Bipolar Disorder - New treatments for bipolar depression 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 bipolar disorder market - page 4
- Summary - page 6
- Datamonitor Pipeline Assessment Summary - page 8
- CHAPTER 2 PATIENT POTENTIAL - page 22
- Definition of bipolar disorder - page 23
- Characteristics of bipolar disorder phases - page 23
- Segmentation of bipolar disorder subtypes - page 24
- Bipolar I disorder - page 25
- Bipolar II disorder - page 25
- Bipolar III disorder (cyclothymia) - page 25
- Epidemiology of bipolar disorder - page 27
- Prevalence and diagnosis rate of bipolar disorder - page 27
- Increased prevalence rate due to relaxing of inclusion criteria - page 27
- Poor correct diagnosis rates leave room for market expansion - page 27
- Prevalence and diagnosis rate of bipolar disorder - page 27
- Unmet needs in bipolar disorder - page 29
- Unmet need 1: improved maintenance therapy - page 29
- Improved prophylactic treatment the key to real patient benefit - page 29
- Unmet need 2: bipolar depression - page 30
- Sufferers spend significantly longer in bipolar depression than mania - page 30
- High suicide rate during depressive phase - page 30
- Traditional antidepressants have limited efficacy - page 31
- Unmet need 3: treatment non-compliance - page 32
- Unmet need 4: side effects - page 32
- Unmet need 5: onset of therapeutic action - page 32
- Unmet need 1: improved maintenance therapy - page 29
- Etiology of bipolar disorder - page 33
- Neurobiology of bipolar disorder - page 33
- Dopamine hypothesis of schizophrenia and bipolar mania - page 34
- Monoamine theory of major depression and bipolar depression - page 35
- Neurobiology of bipolar disorder - page 33
- Definition of bipolar disorder - page 23
- CHAPTER 3 R&D APPROACH - page 37
- Market overview - page 38
- Current treatment paradigms for bipolar disorder - page 38
- Treatment of manic episodes associated with bipolar disorder - page 38
- Maintenance and prophylactic therapy - page 38
- Treatment of bipolar depression - page 39
- Sales of antipsychotics generated approximately half the revenues associated with bipolar disorder pharmacotherapy - page 39
- Off-label use of antidepressants for bipolar disorder treatment - page 40
- Current treatment paradigms for bipolar disorder - page 38
- Classification of pipeline drugs seeking indication in bipolar disorder - page 42
- Novel mood stabilizers - page 42
- Anticonvulsants - page 43
- Antipsychotics - page 44
- Pharmacological development of antipsychotics - page 44
- Mixed molecular targets of the current and pipeline atypical antipsychotics - page 45
- Increasing concentration on side-effect profile for the antipsychotic class of therapy - page 46
- Clinical trial design in bipolar disorder - page 47
- Young mania rating scale - page 47
- Montgomery-Åsberg Depression Rating Scale - page 48
- Hamilton Rating Scale for Depression - page 48
- Positive and Negative Syndrome Scale - page 48
- Problems associated with bipolar disorder clinical trial design - page 48
- Pipeline overview - page 49
- Pipeline drugs in pre-registration - page 49
- Pipeline drugs in Phase III clinical development - page 50
- Pipeline drugs in Phase II clinical development - page 51
- Pipeline drugs in Phase I clinical development - page 51
- Lack of innovative and Phase I drugs found in the bipolar disorder pipeline - page 52
- Key companies involved in the bipolar disorder pipeline - page 53
- Johnson & Johnson's bipolar disorder franchise will decline from 2008 onwards despite the launch of paliperidone - page 53
- Generic incursion expected when key CNS products come off-patent - page 53
- Follow-on antipsychotic may not be sufficiently differentiated - page 53
- Off-label bipolar-specific sales of topiramate may deteriorate following negative trial results - page 54
- RepliGen are developing a novel intracellular mood stabilizer - page 54
- RG-2417 (Uridine) a potential novel mood stabilizer - page 55
- Previous failure to show statistically significant efficacy of secretin in schizophrenia - page 55
- Phase I trial with RG-2133-another Uridine pro-drug - page 56
- Johnson & Johnson's bipolar disorder franchise will decline from 2008 onwards despite the launch of paliperidone - page 53
- Market overview - page 38
- CHAPTER 4 ANTIPSYCHOTIC LATE-STAGE DRUG ANALYSIS & FORECASTS - page 58
- Overview of antipsychotic class of bipolar therapy - page 59
