Parkinson's Disease and Restless Legs Syndrome - Reformulations set to drive near-term growth
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the CNS pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Datamonitor insight into the Parkinson's disease and Restless Legs Syndrome market - page 4
- CHAPTER 2 PATIENT POTENTIAL- PARKINSON'S DISEASE - page 25
- Definition of Parkinson's disease - page 25
- The etiology of PD is not yet clear - page 25
- Segmentation of Parkinson's disease - page 27
- Parkinson's disease is typically classified by the Hoehn & Yahr scale - page 27
- Epidemiology of Parkinson's disease - page 28
- Demographics provide baseline sales growth - page 29
- Several comorbid disorders are thought to result from neurodegeneration in PD - page 31
- Sleep disorders are most common in advanced PD - page 31
- Depression in PD has both psychological and pathological causes - page 32
- Dementia in PD becomes more likely as the disease progresses - page 32
- Psychosis is both a feature of PD and a side effect of treatment - page 33
- New tools are improving diagnosis - page 33
- Treatment strategies in Parkinson's disease - page 34
- Unmet needs in Parkinson's disease - page 36
- Drugs that slow or prevent disease progression - page 37
- Reduction of motor complications - page 38
- Motor fluctuations - page 38
- Dyskinesias - page 39
- Other motor complications - page 40
- Smoother levodopa dosage - page 40
- Lower side effects - page 41
- Reduce pill burden - page 41
- Reduce time to levodopa therapy - page 42
- Lower cost - page 43
- Definition of Parkinson's disease - page 25
- CHAPTER 3 PARKINSON'S DISEASE R&D APPROACH - page 44
- Classification of marketed and pipeline products - page 44
- Market definition for this report - page 44
- Dopaminergics - page 45
- Levodopa still considered most effective agent for reducing PD symptoms - page 46
- Dopamine agonists - page 47
- Dopamine agonists considered first line therapy - page 48
- Mirapex (pramipexole) the market leading dopamine agonist - page 50
- Neupro (rotigotine CDS) offers an alternative delivery method - page 56
- Apokyn (apomorphine) helps niche patient cohort - page 67
- Several dopamine agonists with novel delivery systems are in development - page 68
- Catechol-O-methyltransferase inhibitors - page 69
- Comtan (entacapone) is the market leading COMT-inhibitor - page 69
- Stalevo reduces pill burden - page 76
- Monoamine oxidase inhibitors - page 77
- Selegiline has an established role in the treatment of early PD - page 79
- Zelapar (selegiline; orally disintegrating tablets) may offer advantages over conventional selegiline - page 79
- Azilect (rasagiline) has recently received approval for early and late stage PD - page 81
- Safinamide is the only MAOI in late stage development - page 91
- Other marketed therapies - page 91
- Anticholinergics provide little interest for developers of new treatments - page 91
- N-methlyl-D-aspartate receptor antagonists may hold further potential - page 92
- Novel therapies - page 93
- The potential for adenosine A2a receptor antagonists remains unclear - page 93
- Neuroprotectants aim to slow or stop the progression of PD - page 93
- Cell/ gene therapies are designed to make up for the loss of neurons in PD - page 94
- Clinical trial design in Parkinson's disease - page 95
- Neuroprotection clinical trial design continues to present challenges - page 95
- At risk patients are ideal for studies but are difficult to recruit - page 95
- Choice of clinical endpoints in neuroprotective studies depends on the population studied - page 97
- Futility studies help determine which agents to select for further study - page 98
- Delayed start design aims to separate symptomatic from neuroprotective effect of a study agent - page 100
- Neuroprotection clinical trial design continues to present challenges - page 95
- Clinical trial endpoints in Parkinson's disease - page 102
- Decreased latency to ON time, increased ON time, and decreased OFF time are key endpoints for EU and US approval - page 102
