Pipeline and Commercial Insight: Neuropathic Pain - UCB's Vimpat set to compete with major players

The neuropathic pain market is forecast to almost triple to over $6.3 billion by the end of the forecast period in 2017. The growth in the market is spurred on by the uptake of Pfizer's Lyrica (pregabalin), forecast to reach almost $3 billion in sales by 2017. Vimpat is the most promising pipeline drug, forecast to take some $480m by 2017.

Report Highlights
UCB's Vimpat (lacosamide) demonstrates the most potential in the pipeline and is well suited to compete in this market. Datamonitor has forecast Vimpat to generate over $480m, over a third of the total pipeline sales by 2017.

Neuropathic pain offers diverse market opportunities, with niche underserved neuropathic pain indications (e.g. HIV associated neuropathic pain) offering a good market entry point.

Following the recent negative FDA advice on Cephalon's Fentora, Datamonitor has forecast that the drug will not launch for neuropathic pain. This is a blow to the development of a niche breakthrough neuropathic pain market.
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ABOUT DATAMONITOR HEALTHCARE 2
About the Central Nervous System pharmaceutical analysis team 2
CHAPTER 1 EXECUTIVE SUMMARY 3
Scope of the analysis 3
Datamonitor insight into the Neuropathic pain market 4
Key metrics 6
Datamonitor pipeline assessment summary 10
Related reports 10
CHAPTER 2 NEUROPATHIC PAIN - MARKET OVERVIEW AND POTENTIAL 12
Definition of neuropathic pain 13
Segmentation of neuropathic pain 14
Segmentation of neuropathic pain differs depending on the geographic market 14
General neuropathic pain provides a broader customer base in the EU 15
US approval requires evidence in each neuropathic pain subtype 15
Major neuropathic pain subtypes 16
Diabetic neuropathic pain 16
Post-herpetic neuralgia 16
HIV neuropathic pain 17
Neuropathic low-back pain 17
Other subtypes 18
Epidemiology 18
Diabetic neuropathic pain 20
Post-herpetic neuralgia 21
HIV neuropathic pain 22
Post-operative pain 22
Current market overview 23
Five treatments are currently marketed for neuropathic pain 23
Off-label prescribing 24
US dominated market 27
Unmet need in neuropathic pain 28
Clinical unmet need 28
1. Improved efficacy 29
2. Improved side-effect profile 30
3. Reduced time to onset of action 30
4. Fewer drug-drug interactions 31
5. Pill burden 31
Clinical trial design in neuropathic pain 32
Choice of endpoint is the key clinical trial design factor in neuropathic pain 32
Head-to-head trials of increasing importance 32
Lyrica is the ideal choice of comparator drug for head-to-head clinical trials 32
Length of trial should indicate titration period for physician ease of use 32
The Initiative on Methods, Measurements and Pain Assessments in Clinical trials (IMMPACT) 33
European Federation of Neurological Societies assessment 35
Clinical trial endpoints in neuropathic pain 35
50% reduction in pain is a primary measure of efficacy 35
Multiple pain and quality of life assessment questionnaires should be used in trials 35
Clinical trial drop-out as an endpoint 40
CHAPTER 3 BRAND DYNAMICS AND LEADING COMPARATOR THERAPIES 41
Marketed brands overview 42
Lyrica (pregabalin) 42
Drug overview 42
Forecasts to 2017 43
SWOT 44
Datamonitor drug assessment summary 45
Clinical trial data 45
Lyrica clinical trial 1 46
Lyrica clinical trial 2 46
Lyrica clinical trial 3 47
Neurontin (gabapentin) 48
Drug overview 48
Forecasts to 2017 49
SWOT 50
Clinical trial data 50
Lidoderm (lidocaine) 51
Drug overview 51
Forecasts to 2017 52
Clinical trial data 53
Lidoderm clinical trial 1 53
Lidoderm clinical trial 2 54
Cymbalta (duloxetine) 55
Drug overview 55
Forecasts to 2017 56
SWOT 57
Clinical trial data 57
Tegretol (carbamazepine) 58
Drug overview 58
SWOT 59
CHAPTER 4 FORECAST ANALYSIS 60
Key events 61
New product launches 62
Product launches in Japan 62
Patent expiries 63
Cymbalta 63
Lidoderm 63
