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This BCC Research study offers an overview of the multiple sclerosis (MS) disease-modifying product market, including regulatory issues accompanied by detailed analyses and forecasts by product. Its main objective is to present a comprehensive analysis of the current market for MS disease-modifying products and to forecast this market’s future direction through 2018. Special focus is placed on how new products and technologies will affect current market leaders in the MS treatment sector. Profiles of the many emerging competitors in this sector provide a comprehensive assessment of the various products and technologies entering this market as well as marketing strategies being used to gain a competitive edge.

Use this report to:
- Receive a comprehensive analysis of the current market for MS disease-modifying products and the market's future direction.
- Receive information on various types of MS therapies.
- Receive information about international aspects and regulatory issues of the industry.
- Receive administration profiles of therapies approved to treat MS.

Highlights
- The global market for Multiple Sclerosis (MS) disease-modifying products reached $10.1 billion in 2012 and nearly $10.9 billion in 2013. This market is expected to grow to nearly $14.2 billion in 2018 with a compound annual growth rate (CAGR) of 5.4% over the five-year period from 2013 to 2018.
- Biologics, as a segment, reached $6.3 billion in 2013. The segment is expected to decline to nearly $5.3 billion in 2018, with a CAGR of -3.5% over the five-year period from 2013 to 2018.
- Small molecules, as a segment, reached nearly $4.6 billion in 2013. The segment is projected to grow to nearly $8.9 billion in 2018, with a CAGR of 14.2% over the five-year period from 2013 to 2018.

INTRODUCTION

STUDY GOALS AND OBJECTIVES
BCC Research’s goal in conducting this study was to determine the current status of the market for disease-modifying multiple sclerosis (MS) drugs, biologics and vaccines,
and to assess their growth potential over a five-year period from 2013 through 2018. MS is an autoimmune disease characterized by the body’s own immune system
attacking itself and causing spots of demyelination (plaques) in the brain and spinal cord. Symptoms of MS vary widely depending on the severity of the disease and which
nerve cells are attacked. Today there are currently eight disease-modifying therapies for MS approved throughout the world. Biologics represent the largest class of MS
disease-modifying therapies by sales and by number of approved therapies, accounting for six out of the eight approved MS disease-modifying products (Avonex, Betaseron,
CinnoVex, Extavia, Rebif and Tysabri). Of these biologics, five are beta interferon products. All of these approved MS agents are able to slow down the progression of the
disease but none can reverse any nerve damage that occurs due to demyelination. The initial 2004 Food and Drug Administration (FDA) approval of Biogen Idec’s and
Elan’s Tysabri marked the approval of the first therapeutic for MS that may actually reverse some of the effects of MS.

We were particularly interested in profiling small molecule drugs, therapeutic vaccines and other biologics targeting MS that are in Phase II or III clinical studies, or those with
unique mechanisms of action in earlier stages of development. We identify the leading MS treatments by formulation, by mechanism of action and by geographic location. In
some cases, we discuss notable compounds that failed in clinical testing, such as Roche and Biogen Idec’s Rituxan (rituximab), or that were pulled from the market due
to adverse event or other issues. We also discuss the potential of some compounds that are being tested for other inflammatory or autoimmune disorders that could in the
future potentially be tested as a treatment for or used off-label for MS.Our main objective is to present a comprehensive analysis of the current market for MS
disease-modifying products and to forecast this market’s future direction through 2018.

REASONS FOR DOING THIS STUDY
Disease-modifying agents to treat MS are currently one of the largest classes of pharmaceutical products by sales in the U.S. and throughout the world. Sales of these
agents for MS have grown from less than $1 billion worldwide in 1999 to around $11 billion in 2013. New approaches to treating MS are being pursued by pharmaceutical and biotech companies as many of them look to move beyond agents such as the interferons that primarily slow the progression of MS. These potential new disease-modifying agents with novel mechanisms of action or improved delivery systems will provide powerful new options for patients failing or intolerable to the currently prescribed treatments for MS.