- Pipeline summary - page 59
- Definition of current comparator therapy - page 59
- US market leader status for Seroquel despite not being licensed for maintenance therapy - page 62
- Sales of atypical antipsychotics are higher for bipolar disorder than schizophrenia in the US - page 63
- Short to medium-term sales unaffected by indication expansion - page 64
- Experience from prescribing for schizophrenia drove the bipolar atypical antipsychotic market - page 67
- Indication expansion may not be financially beneficial unless the right bipolar indication is sought - page 67
- Factors required for a pipeline antipsychotic to compete in the bipolar disorder market - page 69
- Market sales and forecast caveats - page 70
- US market leader status for Seroquel despite not being licensed for maintenance therapy - page 62
- Seroquel for bipolar depression - page 71
- Profile - page 71
- Drug overview: indication expansion into bipolar depression imminent - page 71
- Clinical trial data - page 72
- Clinical trial data and pharmacodynamic summary - page 74
- Why would an atypical antipsychotic have therapeutic efficacy against bipolar depression? - page 75
- Patient potential - page 79
- Marketing factors - page 80
- Satisfaction of unmet needs - page 82
- Unmet need 1: improved maintenance therapy - page 82
- Unmet need 2: bipolar depression - page 82
- Unmet need 3: treatment non-compliance - page 82
- Unmet need 4: side effects - page 83
- Unmet need 5: onset of therapeutic action - page 83
- Forecasts to 2015 - page 84
- Brief explanation of impacting factors - page 85
- Datamonitor drug assessment summary - page 86
- Profile - page 71
- Geodon for bipolar depression - page 87
- Profile - page 87
- Drug overview: indication expansion into bipolar depression - page 87
- Clinical trial data - page 87
- Clinical trial data and pharmacokinetic summary - page 90
- Patient potential - page 90
- Marketing factors - page 90
- Satisfaction of unmet needs - page 91
- Unmet need 1: improved maintenance therapy - page 91
- Unmet need 2: bipolar depression - page 91
- Unmet need 3: treatment non-compliance - page 91
- Unmet need 4: side effects - page 91
- Unmet need 5: onset of therapeutic action - page 92
- Forecasts to 2015 - page 92
- Brief explanation of impacting factors - page 93
- Datamonitor drug assessment summary - page 94
- Risperdal Consta - page 95
- Profile - page 95
- Drug overview: intramuscular sustained-release formulation of Risperdal - page 95
- Clinical trial data - page 95
- Clinical trial data and pharmacokinetic summary - page 97
- Patient potential - page 97
- Significant off-label usage reduces the "new" patient population - page 97
- Risperdal Consta will be competing with the oral formulations rather than IM formulations - page 99
- Marketing factors - page 100
- Price is primary concern but sales revenue looks strong - page 100
- Increased use of risperidone might have a positive effect on Risperdal Consta sales - page 101
- J&J should target its marketing of Risperdal Consta towards treating severely manic patients - page 102
- Satisfaction of unmet needs - page 103
- Unmet need 1: improved maintenance therapy - page 103
- Unmet need 2: bipolar depression - page 103
- Unmet need 3: treatment non-compliance - page 103
- Unmet need 4: side effects - page 104
- Unmet need 5: onset of therapeutic action - page 104
- Forecast to 2015 - page 105
- Brief explanation of impacting factors - page 106
- Datamonitor drug assessment summary - page 107
- Profile - page 95
- Intramuscular Abilify - page 108
- Profile - page 108
- Drug overview: intramuscular version of Abilify for acute intervention - page 108
- Clinical trial data - page 108
- Clinical trial data and pharmacokinetic summary - page 111
- Patient potential - page 112
- IM version may boost sales of oral Abilify as a first-line therapy - page 112
- Abilify needs to demonstrate strong efficacy in a head-to-head study - page 113
- Abilify's positive side-effect profile may not be a significant advantage in the acute setting - page 114
- Abilify's lack of sedation may prove to be a disadvantage for acute mania treatment - page 115
- Marketing factors - page 116
- How will Abilify IM be priced? - page 116
- BMS/Otsuka should consider a long-acting IM version of Abilify - page 118
- Satisfaction of unmet needs - page 119
- Unmet need 1: improved maintenance therapy - page 119
