Pipeline Insight: Multiple Sclerosis - The oral revolution
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Datamonitor insight into the multiple sclerosis market - page 4
- Key metrics - page 6
- Datamonitor Pipeline Assessment Summary - page 7
- CHAPTER 2 MULTIPLE SCLEROSIS PIPELINE OVERVIEW AND DYNAMICS - page 9
- Pipeline overview - page 10
- Oral disease-modifying drugs feature heavily in the late-stage MS pipeline - page 10
- The majority of products are in development for RRMS - page 13
- Oral formulations aiming to succeed in a solely injectable market - page 14
- Key companies involved in the multiple sclerosis pipeline - page 16
- Current MS players look to offset mass competition with follow-up products - page 16
- Biogen Idec committed to maintaining MS market leader status - page 16
- Avonex and Tysabri provide Biogen Idec with leader status in MS market - page 16
- Rituxan and BG-12 Phase III MS developments lead the way - page 18
- Early-stage development products add depth to Biogen Idec's MS pipeline - page 19
- Biogen Idec's MS pipeline products are split by class and delivery mechanism - page 19
- In-licensing and collaborations essential to Biogen Idec's future MS advancements - page 19
- Teva looks to supplement its Copaxone franchise - page 20
- Copaxone represents Teva's first branded product and now boasts blockbuster status - page 20
- Oral Copaxone is still many years away from market - page 21
- Laquinimod replaces oral Copaxone developments as Teva's front-running oral MS focus - page 22
- Teva licenses Vaccinex's VX-15 to strengthen its long-term MS developments - page 23
- Key R&D company strategies - page 23
- Combination of oral administration with novel mechanism provides major competitive edge - page 24
- Targeting SPMS and PPMS can reduce competition but will increase R&D challenge - page 24
- In-licensing is increasingly important to secure long-term franchise growth - page 25
- Pipeline overview - page 10
- CHAPTER 3 MULTIPLE SCLEROSIS DISEASE OVERVIEW AND MARKET POTENTIAL - page 27
- Definition of multiple sclerosis - page 28
- There is no universal course for multiple sclerosis - page 28
- Segmentation of multiple sclerosis - page 28
- Researchers have attempted to classify multiple sclerosis according to the clinical course of the disease - page 28
- Epidemiology of multiple sclerosis - page 31
- Young female adults are most at risk of developing MS - page 31
- Genetic and environmental factors appear to play a role in the onset of MS - page 31
- Over 800,000 individuals in the US, Japan and 5EU markets are estimated to suffer from MS - page 33
- US - page 34
- Japan - page 35
- 5EU - page 35
- The majority of patients suffer from relapse remitting multiple sclerosis - page 38
- Unmet needs in multiple sclerosis - page 39
- Prevention and discovery of a cure are the ultimate goals in MS - page 39
- Unmet need 1: improved efficacy - page 41
- Improved disease modifying efficacy is the top unmet need in MS - page 41
- The need for improved symptomatic efficacy remains an issue - page 41
- Unmet need 2: improved side-effect profile - page 42
- Improved side-effect profile is in joint second place as the highest unmet need below improved efficacy. - page 42
- Unmet need 3: approval for a wider range of MS disease severities - page 43
- Approval for a wider range of MS disease severities is regarded as a high unmet need - page 43
- Unmet need 4: improved delivery method - page 44
- The MS market is a solely injectable domain in need of a more less-invasive and user-friendly delivery method - page 44
- Unmet need 5: fewer drug interactions - page 45
- The ability to combine treatments depends on the drug-drug interactions - page 45
- Definition of multiple sclerosis - page 28
- CHAPTER 4 R&D APPROACH - page 47
- Current treatment options - page 48
- Current treatment options - page 48
- There are only six disease-modifying agents currently on the market - page 48
- Across all stages of MS, 45% of total diagnosed patients do not receive disease-modifying therapy - page 50