INTENDED AUDIENCE
We have compiled detailed profiles of the MS disease-modifying products on the market in the U.S. and around the world. We discuss all disease-modifying products in
the Phase I, II and III stages of clinical development and some unique treatments in the preclinical stage of development as well. This study includes technical descriptions of
these products, discussion of their individual efficacy and side effect profiles when possible, what stage of the disease they treat, the major companies focusing on their
development, and international aspects affecting these products. We provide sales forecasts and the reasoning behind our forecasts for products that are on the market
already or that may enter the market through 2018.

This study will be of interest to members of the pharmaceutical, healthcare and biotechnology industries. It will also be a valuable resource for investors that invest in
the pharmaceutical sector. It is written in such a way as to be accessible to an investor or businessperson while maintaining a high level of technical detail.

SCOPE OF REPORT
The emphasis of this report is on these products and about 39 products for MS in various stages of clinical development. Special focus is placed on how new products and technologies will affect current market leaders in the MS treatment sector. Profiles are provided of companies projected to have disease-modifying products on the market during the forecast period and on companies with rich or interesting pipelines.

The study is arranged to offer an overview of the MS disease-modifying product market, including regulatory issues, and accompanied by detailed analyses and forecasts by
product. Profiles of the many emerging competitors in this sector provide a comprehensive assessment of the various products and technologies entering this
market as well as marketing strategies being used to gain a competitive edge.

METHODOLOGY
The market assessments in this report have been assembled based on publicly available information through July 2013. The base year for the report for forecasting purposes is 2013 and forecast data is provided through 2018. Market figures are based on current dollars, and inflation (outside of its effects on drug pricing) is not computed
into the projected forecast figures. MS disease-modifying product development is still evolving as new immunomodulatory treatments are discovered, and other targets prove to be futile in development. The reader is cautioned to use the report data primarily as a guide to assess trends, developments and challenges that the industry faces.

Table Of Contents

Multiple Sclerosis (MS) Drugs and Biologics : Technologies and Global Markets
TABLE OF CONTENTS

CHAPTER 1 INTRODUCTION 2
STUDY GOALS AND OBJECTIVES 2
REASONS FOR DOING THIS STUDY 2
INTENDED AUDIENCE 3
SCOPE OF REPORT 3
METHODOLOGY 3
INFORMATION SOURCES 4
ANALYST'S CREDENTIALS 4
RELATED BCC RESEARCH REPORTS 4
BCC RESEARCH WEBSITE 4
DISCLAIMER 4

CHAPTER 2 SUMMARY 6
SUMMARY TABLE A GLOBAL MARKET FOR MS DISEASE-MODIFYING PRODUCTS,
THROUGH 2018 ($ MILLIONS) 7
SUMMARY FIGURE GLOBAL MARKET FOR THERAPIES TREATING MS, 2011-2018 ($
MILLIONS) 7
SUMMARY TABLE B GLOBAL MARKET FOR MS DISEASE-MODIFYING THERAPIES, BY
REGION, THROUGH 2018 ($ MILLIONS) 8

CHAPTER 3 OVERVIEW 10
DISEASE CHARACTERISTICS 10
HISTORY AND DISCOVERY OF MS 10
SYMPTOMS OF MS 11
PREVALENCE AND INCIDENCE OF MS 11
TABLE 1 MS STATISTICS FROM AROUND THE WORLD, 2013 12
DIAGNOSIS OF MS 12
TYPES OF MS 14
PROGNOSIS 15
TREATMENTS FOR MS 15
TYPES OF MS THERAPIES 15
TABLE 2 CURRENTLY APPROVED MS THERAPIES ON THE MARKET 16
TABLE 3 FEATURES OF SMALL MOLECULE VERSUS BIOLOGIC MS
DISEASE-MODIFYING THERAPIES 17
TABLE 4 WHOLESALE ACQUISITION COST OF SELECTED THERAPIES FOR MS, 2013
($ MILLIONS) 18
TARGETS OF MS THERAPIES 18
VLA-4 (CD49D AND CD29) 18
S1P 19
CD20 19
IL-2 (CD25, CD122 AND CD132) 19
MYELIN BASIC PROTEIN-REACTIVE T-CELLS 20
SIDE EFFECTS OF MS THERAPIES 20
TABLE 5 COMPARISON OF SIDE-EFFECT PROFILES OF MARKETED AND
LATE-CLINICAL STAGE THERAPIES FOR MS 20
MS THERAPIES IN CLINICAL DEVELOPMENT 21
TABLE 6 MS THERAPIES IN CLINICAL TRIALS, ORDERED BY PHASE 21
TABLE 7 MS THERAPIES IN DEVELOPMENT, BY PHASE 22
TABLE 8 MS THERAPIES IN ACTIVE CLINICAL TRIALS BY PRIMARY TARGET 23
TABLE 9 COMPANIES WITH MORE THAN ONE MS THERAPY IN ACTIVE CLINICAL
TRIALS OR ON THE MARKET 23
CLINICAL TRIAL EFFICACY OUTCOME MEASUREMENTS IN MS STUDIES 23
Relapse Rate 24
EDSS 24
Gadolinium-enhanced (GdE) Lesions on MRI 24
TABLE 10 EFFICACY RESULTS OF MS DISEASE-MODIFYING THERAPIES 25