Data definitions, limitations and assumptions 65
Standard units 65
Japanese market data 65
Derivation of sales forecasts and pricing trends 65
Forecast methodology 65
CHAPTER 5 STRATEGIES FOR SUCCESS 66
Key R&D company strategies 67
Reformulation strategies: Gabapentin 67
Gabapentin GR 67
XP13512 68
Patient subgroups 68
CHAPTER 6 PIPELINE OVERVIEW AND DYNAMICS 72
Pipeline overview 73
Classification of pipeline products 74
Glutamate receptor modulators 74
NMDA 74
AMPA 75
Kainate 75
Ion channel modulators 76
Sodium channels 76
Calcium channels 76
GABA modulators 76
Others 77
SNRIs 77
Dopamine modulators 78
Cannabinoid agonists 78
Vanilloid receptor agonists 78
Substance P release modulators 79
ACh receptor agonists 79
NGF modulators 79
TNF alpha antagonists 79
Adrenoceptor modulation 79
Adenosine A2 agonists 80
Free radicals 80
Phase II and above 80
Key companies involved in the neuropathic pain pipeline 84
Pfizer 84
Neurontin 85
Lyrica 86
Eli Lilly 89
Cymbalta 89
UCB 90
Vimpat 91
Brivaracetam 91
Discontinued and suspended projects 92
Projects recently suspended or discontinued 92
ACV-1 92
Pristiq 92
Radafaxine (353162) 94
Lamictal XR 95
Namenda (memantine) 97
Traxoprodil 97
AZD-4282 98
CHAPTER 7 LATE-STAGE DRUG ANALYSIS & FORECASTS 99
Glutamate receptor modulators 100
Pipeline summary 100
Comparative forecasts 102
Definition of current comparator therapy 102
Pfizer's Lyrica is Datamonitor's comparator therapy 102
Lidoderm is the topical comparator therapy 106
Zenvia (dextromethorphan & quinidine sulfate) 107
Drug overview 107
Forecasts to 2017 108
Datamonitor drug assessment summary 109
Patient potential 110
Marketing factors 111
Satisfaction of unmet needs 112
Clinical trial data 113
NP-1 (ketamine & amitriptyline) 114
Drug overview 114
Forecasts to 2017 114
Datamonitor drug assessment summary 116
Patient potential 117
Marketing factors 118
Satisfaction of unmet needs 119
Clinical trial data 119
Other glutamate receptor modulators 121
CNS-5161 121
V3381 124
RGH-896 128
EVT 101 128
NS-1209 129
NGX-426 129
Ion channel modulators 130
Pipeline summary 130
Comparative forecasts 132
Definition of current comparator therapy 132
Vimpat (lacosamide) 133
Drug overview 133
Forecasts to 2017 133
Datamonitor drug assessment summary 134
Patient potential 135
Marketing factors 136
Satisfaction of unmet needs 137
Clinical trial data 138
Ralfinamide 141
Drug overview 141
Forecasts to 2017 142
Datamonitor drug assessment summary 143
Patient potential 144
Marketing factors 145
Satisfaction of unmet needs 145
Clinical trial data 146
Other ion channel modulators 149
Retigabine 149
Bupivacaine (Eladur) 150
Lidocaine patch KN-48 151
Brivaracetam 151
GABA receptor modulators 152
Pipeline summary 152
Comparative forecasts 154
Definition of current comparator therapy 154
XP13512 154
Drug overview 154
Forecasts to 2017 155
Datamonitor drug assessment summary 157
Marketing factors - improved duration of action 158
Patient potential 159
Satisfaction of unmet needs 159
Clinical trial data 159
Gabapentin GR 161
Drug overview 161
Forecasts to 2017 161
Datamonitor drug assessment summary 162
Clinical trial data 163
Other therapies 167
Pipeline summary 167
Comparative forecasts 169
Transacin (NGX-4010) 170
Drug overview 170
Forecasts to 2017 170
Datamonitor drug assessment summary 172
Patient potential 173
Marketing factors 173
Satisfaction of unmet needs 174
Clinical trial data 175
Other drugs 178
Sativex (GW-1000) 178
Fentora (fentanyl buccal transmucosal) 184
BVT.115959 184
Bicifadine 186
NSD-644 187
Reboxetine (+)-(S,S) 187
F13640 187
AS-3201 188
KD7040 188
Ibudilast (AV411) 188
IP 751/CT-3 (ajulemic acid) 189
ADL5859 190
KDS-2000 190
AGN 203818 190
681323 190
Liposomal galantamine 191
TAK-583 191
Botulinum toxin type A-hemagglutinin complex (Dysport) 191
Zucapsaicin 191
2PX 191
CHAPTER 8 INNOVATIVE EARLY-STAGE PROJECTS 192
Key Phase I and preclinical compounds in neuropathic pain 193
Selective sodium channel blockers 196