- Unified Parkinson's Disease Rating Scale offers a more comprehensive measure of PD progression - page 102
- Cognition, behavior and mood- Part I of the UPDRS - page 103
- Activities of daily living- Part II of the UPDRS - page 104
- Motor examination- Part III of the UPDRS - page 105
- Gold standard therapies for Parkinson's disease - page 106
- Classification of marketed and pipeline products - page 44
- CHAPTER 4 PARKINSON'S DISEASE PIPELINE ANALYSIS - page 107
- Pipeline overview - page 107
- Late-stage pipeline overview - page 111
- Registration overview - page 111
- Pre-registration overview - page 112
- Phase III overview - page 113
- Phase II overview - page 114
- Key companies involved in the Parkinson's disease pipeline - page 115
- Big Pharma need to increase investment into drug discovery projects for disease modifying agents - page 115
- Pfizer - page 115
- The symptomatic treatment market provides opportunities for specialty companies - page 117
- Vernalis - page 117
- Big Pharma need to increase investment into drug discovery projects for disease modifying agents - page 115
- CHAPTER 5 DOPAMINERGICS- LATE-STAGE DRUG ANALYSIS AND FORECASTS - page 121
- Overview of the dopaminergic class - page 121
- Pipeline summary - page 121
- V1512 (melevodopa-carbidopa) - page 122
- Drug overview - page 122
- Clinical trials - page 122
- Phase II/III trials conducted by Chiesi - page 123
- Ongoing Phase III trials - page 125
- Pharmacokinetic study - page 126
- Patient potential - page 126
- Marketing factors - page 127
- Further Datamonitor comments - page 128
- Satisfaction of unmet needs - page 128
- Reduction of dyskinesia or OFF time - page 129
- Smoother levodopa dosage - page 129
- Reduce pill burden - page 129
- Lower cost - page 130
- Forecasts to 2015 - page 130
- Datamonitor does not expect V1512 to gain significant sales from current treatments - page 131
- V1512 is at risk of generic entacapone from 2010 - page 131
- Overview of the dopaminergic class - page 121
- CHAPTER 6 DOPAMINE AGONISTS- LATE-STAGE DRUG ANALYSIS AND FORECASTS - page 132
- Overview of the dopamine agonists class - page 132
- Pipeline summary - page 133
- Requip Modutab (ropinirole XL 24 hour) - page 134
- Clinical trials - page 134
- Ongoing Phase III comparison with immediate release ropinirole - page 134
- Patient population - page 134
- Marketing factors - page 135
- Satisfaction of unmet needs - page 136
- Reduction of dyskinesia or OFF time - page 136
- Lower side effects - page 136
- Reduce pill burden - page 137
- Reduce time to levodopa therapy - page 137
- Lower cost - page 137
- Forecasts to 2015 - page 137
- Datamonitor expects Requip Modutab to limit the success of Neupro - page 139
- Generic ropinirole is set to limit the success of Requip Modutab - page 140
- Clinical trials - page 134
- SLV-308 - page 141
- Drug overview - page 141
- Ongoing Phase III clinical trials - page 142
- S308.3.001/ S308.3.003- SLV-308 in treatment of patients with early PD - page 142
- Ascending dose tolerability/ safety study in advanced PD with levodopa - page 142
- Patient potential - page 142
- Marketing factors - page 143
- Datamonitor comments - page 143
- Forecasts to 2015 - page 144
- The role of SLV308 is not yet clear and forecast sales are low - page 145
- Other drugs in the dopamine agonist class - page 146
- Lisuride (TTS/ SubQ) - page 146
- Lisuride TTS - page 146
- Lisuride (SubQ) - page 147
- Datamonitor comments - page 148
- Rotigotine nasal spray - page 149
- Apomorphine nasal powder - page 149
- AMR-101 (apomorphine sublingual) - page 150
- Lisuride (TTS/ SubQ) - page 146
- Overview of the dopamine agonists class - page 132
- CHAPTER 7 ADENOSINE A2A RECEPTOR ANTAGONISTS- LATE-STAGE DRUG ANALYSIS AND FORECASTS - page 151
- Overview of the adenosine A2a receptor antagonist class - page 151
- Pipeline summary - page 151
- KW-6002 (istradefylline) - page 152
- Drug overview - page 152
- Completed Phase III trials - page 152
- Study 6002-US-018- 10, 20, 40mg/day KW-6002 in combination - page 153
- Study 6002-US-013- 20mg/day KW-6002 in combination - page 153