- Unmet need 2: bipolar depression - page 119
- Unmet need 3: treatment non-compliance - page 119
- Unmet need 4: side effects - page 119
- Unmet need 5: onset of therapeutic action - page 119
- Forecast to 2015 - page 120
- Brief explanation of impacting factors - page 121
- Datamonitor drug assessment summary - page 122
- Profile - page 108
- Asenapine - page 123
- Profile - page 123
- Drug overview: "new" atypical antipsychotic - page 123
- Clinical trial data - page 123
- Clinical trial data and pharmacokinetic summary - page 125
- Patient potential - page 128
- Marketing factors - page 128
- Pfizer bring a wealth of experience in marketing atypical antipsychotics to the table - page 128
- Establishing a niche patient population for asenapine will be important for its commercial success in bipolar disorder - page 129
- Delay in development may impact future sales estimates - page 130
- Satisfaction of unmet needs - page 130
- Unmet need 1: improved maintenance therapy - page 130
- Unmet need 2: bipolar depression - page 130
- Unmet need 3: treatment non-compliance - page 130
- Unmet need 4: side-effects - page 131
- Unmet need 5: onset of therapeutic action - page 132
- Forecast to 2015 - page 133
- Brief explanation of impacting factors - page 134
- Datamonitor drug assessment summary - page 135
- Profile - page 123
- Bifeprunox - page 136
- Profile - page 136
- Drug overview: New atypical antipsychotic with similar mode of action to Abilify - page 136
- Clinical trial data - page 136
- Clinical trial data and pharmacokinetic summary - page 139
- Patient potential - page 140
- Bifeprunox unlikely to be used for acute mania, but may have a niche in first-line maintenance therapy - page 140
- Marketing factors - page 142
- Solvay's and Wyeth's experience in psychiatry and Lundbeck's launch of sertindole will provide a strong base for the commercialization of bifeprunox - page 142
- Differentiation from Abilify may become a problem - page 142
- Indication in bipolar depression could boost sales and save time/money - page 143
- Key events which could impact the revenue growth of bifeprunox - page 143
- Satisfaction of unmet needs - page 143
- Unmet need 1: improved maintenance therapy - page 143
- Unmet need 2: bipolar depression - page 144
- Unmet need 3: treatment non-compliance - page 144
- Unmet need 4: side effects - page 144
- Unmet need 5: onset of therapeutic action - page 144
- Forecast to 2015 - page 145
- Brief explanation of impacting factors - page 146
- Datamonitor drug assessment summary - page 147
- Profile - page 136
- Paliperidone ER - page 148
- Profile - page 148
- Drug overview: metabolite of risperidone - page 148
- Clinical trial data - page 148
- Clinical trial data and pharmacokinetic summary - page 150
- Patient potential - page 150
- Development of paliperidone IM for bipolar disorder could be a better strategy - page 151
- Marketing factors - page 153
- Are active metabolites commercially viable? - page 153
- Following Risperdal patent expiry-making the switch to paliperidone versus generic risperidone - page 154
- Satisfaction of unmet needs - page 157
- Unmet need 1: improved maintenance therapy - page 157
- Unmet need 2: bipolar depression - page 157
- Unmet need 3: treatment non-compliance - page 157
- Unmet need 4: side effects - page 158
- Unmet need 5: onset of therapeutic action - page 158
- Forecast to 2015 - page 159
- Brief explanation of impacting factors - page 160
- Datamonitor drug assessment summary - page 161
- Profile - page 148
- Overview of antipsychotic class of bipolar therapy - page 59
- CHAPTER 5 ANTICONVULSANT LATE-STAGE DRUG ANALYSIS & FORECASTS - page 162
- Overview for anticonvulsants - page 163
- Pipeline summary - page 163
- Definition of current comparator therapy - page 163
- Anticonvulsant 'gold-standard': lamotrigine - page 163
- Licarbazepine - page 167
- Profile - page 167
- Drug overview: Metabolite of the anticonvulsant oxcarbazepine - page 167
- Clinical trial data - page 167
- Patient potential - page 172
- Marketing factors - page 172
- Satisfaction of unmet needs - page 173
- Unmet need 1: improved maintenance therapy - page 173
- Unmet need 2: bipolar depression - page 174
- Unmet need 3: treatment non-compliance - page 174
- Unmet need 4: side effects - page 174
- Unmet need 5: onset of therapeutic action - page 174
- Forecast to 2015 - page 175
