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Therapeutic Clinical Intelligence-Inflammatory Bowel Disease

Austin Research Group
March 8, 2007
134 Pages - SKU: ARSG1493572

Abstract Table of Contents Search inside this report Related Reports

Crohn¡¦s Disease Market

In 2007, Remicade (infliximab/Anti-TNF-fÑ), the current market leader in the treatment of moderate-to-severe Crohn¡¦s Disease (CD), is expected to experience fierce challenges for patient share from 2-3 new Anti-TNF class competitors; Humira, Tysabri,Cimzia. Humira (adalimumab) was approved in January 2007 for CD and will compete with Remicade based upon relative efficacy & convenience (Pen Injector); while despite the fact that Tysabri¡¦s (natalizumab/VLA-4) safety will dampen initial uptake, the product¡¦s novel mechanism and efficacy could enable it to capture share within the more severe patient segment. Cimzia¡¦s (certolizumab pegol) 2007 planned launch may be postponed due to FDA regulatory delays, forcing UCB Pharma to conduct an additional study-and making a 2008 launch much more plausible.

Ulcerative Colitis Market

Similarly, the competitive landscape for Ulcerative Colitis (UC) treatments has the potential to shift over the next 2-4 years as more products are undergoing late-phase clinical trials in an attempt to maximize exposure in the IBD therapeutic area and garner share from UC market-leader Remicade. In particular, competitive threats to Remicade may come from programs including; Humira & Orencia recently initiated large phase III studies in moderate-to-severe UC, Tysabri is expected to commence trials in UC in 2007, and novel pipeline programs such as Nuvion (visilizumab) continue to progress.

Scope of Report

The scope of this report will concentrate on the Research & Development (R&D) competitive landscape for moderate-to-severe CD & UC therapeutics. The focus of the intelligence is on the clinical elements of competitive products from a clinical perspective; which provides insight into the strategic opportunities and challenges facing drug developers and marketers. Specifically, the focus of our analysis is on the clincial trial protocol designs and data results for 15 compounds in phase II or beyond that have the potential to alter the market dynamics in IBD over the next 5-7 years.