- Study 6002-EU-007- 40mg/day KW-6002 in combination - page 154
- Completed Phase II trials - page 154
- Study 6002-US-001- 20, 40mg/day KW-6002 in combination - page 154
- Ongoing trials - page 155
- Study 6002-US-051- Phase II monotherapy in early PD - page 155
- Study 6002-0406- Phase II Japan- 20, 40mg/day KW-6002 in combination - page 155
- Study 6002-0407- Phase II Japan- early PD - page 156
- Study 6002-INT-001- long-term safety - page 156
- Study 6002-US-025- long-term safety - page 156
- Patient population - page 157
- Marketing factors - page 157
- Further Datamonitor comments - page 157
- Satisfaction of unmet needs - page 158
- Reduction of dyskinesia or OFF time - page 159
- Lower side effects - page 160
- Reduce pill burden - page 160
- Reduce time to levodopa therapy - page 160
- Lower cost - page 160
- Forecasts to 2015 - page 161
- KW-6002 may provide a novel mechanism for treating 'wearing off' - page 162
- KW-6002 sales are expected to depend on the success of E2007 - page 162
- Approval in Japan and use in early PD may support sales growth - page 162
- Other drugs in the adenosine A2a receptor antagonist class - page 163
- Fipamezole (JP-1730) - page 163
- Clinical trials - page 163
- Sch-58261 analog - page 164
- Fipamezole (JP-1730) - page 163
- Overview of the adenosine A2a receptor antagonist class - page 151
- CHAPTER 8 MAOIS- LATE-STAGE DRUG ANALYSIS AND FORECASTS - page 165
- Overview of the MAOI class - page 165
- Pipeline summary - page 165
- Safinamide (NW-1015) - page 166
- Drug overview - page 166
- Phase III clinical trials - page 166
- Adjunctive treatment to dopamine agonists in patients with early-stage PD. - page 166
- Phase II trials - page 168
- Safinamide as an adjunct to a dopamine agonist in early PD. - page 168
- Phase I trials - page 171
- Patient potential - page 171
- Marketing factors - page 171
- Datamonitor comments - page 172
- Satisfaction of unmet needs - page 172
- Drugs that slow or prevent disease progression - page 173
- Reduction of dyskinesia or OFF time - page 173
- Reduce pill burden - page 174
- Lower cost - page 174
- Forecasts to 2015 - page 174
- Safinamide's benefits over current MAOIs are unclear - page 175
- The ADAGIO study of Azilect will set the first hurdle for safinamide in neuroprotection - page 175
- Overview of the MAOI class - page 165
- CHAPTER 9 NEUROPROTECTANTS- LATE STAGE DRUG ANALYSIS - page 177
- Overview of the neuroprotectant class - page 177
- Pipeline summary - page 177
- Definition of current comparator therapy - page 178
- SR57667 - page 178
- Ongoing clinical trials - page 178
- EFC5287- Phase II study of SR57667 on the progression of PD - page 178
- ACT5288- Study of SR57667 on 18F-Dopa PET imaging in PD patients - page 179
- Further Datamonitor comments - page 179
- Ongoing clinical trials - page 178
- PD-02 (creatine) - page 180
- Phase II clinical trials - page 180
- Phase II futility study of PD-02 in early PD - page 180
- Phase II clinical trials - page 180
- Cereact Capsule (ONO-2506PO) - page 183
- Drug overview - page 183
- Clinical trials - page 184
- Phase II study of ONO-2506PO in patients with PD in Japan. - page 184
- Datamonitor comments - page 184
- GM1 ganglioside - page 185
- Drug overview - page 185
- Clinical trials - page 185
- Phase II study of GM1 ganglioside in mild to moderate PD - page 185
- Second Phase II study of GM1 ganglioside in mild to moderate PD - page 186
- Kinampa (talampanel) - page 187
- Drug overview - page 187
- Clinical trials - page 188
- Phase II study of talampanel on dyskinesias associated with treatment of patients with advanced PD - page 188
- NINDS sponsored Phase II study of talampanel - page 188
- FP-0011 - page 189
- Late-stage development compounds recently discontinued - page 190
- GPI-1485 - page 190
- Phase II study- Guildford Pharmaceuticals/ Amgen - page 191
- Phase II study- Guildford/ SNDC - page 191
- Phase II study- NINDS - page 192
- GPI-1485 - page 190
- Overview of the neuroprotectant class - page 177
- CHAPTER 10 CELL/GENE THERAPY- LATE STAGE PRODUCT ANALYSIS - page 193
- Overview of the cell/gene therapy class - page 193
