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[Report]
Pipeline Insight: Non-insulin Antidiabetics - Type 2 diabetes unlikely to develop into a switch market
Published: 2006/08
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Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- About the cardiovascular pharmaceutical analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the analysis
- Datamonitor insight into the market for non-insulin antidiabetic
pharmacotherapies
- The R&D pipeline for non-insulin antidiabetics is a
mechanistically diverse collection of 77 novel agents at the clinical
stages of drug development and dominated by a set of five pharmaceutical
companies
- The diabetes market is characterized primarily by significant unmet
clinical needs but also by some unmet market needs
- Datamonitor has identified two unmet market needs in the setting of
diabetes.
- Datamonitor has identified two unmet clinical needs in the setting
of diabetes.
- Datamonitor has identified five late-stage candidate drugs likely to
be launched into the diabetes market within the next five years-the DPP-4
inhibitors Galvus (vildagliptin) and Januvia (sitagliptin), the GLP-1
agonists Byetta LAR (exenatide LAR) and liraglutide, and the specific
PPAR-γ modulatormetaglidasen.
- GLP-1 agonists
- DPP-4 inhibitors
- Metaglidasen
- CHAPTER 2 PIPELINE OVERVIEW
- Pipeline overview
- Non-insulin antidiabetic pipeline is mechanistically diversified
- Non-insulin antidiabetic pipeline is rich in Phase I and Phase II
candidates
- The R&D landscape is dominated by five companies: GSK, Roche,
Sanofi-Aventis, Merck & Co. and Novo Nordisk
- CHAPTER 3 PATIENT POTENTIAL
- Definition of diabetes
- Segmentation of diabetes
- Type 1 diabetes
- Type 1.5 diabetes
- Type 2 diabetes
- Epidemiology of diabetes
- Current prevalence of type 1 and type 2 diabetes
- Future prevalence of type 2 diabetes
- Unmet need in diabetes
- Unmet market needs
- Unmet market need 1: routine screening for the detection of Type 2
diabetes mellitus
- Unmet market need 2: greater patient awareness
- Unmet market need 3: greater guideline awareness in physicians
- Unmet clinical needs
- Unmet clinical need 1: greater efficacy of non-insulin antidiabetics
- Unmet clinical need 2: better tolerability of non-insulin
antidiabetics
- CHAPTER 4 R&D APPROACH
- Therapy overview in type 1 and type 2 diabetes
- Type 1 diabetes
- Type 2 diabetes
- Comparator therapies
- Thiazolidinediones
- Weight gain associated with TZD therapy
- Actos (pioglitazone)
- Avandia (rosiglitazone)
- Sulfonylureas
- Biguanides
- Other classes
- Classification of pipeline products
- Incretin mimetics
- Gastric inhibitory polypeptide (GIP)
- Glucagon-like peptide-1 (GLP-1)
- Dipeptidyl PeptidaseIV (DPP-4 Inhibition
- PPAR agonists
- PPAR-γ agonists
- Dual PPAR agonists and PPAR pan agonists
- Sodium glucose co-transporter 2 (SGLT2) inhibitors
- Other classes of agents in development
- Inhibitors of glycogenolysis
- Glucokinase activation
- Clinical trial issues in diabetes
- Efficacy
- Control of average blood glucose levels (HbA1c)
- Bioavailability of non-invasive insulin
- Control of postprandial glucose levels
- Safety and side effects
- Incidence of hypoglycemic events
- Delivery-related complications
- Weight gain
- Patient compliance
- CHAPTER 5 LATE-STAGE DRUG ANALYSIS & FORECASTS: NON-INSULIN
ANTIDIABETICS
- Overview of pharmacotherapies in late-stage development for type 2
diabetes
- DPP-4 inhibitor class
- Januvia (sitagliptin, MK-0431)
- Drug overview
- Clinical data
- Galvus (vildagliptin, LAF-237)
- Drug overview
- Clinical data
- Competitive environment of the DPP-4 inhibitor class
- Comparison with currently marketed oral antidiabetics
- Comparison with other late-stage pipeline agents