- Brief explanation of impacting factors - page 175
- Profile - page 167
- Overview for anticonvulsants - page 163
- CHAPTER 6 NOVEL MOOD STABILIZER LATE-STAGE DRUG ANALYSIS & FORECAST - page 177
- Overview for novel mood stabilizers - page 178
- Pipeline summary - page 178
- Definition of current comparator therapy - page 178
- Mood stabilizer 'gold-standard': lithium - page 178
- RG-2417 (Uridine) - page 179
- Profile - page 179
- Drug overview: Novel metabolism modulator - page 179
- Clinical trial data - page 179
- Patient potential - page 181
- Marketing factors - page 181
- Satisfaction of unmet needs - page 181
- Forecast to 2015 - page 182
- Profile - page 179
- Memantine - page 183
- Profile - page 183
- Drug overview: NMDA receptor antagonist - page 183
- Clinical trial data - page 183
- Patient potential - page 185
- Marketing factors - page 185
- Satisfaction of unmet needs - page 185
- Forecast to 2015 - page 185
- Profile - page 183
- Overview for novel mood stabilizers - page 178
- BIBLIOGRAPHY - page 186
- Journal articles and conference abstracts - page 186
- Websites - page 192
- APPENDIX A - page 194
- Forecast revenues - page 194
- Competitive positioning analysis of pipeline bipolar disorder drugs - page 195
- APPENDIX B - page 196
- Report Methodology - page 196
- Definition of bipolar disorder market - page 196
- Datamonitor forecast methodology - page 199
- Product forecasts - page 199
- Sales calculations - page 199
- Definition of a standard unit - page 199
- Japanese market data - page 200
- Additional information - page 200
- About Datamonitor - page 200
- About Datamonitor Healthcare - page 200
- Datamonitor Healthcare's therapy area capabilities - page 201
- About the CNS analysis team - page 202
- Disclaimer - page 203
- Report Methodology - page 196
- List of Tables
- Table 1: Prevalence data overview of bipolar disorder in the US, Canada and Switzerland, 2006 - page 27
- Table 2: Neurophysiological consequences of reduction in dopamine level - page 34
- Table 3: Young Mania Rating Scale - page 47
- Table 4: Pipeline drugs in pre-registration for bipolar disorder, 2006 - page 49
- Table 5: Pipeline drugs in Phase III development for bipolar disorder, 2006 - page 50
- Table 6: Pipeline drugs in Phase II development for bipolar disorder, 2006 - page 51
- Table 7: Pipeline drugs in Phase I development for bipolar disorder, 2006 - page 51
- Table 8: Key antipsychotics in late-stage R&D pipeline for bipolar disorder, 2006 - page 59
- Table 9: Marketed bipolar disorder-indicated antipsychotics: key facts, 2006 - page 61
- Table 10: FDA approval in schizophrenia and bipolar disorder for atypical antipsychotics - page 65
- Table 11: Binding characteristics of atypical antipsychotics (Ki) - page 75
- Table 12: Factors impacting Seroquel's revenues , 2006-2015 - page 85
- Table 13: Geodon clinical trial program for bipolar depression and bipolar maintenance, 2006 - page 89
- Table 14: Factors impacting Geodon's revenues, 2006-15 - page 93
- Table 15: Price of different formulations of Risperdal ($), 2001-05 - page 100
- Table 16: Factors impacting Risperdal Consta's revenues, 2006-2015 - page 105
- Table 17: All-indication US sales revenues for the rapid-acting atypical antipsychotic IMs ($m), 2002-05 - page 116
- Table 18: Price points for the rapid-acting atypical antipsychotic IMs ($), 2004-06 - page 117
- Table 19: Factors impacting Abilify's revenues , 2006-2015 - page 121
- Table 20: Asenapine clinical trial program in bipolar disorder, 2006 - page 124
- Table 21: Binding characteristics of atypical antipsychotics (Ki) - page 125
- Table 22: Factors impacting asenapine's revenues, 2006-15 - page 134
- Table 23: Bifeprunox clinical trial program in bipolar disorder, 2006 - page 138
- Table 24: Factors impacting bifeprunox's revenues 2006-15 - page 146
- Table 25: Paliperidone ER clinical trial program in bipolar disorder, 2006 - page 149
- Table 26: Factors impacting paliperidone's revenues, 2006-2015 - page 160
- Table 27: Anticonvulsants in late-stage R&D pipeline for bipolar disorder, 2006 - page 163
- Table 28: Licarbazepine clinical trial program for bipolar disorder, 2006 - page 171
- Table 29: Factors impacting licarbazepine's revenues, 2006-2015 - page 175
- Table 30: Novel mood stabilizers in the late-stage R&D pipeline for bipolar disorder, 2006 - page 178
- Table 31: Memantine clinical trial program for bipolar disorder, 2006 - page 184
