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Therapeutic Clinical Intelligence - Type-2 Diabetes Pipeline Descrip...
Diabetes affects more than an estimated 18 million people in the United States and approximately 194 million adults worldwide. The World Health Organization projects that the number of people with diabetes will double to 366 million by 2030. Thiazolidediones (PPAR gamma agonists), such as Actos and Avandia, are currently the market leading therapeutic agents used to treat patients with type-2 diabetes, with 2007 worldwide sales of $3.5 billion and $1.7 billion respectively. However, drugs with novel mechanism that are currently in development such as DPP-IV (dipeptidyl peptidase-4) inhibitors and GLP-1 (Glucagon-like peptide-1) antagonists could pose a competitive threat to the market leaders in the near future. In this report, we profile the 35 most promising compounds in mid-to-late stage development for the treatment of Type-2 Diabetes. The assessment provides decision makers with insight into the crowded R&D environment for Type-2 Diabetes therapeutics and analyzes clinical intelligence on key competitors that have the potential to impact the market over the next five to seven years. The Therapeutic Clinical Intelligence Report Series provides clients within the pharmaceutical and biotechnology industry with detailed information and analysis of competitive products in the development pipeline. Reports contain synthesized information and analysis of clinical development activities for products within multiple therapeutic categories and contain detailed evaluations of completed and ongoing competitor studies that capture key elements of the study protocol including: - Trial design - Start and end dates - Study size and patient type - Number of participating sites - Dosing regimen - Endpoints - Safety and efficacy results Clients utilize the report as a resource to support key decisions including: - Analyzing the overall depth and breadth of the competitive landscape within a therapeutic area - Assessing target product profiles of key current and future competitors - Benchmarking competitor clinical trial designs and results - Developing clinical analogues to support go-no-go decisions - Identifying clinical hurdles posed by competitors - Designing clinical trials more effectively to maximize a product’s penetration
Contents:
Section 1: Executive Summary Scope of Research & Analysis Type-2 Diabetes Disease Overview Overview of Progression to Type 2 Diabetes Global Projections for the Diabetes Epidemic: 2003-2025 Epidemiology of T2 Diabetes: Current and predicted prevalence Currently Available Treatments for T2 Diabetes Unmet Need in Type-2 Diabetes Market FDA Summary Guidance for Development of T2 Diabetes Therapeutics Overview of Competitive Landscape: Late-Stage Products Profiled in Intelligence Report Overview of Competitive Landscape: Mid & Early Stage Products Profiled in Intelligence Report Competitive Launch Timeline Analysis Overview of Clinical Trials Landscape Section 2: The Current Market Leaders in T2 Diabetes Actos Product Overview—Competitor Snapshot Avandia Product Overview—Competitor Snapshot
Byetta Product Overview—Competitor Snapshot Januvia Product Overview—Competitor Snapshot Symlin Product Overview—Competitor Snapshot Galvus Product Overview—Competitor Snapshot Section 3: Future Competitive Threats Novel Therapeutics in Late-Stage Development Alogliptin (SYR-322) Alogliptin Product Overview—Competitor Snapshot Alogliptin Phase II Study Design & Results Alogliptin Phase III Study Design (Ongoing) Alogliptin Phase III Study Design (Ongoing) Alogliptin Phase III Study Design (Ongoing) Alogliptin Phase III Study Design (Ongoing) Alogliptin Phase III Study Design & Results Alogliptin Phase III Study Design (Ongoing) Alogliptin Phase III Study Design (Ongoing) Liraglutide Liraglutide Product Overview—Competitor Snapshot Liraglutide Phase II Study Design & Results Liraglutide Phase II Study Design & Results Overview of Liraglutide Registrational Program Liraglutide Phase III Study Design & Results LEAD 1 Liraglutide Phase III Study Design (Ongoing) LEAD 2 Liraglutide Phase III Study Design & Results LEAD 3 Liraglutide Phase III Study Design (Ongoing) LEAD 4 Liraglutide Phase III Study Design (Ongoing) LEAD 5 Liraglutide Phase III Study Design & Results LEAD 6 Liraglutide Phase III Study Design (Ongoing) Japan NDA-Enabling Trial Saxagliptin Saxagliptin Product Overview—Competitor Snapshot Saxagliptin Phase I Studies (#1 & #2): Design & Results Saxagliptin Phase III Study Design & Results Saxagliptin Phase III Study Design Saxagliptin Phase III Study Design Saxagliptin Phase III Study Design & Results Saxagliptin Phase III Study Design (Ongoing) Saxagliptin Phase III Study Design (Ongoing) AGI-1067 AGI-1067 Product Overview—Competitor Snapshot AGI-1067 Phase III Study Design & Interim Results (Ongoing) ANDES (AGI-1067 as a Novel Antidiabetic Agent Evaluation Study) Exanatide LAR (exenatide) Exenatide LAR Product Overview—Competitor Snapshot Exenatide LAR Phase II Study Design & Results Exenatide LAR Phase II Study Design (Ongoing) Exenatide LAR Phase III Study Design & Results-DURATION-1 Exenatide LAR Phase III Study Design (Ongoing) Exenatide LAR Phase III Study Design (Ongoing) Exenatide LAR Phase III Study Designs (Ongoing) Dapagliflozin Dapagliflozin Product Overview—Competitor Snapshot Dapagliflozin Phase II Study Design & Results Overview of Dapagliflozin Registrational Program Dapagliflozin Phase III Study Design (Ongoing) Dapagliflozin Phase III Study Design (Ongoing) Dapagliflozin Phase III Study Design (Ongoing) Dapagliflozin Phase III Study Design (Ongoing)