- Pipeline summary - page 193
- Definition of current comparator therapy - page 193
- Spheramine (RPE cell therapy) - page 194
- Drug overview - page 194
- Clinical trials - page 194
- Phase I/II open-label study - page 195
- The STEPS trial- Phase II double-blind study - page 196
- Further Datamonitor comments - page 196
- AV201 (AAV-AADC) - page 197
- Drug overview - page 197
- Clinical trials - page 198
- Phase I/II increasing dose trial - page 198
- Overview of the cell/gene therapy class - page 193
- CHAPTER 11 OTHERS- LATE-STAGE DRUG ANALYSIS AND FORECASTS - page 199
- Overview of the others class - page 199
- Pipeline summary - page 199
- E2007 - page 200
- Drug overview - page 200
- Completed Phase II trials - page 200
- Study 204- Phase IIb proof-of-concept - page 200
- Ongoing Phase III trials - page 202
- Study E2007-E044-301- E2007 in levodopa treated PD patients with motor fluctuations - page 202
- Patient potential - page 203
- Marketing factors - page 203
- Further Datamonitor comments - page 203
- Satisfaction of unmet needs - page 204
- Reduction of dyskinesia or OFF time - page 204
- Lower side effects - page 205
- Lower cost - page 205
- Forecasts to 2015 - page 205
- E2007 is positioned as an alternative treatment for reducing OFF time - page 206
- Other drugs in the others class - page 206
- Tremode (zonisamide) - page 206
- Drug overview - page 206
- Clinical trials - page 207
- Forecast - page 207
- Keppra (levetiracetam) - page 208
- Clinical trials - page 208
- ACP-103 - page 210
- Phase II study of ACP-103 on levodopa-induced dykinesias in PD - page 210
- Tremode (zonisamide) - page 206
- Late-stage development compounds recently discontinued - page 211
- Sarizotan (EMD-128130) - page 211
- Drug overview - page 211
- Clinical trials - page 212
- Further Datamonitor comments - page 214
- Tesofensine (NS2330) - page 215
- Drug overview - page 215
- Clinical trials - page 215
- Datamonitor comments - page 218
- Sarizotan (EMD-128130) - page 211
- Overview of the others class - page 199
- CHAPTER 12 INNOVATIVE EARLY-STAGE PARKINSON'S DISEASE PROJECTS - page 219
- Phase I and preclinical pipeline overview - page 219
- Phase I overview - page 219
- Preclinical overview - page 220
- Key Phase I and preclinical projects in PD - page 223
- Prosavin - page 223
- Alpha (α)-synuclein modulation - page 224
- Phase I and preclinical pipeline overview - page 219
- CHAPTER 13 PATIENT POTENTIAL- RESTLESS LEGS SYNDROME - page 226
- Definition of Restless Legs Syndrome - page 226
- Etiology - page 227
- Diagnosis - page 228
- Segmentation of Restless Legs Syndrome - page 229
- Severity - page 229
- International Restless Legs Syndrome Study Group Rating Scale (IRLS). - page 229
- Comorbidities - page 231
- Severity - page 229
- Epidemiology of Restless Legs Syndrome - page 232
- Prevalence - page 232
- Treatment strategies in Restless Legs Syndrome - page 236
- Unmet needs in Restless Legs Syndrome - page 237
- Greater efficacy - page 237
- Faster onset of action - page 238
- Longer duration of action - page 238
- Improved side effect profile - page 238
- Effective second-line treatment - page 239
- Reduced frequency of dosing - page 239
- Definition of Restless Legs Syndrome - page 226
- CHAPTER 14 RESTLESS LEGS SYNDROME R&D APPROACH - page 240
- Classification of marketed and pipeline products - page 240
- Market definition of Restless Legs Syndrome for this report - page 240
- Dopaminergic stimulation provides the mainstay of RLS treatment - page 240
- Dopamine agonists are the first-line choice - page 240
- Levodopa use is limited by the risk of augmentation - page 241
- Anticonvulsants are typically used in treatment resistant RLS - page 241
- Opioids can be useful for treatment resistant, painful RLS - page 242
- Sedatives may alleviate sleep disturbance - page 243
- Iron infusion poses a potential risk to RLS revenues - page 243
- Clinical trial design in Restless Legs Syndrome - page 244
- The IRLS is considered an essential primary efficacy measure - page 244
- Clinical Global Impression (CGI) - page 244