- Table 32: Datamonitor's forecast bipolar disorder revenues of marketed and pipeline drugs across the US, EU and Japan ($m), 2006-2014 - page 194
- Table 33: Summary of commercial and research/clinical attractiveness of late-Phase drugs for bipolar disorder - page 195
- Table 34: Diagnostic criteria for bipolar I disorders - page 197
- Table 35: Diagnostic criteria for other types of bipolar disorders - page 198
- List of Figures
- Figure 1: Bipolar disorder market forecast, 2006-15 - page 6
- Figure 2: Generic incursion on global bipolar disorder atypical antipsychotic market - page 7
- Figure 3: Datamonitor drug assessment summary - page 8
- Figure 4: Symptoms associated with the two primary phases of bipolar disorder - page 24
- Figure 5: Cycles of bipolar disorder phase over time - page 26
- Figure 6: Unmet needs in bipolar disorder, 2006 - page 29
- Figure 7: US bipolar disorder market revenues by drug class, 2002-05 - page 40
- Figure 8: Drug classes in development for the treatment of bipolar disorder, 2006 - page 42
- Figure 9: Antipsychotic market structure based on bipolar disorder-specific sales revenue in the seven major markets, 2005 - page 62
- Figure 10: US revenue split of antipsychotics between bipolar disorder, schizophrenia and all other indications, 2005 - page 64
- Figure 11: The US bipolar disorder specific quarterly sales revenue for atypical antipsychotics, 2003-05 - page 66
- Figure 12: US quarterly promotional spend on non-direct to customer advertising for atypical antipsychotics, 2003-05 - page 69
- Figure 13: BOLDER I clinical trial path for Seroquel - page 73
- Figure 14: Datamonitor's forecast of bipolar-specific sales revenue for Seroquel across the seven major markets ($m), 2006-2015 - page 84
- Figure 15: Datamonitor's competitive positioning analysis of Seroquel for bipolar depression, 2006 - page 86
- Figure 16: Datamonitor's forecast of bipolar-specific sales revenue for Geodon across the seven major markets ($m), 2006-2015 - page 92
- Figure 17: Datamonitor's competitive positioning analysis of Geodon for bipolar disorder, 2006 - page 94
- Figure 18: Comparison of the proportion of US bipolar-specific sales for the two formulations of Risperdal, 2005 - page 98
- Figure 19: Bipolar-specific sales revenue for the two formulations of Risperdal in the US ($m), 2003-05 - page 99
- Figure 20: Datamonitor's forecast of bipolar-specific sales revenue for Risperdal Consta across the seven major markets ($m), 2006-2015 - page 105
- Figure 21: Datamonitor's competitive positioning analysis of Risperdal Consta for bipolar disorder, 2006 - page 107
- Figure 22: Datamonitor's forecast of bipolar-specific sales revenue for Abilify (oral and IM) across the seven major markets ($m), 2006-2015 - page 120
- Figure 23: Datamonitor's competitive positioning analysis of Abilify IM for bipolar disorder, 2006 - page 122
- Figure 24: Receptor affinity profiles for asenapine and risperidone - page 126
- Figure 25: Datamonitor's forecast of bipolar-specific sales revenue for asenapine across the seven major markets ($m), 2006-2015 - page 133
- Figure 26: Datamonitor's competitive positioning analysis of asenapine for bipolar disorder, 2006 - page 135
- Figure 27: Datamonitor's forecast of bipolar-specific sales revenue for bifeprunox across the seven major markets ($m), 2006-2015 - page 145
- Figure 28: Datamonitor's competitive positioning analysis of bifeprunox for bipolar disorder, 2006 - page 147
- Figure 29: Paliperidone ER only meets one of the criteria for a commercially successful active metabolite - page 154
- Figure 30: Datamonitor's forecast of bipolar-specific sales revenue for paliperidone ER across the seven major markets ($m), 2006-2015 - page 159
- Figure 31: Datamonitor's competitive positioning analysis of paliperidone for bipolar disorder, 2006 - page 161
- Figure 32: US revenue split of anticonvulsants between bipolar disorder and all other indications, 2005 - page 165
- Figure 33: US bipolar disorder-specific sales revenue for on- and off-label use of anticonvulsants, 2005 - page 166
- Figure 34: Licarbazepine meets two of the criteria for a commercially successful active metabolite - page 173
- Figure 35: Datamonitor's forecast of bipolar-specific sales revenue for licarbazepine across the seven major markets ($m), 2006-2015 - page 175
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