- Inter-class comparison of key clinical trial data of sitagliptin
(Januvia) with vildagliptin (Galvus)
- SWOT analysis: Januvia (sitagliptin)
- SWOT analysis: Galvus (vildagliptin)
- Forecast: Galvus and Januvia
- GLP-1 class
- Byetta LAR (exenatide LAR)
- Drug overview
- Parent product: Byetta (exenatide), Byetta BID
- Clinical data
- Liraglutide (NN-2211)
- Drug overview
- Clinical data
- Competitive environment of the GLP-1 class
- Points of consideration: Byetta LAR
- Points of consideration: Liraglutide
- SWOT-Analysis: Byetta LAR (exenatide LAR)
- SWOT-Analysis: Liraglutide
- Forecast: Byetta LAR and liraglutide
- Metaglidasen (MBX-102)
- Drug overview
- Clinical data
- Phase II
- Competitive environment
- SWOT-Analysis: metaglidasen
- Forecast: metaglidasen
- Datamonitor does not believe non-injectable insulins to be able to
compete with non-insulin antidiabetics
- Datamonitor drug assessment summary
- CHAPTER 6 OTHER NON-INSULIN ANTIDIABETICS
- 625019
- 677954
- 825964
- 189075
- Ro-0730699
- DRF-2593 (Balaglitazone)
- PHX-1149
- AMG-221
- APD-668
- Arimoclomol (BRX-345)
- Anti-CD3
- Drug overview
- Phase I/II clinical trials
- AVE-0847
- AVE-2268
- AVE-5376
- AVE-8134
- AZD-6610
- AZD-8677
- AVE-0010 (ZP-10)
- Drug overview
- Clinical data
- BAY-73-7977
- BI-1356-BS
- BIM-51077 (ITM-077)
- BLX-1002
- Drug overview
- Clinical data
- CJC-1134-PC
- CKD-501
- CS-917 (MB-6322)
- Denagliptin (Redona, 823093)
- Drug overview
- Clinical data
- Diamyd (GAD-65)
- Drug overview
- Clinical data
- Phase II: 47 patients with latent autoimmune diabetes in adults
(LADA)
- Phase II: 70 patients with recent onset type 1 diabetes
- Phase II/III: 160 patients with Latent Autoimmune Diabetes in Adults
(LADA)
- DiaPep277 (AVE-0277)
- Drug overview
- Clinical data
- Phase II: 35 patients with newly diagnosed type 1 diabetes
- DIO-901
- DIO-902
- Drug overview
- Clinical data
- EMD-387008
- EN-122004
- GRC-8200
- 716155 (albugon)
- K-111
- KRP-104
- ISIS-113715
- Drug overview
- Clinical data
- MB-07803
- MBX-2044
- MK-0533
- MK-0893
- MK-0941
- MP-513
- Naveglitazar (LY-818, LY519818)
- iPlex (mecasermin rinfabate)
- Drug overview
- Clinical data
- Phase II: type 1 diabetes
- Phase II: type 1 diabetes
- Phase II: type 2 diabetes
- Phase II: type 2 diabetes
- Netoglitazone (MCC-555)
- NN-0606
- NN-9101
- ONO-5129
- PLX-204
- PSN-010
- PSN-357
- PSN-9301 (P93/01)
- Drug overview
- Clinical data
- R-1438
- R-1439
- R-1440
- AVR-118 (reticulose, Product R)
- CS-011 (rivoglitazone)
- Saxagliptin (BMS-477118)
- TS-033
- SGLT2 Inhibitor (lab code undisclosed)
- Solabegron (427353)
- SSR-162369
- CS-872
- SYR-322
- T-1095
- TA-6666
- TAK-654
- TH-0318
- Drug overview
- Clinical data
- TS-021
- TRX-4 (agCD3)
- Drug overview
- Clinical data
- E1-INT
- APPENDIX A
- Datamonitor drug assessment summary
- Bibliography
- Report methodology
- APPENDIX B
- About Datamonitor
- About Datamonitor Healthcare
- Datamonitor Healthcare's therapy area capabilities
- About the cardiovascular analysis team
- Disclaimer
- List of Tables
- Table 1: Pipeline of non-insulin antidiabetic agents, 2006
- Table 2: The pipeline for non-insulin antidiabetic agents is
mechanistically diversified: full listing, 2006
- Table 3: The pipeline for non-insulin antidiabetic agents is
mechanistically diversified, 2006
- Table 4: Acute pipeline of non-insulin antidiabetic agents by company,
2006
- Table 5: Collaborative nature of R&D projects among key players in
the non-insulin antidiabetic therapy sector, 2006
- Table 6: Prevalence of diabetes mellitus is forecast to increase by
the International Diabetes Foundation (IDF), 2003-2025
- Table 7: Prevalence rate of type 1 and type 2 diabetes in the seven
major markets (%), 2006-2015