- Quality of life (QOL) measures - page 244
- Sleep disturbance - page 245
- Cardiovascular risks - page 245
- The IRLS is considered an essential primary efficacy measure - page 244
- GSK's Requip (ropinirole)-the gold standard Restless Legs Syndrome treatment - page 245
- Drug overview - page 245
- Completed Phase III trials - page 246
- Study design - page 246
- Results - page 247
- Long-term maintenance of efficacy - page 251
- Ongoing trials - page 252
- Study ROR104836 - page 252
- TREAT RLS PRN - page 252
- Further Datamonitor comments - page 252
- Strategies for success - page 253
- Classification of marketed and pipeline products - page 240
- CHAPTER 15 RESTLESS LEGS SYNDROME PIPELINE ANALYSIS - page 255
- Overview of treatments in development for Restless Legs Syndrome - page 255
- Pipeline summary - page 255
- Requip XR (ropinirole extended release) - page 256
- Drug overview - page 256
- Phase III clinical trials - page 256
- US/EU Phase III study of Requip vs. Requip XR- 101468/204 - page 256
- N. American Phase III study- 101468/205 - page 256
- The ROX104805 Phase III study - page 257
- Patient potential - page 257
- Marketing factors - page 257
- Satisfaction of unmet needs - page 258
- Longer duration of action - page 258
- Onset of action - page 259
- Forecasts to 2015 - page 259
- Requip XR is expected to be eclipsed by Neupro - page 260
- Generic ropinirole is set to limit Requip XR revenues - page 260
- Transdermal rotigotine patch - page 261
- Drug overview - page 261
- Completed trials - page 261
- SP709- Phase II EU proof-of-concept study - page 261
- Open-label EU extension study - page 262
- Ongoing trials - page 263
- SP792- Phase III US study - page 263
- SP793- Open-label extension to SP792 - page 263
- SP790- Phase III EU study - page 263
- SP794- EU sleep lab trial - page 264
- Patient potential - page 264
- Marketing factors - page 265
- Further Datamonitor comments - page 265
- Satisfaction of unmet needs - page 266
- Longer duration of action - page 266
- Faster onset of action - page 266
- Greater efficacy - page 266
- Forecasts to 2015 - page 267
- Disadvantages associated with a patch formulation may limit sales - page 268
- XP13512 - page 268
- Completed trials - page 269
- Phase IIa - page 269
- Phase IIb - page 270
- Ongoing trials - page 271
- XP052- US Phase III study - page 271
- XP053- US Phase III study - page 271
- XP060- US long-term withdrawal study - page 272
- XP055- US open-label extension study - page 272
- Patient potential - page 272
- Marketing factors - page 272
- Satisfaction of unmet needs - page 273
- Greater efficacy - page 274
- Faster onset of action - page 274
- Duration of action - page 274
- Effective second-line treatment - page 274
- Improved side effect profile - page 275
- Forecasts to 2015 - page 275
- XP13512 is expected to be positioned as an alternative to dopamine agonists - page 276
- Completed trials - page 269
- Other drugs for Restless Legs Syndrome - page 276
- Lisuride TTS - page 276
- KW-6002 (istradefylline) - page 277
- Safinamide - page 278
- Keppra (levetiracetam) - page 278
- Topamax (topiramate) - page 278
- Overview of treatments in development for Restless Legs Syndrome - page 255
- BIBLIOGRAPHY - page 280
- References - page 280
- Websites - page 295
- APPENDIX - page 300
- Forecast revenues - page 300
- Methodology - page 303
- Datamonitor forecast methodology - page 303
- Product forecasts - page 303
- Sales calculations - page 303
- Definition of a standard unit - page 304
- Japanese market data - page 304
- Additional assumptions - page 305
- Datamonitor forecast methodology - page 303
- Report methodology - page 305
- Contributing experts - page 305
- About Datamonitor - page 306
- About Datamonitor Healthcare - page 306
- About the CNS analysis team - page 307
- Disclaimer - page 308
- List of Tables
- Table 1: The five stages of PD according to the Hoehn & Yahr scale - page 27
- Table 2: Prevalence of PD across the three major market regions, 2006 - page 29
- Table 3: Diagnosed PD population in the US, Japan, and M5EU by severity - page 31
- Table 4: Key dopamine agonists - page 48
