Pipeline Insight: Non-insulin Antidiabetics - Three New Classes Compete for Market Control
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the Cardiovascular and Diabetes pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 4
- Scope of the analysis - page 4
- Datamonitor insight into the diabetes market - page 6
- Despite the presence of well tried and liked compounds for the treatment of diabetes, such as insulin, metformin and sulfonylureas and the recent introduction of new classes such as thiazolidinediones (TZDs), alpha glucosidase inhibitors (AGIs) and prandial glucose regulators (PGRs), there are still important unmet needs in the treatment of diabetes. - page 6
- One of the most exciting classes of agents in development is GLP-1 agonists, these aim to address two of the main unmet needs in diabetes treatment, prolonged efficacy and the potential to act on the underlying cause of the disease rather than on its symptoms. - page 7
- Another class of agents expected to enter the market in the following years are DPPIV inhibitors, these are targeting the same biochemical pathway as GLP-1 agonists, but instead of supplementing the natural pool of GLP-1, they attempt to inhibit the enzyme responsible for its breakdown. - page 8
- Dual PPAR agonists were once hailed as the next big development in the treatment of diabetes. However the recent withdrawal of many leading agents following safety concerns has prompted the FDA to request additional safety data before considering the approval of any such compounds. This development will severely delay the progress of dual PPAR analogs - page 9
- Summary - page 12
- Key metrics - page 13
- CHAPTER 2 PATIENT POTENTIAL - page 25
- Definition of diabetes - page 25
- Segmentation of diabetes - page 25
- Type 1 diabetes - page 25
- Type 1.5 diabetes - page 26
- Type 2 diabetes - page 26
- Complications of diabetes - page 28
- Nephropathy - page 28
- Retinopathy - page 28
- Neuropathy - page 29
- Macrovascular complications - page 29
- Economic Impact of Diabetes - page 31
- Low diagnosis rates remain an unresolved issue - page 31
- Epidemiology of diabetes - page 32
- Current prevalence of type 1 and type 2 diabetes - page 32
- Future prevalence of type 2 diabetes - page 33
- Methodology - page 34
- Future trends in the incidence and prevalence of diabetes - page 35
- Unmet need in diabetes - page 36
- CHAPTER 3 R&D APPROACH - page 39
- The gold standard in type 1 and type 2 diabetes - page 39
- Type 1 diabetes - page 39
- Type 2 diabetes - page 41
- Classification of pipeline products - page 41
- Incretin mimetics - page 41
- GIP - page 43
- Current Status of Drugs in Development - page 45
- GLP-1 - page 46
- Dipeptidyl Peptidase IV Inhibition - page 53
- PPAR agonists - page 54
- PPAR-gamma agonists - page 54
- Dual PPAR agonists and PPAR pan agonists - page 57
- Other classes of agents in development - page 59
- Incretin mimetics - page 41
- Clinical trial issues in diabetes - page 60
- The gold standard in type 1 and type 2 diabetes - page 39
- CHAPTER 4 DIABETES PIPELINE ANALYSIS - page 63
- Pipeline overview - page 63
- Key companies involved in the diabetes pipeline - page 64
- Novo Nordisk - page 64
- Marketed products - page 64
- R&D Compounds - page 68
- Overall comments - page 70
- BMS - page 70
- Marketed products - page 70
- R&D compounds - page 73
- Overall Comments - page 73
- Eli Lilly - page 74
- Marketed products - page 74
- R&D Compounds - page 76
- Overall Comments - page 77
- GlaxoSmithKline - page 78
- Marketed products - page 78
- R&D compounds - page 81
- Overall comments - page 81
- Novo Nordisk - page 64
- CHAPTER 5 INCRETIN MIMETICS - page 82
- Pipeline summary - page 83
- GLP-1 agonists - page 84
- Pipeline summary - page 84
- Pre-reg compounds - page 84
- Exenatide - page 84
- Profile - page 84
- Clinical trial data - page 85
- Unmet needs and forecast - page 90
- Profile - page 84
- Phase II compounds - page 95
- Exenatide LAR - page 95
- Clinical trial data - page 95
- Unmet needs and forecast - page 96
- Liraglutide - page 98
- Profile - page 98
- Clinical trial data - page 99
- Unmet needs and forecast - page 101
- Profile - page 98