Section 1: Executive Summary: Scope of Assessment; Overview of Competitive Landscape for IBD; Products Profiled in IBD Clinical Intelligence Report; Snap-Shot of Ongoing Clinical Trials in Crohn’s Disease and Ulcerative Colitis; Ongoing Clinical Trials-Key Players in IBD; Key Competitor Product Profiles; Key Competitor Filing and Approval Timeline; Overview of Key Competitor Pivotal Trial Designs; Analysis of Study Time-to-Complete & Number of Patients for Pivotal Trials in Crohn’s Disease
Section 2: The Market Leader-Remicade: Product Overview—Competitor Snapshot; Remicade’s Path-to-Market & Development Timeline
Remicade (Infliximab) Crohn’s Disease: Phase I Study: Design & Results Overview; Phase II (Study T11): Design & Results Overview; Phase II Study Design (T16); Phase II Study Design (T16)-Continued; Phase II Study Results (T16); Phase II Study Results (T16): Open Label Analysis; Remicade Phase III Trial Design (ACCENT-1); Remicade Phase III Trial Results (ACCENT-1); Phase III Trial Design (ACCENT-2); Remicade Phase III Trial Results (ACCENT-2); Remicade Study Design in Pediatric Patients Crohn’s Disease; Remicade Study Results in Pediatric Patients with Crohn’s Disease; Ongoing Studies Industry-sponsored with Remicade Clinical in Crohn’s Disease; Ongoing Studies Industry-sponsored with Remicade in Crohn’s Disease
Remicade (Infliximab) Ulcerative Colitis: Phase III Trial Design (ACT-1 & ACT-2); Phase III Trial Results (ACT-1); Phase III Trial Results (ACT-2); Phase III Trial Results (ACT-1 & ACT-2); Ongoing Studies with Remicade in Ulcerative Colitis
Section 3: Current & Future Competitors in IBD
Humira (Adalimumab) Crohn’s Disease: Humira Product Overview—Competitor Snapshot; Phase II Study Design and Results; Phase II Study Design; Phase II Study Results; Phase II Study Design & Results; Phase III Study Design (CHARM); Phase III Study Results (CHARM); Phase III Study Design (CLASSIC I & II); Phase III Study Results (CLASSIC-1 & CLASSIC-2); Phase III Study Results (CLASSIC-2); Phase III Study Design (GAIN); Phase III Study Results (GAIN); Ongoing Studies in Crohn’s Disease; Ongoing Phase III Study in Crohn’s Disease
Humira (Adalimumab) Ulcerative Colitis: Phase II/III Ongoing Study
Cimzia (certolizumab) Crohn’s Disease: Product Overview: Competitor Snapshot; Phase III Study Design (PRECiSE 1&2); Phase III Study Results (PRECiSE 1&2); Ongoing Studies in Crohn’s Disease
Tysabri (natalizumab) Crohn’s Disease: Product Overview—Competitor Snapshot; Phase II Study Design; Phase II Study Results; Phase III Study Design (ENACT-1); Phase III Study Results (ENACT-1); Phase III Study Design (ENACT-2); Phase III Study Results (ENACT-2); Phase III Study Design (ENCORE); Phase III Study Results (ENCORE)
Orencia (abatacept) Crohn’s Disease: Orencia Product Overview: Competitor Snapshot; Orencia Phase III Study Design
Orencia (abatacept) Ulcerative Colitis: Orencia Phase III Study Design
Nuvion (Visilizumab) Ulcerative Colitis: Nuvion Product Overview: Competitor Snapshot; Nuvion Phase I/II Study Design & Results; Nuvion Ongoing Phase II/III Study in Ulcerative Colitis; Nuvion Ongoing Studies in Ulcerative Colitis
Section 4: Products to Watch
Rituxan (rituximab) Ulcerative Colitis: Rituxan: Product Overview: Competitor Snapshot; Rituxan Phase II/III Ongoing Study Design
ABT-874 Crohn’s Disease: ABT-874 Product Overview: Competitor Snapshot; ABT-874 Phase II Study Design; ABT-874 Phase II Study Results
MLN-02 Ulcerative Colitis: MLN02: Product Overview—Competitor Snapshot; MLN-02 Phase II Study Design; MLN-02 Phase II Study Results
Traficet-EN (CCX282-B) Crohn’s Disease: Traficet-EN Product Overview-Competitor Snapshot; Traficet-EN Phase II Study Design; Traficet-EN Phase II Study Results; Traficet-EN Ongoing Study in Crohn’s Disease
Firategrast (683699) Crohn’s Disease: Firategrast Product Overview: Competitor Snapshot; Firategrast Phase II Study Design
MDX-1100 Crohn’s Disease: MDX-1100 Product Overview: Competitor Snapshot; MDX-1100 Ongoing Study in Crohn’s Disease; MDX-1100 Ongoing Study in Crohn’s Disease (con’t)
Section 5: On the Radar-Future Development Plan Uncertain
AZD-9056 IBD (Undisclosed): AZD-9056 Product Overview: Competitor Snapshot; AZD-9056 Ongoing Study (POPCORN)
Semapimod (CNI-1493) Crohn’s Disease: Semapimod Product Overview: Competitor Snapshot; Semapimod (CNI-1493) Clinical Trials:
RDP-58: RDP58 Product Overview: Competitor Snapshot; RDP-58 Phase II Clinical Trial Design & Results- Ulcerative Colitis
Section 6: APPENDIX: References; References (Continued); Disclaimer; Report Licensing
Figures: Figure 1: Overview of IBD Competitive Landscape; Figure 2: Snap-Shot of Ongoing Clinical Trials in IBD; Figure 3: Ongoing Studies of Key Players in IBD; Figure 4: Key Competitor Filings & Approval Timeline; Figure 5: Analysis of Study Time-to-Complete for Pivotal Trials in Crohn’s Disease; Figure 6: Trial Sizes—Total Number of Patients in Pivotal Studies
Tables (Section 1 Only): Table 1: Products Profiled in the Report; Table 2: Key Competitor Product Profiles; Table 3: Overview of Key Competitor Pivotal Trial Designs

Therapeutic Clinical Intelligence-Inflammatory Bowel Disease

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