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CNS Drug Discoveries: Multiple Sclerosis Chapter
Espicom Business Intelligence Ltd, Aug 2008, Pages: 128
Multiple Sclerosis 1
EXECUTIVE SUMMARY 1
THE FACTS 2
What is multiple sclerosis and why are we interested in it? 2
PATIENT STATISTICS 4
Incidence, diagnosis rates and treatment; now and in the future .4
MS Categories 5
Types of MS 6
PATIENT MODEL 7
The treatable MS patient population will have a CAGR 2007E-2014E - 2.5 per cent .7
Summary of Patient Population Forecasts (2007A-2014E) .7
Model Assumptions .7
DRUG GROWTH DRIVERS 8
DRUG GROWTH RISKS/DAMPENERS 10
THE MS MARKET 11
Global CNS Market (US$91.9 billion) .11
The Major Players 12
Market Share of Major MS Players by Sales (Dec 2007A) 12
Players and Products in 2007 13
Players and Products in 2014 14
CURENT MS TREATMENTS 16
Leading Brands 17
Comparison of Leading MS Agents 17
Current Products' Patent Exposure 18
Patent Exposure of Leading MS Brands 19
ANALYSIS OF LEADING BRANDS 20
Disease-modifying Agents 21
Avonex 21
Novelty/rationale for mechanism of action 21
Proof of concept/clinical data .21
Management/clinical expertise .22
Competition within the market-place/gaining share of voice 22
Risks associated with developing a drug within a therapeutic class 23
Filings and approval .23
Sales forecasts and assumptions 23
Competitor ratio analysis 24
Betaferon/Betaseron .25
Novelty/rationale for mechanism of action 25
Proof of concept/clinical data .25
Management/clinical expertise .26
Competition within the market-place/gaining share of voice 27
Risks associated with developing a drug within a therapeutic class 27
Filings and approval .28
Sales forecasts and assumptions 28
Competitor ratio analysis 29
Copaxone 30
Novelty/rationale for mechanism of action 30
Proof of concept/clinical data .30
Management/clinical expertise .31
Competition within the market-place/gaining share of voice 31
Risks associated with developing a drug within a therapeutic class 32
Filings and approval .33
Sales forecasts and assumptions 33
Competitor ratio analysis 34
Rebif .35
Novelty/rationale for mechanism of action 35
Proof of concept/clinical data .35
Management/clinical expertise .36
Competition within the market-place/gaining share of voice 36
Risks associated with developing a drug within a therapeutic class 37
Filings and approval .37
Competitor ratio analysis 38
Tysabri .39
Novelty/rationale for mechanism of action 39
Proof of concept/clinical data .39
Management/clinical expertise .40
Competition within the market-place/gaining share of voice 41
Risks associated with developing a drug within a therapeutic class 41
Filings and approval .42
Sales forecasts and assumptions 42
Competitor ratio analysis 43
Novantrone 44
Novelty/rationale for mechanism of action 44
Proof of concept/clinical data .44
Management/clinical expertise .44
Competition within the market-place/gaining share of voice 45
Risks associated with developing a drug within a therapeutic class 45
Filings and approval .45
Sales forecasts and assumptions 46
Competitor ratio analysis 46
GLOBAL SALES FORECASTS OF CURRENT TREATMENTS 2007A-2014E .47
Sales Forecasts of Current Leading MS Drugs 47
Model Assumptions 47
NEW DRUGS IN R&D 49
Drugs in Development to Treat MS .49
ANALYSIS OF PHASE III DRUGS 51
New Drugs in Phase III Development to Treat MS 51
Disease-modifying Agents 52
BG-12 52
Novelty/rationale for mechanism of action 52
Proof of concept/clinical data .52
Management/clinical expertise .52
Competition within the market-place/gaining share of voice 52
Risks associated with developing a drug within a therapeutic class 53
Filings and approval .53
Sales forecasts and assumptions 53
Competitor ratio analysis 54
Campath 55
Novelty/rationale for mechanism of action 55
Proof of concept/clinical data .55
Management/clinical expertise .55
Competition within the market-place/gaining share of voice 56
Risks associated with developing a drug within a therapeutic class 56
Filings and approval .57
Sales forecasts and assumptions 57
Competitor ratio analysis 57
Fingolimod 58
Novelty/rationale for mechanism of action 58
Proof of concept/clinical data .58
Management/clinical expertise .58
Competition within the market-place/gaining share of voice 59
Risks associated with developing a drug within a therapeutic class 59
Filings and approval 59
Sales forecasts and assumptions 60
Competitor ratio analysis 60
Laquinimod 61
Novelty/rationale for mechanism of action 61
Proof of concept/clinical data .61
Management/clinical expertise .61
Competition within the market-place/gaining share of voice 62
Risks associated with developing a drug within a therapeutic class 62
Filings and approval .63
Sales forecasts and assumptions 63
Competitor ratio analysis 63
MBP8298 64
Novelty/rationale for mechanism of action 64
Proof of concept/clinical data .64
Management/clinical expertise .64
Competition within the market-place/gaining share of voice 65
Risks associated with developing a drug within a therapeutic class 65
Filings and approval .65
Sales forecasts and assumptions 66
Competitor ratio analysis 66
Mylinax 67
Novelty/rationale for mechanism of action 67
Proof of concept/clinical data .67
Management/clinical expertise .67
Competition within the market-place/gaining share of voice 68