Vanilloid TRPV1 antagonists 197
Preclinical trial data 197
NGX-1998 198
GRC-6211 198
SAR-115740 198
N-type calcium channel blockers 198
Spinal cord and peripheral nerve stimulation 199
BIBLIOGRAPHY 200
Journals 200
Websites 206
Datamonitor reports 216
APPENDIX A 218
Methodology 218
Datamonitor forecast methodology 218
ICD-10 codes 218
Product forecasts 219
Definition of a standard unit 220
Datamonitor drug assessment summary 221
Contributing experts 222
Biographies 222
APPENDIX B 224
About Datamonitor 224
About Datamonitor Healthcare 224
Datamonitor Healthcare's therapy area capabilities 225
About the Disease analysis team 226
Disclaimer 227
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Table 1: Neuropathic pain market size across the seven major markets ($m), 2007 and 2017 6
Table 2: Sales forecasts ($m) of key pipeline products in neuropathic pain, 2007-2017 8
Table 3: Abbreviations for neuropathic pain subtypes 14
Table 4: Diabetic neuropathic pain patient populations across the seven major markets, 2008 20
Table 5: Post-herpetic neuralgia patient population across the seven major markets, 2008 21
Table 6: HIV neuropathic pain patient population across the seven major markets, 2008 22
Figure 7: Key unmet needs in neuropathic pain, 2008 29
Table 7: Recommended core outcomes measures for clinical trials of chronic pain treatment efficacy 34
Table 8: Forecast launch dates for neuropathic pain drugs in the US and 5EU, 2008-2012 62
Table 9: Forecast launch dates for neuropathic pain drugs in Japan, 2010-2012 62
Table 10: Pivotal patent expiries for key marketed neuropathic pain drugs in the US and 5EU, 2012-16 63
Table 11: Neuropathic pain market sub-type definition by ICD-10 codes 71
Table 12: Number of key neuropathic pain drugs by class and phase of development, 2008 74
Table 13: Phase II & III R&D pipeline for neuropathic pain, 2008 80
Table 14: Key glutamate receptor modulators in the late-stage R&D pipeline for neuropathic pain, 2008 100
Table 15: Lyrica: key facts 105
Table 16: Estimated key events, approvals and launch dates impacting Zenvia's revenue forecast, 2008-2017 109
Table 17: Estimated key events, approvals and launch dates impacting NP-1's revenue forecast, 2008-2017 116
Table 18: Key ion channel modulators in the late-stage R&D pipeline for neuropathic pain, 2008 130
Table 19: Estimated key events, approvals and launch dates impacting Vimpat's revenue forecast, 2008-2017 134
Table 20: Estimated key events, approvals and launch dates impacting ralfinamide's revenue forecast, 2008-2017 143
Table 21: Key GABA modulators in the late-stage R&D pipeline for neuropathic pain, 2008 152
Table 22: Estimated key events, approvals and launch dates impacting XP13512's revenue forecast, 2008-2017 157
Table 23: Other drugs in late-stage R&D pipeline for neuropathic pain, 2008 167
Table 24: Estimated key events, approvals and launch dates impacting Transacin's revenue forecast, 2008-2017 172
Table 25: Key drugs in Phase I development for neuropathic pain, 2008 193
Table 26: Key drugs in preclinical development for neuropathic pain, 2008 194
Table 27: Neuropathic pain market definition by ICD-10 codes 218
Table 28: Datamonitor drug assessment parameters 221
Figure 1: Forecast of the neuropathic pain market value across the seven major markets, 2008-2017 7
Figure 2: Key neuropathic pain pipeline drug historical sales and forecasts, 2004-2017 9
Figure 3: Datamonitor drug assessment summary of pipeline therapies in development for neuropathic pain, 2008 10
Figure 4: Sales of molecules for neuropathic pain ($m), 2007 23
Figure 5: Total neuropathic pain sales across the seven major markets by region, 2004-07 27
Figure 6: Total neuropathic pain sales in the six major markets($m), 2007 28
Figure 8: Historical and forecast neuropathic pain-specific sales revenue for key brand and pipeline drugs across the seven major markets, 2004-2017 42
Figure 9: Sales forecast for Lyrica in neuropathic pain across the seven major markets to 2017 43