CHAPTER 4 TECHNOLOGY 27
OVERVIEW 27
TABLE 11 GLOBAL SALES OF MS DISEASE-MODIFYING THERAPIES BY
FORMULATION, THROUGH 2018 ($ MILLIONS) 27
TABLE 12 ADMINISTRATION PROFILES OF THERAPIES APPROVED TO TREAT MS 28

CHAPTER 5 PATENT EVALUATION 30
PATENT LENGTH AND MARKET EXCLUSIVITY 30
ORPHAN DRUG EXCLUSIVITY 30
TABLE 13 U.S. PATENT EXPIRATION DATES OF THERAPIES FOR MS ON THE MARKET
OR IN PHASE III DEVELOPMENT 31
TABLE 14 PATENT APPLICATIONS 32
TABLE 15 ISSUED PATENTS 47
TABLE 16 PATENT ASSIGNEES (NUMBER OF PATENTS) 56

CHAPTER 6 SMALL MOLECULE MS DRUGS 64
MARKET OVERVIEW 64
TABLE 17 GLOBAL MARKET FOR SMALL MOLECULE MS DISEASE-MODIFYING
DRUGS BY INDIVIDUAL DRUG, THROUGH 2018 ($ MILLIONS) 64
SMALL MOLECULE MS DISEASE-MODIFYING DRUGS 65
COPAXONE (GLATIRAMER ACETATE, COPOLYMER 1) 65
TABLE 18 COPAXONE PIVOTAL STUDY RESULTS 66
NOVANTRONE (MITOXANTRONE) 67
GILENYA (FINGOLIMOD, FTY720) 68
TABLE 19 GILENYA PIVOTAL PHASE III STUDY RESULTS 69
AUBAGIO (TERIFLUNOMIDE) 70
TABLE 20 AUBAGIO PHASE III STUDY RESULTS FROM TEMSO AND TEMPO 70
TECFIDERA (DIMETHYL FUMARATE) 70
TABLE 21 TECFIDERA GLOBAL PHASE III CLINICAL PROGRAM 71
FIRATEGRAST (SB683699, T-0047) 72
SIPONIMOD (BAF312) 73
ONO-4641 73
ACT-128800 73
MASITINIB 74
TRIMESTA (ESTRIOL) 74
MN-166 75

CHAPTER 7 BIOLOGICS FOR MS 77
TABLE 22 GLOBAL MARKET FOR BIOLOGICS FOR MS BY INDIVIDUAL DRUGS,
THROUGH 2018 ($ MILLIONS) 77
TABLE 23 BIOLOGICS FOR MS BY CLASS 77
MABS ANTIBODIES FOR MS 78
TABLE 24 BENEFITS AND CHARACTERISTICS OF MABS 78
TABLE 25 SELECTED ANTIBODIES IN DEVELOPMENT FOR MS 79
TYSABRI (NATALIZUMAB) 79
TABLE 26 TYSABRI SENTINEL AND AFFIRM STUDY RESULTS 80
ZENAPAX (DACLIZUMAB) 81
TABLE 27 DACLIZUMAB CHOICE STUDY RESULTS 83
OCRELIZUMAB (RG1594) 84
ARZERRA (OFATUMUMAB) 84
AIN457 85
LY2127399 85
BIIB033 86
INTERFERON BETAS 86
BETASERON, BETAFERON (INTERFERON BETA-1B, BAY86-5046) 87
TABLE 28 TWO-YEAR BETASERON RRMS STUDY RESULTS 88
TABLE 29 THREE-YEAR BETASERON RRMS STUDY RESULTS 89
AVONEX (INTERFERON BETA-1A) 89
TABLE 30 AVONEX PIVOTAL PHASE III STUDY RESULTS 90
REBIF (INTERFERON BETA-1A) 91
EXTAVIA (INTERFERON BETA-1B) 92
CINNOVEX (INTERFERON BETA-1A) 93
PEG INTERFERON BETA-1A (BIIB017) 93
THERAPEUTIC VACCINES 94
TCELNA (FORMERLY KNOWN AS TOVAXIN) 95
ATX-MS-1467 95
RTL1000 96
BHT-3009 96
ATL1102 (FORMERLY TV-1102) 97