- Table 5: Study design in the assessment of pramipexole in early PD - page 51
- Table 6: Study design in the assessment of pramipexole in early PD - page 52
- Table 7: Adverse events occurring in >5% of early PD patients on pramipexole as a monotherapy - page 53
- Table 8: Study design for pramipexole in advanced PD with levodopa - page 54
- Table 9: Key results from study of pramipexole vs. placebo in advanced PD with levodopa - page 55
- Table 10: Adverse events occurring in >5% of advanced PD patients treated with pramipexole in addition to levodopa - page 56
- Table 11: Number of adverse events occurring with Neupro vs. placebo - page 60
- Table 12: Study design in the assessment of rotigotine CDS in early PD - page 61
- Table 13: Key results from large scale studies of rotigotine CDS in treating patients with early PD - page 62
- Table 14: Commonly occurring adverse events that were more frequent in those treated with rotigotine than placebo - page 65
- Table 15: Results from the N. American study (SEESAW) of entacapone in patients experiencing ON and OFF periods despite optimized levodopa therapy - page 72
- Table 16: Results from the Nordic study (NOMECOMT) of entacapone in patients experiencing ON and OFF periods despite optimized levodopa therapy - page 74
- Table 17: Results from the German-Austrian study of entacapone in patients taking levodopa-DDI and experiencing 'wearing off' - page 75
- Table 18: Adverse events occurring in ≥5% of entacapone patients - page 76
- Table 19: Pros and cons of neuroprotection study endpoints - page 97
- Table 20: Possible criteria for agent selection for neuroprotection studies - page 99
- Table 21: Comparison of convention trial design versus the futility trial design - page 100
- Table 22: Unified Parkinson's Disease Rating Scale : cognition, behavior and mood - page 104
- Table 23: Number of R&D projects in each class split by phase of development for PD, 2006 - page 107
- Table 24: Compounds in registration for PD, 2006 - page 111
- Table 25: Compounds in pre-registration for PD, 2006 - page 112
- Table 26: Compounds in Phase III development for PD, 2006 - page 113
- Table 27: Compounds in Phase II development for PD, 2006 - page 114
- Table 28: Pfizer's R&D pipeline for PD treatments, 2006 - page 116
- Table 29: Vernalis' R&D pipeline for PD treatments, 2006 - page 119
- Table 30: Key products in late-stage development for the dopaminergic class, 2006 - page 121
- Table 31: Phase II studies of V1512 conducted by Chiesi - page 123
- Table 32: Phase III studies of V1512 conducted by Chiesi - page 124
- Table 33: Impacting factors on the sales of V1512, 2006-15 - page 130
- Table 34: Key products in late-stage development for the dopamine agonist class, 2006 - page 133
- Table 35: Impacting factors on the sales of Requip Modutab, 2006-15 - page 139
- Table 36: Impacting factors on the sales of SLV-308, 2006-15 - page 145
- Table 37: Key products in late-stage development for the adenosine A2a receptor antagonist class, 2006 - page 151
- Table 38: Impacting factors on the sales of KW-6002, 2006-15 - page 161
- Table 39: Key products in late-stage development for the MAOI class, 2006 - page 165
- Table 40: Number of withdrawals and reasons given - page 170
- Table 41: Impacting factors on the sales of safinamide, 2006-15 - page 175
- Table 42: Key products in late-stage development for the neuroprotectant class, 2006 - page 177
- Table 43: Patient characteristics at baseline - page 181
- Table 44: Change in UPDRS score from baseline to 12 months or the need for symptomatic therapy (whichever first) - page 182
- Table 45: Discontinued projects in the neuroprotectant class, 2005-06 - page 190
- Table 46: Key products in late-stage development for the cell/gene therapy class, 2006 - page 193
- Table 47: Key products in late-stage development for the others class, 2006 - page 199
- Table 48: Impacting factors on the sales of E2007, 2006-15 - page 206
- Table 49: Discontinued R&D projects in the 'others' class, 2005-06 - page 211
- Table 50: Projects in Phase I development for PD, 2006 - page 219