- CJC-1131 - page 104
- Profile - page 104
- Clinical trial data - page 105
- Datamonitor opinion - page 107
- Profile - page 104
- AVE-0010 - page 108
- Profile - page 108
- Clinical trial data - page 108
- Profile - page 108
- BIM-51077 - page 108
- Profile - page 108
- Preclinical data - page 109
- Profile - page 108
- Overall comments - page 109
- DPPIV inhibitors - page 111
- Pipeline summary - page 111
- Phase III compounds - page 112
- LAF-237 - page 112
- Profile - page 112
- Clinical trial data - page 112
- Unmet needs and forecast - page 114
- Profile - page 112
- MK-431 - page 117
- Clinical trial data - page 117
- Unmet needs and forecast - page 118
- Phase II compounds - page 120
- PSN-9301 - page 120
- Profile - page 120
- Clinical trial data - page 120
- Profile - page 120
- Overall comments - page 121
- CHAPTER 6 PPAR AGONISTS - page 124
- Pipeline summary - page 125
- PPAR-gamma agonists - page 126
- Pipeline summary - page 126
- Phase II compounds - page 126
- Rivoglitazone (CS-011) - page 126
- Profile - page 126
- Clinical trial data - page 127
- Profile - page 126
- T-131 - page 127
- Profile - page 127
- Clinical trial data - page 128
- Profile - page 127
- MBX-102 - page 129
- Profile - page 129
- Clinical trial data - page 129
- Profile - page 129
- R-483 - page 129
- Profile - page 129
- Phase I and earlier compounds - page 130
- CLX-0921 - page 130
- Profile - page 130
- Overall Comments - page 130
- Dual PPAR agonists and PPAR pan agonists - page 132
- Pipeline summary - page 132
- Phase III compounds - page 132
- Galida (tesaglitazar) - page 132
- Profile - page 132
- Clinical trial data - page 132
- Unmet needs and forecast - page 134
- Profile - page 132
- Muraglitazar - page 136
- Profile - page 136
- Clinical trial data - page 136
- Unmet needs and forecast - page 138
- Profile - page 136
- Naveglitazar (LY-818) - page 140
- Profile - page 140
- Clinical trial data - page 140
- Unmet needs and forecast - page 141
- Profile - page 140
- TAK-559 - page 143
- Profile and Clinical trial data - page 143
- Overall Comments - page 144
- Phase II compounds - page 147
- Netoglitazone - page 147
- Profile - page 147
- Preclinical data - page 147
- Profile - page 147
- GW-677594 - page 148
- Profile - page 148
- Overall Comments - page 148
- Phase I compounds - page 149
- LY-929 - page 149
- Profile and Clinical trial data - page 149
- CHAPTER 7 OTHER KEY COMPOUNDS IN THE DIABETES PIPELINE - page 151
- Pipeline summary - page 153
- Symlin (pramlintide) - page 153
- Profile - page 153
- Regulatory issues - page 154
- Clinical trial data - page 155
- Additional clinical trial data - page 158
- Unmet needs and forecast - page 160
- Sodium Glucose co Transporter (SGLT) inhibitors - page 164
- Pipeline summary - page 164
- T-1095 - page 165
- Profile - page 165
- AVE-2268 - page 165
- Profile - page 165
- 869682 (KGT-1251) - page 165
- Profile and Clinical trial data - page 165
- APPENDIX A - page 167
- Contributing experts - page 167
- Bibliography - page 167
- Epidemiology - page 167
- Clinical trial data - page 168
- Report methodology - page 171
- APPENDIX B - page 172
- About Datamonitor - page 172
- About Datamonitor Healthcare - page 172
- Datamonitor Healthcare's research and analysis methodologies - page 173
- Datamonitor Healthcare's therapy area capabilities - page 173
- About the Cardiovascular and Diabetes analysis team - page 174
- Disclaimer - page 175
- About Datamonitor - page 172
- List of Tables
- Table 1: Prevalence of type 1 and type 2 diabetes across the seven major markets, 2004 - page 13
- Table 2: Future prevalence of type 1 and type 2 diabetes in the seven major markets, 2004-12 - page 14
- Table 3: Forecast key products in diabetes pipeline ($m), 2005-12 - page 15
- Table 4: Prevalence of type 1 and type 2 diabetes across the seven major markets, 2004 - page 32
- Table 5: Future prevalence of type 1 and type 2 diabetes in the seven major markets, 2004-12 - page 34
- Figure 4: Unmet needs in diabetes, 2004 - page 36
- Table 6: Characteristics of GIP and GLP-1 - page 43
- Table 7: R&D pipeline in diabetes, 2004 - page 63
- Table 8: Key GLP-1 agonists in development, 2004 - page 84
