, 2010 170Table 77: RG7159: key historical events, 2007-2010 171Table 78: Clinical development of RG7159 in chronic lymphocytic leukemia (CLL), 2010 172Table 79: Sales forecast for RG7159 in chronic lymphocytic leukemia (CLL) across the seven major markets, 2010-19 ($m) 176Table 80: Different definitions of accelerated phase chronic myeloid leukemia (AP-CML), 2010 179Table 81: Different definitions of blast crisis chronic myeloid leukemia (BC-CML) 180Pipeline Insight: Leukemias Underserved patient populations offer potential for market growth Page 10/15
    • Find Industry reports, Company profilesReportLinker and Market StatisticsTable 82: Crude incidence rates of chronic myeloid leukemia (CML) per 100,000 population in the seven major pharmaceuticalmarkets, 2002 181Table 83: Forecast incidence of chronic myeloid leukemia (CML) in the seven major pharmaceutical markets, 2002-2019 182Table 84: Forecast prevalence of chronic myeloid leukemia (CML) in the seven major pharmaceutical markets, 2010-19 184Table 85: Number of chronic phase chronic myeloid leukemia (CP-CML) patients in first complete cytogenetic remission (CCyR)receiving a tyrosine kinase inhibitor in the seven major markets, 2010-19 186Table 86: Leading agents for chronic myeloid leukemia (CML), 2010 187Table 87: Gleevec (imatinib; Novartis) - drug profile, 2010 189Table 88: Number of chronic myeloid leukemia (CML) patients developing Gleevec resistance in the seven major pharmaceuticalmarkets, 2010-19 191Table 89: Minimum acceptable product profile (MAPP) and target product profile (TPP) for treatment of newly diagnosed chronicphase chronic myeloid leukemia (CP-CML), 2010 193Table 90: Minimum acceptable product profile (MAPP) and target product profile (TPP) treatment of Gleevec-refractory/intolerantchronic phase chronic myeloid leukemia (CP-CML), 2010 194Table 91: Drugs in late-phase clinical development for chronic myeloid leukemia (CML), 2010 195Table 92: Forecast assumptions for drugs in late-phase clinical development for chronic myeloid leukemia (CML) across the sevenmajor markets, 2010 197Table 93: Sales forecasts for drugs in late-phase clinical development for chronic myeloid leukemia (CML) across the seven majormarkets, 2010-19 ($m) 198Table 94: Bosutinib - drug profile, 2010 200Table 95: Bosutinib: key historical events, 2006-2010 201Table 96: Clinical development of bosutinib in chronic myeloid leukemia (CML), 2010 201Table 97: Sales forecast for bosutinib in chronic myeloid leukemia (CML) across the seven major markets, 2010-19 ($m) 208Table 98: Omapro - drug profile, 2010 210Table 99: Omapro: key historical events, 2004-2010 211Table 100: Clinical development of Omapro in chronic myeloid leukemia (CML), 2010 212Table 101: Sales forecast for Omapro in chronic myeloid leukemia (CML) across the seven major markets, 2010-19 ($m) 218Table 102: Datamonitor drug assessment parameters 234List of FiguresFigure 1: Number of drugs in clinical development for the four principal subtypes of leukemia, by phase of development, 2010 10Figure 2: Number of drugs in clinical development for leukemia, by phase of development and class, 2010 11Figure 3: Forecast incidence of acute lymphoblastic leukemia (ALL) in the seven major pharmaceutical markets, 2010-19 27Figure 4: Summary of unmet needs in acute lymphoblastic leukemia (ALL), 2010 33Figure 5: Datamonitor drug assessment for drugs in late-phase clinical development for acute lymphoblastic leukemia (ALL), 2010 39Figure 6: Summary of data from GRASPALL Phase II study of Graspa in relapsed acute lymphoblastic leukemia (ALL) 44Figure 7: Graspa - SWOT analysis in acute lymphoblastic leukemia (ALL), 2010 45Figure 8: Summary of data from rALLy Phase II study of Marqibo in relapsed acute lymphoblastic leukemia (ALL) 50Figure 9: Summary of data from Phase I/II study of Marqibo in relapsed/refractory acute lymphoblastic leukemia (ALL) 51Figure 10: Marqibo - SWOT analysis in acute lymphoblastic leukemia (ALL), 2010 52Figure 11: Datamonitor drug assessment summary for Marqibo in acute lymphoblastic leukemia (ALL), 2010 53Figure 12: Summary of data from Phase II study of Rituxan/MabThera in newly-diagnosed Philadelphia chromosome-negative,CD20-positive precursor B-cell acute lymphoblastic leukemia (ALL) 59Figure 13: Summary of data from Phase II study of Rituxan/MabThera in newly-diagnosed Burkitt-type acute lymphoblastic leukemia(ALL)/Burkitt lymphoma 60Figure 14: Rituxan/MabThera - SWOT analysis in acute lymphoblastic leukemia (ALL), 2010 61Figure 15: Datamonitor drug assessment summary for Rituxan in acute lymphoblastic leukemia (ALL), 2010 62Figure 16: Forecast incidence of acute myeloid leukemia (AML) in the seven major pharmaceutical markets, 2010-19 71Figure 17: Summary of unmet needs in acute myeloid leukemia (AML), 2010 75Figure 18: Datamonitor drug assessment for drugs in late-phase clinical development for acute myeloid leukemia (AML), 2010 81Figure 19: Summary of data from Phase II study of AS1413 in secondary acute myeloid leukemia (AML) 88Pipeline Insight: Leukemias Underserved patient populations offer potential for market growth Page 11/15