- RRMS and SPMS patients are most likely to recieve disease-modifying therapy - page 50
- Classification of pipeline products - page 51
- Novel drug classes look to capitalize in a largely undifferentiated market - page 52
- Cytokines - page 54
- Interferons - page 54
- Interleukin antibodies - page 55
- Other cytokines - page 55
- Immunomodulators - page 56
- Myelin basic protein modulators - page 57
- Dehydrogenase inhibitors - page 57
- Human immunoglobulins - page 58
- Therapeutic vaccines - page 58
- Others - page 59
- Clinical trial design in multiple sclerosis - page 60
- Approved MS disease-modifying drugs set the standard for future trial design - page 60
- The revised McDonald criteria allows trials to include patients earlier in the course of their disease - page 60
- Placebo-controlled MS trials might be considered unethical - page 61
- A placebo control arm is essential in Phase III trials but less of an issue in Phase II trials - page 62
- The SENTINEL and BEYOND trials provide alternative trial design - page 62
- Clinical trial endpoints in multiple sclerosis - page 63
- Relapse rate - page 63
- Disability/progression measures - page 64
- Fatigue - page 64
- Expanded disability status scale - page 64
- Multiple Sclerosis Functional Composite - page 67
- Health-related quality-of-life assessments - page 67
- The Multiple Sclerosis Quality of Life-54 instrument - page 68
- Multiple Sclerosis Impact Scale - page 68
- Multiple Sclerosis Symptom and Impact Diary - page 69
- MRI measures - page 69
- Conventional MRI techniques to assess lesions - page 70
- Advanced MRI techniques - page 70
- Brain atrophy - page 70
- CHAPTER 5 CYTOKINE LATE-STAGE DRUG ANALYSIS & FORECASTS - page 72
- Cytokine pipeline Overview - page 73
- Pipeline summary - page 73
- Definition of current comparator therapy - page 73
- MS disease-modifier 'gold-standard' is Avonex - page 73
- Two key studies evaluated the clinical effectiveness of Avonex in MS - page 75
- Contraindications and adverse reactions reported with the use of Avonex - page 76
- Avonex's major competitors and key strengths and weaknesses - page 76
- MS disease-modifier 'gold-standard' is Avonex - page 73
- Interferon pipeline overview - page 79
- Pipeline summary - page 79
- There are two interferon drugs in the late-stage R&D pipeline for MS in 2007 - page 79
- Pipeline summary - page 79
- Alferon N injection (interferon alfa-n3) - page 79
- Drug overview - page 79
- Clinical trial data - page 80
- Alferon N under Hemispherx - page 80
- Retrospective, uncontrolled study - page 80
- Drug evaluation - page 80
- Tauferon - page 82
- Drug overview - page 82
- Clinical trial data - page 82
- Pre-clinical and Phase I - page 82
- Phase II trial initiated - page 82
- Drug evaluation - page 82
- Interleukin antibodies pipeline overview - page 83
- Pipeline summary - page 83
- There are three interleukin antibodies in the late-stage R&D pipeline for MS in 2007 - page 83
- Pipeline summary - page 83
- Daclizumab - page 83
- Drug overview - page 83
- Clinical trial data - page 84
- Phase II open-label clinical studies - page 84
- Phase II CHOICE study assessing daclizumab added to ongoing interferon-beta treatment - page 85
- CHOICE study meets primary endpoint - page 85
- Drug evaluation - page 86
- CNTO-1275 - page 87
- Drug overview - page 87
- Clinical trial data - page 87
- Phase I data show subcutaneous injection of CNT0-1275 is well tolerated - page 87
- Patient recruitment completed in safety and efficacy Phase II trial - page 88
- Drug evaluation - page 88
- ABT-874 - page 89
- Drug overview - page 89
- Clinical trial data - page 89
- Drug evaluation - page 90
- Other cytokines pipeline overview - page 90
- Pipeline summary - page 90
- There are four other cytokine drugs in the late-stage R&D pipeline for multiple sclerosis in 2007 - page 90
- Pipeline summary - page 90
- Rituxan (rituximab) - page 91
- Drug overview - page 91
- Rituxan was first approved for non-Hodgkin's lymphoma in 1997 - page 91
- Ongoing developments of Rituxan in multiple indications - page 91
- Clinical trial data - page 92
