Market Report Source

Overview

Overview of Clinical Intelligence Report Series

Austin Research Analytics Group’s (ARAG) Clinical Intelligence Report Series provides clients within the pharmaceutical and biotechnology industry with detailed competitive information to facilitate key analysis and decision-making. Clients utilize the report as an 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

Reports contain synthesized information and analysis of clinical development activities for key marketed and pipeline products within multiple therapeutic categories and generally include the following data points:

• Product Overview: Mechanism of Action, Developing Companies, Indications and Phase of Development.
• 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

What’s New in Volume II

• Campath Phase 2 3-year data
• CDP-323 Phase 2 study design
• Teriflunomide Phase 3 study designs
• Laquinimod Phase 3 design
• MN-166 Phase 2 study results
• Rituxan Phase 2 RRMS study results
• Daclizumab Phase 2 study results
• CNTO-1275 Phase 1 study results
• BHT-3009 Safety Results
• AZD-9504 Product SnapShot & Preclinical data

Table of Contents

Section 1: Executive Summary
Multiple Sclerosis Disease Overview
Multiple Sclerosis Disease Epidemiology
MS Market Overview: Clinical Courses of MS
MS Patient Population
Unmet Needs in MS treatment market
MS Competitive Landscape-Oral Challengers Inevitable
Market Leaders will see new challengers enter the market over the next 2-5 years.
Overview of Competitive Landscape: Trends & Observations
Definitions and Terminology
Overview of MS Clinical Trial Designs
MS Pivotal Trial Sizes: Observations & Trends
Overview of Competitive Landscape: Pipeline Products Profiled in Clinical Intelligence Report
Comparison of product profiles for marketed MS products

Section 2: The Current Market Leaders in Multiple Sclerosis
Worldwide Sales of Marketed MS Therapeutics
Historic Group Share Comparisons
Launch Timelines for MS Competitive Landscape
Avonex (interferon beta-1a)
Product Overview—Competitor Snapshot
Pharmacokinetic Study: Design & Results Overview
Phase III Pivotal Trial Design (Study-1)
Phase III Pivotal Trial Results (Study-1)
Phase III Pivotal Trial Design (Study-2)
Phase III Pivotal Trial Results (Study-2)
Phase III Pivotal Trial: Select Safety Results (Study-1 & 2)
Post-Marketing Study Design (CHAMPS/CHAMPIONS)
Post-Marketing Study Results (CHAMPIONS)
Rebif (interferon beta-1a)
Product Overview—Competitor Snapshot
Phase III Trial Design & Results (Study-1)
Phase III Trial Design & Results (Study-2)
Phase III Efficacy Results (Study-2)
Copaxone (glatiramer acetate)
Product Overview—Competitor Snapshot
Phase III Pivotal Trial Design & Results (Study-1)
Phase III Pivotal Trial Design & Results (Study-2)
Phase III Pivotal Trial Results
Betaseron (interferon beta-1b)
Product Overview—Competitor Snapshot
Phase III Study Design (Study 1)
Phase III Study Results (Study 1)
Phase III Study Design (Study 2&3)
Phase III Study Design & Results (Study 4)
Tysabri (natalizumab)
Product Overview—Competitor Snapshot
Overview of Phase I & Phase II Clinical Trials in MS
Clinical Development Timeline
Overview of Phase III and Additional Clinical Trial in MS
Phase III Pivotal Trials
Phase III Study Design (1801-AFFIRM)
Phase III Study Results (1801-AFFIRM)
Phase III Study Design (1803-SENTINEL)
Phase III Study Results (1803-SENTINEL)
Ongoing Study in MS (Re-Initiation of Dosing)
Ongoing Study in MS (Drug-Clearance)