    • Find Industry reports, Company profilesReportLinker and Market StatisticsFigure 20: AS1413 - SWOT analysis in acute myeloid leukemia (AML), 2010 89Figure 21: Datamonitor drug assessment summary for AS1413 in acute myeloid leukemia (AML), 2010 90Figure 22: Summary of preliminary data from the CLASSIC II Phase II study of Clolar/Evoltra in newly-diagnosed elderly acutemyeloid leukemia (AML) patients 97Figure 23: Summary of preliminary data from a Phase II study of Clolar/Evoltra in combination with low-dose cytarabine innewly-diagnosed elderly acute myeloid leukemia (AML) patients 98Figure 24: Clolar/Evoltra - SWOT analysis in acute myeloid leukemia (AML), 2010 99Figure 25: Datamonitor drug assessment summary for Clolar/Evoltra in acute myeloid leukemia (AML), 2010 100Figure 26: Summary of data from Phase II trial of Dacogen in previously untreated elderly acute myeloid leukemia (AML) patients 107Figure 27: Summary of data from a multicenter Phase II trial of Dacogen in previously untreated elderly acute myeloid leukemia (AML)patients 108Figure 28: Dacogen - SWOT analysis in acute myeloid leukemia (AML), 2010 109Figure 29: Datamonitor drug assessment summary for Dacogen in acute myeloid leukemia (AML), 2010 110Figure 30: Summary of data from Phase Ib study of midostaurin in newly-diagnosed acute myeloid leukemia (AML) 116Figure 31: Midostaurin - SWOT analysis in acute myeloid leukemia (AML), 2010 117Figure 32: Datamonitor drug assessment summary for midostaurin in acute myeloid leukemia (AML), 2010 118Figure 33: Phase I/II trial results investigating PR1 peptide antigen in mixed myeloid hematological malignancies 124Figure 34: PR1 peptide antigen - SWOT analysis in acute myeloid leukemia (AML), 2010 125Figure 35: Datamonitor drug assessment summary for PR1 peptide antigen in acute myeloid leukemia (AML), 2010 126Figure 36: Characteristic immunophenotype of accumulating malignant B-lymphocytes in chronic lymphocytic leukemia (CLL) 129Figure 37: Forecast incidence of chronic lymphocytic leukemia (CLL) in the seven major pharmaceutical markets, 2010-19 135Figure 38: Summary of unmet needs in chronic lymphocytic leukemia (CLL), 2010 140Figure 39: Datamonitor drug assessment for drugs in late-phase clinical development for chronic lymphocytic leukemia (CLL), 2010145Figure 40: Summary of data from Phase II clinical trial of alvocidib in relapsed/refractory chronic lymphocytic leukemia (CLL) 151Figure 41: Alvocidib - SWOT analysis in chronic lymphocytic leukemia (CLL), 2010 153Figure 42: Datamonitor drug assessment summary for alvocidib in chronic lymphocytic leukemia (CLL), 2010 154Figure 43: Phase II study of Revlimid in relapsed/refractory chronic lymphocytic leukemia (CLL), 161Figure 44: Preliminary data from Phase II study of Revlimid as first-line treatment in elderly chronic lymphocytic leukemia (CLL)patients 162Figure 45: Preliminary data from Phase II trial of Revlimid plus Rituxan in relapsed/refractory chronic lymphocytic leukemia (CLL) 163Figure 46: Revlimid - SWOT analysis in chronic lymphocytic leukemia (CLL), 2010 164Figure 47: Datamonitor drug assessment summary for Revlimid in chronic lymphocytic leukemia (CLL), 2010 165Figure 48: RG7159 - SWOT analysis in chronic lymphocytic leukemia (CLL), 2010 173Figure 49: Datamonitor drug assessment summary for RG7159 in chronic lymphocytic leukemia (CLL), 2010 174Figure 50: Forecast incidence of chronic myeloid leukemia (CML) in the seven major pharmaceutical markets, 2010-19 183Figure 51: Forecast prevalence of chronic myeloid leukemia (CML) in the seven major pharmaceutical markets, 2010-19 185Figure 52: Summary of unmet needs in chronic lymphocytic leukemia (CML), 2010 190Figure 53: Datamonitor drug assessment for drugs in late-phase clinical development for chronic myeloid leukemia (CML), 2010 196Figure 54: Phase II study of bosutinib in Gleevec-resistant/intolerant chronic myeloid leukemia (CML) in chronic phase 202Figure 55: Phase II study of bosutinib in Gleevec-resistant/intolerant chronic myeloid leukemia (CML) in accelerated phase or blastcrisis 203Figure 56: Bosutinib - SWOT analysis in chronic myeloid leukemia (CML), 2010 204Figure 57: Datamonitor drug assessment summary for bosutinib in chronic myeloid leukemia (CML), 2010 205Figure 58: Study 202: Interim data from Phase II/III study of Omapro in Gleevec-resistant chronic myeloid leukemia (CML) patientswith the T315I mutation 213Figure 59: Study 203: Interim data from Phase II/III study of Omapro in chronic myeloid leukemia (CML) patients resistant/intolerant toat least two tyrosine kinase inhibitors 214Figure 60: Omapro - SWOT analysis in chronic myeloid leukemia (CML), 2010 215Figure 61: Datamonitor drug assessment summary for Omapro in chronic myeloid leukemia (CML), 2010 216Pipeline Insight: Leukemias Underserved patient populations offer potential for market growth Page 12/15
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