Therapeutic Clinical Intelligence - Multiple Sclerosis Volume II

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