- Positive 24-week 'HERMES' Phase II RRMS data - page 92
- Results from Phase II/III PPMS OLYMPUS trial expected in H1-2007 - page 92
- Additional PPMS study in four patients shows Rituxan suppresses B-cells - page 93
- Patient potential - page 93
- Marketing potential - page 94
- Satisfaction of unmet needs - page 95
- Unmet need 1: improved efficacy - page 95
- Unmet need 2: improved side-effect profile - page 96
- Unmet need 3: approval for a wider range of MS severities - page 96
- Unmet need 4: improved delivery method - page 96
- Unmet need 5: fewer drug interactions - page 96
- Forecasts to 2016 - page 97
- Datamonitor drug assessment summary - page 99
- Drug overview - page 91
- Campath (alemtuzumab) - page 99
- Drug overview - page 99
- Clinical trial data - page 100
- Early pilot MS studies - page 100
- Suspension of Phase II RRMS CAMPATH MS 223 trial due to safety concerns - page 100
- Drug evaluation - page 102
- ATL-1102 (ISIS-107248) - page 102
- Drug overview - page 102
- Clinical trial data - page 103
- ATL-1102 proved well-tolerated through Phase I studies - page 103
- Phase II ATL-1102 study in RRMS patients restarts after one-year suspension - page 103
- Recent animal study supports the use of ATL-1102 in MS - page 105
- Drug evaluation - page 105
- MLN1202 - page 106
- Drug overview - page 106
- Clinical trial data - page 106
- Results from Phase II trial in 40 RRMS patients set for H1-2007 - page 106
- Drug evaluation - page 107
- Cytokine pipeline Overview - page 73
- CHAPTER 6 IMMUNOMODULATOR LATE-STAGE DRUG ANALYSIS AND FORECASTS - page 108
- Comparative forecasts - page 109
- Comparative Datamonitor drug assessment summaries - page 110
- Overview - page 111
- Pipeline summary - page 111
- There are four key immunomodulator drugs in the late-stage R&D pipeline for multiple sclerosis in 2007 - page 111
- Pipeline summary - page 111
- BG-12 - page 111
- Drug overview - page 111
- Clinical trial data - page 112
- BG-12 achieves primary endpoint in a 257- patient Phase II RRMS study - page 112
- Phase III BG-12 MS clinical program includes the DEFINE and CONFIRM international trials that plan to enroll more than 2,000 patients - page 113
- Patient potential - page 113
- Marketing potential - page 114
- Satisfaction of unmet needs - page 115
- Unmet need 1: improved efficacy - page 115
- Unmet need 2: improved side-effect profile - page 115
- Unmet need 3: approval for a wider range of MS severities - page 115
- Unmet need 4: improved delivery method - page 116
- Unmet need 5: fewer drug interactions - page 116
- Forecasts to 2016 - page 116
- Datamonitor drug assessment summary - page 118
- Laquinimod (SAIK-MS) - page 118
- Drug overview - page 118
- Clinical trial data - page 119
- Phase I dose escalation study meets primary endpoint and identifies 1.2mg as being the maximum-tolerated daily dose. - page 119
- Phase II trial primary endpoint met with laquinimod 0.3mg/day - page 119
- 77% of patients remained relapse-free during Phase II investigation trial of laquinimod at a higher dose - page 120
- Teva discusses Phase III Laquinimod clinical program plan with regulatory authorities on back of positive Phase IIb safety and efficacy results - page 120
- Patient potential - page 121
- Marketing potential - page 122
- Satisfaction of unmet needs - page 122
- Unmet need 1: improved efficacy - page 122
- Unmet need 2: improved side-effect profile - page 123
- Unmet need 3: approval for a wider range of MS severities - page 123
- Unmet need 4: improved delivery method - page 123
- Unmet need 5: fewer drug interactions - page 123
- Forecasts to 2016 - page 124
- Datamonitor drug assessment summary - page 126
- Cpn10 (XToll) - page 126
- Drug overview - page 126
- Clinical trial data - page 127
- Phase I studies demonstrate tolerability of Cpn10 IV infusion and SC injection - page 127
- Undisclosed Phase IIa trial results meet set objectives - page 127
- Drug evaluation - page 128
- GEM-SP - page 128
- Drug overview - page 128
- Clinical trial data - page 129
- Drug evaluation - page 129
- TV-5010 - page 129
- Drug overview - page 129
- Drug evaluation - page 130