CHAPTER 8 DISEASE APPLICATIONS 99
OVERVIEW 99
TABLE 31 LABELS OF APPROVED DISEASE MODIFYING THERAPIES FOR MS 100
MS SUBGROUPS 103
RRMS 103
SPMS 103
PPMS 104
PRMS 105
THE MARKET FOR MS THERAPIES BY MS DISEASE SUBGROUP CLASSIFICATION 105

CHAPTER 9 COMPANY PROFILES 107
AB SCIENCE 107
AB SCIENCE USA 107
ABBVIE 107
ACORDA THERAPEUTICS INC. 108
ACTELION 108
ACTIVE BIOTECH 109
ANTISENSE THERAPEUTICS 109
APITOPE 110
ARTIELLE IMMUNOTHERAPEUTICS 111
BAYER AG 111
BAYER (U.S. LOCATION) 111
BAYHILL THERAPEUTICS 112
BIOGEN IDEC 113
CINNAGEN 114
DAIICHI SANKYO 114
ELI LILLY 115
FAST FORWARD LLC 115
FIVE PRIME THERAPEUTICS 116
GENMAB 116
GENMAB (U.S. LOCATION) 116
GENZYME 117
GLAXOSMITHKLINE 117
GLAXOSMITHKLINE (U.S. LOCATION) 118
GW PHARMACEUTICALS 118
INNATE IMMUNOTHERAPEUTICS 118
AUSTRALIAN OFFICE 118
NEW ZEALAND OFFICE 119
MEDICINOVA 119
MERCK KGAA (MERCK SERONO) 120
MITSUBISHI TANABE PHARMA 120
NOVARTIS 121
ONO PHARMA 121
OPEXA THERAPEUTICS 122
PFIZER 122
ROCHE 123
SANOFI-AVENTIS 123
SYNTHETIC BIOLOGICS 124
TEVA PHARMACEUTICAL INDUSTRIES 124

CHAPTER 10 INTERNATIONAL ASPECTS AND REGULATORY ISSUES 126
MARKET BY REGION 126
TABLE 32 GLOBAL FORECAST FOR MS DISEASE-MODIFYING THERAPIES BY REGION,
THROUGH 2018 ($ MILLIONS) 126
UNITED STATES 127
The FDA Modernization Act of 1997 127
Fast-Track Status 127
Special Protocol Assessments 128
New Surveillance and Safety Requirements 128
Approvable Letters 129
Consumer Confidence 129
Medicare 130
Other Healthcare Changes 130
EUROPEAN UNION 131
New Drug Approvals and Innovation 131
Drug Reimbursement and Reference Pricing 132
Relocation of RandD 133
JAPAN 133
New Drug Approvals 133
Regulatory Climate 134
Relationship between Academia and Industry 135

CHAPTER 11 FUTURE DIRECTIONS 137
UNMET NEED STILL REMAINS HIGH 137
PATENT EXPIRIES AND PRICING PRESSURE MAY RESTRAIN THE MARKET
GROWTH 137
DEVELOPMENT OF TREATMENT OPTIONS FOR THE PROGRESSIVE FORMS OF MS
HAS THE POTENTIAL TO EXPAND AND GROW THE MARKET 138
THE ROLE OF BIOMARKERS AND PHARMACOGENOMICS 139
COMBINATION THERAPIES 140