Risks associated with developing a drug within a therapeutic class 68
Filings and approval .69
Sales forecasts and assumptions 69
Competitor ratio analysis 69
Teriflunomide 70
Novelty/rationale for mechanism of action 70
Proof of concept/clinical data .70
Management/clinical expertise .70
Competition within the market-place/gaining share of voice 70
Risks associated with developing a drug within a therapeutic class 71
Filings and approval .71
Sales forecasts and assumptions 71
Competitor ratio analysis 72
MS Symptoms 73
Neurelan 73
Novelty/rationale for mechanism of action 73
Proof of concept/clinical data .73
Trial MS-F202: Timed 25-foot Walk Response Rate of MS Patients Treated with Fampridine SR 74
Management/clinical expertise .74
Competition within the market-place/gaining share of voice 75
Risks associated with developing a drug within a therapeutic class 75
Filings and approval .75
Sales forecasts and assumptions 75
Competitor ratio analysis 76
GLOBAL SALES FORECASTS OF PHASE III MS DRUGS 2009E-2014E .77
Sales Forecasts of Phase III Developmental MS Drugs 77
Model Assumptions 77
ANALYSIS OF PHASE II DRUGS 78
New Drugs in Early Clinical Development to Treat MS 78
Disease-modifying Agents 80
ATL1102/TV1102 .80
Novelty/rationale for mechanism of action 80
Proof of concept/clinical data .80
Management/clinical expertise .80
Competition within the market-place/gaining share of voice 81
Risks associated with developing a drug within a therapeutic class 81
Filings and approval .81
Sales forecasts and assumptions 81
Competitor ratio analysis 82
CDP323 83
Novelty/rationale for mechanism of action 83
Proof of concept/clinical data .83
Management/clinical expertise .83
Competition within the market-place/gaining share of voice 83
Risks associated with developing a drug within a therapeutic class 84
Filings and approval .84
Sales forecasts and assumptions 84
Competitor ratio analysis 85
Daclizumab 86
Novelty/rationale for mechanism of action 86
Proof of concept/clinical data .86
Management/clinical expertise .86
Competition within the market-place/gaining share of voice 87
Risks associated with developing a drug within a therapeutic class 87
Filings and approval .88
Sales forecasts and assumptions 88
Competitor ratio analysis 88
Firategrast 89
Novelty/rationale for mechanism of action 89
Proof of concept/clinical data .89
Management/clinical expertise .89
Competition within the market-place/gaining share of voice 90
Risks associated with developing a drug within a therapeutic class 90
Filings and approval .90
Sales forecasts and assumptions 90
Competitor ratio analysis 91
Ibudilast .92
Novelty/rationale for mechanism of action 92
Proof of concept/clinical data .92
Management/clinical expertise .92
Competition within the market-place/gaining share of voice 92
Risks associated with developing a drug within a therapeutic class 93
Filings and approval 93
Sales forecasts and assumptions 93
Competitor ratio analysis 93
Vaccines 94
BHT-3009 94
Novelty/rationale for mechanism of action 94
Proof of concept/clinical data .94
Management/clinical expertise .94
Competition within the market-place/gaining share of voice 95
Risks associated with developing a drug within a therapeutic class 95
Filings and approval 95
Sales forecast and assumptions .95
Competitor ratio analysis 95
NeuroVax 96
Novelty/rationale for mechanism of action 96
Proof of concept/clinical data .96
Management/clinical expertise .96
Competition within the market-place/gaining share of voice 97
Risks associated with developing a drug within a therapeutic class 97
Filings and approval .97
Sales forecasts and assumptions 97
Competitor ratio analysis 97
Tovaxin 98
Novelty/rationale for mechanism of action 98
Proof of concept/clinical data .98
Management/clinical expertise .99
Competition within the market-place/gaining share of voice 99
Risks associated with developing a drug within a therapeutic class 99
Filings and approval .99
Sales forecasts and assumptions 99
Competitor ratio analysis 100
GLOBAL SALES FORECASTS OF PHASE II MS DRUGS 2011E - 2014E 101
Sales Forecasts of Phase II Developmental MS Drugs 101
Model Assumptions 101
COMPETITOR RATIO ANALYSIS 102
COMPETITOR RATIO ANALYSIS - PRODUCTS 103
CR Analysis of MS Agents Approved by 2014 - Based on Drug Class 104
COMPETITOR RATIO ANALYSIS - COMPANIES 105
CR Analysis of MS Agents Approved by 2014 - Based on Company .106
WINNERS & LOSERS .107
Summary of Key Companies and Drugs in the MS Market by 2014 .107
DISCONTINUATION OF DRUGS 110
MS Drugs Discontinued from Clinical Development 110
MS APPENDIX 1 112
Clinical Diagnostic Test for MS 112
MS APPENDIX 2 114
Expanded Disability Status Scale (EDSS) 114
MS APPENDIX 3 116
Phase Transition Probability 116
Probability of Launch 116
MS APPENDIX 4 117
MS Patient Model 117
Summary of US MS Patient Population Forecasts 117
Summary of Europe (Top 5) MS Patient Population Forecasts 118
Summary of Japan MS Patient Population Forecasts 118
MS APPENDIX 5 119
Global MS Drugs Sales 2007A-2014E . 119
Global MS Drug Sales 2007A-2014E 119
MS APPENDIX 6 121
Competitor Ratio Analysis Criteria 121
Key MS Drugs on the Market by 2014 121
MS GLOSSARY 122
MS REFERENCES 127
ACRONYMNS 128
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