Section 3: Future Competitive Threats – The Oral Challengers
Fingolimod (FTY-720)
Product Overview: Competitor Snapshot
Phase II Study Design
Phase II Study Results
Phase II Study Results-Reduction in Gd+ Lesions
Phase II Study Results-Reduction in Relapse Rates
Ongoing Study in MS (Heart & Lung Function)
Ongoing Phase II/III Study in MS (Head-to-Head vs. Avonex)
Ongoing Pivotal Phase III Study in MS (U.S.)
Ongoing Pivotal Phase III Study in MS (Europe)
Mylinax (Oral Cladribine)
Product Overview: Competitor Snapshot
Phase II Study Design & Results (IV Formulation)
Phase II Study Design & Results
Ongoing Phase II/III Study in MS (ONWARD-Combination with Rebif)
Ongoing Pivotal Phase III Study in MS (CLARITY)
Teriflunomide
Product Overview: Competitor Snapshot
Phase II Study Design & Results
Ongoing Pivotal Phase III Study in MS (Europe & Canada)
Planned Clinical Trials for Teriflunomide in MS (U.S. Pivotal Study & Combination Trials)
Panaclar/BG-12 (Fumarate)
Product Overview: Competitor Snapshot
Phase II Study Design & Results
Ongoing Pivotal Phase III Study in MS (DEFINE)
Panaclar Ongoing Pivotal Phase III Study in MS (CONFIRM-Comparison to Copaxone)
Laquinimod (SAIK-MS)
Product Overview: Competitor Snapshot
Phase II Study Design & Results
Phase IIb Study Design
CellCept (mycophenolate mofetil)
Product Overview: Competitor Snapshot
Phase II Study Design & Results
Phase II/III Study Design (Ongoing)
Firategrast (683699)
Product Overview: Competitor Snapshot
Phase II Study Design (Ongoing)
CDP-323
Product Overview: Competitor Snapshot
Phase I Study Design & Results
R-3477
R-3477 Product Overview: Competitor Snapshot
MN-166 (Ibudilast)
(Ibudilast) Product Overview: Competitor Snapshot
Pilot Study Design & Results
Phase II Study Design
Pirfenidone
Product Overview: Competitor Snapshot
AZD-4750
Product Overview: Competitor Snapshot
AZD-5940
Product Overview: Competitor Snapshot
R-1295
Product Overview: Competitor Snapshot
CCX-915
Product Overview: Competitor Snapshot
Development Update
RPI 78M
Product Overview: Competitor Snapshot

Section 4: Future Competitive Threats – Monoclonal Antibodies
Rituxan (Rituximab)
Product Overview: Competitor Snapshot
Phase I MS Study Design & Results
Phase II Study Design (HERMES)
Phase II/III Study Design (OLYMPUS)
Campath (alemtuzumab)
Product Overview: Competitor Snapshot
Phase II Study Design (CAMS223- versus Rebif)
ABT-874
Product Overview: Competitor Snapshot
Phase II Study Design (Assumed completed and awaiting results)
Daclizumab
Product Overview: Competitor Snapshot
Phase II Study Design (CHOICE)
MLN-1202
Product Overview: Competitor Snapshot
Phase II Study Design (Assumed completed and awaiting results)
CNTO-1275
Product Overview: Competitor Snapshot
Phase I Study Design & Results
Phase II Study Design
Ocrelizumab
Product Overview: Competitor Snapshot
Section 5: Future Competitive Threats-Other Novel Biologics
MBP-8298
Product Overview: Competitor Snapshot
Phase II Study Design & Results
Phase II/III Study Design (MAESTRO-01**)
Ongoing Phase II Study Design (MINDSET-01)
BHT-3009
Product Overview: Competitor Snapshot
Phase I/II Study Design & Results
RG-2077
Product Overview: Competitor Snapshot
Phase I Study Design
atacicept (TACI-Ig)
Product Overview: Competitor Snapshot
Overview of Molecule & Mechanism of Action

Section 6: APPENDIX
Disclaimer
Report Licensing

Figures (Section 1 & 2 Only)
Figure 1: Multiple Sclerosis Disease Epidemiology
Figure 2: MS Market Overview: Clinical Courses of MS
Figure 3: MS Patient Population
Figure 4: Unmet Needs in MS treatment market
Figure 5: Market Leaders will see new challengers enter the market over the next 2-5 years.
Figure 6: Overview of Competitive Landscape: Trends & Observations
Figure 7: Overview of MS Clinical Trial Designs
Figure 8: Ongoing Clinical Trials in MS: Competitive environment for patient recruitment
Figure 9: Ongoing Clinical Trials in MS: Marketed Products
Figure 10: Worldwide Sales of Marketed MS Therapeutics
Figure 11: Historic Group Share Comparisons
Figure 12: Launch Timelines for MS Competitive Landscape

Tables (Section-1 Only)
Table 1: Overview of Competitive Landscape: Pipeline Products Profiled in Clinical Intelligence Report
Table 2: Comparison of product profiles for marketed MS products