LIST OF TABLES

SUMMARY TABLE A GLOBAL MARKET FOR MS DISEASE-MODIFYING PRODUCTS,
THROUGH 2018 ($ MILLIONS) 7
SUMMARY TABLE B GLOBAL MARKET FOR MS DISEASE-MODIFYING THERAPIES, BY
REGION, THROUGH 2018 ($ MILLIONS) 8
TABLE 1 MS STATISTICS FROM AROUND THE WORLD, 2013 12
TABLE 2 CURRENTLY APPROVED MS THERAPIES ON THE MARKET 16
TABLE 3 FEATURES OF SMALL MOLECULE VERSUS BIOLOGIC MS
DISEASE-MODIFYING THERAPIES 17
TABLE 4 WHOLESALE ACQUISITION COST OF SELECTED THERAPIES FOR MS, 2013 ($
MILLIONS) 18
TABLE 5 COMPARISON OF SIDE-EFFECT PROFILES OF MARKETED AND
LATE-CLINICAL STAGE THERAPIES FOR MS 20
TABLE 6 MS THERAPIES IN CLINICAL TRIALS, ORDERED BY PHASE 21
TABLE 7 MS THERAPIES IN DEVELOPMENT, BY PHASE 22
TABLE 8 MS THERAPIES IN ACTIVE CLINICAL TRIALS BY PRIMARY TARGET 23
TABLE 9 COMPANIES WITH MORE THAN ONE MS THERAPY IN ACTIVE CLINICAL
TRIALS OR ON THE MARKET 23
TABLE 10 EFFICACY RESULTS OF MS DISEASE-MODIFYING THERAPIES 25
TABLE 11 GLOBAL SALES OF MS DISEASE-MODIFYING THERAPIES BY FORMULATION,
THROUGH 2018 ($ MILLIONS) 27
TABLE 12 ADMINISTRATION PROFILES OF THERAPIES APPROVED TO TREAT MS 28
TABLE 13 U.S. PATENT EXPIRATION DATES OF THERAPIES FOR MS ON THE MARKET
OR IN PHASE III DEVELOPMENT 31
TABLE 14 PATENT APPLICATIONS 32
TABLE 15 ISSUED PATENTS 47
TABLE 16 PATENT ASSIGNEES (NUMBER OF PATENTS) 56
TABLE 17 GLOBAL MARKET FOR SMALL MOLECULE MS DISEASE-MODIFYING DRUGS
BY INDIVIDUAL DRUG, THROUGH 2018 ($ MILLIONS) 64
TABLE 18 COPAXONE PIVOTAL STUDY RESULTS 66
TABLE 19 GILENYA PIVOTAL PHASE III STUDY RESULTS 69
TABLE 20 AUBAGIO PHASE III STUDY RESULTS FROM TEMSO AND TEMPO 70
TABLE 21 TECFIDERA GLOBAL PHASE III CLINICAL PROGRAM 71
TABLE 22 GLOBAL MARKET FOR BIOLOGICS FOR MS BY INDIVIDUAL DRUGS,
THROUGH 2018 ($ MILLIONS) 77
TABLE 23 BIOLOGICS FOR MS BY CLASS 77
TABLE 24 BENEFITS AND CHARACTERISTICS OF MABS 78
TABLE 25 SELECTED ANTIBODIES IN DEVELOPMENT FOR MS 79
TABLE 26 TYSABRI SENTINEL AND AFFIRM STUDY RESULTS 80
TABLE 27 DACLIZUMAB CHOICE STUDY RESULTS 83
TABLE 28 TWO-YEAR BETASERON RRMS STUDY RESULTS 88
TABLE 29 THREE-YEAR BETASERON RRMS STUDY RESULTS 89
TABLE 30 AVONEX PIVOTAL PHASE III STUDY RESULTS 90
TABLE 31 LABELS OF APPROVED DISEASE MODIFYING THERAPIES FOR MS 100
TABLE 32 GLOBAL FORECAST FOR MS DISEASE-MODIFYING THERAPIES BY REGION,
THROUGH 2018 ($ MILLIONS) 126


LIST OF FIGURES

SUMMARY FIGURE GLOBAL MARKET FOR THERAPIES TREATING MS, 2011-2018 ($
MILLIONS) 7

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