治療薬の臨床インテリジェンス：多発性硬化症（Vol.2）

Abstract

Scope of Report

The scope of this report will primarily concentrate on the R&D competitive landscape for Multiple Sclerosis (MS) from a clinical perspective.

This methodological approach is intended to provide insight into the strategic opportunities and challenges, as well as the clinical hurdles facing MS drug developers.

Specifically, the focus of our analysis is on the clinical trial design and data results for compounds in phase II or beyond that have the potential to alter the market dynamics in MS over the next 3-7 years.

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
• Comparison of product profiles of key late-stage competitors in the pipeline for MS
• Ongoing Clinical Trials in MS: Competitive environment for patient recruitment
• Ongoing Clinical Trials in MS: Marketed 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