- Table 8: Estimated absolute prevalence of diabetes in the seven major
markets (millions), 2006-2015
- Table 9: Safety of pioglitazone
- Table 10: Comparator Oral Antidiabetics of the TZD Class
- Table 11: Weight gain associated with Actos (kg)
- Table 12: Weight gain associated with Avandia (kg)
- Table 13: Comparator oral antidiabetics of the sulfonylurea class
- Table 14: Metformin is the only representative of the biguanide class
- Table 15: Characteristics of GIP and GLP-1
- Table 16: Key pipeline non-insulin antidiabetic therapies, 2006
- Table 17: Trial data overview: Galvus, June 2006
- Table 18: Trial data overview: Januvia, June 2006
- Table 19: Key adverse event data comparing Januvia and Galvus as
metformin adjuncts, 2006
- Table 20: Sales forecast for Januvia, 2007-15
- Table 21: Sales forecast for Galvus, 2007-15
- Table 22: Comparison of GLP-1 agonists with DPP-4 inhibitors, 2006
- Table 23: Comparative analysis of Byetta BID, Byetta LAR and
liraglutide, 2006
- Table 24: GLP-1 agonist class: Comparison between Byetta LAR and
liraglutide, 2006
- Table 25: Sales forecast for Byetta LAR, 2010-2015
- Table 26: Sales forecast for liraglutide, 2009-15
- Table 27: Sales forecast for metaglidasen, 2011-2015
- Table 28: Research, clinical and commercial attractiveness of key
pipeline non-insulin antidiabetics: basis dataset
- Table 29: Datamonitor drug assessment parameters
- List of Figures
- Figure 1: Pipeline of non-insulin antidiabetic drugs, 2006
- Figure 2: The pipeline of non-insulin antidiabetic agents is
mechanistically diverse, 2006
- Figure 3: Pipeline maturity: percentage of R&D products in each
phase of development, 2006
- Figure 4: Collaborative nature of R&D projects among key players
in the non-insulin antidiabetic therapy sector, 2006
- Figure 5: Comparison of glucose testing
- Figure 6: Current NIADs do not address all medical aspects of type 2
diabetes
- Figure 7: Regulation of blood glucose levels by insulin, glucagon and
amylin
- Figure 8: Mechanism of action of TZDs
- Figure 9: Mechanism of action of sulfonylureas and prandial glucose
regulators
- Figure 10: Mechanism of action of metformin
- Figure 11: History of GLP-1, 1930-2006
- Figure 12: Mechanism of action of GLP-1
- Figure 13: GLP-1 effects on β cells
- Figure 14: Functional pancreatic effects of GLP-1
- Figure 15: Mechanism of action of GLP-1 agonists
- Figure 16: Mechanism of action of DPP-4 inhibitors
- Figure 17: Combined theoretical benefits of PPAR pan agonists
- Figure 18: SWOT: Januvia (sitagliptin), 2006
- Figure 19: SWOT: Galvus (vildagliptin), 2006
- Figure 20: Sales forecast for Januvia and Galvus, 2007-2016
- Figure 21: SWOT: Byetta LAR, 2006
- Figure 22: SWOT: Liraglutide, 2006
- Figure 23: Sales forecast for Byetta LAR, 2010-2015
- Figure 24: Sales forecast for liraglutide, 2009-2015
- Figure 25: SWOT: metaglidasen (MBX-102), 2006
- Figure 26: Sales forecast for metaglidasen, 2011-2015
- Figure 27: Overview of sales forecasts for the five pipeline agents
analyzed in the present report, 2006-2015
- Figure 28: Research, clinical and commercial attractiveness of key
pipeline non-insulin antidiabetics: bubble chart
- Figure 29: Research, clinical and commercial attractiveness of
late-stage candidate drugs in diabetes setting: radar plot
- Figure 30: Example of Datamonitor drug assessment scorecard
- Figure 31: Example of Datamonitor drug assessment graph
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[Report]
Pipeline Insight: Non-insulin Antidiabetics - Type 2 diabetes unlikely to develop into a switch market
Published: 2006/08
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Published by : Datamonitor  |
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Product Code : DC43896 |
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