- Table 51: Projects in preclinical development for PD, 2006 - page 220
- Table 52: Projects in preclinical development for PD, 2006 (continued) - page 221
- Table 53: Projects in preclinical development for PD, 2006 (continued) - page 222
- Table 54: The International Restless Legs Syndrome Study Group Rating Scale (IRLS) - page 230
- Table 55: The prevalence of RLS in the US, M5EU and Japan, 2006 - page 232
- Table 56: Dose titration schedule for ropinirole in treating RLS - page 246
- Table 57: Trial end points used in pivotal studies of Requip for RLS - page 247
- Table 58: TREAT RLS US study of ropinirole vs. placebo - page 249
- Table 59: TREAT RLS 1 study of ropinirole vs. placebo conducted in the EU and other countries - page 249
- Table 60: TREAT RLS 2 study of ropinirole vs. placebo conducted in the US and other countries - page 250
- Table 61: Products in development for RLS, 2006 - page 255
- Table 62: Impacting factors on Requip XR RLS sales, 2006-15 - page 260
- Table 63: Impacting factors on transdermal rotigotine RLS sales, 2006-15 - page 268
- Table 64: Results of Phase IIb study - page 270
- Table 65: Impacting factors on XP13512 RLS sales, 2006-15 - page 276
- Table 66: Forecast Parkinson disease drug revenues, 2006-2015 - page 301
- Table 67: Forecast Restless Legs Syndrome drug revenues, 2006-2015 - page 302
- Table 68: Parkinson's disease and Restless Legs Syndrome market definition by ICD10 code - page 303
- List of Figures
- Figure 1: Projection of the population aged 65 or greater, across the three major market regions, 2005-2050 - page 30
- Figure 2: Current treatment pathway of PD patients as recommended by guidelines - page 34
- Figure 3: Recommendations for management of Parkinson's disease according to stage of disease - page 35
- Figure 4: Key unmet needs in Parkinson's disease treatment - page 36
- Figure 5: Unmet needs according to stage of disease - page 37
- Figure 6: Levodopa dose required to relieve symptoms compared to dose required to induce dyskinesias - page 40
- Figure 7: Mechanism of action of AADC inhibitors (DDI) - page 46
- Figure 8: Results from the long-term study of Requip vs. levodopa on the development of dyskinesia - page 49
- Figure 9: Key results from six month trial of pramipexole monotherapy vs. placebo in treating patients with early PD - page 51
- Figure 10: Key results from mixed-dose study of pramipexole monotherapy vs. placebo in treating patients with early PD - page 53
- Figure 11: Key results from study of pramipexole vs. placebo in advanced PD with levodopa - page 55
- Figure 12: Neupro patch sizes and corresponding doses - page 57
- Figure 13: Change in UPDRS-II-III scores compared to placebo for groups taking 2 to 8mg/24hrrotigotine - page 58
- Figure 14: UPDRS part II and III scores with Neupro vs. placebo - page 59
- Figure 15: Study SP512 results- comparison of rotigotine vs. placebo in early PD over 24 weeks maintenance - page 63
- Figure 16: Study SP513 results - comparison of rotigotine vs. ropinirole or placebo in early PD over 24 weeks maintenance - page 64
- Figure 17: Pooled results from three-randomized controlled clinical trials evaluating efficacy of Apokyn - page 68
- Figure 18: Mechanism of action of COMT inhibitor, entacapone - page 70
- Figure 19: Key results from the N. American study (SEESAW) of entacapone in patients experiencing ON and OFF periods despite optimized levodopa therapy - page 71
- Figure 20: Key results from the Nordic study (NOMECOMT) of entacapone in patients experiencing ON and OFF periods despite optimized levodopa therapy - page 73
- Figure 21: Mechanism of action of MAO-B inhibitors - page 78
- Figure 22: Mean daily percentage awake OFF time with Zelapar (1.25 and 2.5mg/day) against placebo - page 80
- Figure 23: TEMPO study- change in UPDRS score with 1mg/day rasagiline vs. placebo over six months - page 83
- Figure 24: TEMPO study- change in UPDRS score with rasagiline vs. placebo over 12 months - page 84
- Figure 25: Change over 18 weeks in the LARGO study of rasagiline as an adjunct to treatment in patients with moderate-to-advanced PD - page 86