Figure 10: Lyrica SWOT analysis 44
Figure 11: Datamonitor's competitive positioning analysis of Lyrica, 2008 45
Figure 12: Historical and forecast sales for Neurontin in neuropathic pain across the seven major markets, 2004-2017 49
Figure 13: Neurontin SWOT analysis 50
Figure 14: Historical and forecast sales for Lidoderm in neuropathic pain across the seven major markets, 2004-2017 52
Figure 15: Lidoderm SWOT analysis 53
Figure 16: Sales forecast for Cymbalta in neuropathic pain across the seven major markets, 2004-2017 56
Figure 17: Cymbalta SWOT analysis 57
Figure 18: Tegretol SWOT analysis 59
Figure 19: Impact of each key event on the neuropathic pain market across the seven major markets, 2008-2017 61
Figure 20: Population of neuropathic pain subtypes in the seven major markets, 2008 69
Figure 21: Percentage neuropathic pain sales by subtype, 2008 70
Figure 22: Drugs in development for neuropathic pain by class and development stage, 2008 73
Figure 23: Pfizer sales by therapeutic area 2006 85
Figure 24: Sales of Neurontin, gabapentin and Lyrica for neuropathic pain ($m), 2003-07 86
Figure 25: Historical sales of Lyrica, Neurontin, Cymbalta and generic gabapentin, 2003-07 87
Figure 26: Pfizer's Lyrica and CNS sales 2004-07 ($ billion) 88
Figure 27: Eli Lilly sales by therapeutic area, 2006 89
Figure 28: Cymbalta neuropathic pain specific sales in the seven major markets, 2003-07 ($m) 90
Figure 29: UCB sales by therapeutic area, 2007 91
Figure 30: Datamonitor drug assessment summary of key glutamate receptor modulators in development for neuropathic pain, 2008 101
Figure 31: Sales forecasts for glutamate receptor modulators in neuropathic pain across the seven major markets, 2008-2017 102
Figure 32: Sales forecast for Zenvia in neuropathic pain across the seven major markets, 2009-2017 108
Figure 33: Datamonitor's competitive positioning analysis of Zenvia, 2008 110
Figure 34: Sales forecast for NP-1 in neuropathic pain across the seven major markets, 2008-2017 115
Figure 35: Datamonitor's competitive positioning analysis of NP-1, 2008 117
Figure 36: Datamonitor drug assessment summary of pipeline ion channel modulators in development for neuropathic pain, 2008 131
Figure 37: Sales forecasts for ion channel modulators in neuropathic pain across the seven major markets, 2008-2017 132
Figure 38: Sales forecast for Vimpat in neuropathic pain across the seven major markets, 2008-2017 133
Figure 39: Datamonitor's competitive positioning analysis of Vimpat in neuropathic pain, 2008 135
Figure 40: Sales forecast for ralfinamide in neuropathic pain across the seven major markets, 2010-2017 142
Figure 41: Datamonitor's competitive positioning analysis of ralfinamide in neuropathic pain, 2008 144
Figure 42: Datamonitor drug assessment summary of pipeline GABA receptor modulators in development for neuropathic pain, 2008 153
Figure 43: Sales forecasts for GABA modulators in neuropathic pain across the seven major markets, 2008-2017 154
Figure 44: Sales forecast for XP13512 in neuropathic pain across the seven major markets, 2008-2017 156
Figure 45: Datamonitor's competitive positioning analysis of XP13512, 2008 158
Figure 46: Sales forecast for Gabapentin GR in neuropathic pain across the seven major markets, 2009-2017 162
Figure 47: Datamonitor's competitive positioning analysis of Gabapentin GR, 2008 163
Figure 48: Datamonitor drug assessment summary other therapies in development for neuropathic pain, 2008 168
Figure 49: Sales forecasts for 'Other' drugs in neuropathic pain across the seven major markets, 2008-2017 169
Figure 50: Sales forecast for Transacin in neuropathic pain across the seven major markets, 2008-2017 171
Figure 51: Datamonitor's competitive positioning analysis of Transacin in neuropathic pain, 2008 173
Figure 52: Datamonitor drug assessment summary of neuropathic pain treatments, 2007 222
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