IntroductionSales of multiple sclerosis disease-modifying therapies exceeded $6.0 billion in 2008 across the seven major markets (US, Japan, France, Germany, Italy, Spain and the UK). Datamonitor anticipates the combination of continuing strong historical growth dynamics and the uptake of the first oral therapies to result in the market value peaking at $8.4 billion in 2013 before the advent of biosimilars.Scope*Analysis of multiple sclerosis diagnosis, treatment, prevalence trends, and key unmet market needs.*Review of the late-stage disease-modifying multiple sclerosis pipeline, including analysis of key R&D company strategies.*In depth analysis of historic (2004-08) and future (2009-2018) seven major market sales value dynamics.*Commercial and clinical assessment of key late-stage pipeline drugs, with key opinion leader comment and region-specific sales forecasts to 2018.HighlightsAlthough there are number of exciting developments present in the late-stage pipeline, the risk-benefit ratio of the leading candidates remains uncertain. In a situation reminiscent of Tysabri (natalizumab, Biogen Idec/Elan), potent efficacy has been accompanied by an increased risk of adverse events compared to first-line currently marketed drugs.With impressive efficacy data, and despite incidents of malignancies, Datamonitor expects the two most advanced oral developments, Mylinax (oral cladribine; Merck Serono) and fingolimod (FTY720; Novartis) to become first-line therapies. With seven major market sales of $1.2 billion, fingolimod is forecast to become the new market leader in 2018.Late-stage trial results suggest that Campath (alemtuzumab; Genzyme/Bayer Schering) is the most efficacious MS treatment to date. With the final positioning strategy unclear, Datamonitor believes Campath is most likely to be restricted to the short-term treatment of severe early cases and rapidly-progressive forms of MS because of safety concerns.Reasons to Purchase*Analyze competitive environment at time of product launch.*Validate internal forecasts and market potential for pipeline products.*Identify licensing opportunities based on company portfolio and market needs.

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Pipeline Insight: Multiple Sclerosis - Risk-benefit ratio under the
spotlight for potent pipeline drugs
Published on December 2009
Report Summary
Introduction
Sales of multiple sclerosis disease-modifying therapies exceeded $6.0 billion in 2008 across the seven major markets (US, Japan,
France, Germany, Italy, Spain and the UK). Datamonitor anticipates the combination of continuing strong historical growth dynamics
and the uptake of the first oral therapies to result in the market value peaking at $8.4 billion in 2013 before the advent of biosimilars.
Scope
*Analysis of multiple sclerosis diagnosis, treatment, prevalence trends, and key unmet market needs.
*Review of the late-stage disease-modifying multiple sclerosis pipeline, including analysis of key R&D company strategies.
*In depth analysis of historic (2004-08) and future (2009-2018) seven major market sales value dynamics.
*Commercial and clinical assessment of key late-stage pipeline drugs, with key opinion leader comment and region-specific sales
forecasts to 2018.
Highlights
Although there are number of exciting developments present in the late-stage pipeline, the risk-benefit ratio of the leading candidates
remains uncertain. In a situation reminiscent of Tysabri (natalizumab, Biogen Idec/Elan), potent efficacy has been accompanied by an
increased risk of adverse events compared to first-line currently marketed drugs.
With impressive efficacy data, and despite incidents of malignancies, Datamonitor expects the two most advanced oral developments,
Mylinax (oral cladribine; Merck Serono) and fingolimod (FTY720; Novartis) to become first-line therapies. With seven major market
sales of $1.2 billion, fingolimod is forecast to become the new market leader in 2018.
Late-stage trial results suggest that Campath (alemtuzumab; Genzyme/Bayer Schering) is the most efficacious MS treatment to date.
With the final positioning strategy unclear, Datamonitor believes Campath is most likely to be restricted to the short-term treatment of
severe early cases and rapidly-progressive forms of MS because of safety concerns.
Reasons to Purchase
*Analyze competitive environment at time of product launch.
*Validate internal forecasts and market potential for pipeline products.
*Identify licensing opportunities based on company portfolio and market needs.
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Table of Content
TABLE OF CONTENTS
Overview 1
Catalyst 1
Summary 1
ABOUT DATAMONITOR HEALTHCARE 2
About the central nervous system pharmaceutical analysis team 2
Executive Summary 3
Strategic scoping and focus 3
Datamonitor insight into the multiple sclerosis market 3
Related reports 4
1. Pipeline Overview and Dynamics 8
Key findings 8
Pipeline overview 9
Classification of pipeline products 10
Key companies involved in the multiple sclerosis pipeline 14
Key R&D company strategies 15
2. Disease Overview ' Market Potential 18
Key findings 18
Definition 19
Patient segmentation 19
Epidemiology 20
Current treatment options 27
Current gold standard and comparator therapies 28
Current market overview 29
Unmet need in multiple sclerosis 32
Target product profile versus current level of attainment 38
3. R&D Approach 39
Key findings 39
Clinical trial design in multiple sclerosis 40
Clinical trial endpoints in multiple sclerosis 41
Typical multiple sclerosis clinical trial 46
4. Pipeline Analysis & Forecasts: Prevention of Immunoactivation 47
Key findings 47
Overview for prevention of immunoactivation 48
Panaclar (dimethyl fumarate; Biogen Idec) 50
Laquinimod (ABR216062; Teva Pharmaceuticals) 60
Zenapax (daclizumab; Facet Biotech/Biogen Idec) 69
BIIB017 (PEGylated interferon beta-1a; Biogen Idec) 77
Late-stage development compounds recently discontinued 80
5. Pipeline Analysis & Forecasts: Lymphocyte Trafficking 81
Key findings 81
Overview for lymphocyte trafficking therapies 82
Fingolimod (FTY720; Novartis) 84
Late-stage development compounds recently discontinued 96
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6. Pipeline Analysis & Forecasts: Lymphocyte Depletion 97
Key findings 97
Overview for lymphocyte depletion therapies 98
Mylinax (Oral cladribine; Merck Serono) 100
Teriflunomide (HMR1726; Sanofi-Aventis) 111
Campath (alemtuzumab; Genzyme/Bayer Schering) 122
Ocrelizumab (R15-2477; Roche [Genentech]/Biogen Idec) 130
Tovaxin (Opexa Therapeutics) 137
Late-stage development compounds recently discontinued 141
7. Innovative Early-Stage Approaches 142
Key findings 142
The future of treatment in multiple sclerosis 143
Innovative early-stage approaches 144
Key early-stage compounds in multiple sclerosis 148
Bibliography 149
Journal papers 149
Websites 151
Datamonitor reports 155
Other sources 155
APPENDIX 156
Methodology 156
Contributing experts 157
About Datamonitor 158
Datamonitor consulting 159
Disclaimer 161
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