Balaglitazone Balaglitazone Product Overview—Competitor Snapshot Balaglitazone Phase II Study Design & Results Balaglitazone Phase III Study Design (Ongoing) BI-1356 BI-1356 Product Overview—Competitor Snapshot BI-1356 Phase I/II Study Design & Results BI-1356 Phase I/II Study Design & Results BI-1356 Phase I/II Study Design (ongoing) BI-1356 Phase III Study Design (Ongoing) BI-1356 Phase III Study Design (Ongoing) BI-1356 Phase III Study Design (Ongoing) BI-1356 Phase III Study Design (Ongoing) BI-1356 Phase III Study Design (Ongoing) rivoglitazone (CS-011) rivoglitazone Product Overview—Competitor Snapshot Rivoglitazone Phase II/III Study Design & Results Rivoglitazone Phase III Study Design (Ongoing) AVE-0010 AVE-0010 Product Overview—Competitor Snapshot AVE-0010 Phase IIa Study Design & Results AVE-0010 Phase IIb Study Design AVE-0010 Phase 2b Top-Line Efficacy Results AVE-0010 Product Positioning R1583 R1583 Product Overview—Competitor Snapshot R1583 Phase II Study Design & Results R1583 Phase II Study Design & Results R1583 Phase II Study Design & Results R1583 Phase II Study Design & Results AVE-2268 AVE-2268 FDC Product Overview—Competitor Snapshot AVE-2268 Phase IIb Study Design remogliflozin Remogliflozin Product Overview—Competitor Snapshot Remogliflozin Phase I Study Design (Ongoing) Remogliflozin Phase I Study Design (Ongoing) Remogliflozin Phase II Study Design (Ongoing) Remogliflozin Phase II Study Design (Ongoing) Remogliflozin Phase II Study Design (Completed) PHX1149 PHX1149 Product Overview—Competitor Snapshot PHX1149 Phase I Study Design & Results PHX1149 Phase I Study Design & Results PHX1149 Phase IIa Study Design & Results PHX1149 Phase IIb Study Design (Ongoing) INT131 INT131 Product Overview—Competitor Snapshot INT131 Phase I Study Design & Results INT131 Phase I Study Design & Results INT131 Phase IIa Study Design & Results INT131 Phase IIb Study Design (Ongoing) albiglutide albiglutide Product Overview—Competitor Snapshot
albiglutide Phase I Study Design albiglutide Phase I Study Design albiglutide Phase I/II Study Design (Ongoing) albiglutide Phase IIb Study Design (Ongoing) Section 4: Long-Term Potential Competitive Threats Innovative Therapies in Mid-Stage Development Aleglitazar Aleglitazar Product Overview—Competitor Snapshot Aleglitazar Phase IIb Study Design (Ongoing) Aleglitazar Phase IIb Study Design (Ongoing) PF-00734200 PF-00734200 Product Overview—Competitor Snapshot PF-00734200 Phase IIa Study Design & Results PF-00734200 Phase IIa Study Design (Ongoing) PF-00734200 Phase II Study Design (Ongoing) R1579 R1579 Product Overview—Competitor Snapshot R1579 Phase I Study Design & Results R1579 Phase II Study Design (Ongoing) TAK-472 (SYR-472) TAK-472 Product Overview—Competitor Snapshot TAK-472 Phase II Study Design (Ongoing) AMG-222 (ALS 2-0426) AMG-222 Product Overview—Competitor Snapshot INCB13739 INCB13739 Product Overview—Competitor Snapshot INCB13739 Phase I Study Design & Results INCB13739 Phase IIa Study Design & Results MB07803 MB07803 Product Overview—Competitor Snapshot MB07803 Phase IIa Study Design & Results ISIS 113715 ISIS 113715 Product Overview—Competitor Snapshot ISIS 113715 Phase I Study Design & Result ISIS 113715 Phase II Study Design & Results ISIS 113715 Phase II Study Design (Ongoing) AZD2207 AZD2207 Product Overview—Competitor Snapshot DIO-902 DIO-902 Product Overview—Competitor Snapshot DIO-902 Phase IIa Study Design & Results DIO-902 Phase II/III Study Design (Ongoing) DIO-902 Phase II/III Extension Study Design (Ongoing) EMD 387008 EMD 387008 Product Overview—Competitor Snapshot indeglitazar indeglitazar Product Overview—Competitor Snapshot indeglitazar Phase IIa Study Design & Results azilsartan azilsartan Product Overview—Competitor Snapshot
MBX-2044 MBX-2044 Product Overview—Competitor Snapshot MBX-2044 Phase IIa Study Design & Results CJC-1134-PC CJC-1134-PC Product Overview—Competitor Snapshot CJC-1134-PC Phase I/II Study Design & Results CJC-1134-PC Phase I/II Study Design & Results CJC-1134-PC Phase II Study Design (Ongoing) CJC-1134-PC Phase II Study Design (Ongoing) CRx-401 CRx-401 Product Overview—Competitor Snapshot CRx-401 Phase II Study Design (Ongoing) K-111 K-111 Product Overview—Competitor Snapshot K-111 Phase IIa Study Design & Results K-111 Phase IIa Study Design & Results MP-513 MP-513 Product Overview—Competitor Snapshot MP-513 Phase II Study Design (Ongoing) AKP-020 AKP-020 Product Overview—Competitor Snapshot AKP-020 Phase II Study Design (Discontinued) AVE0847 AVE0847 Product Overview—Competitor Snapshot AVE0847 Phase II Study Design (Completed-Results Unpublished) Section 5: APPENDIX Disclaimer Report Licensing
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