- Figure 26: Change in daily ON time without troublesome dyskinesia over 18 weeks in the LARGO study of rasagiline as an adjunct to treatment in patients with moderate-to-advanced PD - page 87
- Figure 27: Change in daily ON time with troublesome dyskinesia over 18 weeks in the LARGO study of rasagiline as an adjunct to treatment in patients with moderate-to-advanced PD - page 88
- Figure 28: Change in daily OFF time over 26 weeks in the PRESTO study of rasagiline as an adjunct to treatment in moderate-to-advanced PD patients with motor complications - page 90
- Figure 29: Recommendations for management of Parkinson's disease according to stage of disease - page 106
- Figure 30: Number of R&D projects at each stage of development, 2006 - page 108
- Figure 31: Vernalis' inline and pipeline PD product range and where they fit into the PD disease stages, 2006 - page 120
- Figure 32: Depicts V1512's (CNP-1512) ability to reduce OFF time in Phase II/III studies of PD patients experiencing motor fluctuations - page 125
- Figure 33: V1512's positioning against current unmet needs - page 129
- Figure 34: Forecast Parkinson's disease sales for V1512 across the US and EU, 2006-2015 - page 130
- Figure 35: Requip Modutab's positioning against current unmet needs - page 136
- Figure 36: Forecast Parkinson's disease sales for Requip Modutab across the US and EU, 2006-2015 - page 138
- Figure 37: Forecast Parkinson's disease sales for SLV-308 across the US and EU, 2006-2015 - page 144
- Figure 38: KW-6002's position against current unmet needs - page 159
- Figure 39: Datamonitor's forecast of KW-6002's revenues across the US, EU and Japan ($m), 2006-2015 - page 161
- Figure 40: UPDRS-III scores over the Phase II trials of safinamide in a subset of patients also taking one dopamine agonist - page 169
- Figure 41: Safinamide's position against current unmet needs - page 173
- Figure 42: Datamonitor's forecast of safinamide's revenues across the US, EU and Japan ($m), 2006-2015 - page 174
- Figure 43: Participant flow in the Phase II study of PD-02 in early PD - page 181
- Figure 44: E2007 proof-of-concept Phase II trial results - page 201
- Figure 45: E2007's position against current unmet needs - page 204
- Figure 46: Datamonitor's forecast of E2007's revenues across the US, EU and Japan ($m), 2006-2015 - page 205
- Figure 47: Phase II trial results of NS2330 in advanced PD - page 217
- Figure 48: Results showing the effects of ProSavin in MPTP-treated primates - page 223
- Figure 49: The proportion of individuals with RLS classified as having a medically significant diagnosis - page 234
- Figure 50: The prevalence of RLS in the EU by age group - page 235
- Figure 51: Key unmet needs in RLS treatment - page 237
- Figure 52: Change in IRLS total score over 12 weeks (pooled results from the three pivotal studies used for US filing) - page 248
- Figure 53: Most common adverse events reported in patients treated with ropinirole in TREAT RLS trials - page 251
- Figure 54: Unmet needs associated with Requip - page 253
- Figure 55: Requip XR's potential advantages over current treatments - page 258
- Figure 56: Forecast RLS sales for Requip XR across the US and EU, 2006-2015 - page 259
- Figure 57: Transdermal rotigotine's potential advantages over current treatments - page 266
- Figure 58: Forecast RLS sales for transdermal rotigotine across the US and EU, 2006-2015 - page 267
- Figure 59: XP13512's potential advantages over current treatments - page 273
- Figure 60: Forecast RLS sales for XP13512 across the US, EU and Japan 2006-2015 - page 275
Other users found this report page using the following search terms: neuroprotection neurodegeneration neurodegenerative parkinsons study parkinsons 60020407 chiesi talampanel drugs istradefylline burden pill 204
If you can't find a report that meets your needs contact LeadDiscovery. We are one of the few report providers with extensive drug development experience and we frequently use this knowledge to help clients source the most appropriate reports or produce reports for them from scratch.