- Table 9: Assumptions and factors influencing exenatide's sales forecast - page 91
- Table 10: Assumptions and factors influencing exenatide LAR's sales forecast - page 97
- Table 11: Assumptions and factors influencing liraglutide's sales forecast - page 102
- Table 12: Key DPPIV inhibitors in development, 2004 - page 111
- Table 13: Assumptions and factors influencing LAF-237's sales forecast - page 115
- Table 14: Assumptions and factors influencing MK-431's sales forecast - page 119
- Table 15: Key PPAR agonists in development, 2004 - page 126
- Table 16: Key dual and pan PPAR agonists in development, 2004 - page 132
- Table 17: Assumptions and factors influencing Galida's sales forecast - page 135
- Table 18: Assumptions and factors influencing muraglitazar's sales forecast - page 139
- Table 19: Assumptions and factors influencing naveglitazar's sales forecast - page 142
- Table 20: Key products the R&D pipeline for human amylin analogs, 2004 - page 153
- Table 21: Assumptions and factors influencing Symlin's sales forecast - page 161
- Table 22: Key products in late-stage R&D pipeline for sodium glucose cotransporter inhibitors, 2004 - page 164
- List of Figures
- Figure 1: Impacts on the global antidiabetics market to 2012 - page 12
- Figure 2: Comparative forecast sales of all key developmental compounds in the diabetes pipeline, 2005-2012 - page 15
- Figure 3: Comparison of glucose testing - page 27
- Figure 5: History of GLP-1, 1930-2004 - page 41
- Figure 6: Mechanism of action of GLP-1 - page 47
- Figure 7: GLP-1 effects on beta cells - page 49
- Figure 8: Functional pancreatic effects of GLP-1 - page 49
- Figure 9: Mechanism of action of GLP-1 agonists - page 53
- Figure 10: Mechanism of action of DPPIV inhibitors - page 54
- Figure 11: Mechanism of action of TZDs - page 56
- Figure 12: Combined benefits of PPAR pan agonists - page 59
- Figure 13: Key products in the R&D pipeline for incretin mimetics, 2004 - page 83
- Figure 14: Satisfaction of unmet needs by exenatide in comparison to insulin - page 90
- Figure 15: Global sales forecast for exenatide ($m), 2005-12 - page 92
- Figure 16: Satisfaction of unmet needs by exenatide LAR in comparison to insulin - page 96
- Figure 17: Global sales forecast for exenatide LAR ($m), 2007-12 - page 98
- Figure 18: Satisfaction of unmet needs by liraglutide in comparison to insulin - page 101
- Figure 19: Global sales forecast for liraglutide ($m), 2007-12 - page 103
- Figure 20: Satisfaction of unmet needs by the leading GLP-1 agonists - page 110
- Figure 21: Comparative forecasted sales of the leading GLP-1 agonists - page 111
- Figure 22: Satisfaction of unmet needs by LAF-237 in comparison to TZDs - page 115
- Figure 23: Global sales forecast for LAF-237 ($m), 2007-12 - page 116
- Figure 24: Satisfaction of unmet needs by MK-431 in comparison to TZDs - page 118
- Figure 25: Global sales forecast for MK-431 ($m), 2009-12 - page 119
- Figure 26: Satisfaction of unmet needs by the leading DPPIV inhibitors - page 122
- Figure 27: Comparative forecasted sales of the leading DPPIV inhibitors - page 123
- Figure 28: Key products in the R&D pipeline for PPAR agonists, 2004 - page 125
- Figure 29: Satisfaction of unmet needs by Galida in comparison to TZDs - page 134
- Figure 30: Global sales forecast for Galida ($m), 2009-12 - page 135
- Figure 31: Satisfaction of unmet needs by muraglitazar in comparison to TZDs - page 138
- Figure 32: Global sales forecast for muraglitazar ($m), 2006-12 - page 139
- Figure 33: Satisfaction of unmet needs by naveglitazar in comparison to TZDs - page 141
- Figure 34: Global sales forecast for naveglitazar ($m), 2010-12 - page 142
- Figure 35: Satisfaction of unmet needs by the leading dual PPAR agonists - page 146
- Figure 36: Comparative forecasted sales of the leading dual PPAR agonists - page 146
- Figure 37: Regulation of blood glucose levels by insulin, glucagon and amylin - page 152
- Figure 38: Satisfaction of unmet needs by Symlin in comparison to Insulin - page 160
- Figure 39: Global sales forecast for Symlin ($m), 2005-12 - page 161
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