- CHAPTER 7 MYELIN BASIC PROTEIN MODULATOR LATE-STAGE DRUG ANALYSIS AND FORECASTS - page 131
- Overview - page 132
- Pipeline summary - page 132
- There are two myelin basic protein modulator drugs in the late-stage R&D pipeline for MS in 2007 - page 132
- Pipeline summary - page 132
- MBP-8298 - page 132
- Drug overview - page 132
- The design of MBP-8298 includes MBP residues 85-96 plus amino acid extension at both ends - page 133
- MBP-8298 apparently induces immunological tolerance to autoimmune targeting of MBP - page 133
- The University of Alberta has been granted 88 worldwide patents concerning MBP-8298 - page 133
- Clinical trial data - page 134
- An in-depth development program of MBP-8298 sees it currently progressing through three MS clinical trials - page 134
- MBP-8298 showed a reduction of MBP autoantibody in the CSF in chronic progressive MS sufferers during Phase I studies - page 134
- Positive Phase II chronic progressive MS study results paved the way for Phase III SPMS trials - page 134
- The MAESTRO-01 & MAESTRO-03 Phase II/III clinical trials in SPMS patients - page 136
- Commencement of MINDSET-01 Phase II RRMS trial as BioMS aims to advance MBP-8298 into a second indication - page 137
- Patient potential - page 138
- Marketing potential - page 139
- Satisfaction of unmet needs - page 140
- Unmet need 1: improved efficacy - page 140
- Unmet need 2: improved side-effect profile - page 140
- Unmet need 3: approval for a wider range of MS severities - page 140
- Unmet need 4: improved delivery method - page 141
- Unmet need 5: fewer drug interactions - page 141
- Forecasts to 2016 - page 141
- Datamonitor drug assessment summary - page 144
- Drug overview - page 132
- BHT-3009 - page 144
- Drug overview - page 144
- Clinical trial data - page 145
- Phase I MS trial of BHT-3009 as monotherapy or in combination with atorvastatin - page 145
- Phase II RRMS trial initiated in February 2006 - page 145
- Drug evaluation - page 146
- Overview - page 132
- CHAPTER 8 DEHYDROGENASE INHIBITOR LATE-STAGE DRUG ANALYSIS AND FORECASTS - page 147
- Overview - page 148
- Pipeline summary - page 148
- There are two dehydrogenase inhibitor drugs in the late-stage R&D pipeline for MS in 2007 - page 148
- Pipeline summary - page 148
- Teriflunomide (HMR-1726) - page 148
- Drug overview - page 148
- Clinical trial data - page 149
- Phase II proof-of-concept study with 179 MS patients - page 149
- Pivotal Phase III study EFC6049 continues to recruit two years after initiation - page 150
- Sanofi-Aventis discloses long-term Teriflunomide development plans and look to initiate combination studies and studies in early MS - page 150
- Patient potential - page 151
- Marketing potential - page 152
- Satisfaction of unmet needs - page 153
- Unmet need 1: improved efficacy - page 153
- Unmet need 2: improved side-effect profile - page 153
- Unmet need 3: approval for a wider range of MS severities - page 153
- Unmet need 4: improved delivery method - page 154
- Unmet need 5: fewer drug interactions - page 154
- Forecasts to 2016 - page 154
- Datamonitor drug assessment summary - page 156
- CellCept (mycophenolate mofetil) - page 156
- Drug overview - page 156
- Clinical trial data - page 157
- Phase III RRMS trial of CellCept as monotherapy or in combination with Avonex - page 157
- Drug evaluation - page 158
- Overview - page 148
- CHAPTER 9 HUMAN IMMUNOGLOBULIN LATE-STAGE DRUG ANALYSIS AND FORECASTS - page 159
- Overview - page 160
- Pipeline summary - page 160
- There are two human immunoglobulin drugs in the late-stage R&D pipeline for MS in 2007 - page 160
- Pipeline summary - page 160
- Venilon - page 160
- Drug overview - page 160
- Drug evaluation - page 161
- Gamunex (IGIV) - page 161
- Drug overview - page 161
- Clinical trial data - page 161
- Phase II trial in RRMS patients was started in 2002 and is now complete - page 161
- Drug evaluation - page 163
- Overview - page 160
- CHAPTER 10 THERAPEUTIC VACCINE LATE-STAGE DRUG ANALYSIS AND FORECASTS - page 164
- Overview - page 165
- Pipeline summary - page 165
