Market Report Source

Overview

Overview of Clinical Intelligence Report Series

ARAG’s Therapeutic Clinical Intelligence Report Series provides clients within the Life-Sciences industry with detailed
competitive information to facilitate analysis of key therapeutics areas. and decision-making. Clients utilize the report as an
essential resource to support decision-making activities 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 of competitors to support “go-no-go” decisions
• Identifying clinical hurdles posed by competitor data and future development plans
• Designing clinical trials more effectively or to facilitate a fast-to-market development scenario

The Clinical Intelligence Reports contain synthesized information and analysis of clinical development programs for select
marketed and pipeline products within multiple a specific therapeutic area.

Each product profiled in the report is presented in a matrix format brief with the following sections and data points:

1) Product Overview:

• Mechanism of Action
• Developing Companies
• Indications and Phase of Development

2) Clinical Trial Assessments: 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

Table of Contents

Secton 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 (Adalimunab) 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) Ullcceerraattiivvee Coolliittiiss
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
Firategraset (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 (CNII—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