Therapeutic Market Outlooks

Multiple Sclerosis
Publication Date: July 2008

Table of Contents

Disease Etiology................................................................. 12
Possible Causes of Multiple Sclerosis............................... 12
Epidemiology & Patient Population Estimates......................... 14
Theoretical Patient Population........................................ 14
Risk, Pre-Disposing Factors...................................... 14
Diagnosis Rates...................................................... 16
Addressable Patient Population ...................................... 16
Treated Patient Population ............................................ 16
U.S. Multiple Sclerosis Market Models, 2005-2014E ................ 17
Market Definitions ........................................................ 17
Forecasting Methodology............................................... 17
Market Revenue Forecasts............................................. 22
AVOS Physician Panel Results .............................................. 23
Physician Diagnosis Pattern ........................................... 23
Disease Progression and Symptoms................................ 23
Physician Treatment Patterns......................................... 23
Mild-to-Moderate RRMS – First-Line Treatments ......... 25
Mild-to-Moderate RRMS – Second-Line Treatments..... 26
Aggressive MS – First-Line Treatments...................... 26
Aggressive MS – Second-Line and Last Resort
Treatments ............................................................ 27
Patient Compliance ....................................................... 28
Key Factors of Non-Compliance ................................ 28
Physician Product Selection Criteria ................................ 29
Physician Comments on Product Criteria.................... 29
Physician Product Comparison and Ratings...................... 30
Market Dynamics and Assessment........................................ 32
Leading Products.......................................................... 32
Market History ............................................................. 32
Current Market Environment.......................................... 33
Future Market Environment ........................................... 35
Generic Biologics .................................................... 35

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 Introduction of Novel MS Therapies .......................... 36
Increases in the MS Population ................................ 39
Increased Awareness and Diagnosis ......................... 40
New Frontiers in R&D.............................................. 40
Increased Regulatory Standards ............................... 40
Unmet Medical Needs in MS..................................... 41
Prospects for Future Therapies ...................................... 42
Future Strategies for MS Therapies ........................... 42
Product Profiles: Inline and Select Pipeline
Avonex........................................................................ 44
U.S. Perspective ..................................................... 44
Worldwide Perspective ............................................ 45
AVOS Physician Panel Discussions ............................ 45
Betaseron.................................................................... 46
U.S. Perspective ..................................................... 46
Worldwide Perspective ............................................ 47
AVOS Physician Panel Discussions ............................ 47
Rebif........................................................................... 48
U.S. Perspective ..................................................... 48
Worldwide Perspective ............................................ 49
AVOS Physician Panel Discussions ............................ 49
Copaxone .................................................................... 50
U.S. Perspective ..................................................... 50
Worldwide Perspective ............................................ 51
AVOS Physician Panel Discussions ............................ 51
Tysabri........................................................................ 52
U.S. Perspective ..................................................... 52
Worldwide Perspective ............................................ 54
AVOS Physician Panel Discussions ............................ 54
Novantrone.................................................................. 55
U.S. and Worldwide Perspective ............................... 55
Product History ...................................................... 55
AVOS Physician Panel Discussions ............................ 55
Extavia........................................................................ 56
U.S. Perspective ..................................................... 56
Worldwide Perspective ............................................ 57
Cladribine .................................................................... 58

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 U.S. Perspective ..................................................... 58
Worldwide Perspective ............................................ 59
FTY720 ....................................................................... 60
U.S. Perspective ..................................................... 60
Worldwide Perspective ............................................ 61
Campath ..................................................................... 62
U.S. Perspective ..................................................... 62
Worldwide Perspective ............................................ 63
Laquinimod.................................................................. 64
U.S. Perspective ..................................................... 64
Worldwide Perspective ............................................ 65
Teriflunomide............................................................... 66
U.S. Perspective ..................................................... 66
Worldwide Perspective ............................................ 67
Drugs in Development ........................................................ 68
R&D Overview ............................................................. 68
Spectrum of Current MS Research ............................ 68
Conditions in the MS Therapeutic Market Inviting
Scrutiny and Caution from the FDA ........................... 69
Assessment of R&D Success Rates ................................. 70
Products in the Pipeline................................................. 72
Phase III (13 Agents).............................................. 72
Phase II (Six Agents) .............................................. 73
Appendix........................................................................... 74
Vital Statistics of Inline and Pipeline MS Agents................ 74

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