- There are two therapeutic vaccine drugs in the late-stage R&D pipeline for MS in 2007 - page 165
- Pipeline summary - page 165
- NeuroVax - page 165
- Drug overview - page 165
- Clinical trial data - page 166
- Phase I data presented in the late 1990s showed potential for the TCR peptide vaccine - page 166
- NeuroVax remains in Phase II trials, six years after studies began - page 166
- Drug evaluation - page 169
- Tovaxin - page 170
- Drug overview - page 170
- Clinical trial data - page 170
- Positive interim results from two Phase I/II clinical trials released in 2005 - page 170
- TERMS 150 patient Phase IIb trial initiated in August 2006 - page 171
- Drug evaluation - page 172
- Overview - page 165
- CHAPTER 11 OTHER LATE-STAGE DRUG ANALYSIS AND FORECASTS - page 173
- Comparative forecasts - page 174
- Comparative Datamonitor drug assessment summaries - page 175
- Overview - page 176
- Pipeline summary - page 176
- There are six drugs classified as other in the late-stage R&D pipeline for MS in 2007 - page 176
- Pipeline summary - page 176
- Mylinax (oral cladribine) - page 177
- Drug overview - page 177
- Mylinax awarded Fast Track status by FDA for relapsing forms of MS - page 177
- Clinical trial data - page 177
- Previous studies of injectable cladribine support the use of the drug in MS - page 177
- Achievement of therapeutic drug blood levels led the way for Mylinax Phase III studies - page 178
- Phase III CLARITY study recruits over 1,300 RRMS patients - page 178
- Initiation of ONWARD study of Mylinax & new formulation of Rebif add-on treatment - page 179
- Patient potential - page 179
- Marketing potential - page 181
- Satisfaction of unmet needs - page 182
- Unmet need 1: improved efficacy - page 182
- Unmet need 2: improved side-effect profile - page 182
- Unmet need 3: approval for a wider range of MS severities - page 182
- Unmet need 4: improved delivery method - page 183
- Unmet need 5: fewer drug interactions - page 183
- Forecasts to 2016 - page 183
- Datamonitor drug assessment summary - page 185
- Drug overview - page 177
- Fingolimod (FTY720) - page 186
- Drug overview - page 186
- Clinical trial data - page 186
- Positive Phase II trial data reported by Novartis in January 2005 - page 186
- Six-month Phase II trial data presented in June 2005 at the 15th European Neurological Society meeting in Vienna, Austria - page 187
- 12-month Phase II data show sustained benefits and good tolerability of fingolimod - page 187
- Positive 18-month and two-year data presented - page 188
- Phase III FREEDOMS program and FTY720D2309 trial evaluating the daily dosing of FTY720 have been initiated - page 189
- TRANSFORMS study - page 190
- Patient potential - page 190
- Marketing potential - page 192
- Satisfaction of unmet needs - page 193
- Unmet need 1: improved efficacy - page 193
- Unmet need 2: improved side-effect profile - page 194
- Unmet need 3: approval for a wider range of MS severities - page 194
- Unmet need 4: improved delivery method - page 194
- Unmet need 5: fewer drug interactions - page 195
- Forecasts to 2016 - page 195
- Datamonitor drug assessment summary - page 197
- MN-166 (ibudilast) - page 197
- Drug overview - page 197
- Clinical trial data - page 198
- One year Phase II efficacy data expected in Q107 - page 198
- Drug evaluation - page 198
- Firategrast (SB-683699; T-0047) - page 199
- Drug overview - page 199
- Clinical trial data - page 199
- Phase II trials of SB-683699 suspended because of safety concerns - page 199
- Phase II MS trial resumed in January 2007 - page 200
- Drug evaluation - page 200
- Oral E3 (Trimesta) - page 200
- Drug overview - page 200
- Clinical trial data - page 201
- Drug evaluation - page 201
- E2007 - page 201
- Drug overview - page 201
- CHAPTER 12 INNOVATIVE EARLY-STAGE PROJECTS - page 202
- Key Phase I and preclinical compounds in multiple sclerosis - page 203
- BalanCell - page 205
- Nanocort - page 206
- CHAPTER 13 SYMPTOMATIC MULTIPLE SCLEROSIS PIPELINE - page 208
- Overview - page 209
- Pipeline summary - page 209
- Fampridine-SR - page 209
- Drug overview - page 209
- Clinical trial data - page 210
- MCT-125 - page 212
- Drug overview - page 212
- Erythropoietin - page 212
- Drug overview - page 212
- Overview - page 209
- BIBLIOGRAPHY - page 213
- Journals - page 213
- Websites - page 217
- Posters - page 221
- APPENDIX A - page 223
- Methodology - page 223
- Definition of the MS market - page 223
- Datamonitor forecast methodology - page 223
- Estimated 2006 sales revenue - page 223
- Product forecasts - page 223
- Definition of a standard unit - page 224
- Estimation of launch dates - page 224
- Patent expiry and generic assumptions - page 224
- Japanese market data - page 226
- Additional information - page 226
- Datamonitor drug assessment summary - page 227
- Contributing experts - page 228
- Report methodology - page 228
- Methodology - page 223
- APPENDIX B - page 229
- About Datamonitor - page 229
- Datamonitor Healthcare's therapy area capabilities - page 229
- About the CNS analysis team - page 230
- Disclaimer - page 231
- List of Tables
- Table 1: Forecast key pipeline products for multiple sclerosis in the seven major markets ($), 2006-2016 - page 6
- Table 2: Disease-modifying pipeline drugs in Phase III development for multiple sclerosis, 2007 - page 10
- Table 3: Disease-modifying pipeline drugs in Phase II development for multiple sclerosis, 2007 - page 11
- Table 4: Biogen Idec's pipeline multiple sclerosis drugs, 2007 - page 18
- Table 5: Teva's pipeline multiple sclerosis drugs, 2007 - page 22
- Table 6: Prevalence of multiple sclerosis in the seven major markets, 2006 - page 33
- Table 7: The average rating of the clinical unmet needs in multiple sclerosis - page 40
- Table 8: Key facts for marketed disease-modifying drugs for multiple sclerosis in the seven major markets, 2007 - page 49
- Table 9: Percentage of patients diagnosed with each stage of MS who receive disease-modifying drug therapy, 2006 - page 50
- Table 10: Expanded Disability Status Scale (EDSS) for multiple sclerosis - page 65
- Table 11: Key interferon drugs in late-stage R&D pipeline for MS, 2007 - page 73
- Table 12: Biogen Idec's Avonex: key facts - page 74
- Table 13: Comparisons of the four leading MS disease-modifiers - page 77
- Table 14: Key interferon drugs in late-stage R&D pipeline for multiple sclerosis, 2007 - page 79
- Table 15: Key interleukin antibody drugs in late-stage R&D pipeline for multiple sclerosis, 2007 - page 83
- Table 16: Key other cytokine drugs in late-stage R&D pipeline for multiple sclerosis, 2007 - page 90
- Table 17: Key events, approval and launch dates impacting Rituxan revenue forecasts for multiple sclerosis in the seven major markets, 2007-2016 - page 97
- Table 18: Key immunomodulator drugs in late-stage R&D pipeline for multiple sclerosis, 2007 - page 111
- Table 19: Key events and launch dates impacting BG-12 revenue forecasts in the seven major markets, 2007-2016 - page 116
- Table 20: Key events and launch dates impacting Laquinimod revenue forecasts for multiple sclerosis in the seven major markets, 2007-2016 - page 124
- Table 21: Key myelin basic protein modulator drugs in late-stage R&D pipeline for MS, 2007 - page 132
- Table 22: Key events, approval and launch dates impacting MBP-8298 revenue forecast for multiple sclerosis in the seven major markets, 2007-2016 - page 142
- Table 23: Key dehydrogenase inhibitor drugs in late-stage R&D pipeline for multiple sclerosis, 2007 - page 148
- Table 24: Key events and launch dates impacting Teriflunomide revenue forecasts for multiple sclerosis in the seven major markets, 2007-2016 - page 154
- Table 25: Key human immunoglobulin drugs in late-stage R&D pipeline for multiple sclerosis, 2007 - page 160
- Table 26: Key therapeutic vaccine drugs in late-stage R&D pipeline for multiple sclerosis, 2007 - page 165
- Table 27: Key other drugs in late-stage R&D pipeline for multiple sclerosis, 2007 - page 176
- Table 28: Key events and launch dates impacting Mylinax revenue forecast for multiple sclerosis in the seven major markets, 2007-2016 - page 183
- Table 29: Key events and launch dates impacting Fingolimod revenue forecast for multiple sclerosis in the seven major markets, 2007-2016 - page 195
- Table 30: Drugs in Phase I development for multiple sclerosis, 2007 - page 203
- Table 31: Drugs in clinical and pre-clinical development for multiple sclerosis, 2007 - page 204
- Table 32: Key drugs in late-stage R&D pipeline for symptomatic treatment of multiple sclerosis, 2007 - page 209
- Table 33: Estimation of launch dates by phase of development - page 224
- Table 34: Estimated generic discounts by country, 2006 - page 225
- Table 35: Estimation of brand erosion by following patent expiry by country - page 226
- Table 36: Datamonitor's pipeline drug assessment weighting scale - page 227
- List of Figures
- Figure 1: Datamonitor's multiple sclerosis drug assessment summary for the seven major markets ($m), 2007-2016 - page 7
- Figure 2: Breakdown of the late stage pipeline by form of multiple sclerosis, 2007 - page 13
- Figure 3: Delivery method of multiple sclerosis pipeline drugs, 2007 - page 15
- Figure 4: Injection method of the 15 injectable multiple sclerosis pipeline drugs, 2007 - page 15
- Figure 5: Segmentation of multiple sclerosis - page 30
- Figure 6: World distribution of multiple sclerosis - page 32
- Figure 7: Percentage of diagnosed MS patients who suffer from each type of MS, 2006 - page 39
- Figure 8: Clinical unmet needs in multiple sclerosis according to KOLs, 2007 - page 40
- Figure 9: Percentage of patients diagnosed with each stage of MS who receive disease-modifying drug therapy, 2006 - page 51
- Figure 10: Breakdown of the late-stage multiple sclerosis pipeline by class, 2007 - page 53
- Figure 11: Datamonitor's forecast of sales for Rituxan for multiple sclerosis across the seven major markets ($m), 2007-2016 - page 98
- Figure 12: Datamonitor's competitive positioning analysis for Rituxan in the seven major markets, 2007-2016 - page 99
- Figure 13: Datamonitor's comparative forecast of sales for late-stage immunomodulator products across the seven major markets ($m), 2007-2016 - page 109
- Figure 14: Datamonitor's competitive positioning analysis for BG-12 and Laquinimod in the seven major markets, 2007-2016 - page 110
- Figure 15: Datamonitor's forecast of sales for BG-12 across the seven major markets ($m), 2007-2016 - page 117
- Figure 16: Datamonitor's competitive positioning analysis for BG-12 in the seven major markets, 2007-2016 - page 118
- Figure 17: Datamonitor's forecast of sales for Laquinimod across the seven major markets ($m), 2007-2016 - page 125
- Figure 18: Datamonitor's competitive positioning analysis for Laquinimod in the seven major markets, 2007-2016 - page 126
- Figure 19: MBP-8298 stage of development - page 134
- Figure 20: Datamonitor's forecast of sales for MBP-8298 across the seven major markets for multiple sclerosis ($m), 2007-2016 - page 143
- Figure 21: Datamonitor's competitive positioning analysis for MBP-8298 in the seven major markets, 2007-2016 - page 144
- Figure 22: The patient flow for the study population. - page 149
- Figure 23: Datamonitor's forecast of sales for Teriflunomide in multiple sclerosis across the seven major markets ($m), 2007-2016 - page 155
- Figure 24: Datamonitor's competitive positioning analysis for Teriflunomide in the seven major markets, 2007-2016 - page 156
- Figure 25: Datamonitor's comparative forecast of sales for the other late-stage products across the seven major markets ($m), 2007-2016 - page 174
- Figure 26: Datamonitor's competitive positioning analysis for Mylinax and Fingolimod in the seven major markets, 2007-2016 - page 175
- Figure 27: Datamonitor's forecast of sales for Mylinax across the seven major markets for multiple sclerosis ($m), 2007-2016 - page 184
- Figure 28: Datamonitor's competitive positioning analysis for Mylinax in the seven major markets, 2007-2016 - page 185
- Figure 29: Datamonitor's forecast of sales for Fingolimod in multiple sclerosis across the seven major markets ($m), 2007-2016 - page 196
- Figure 30: Datamonitor's competitive positioning analysis for Fingolimod in the seven major markets, 2007-2016 - page 197
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