Pipeline Insight: Schizophrenia
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 schizophrenia market - page 5
- Key metrics - page 7
- CHAPTER 2 PATIENT POTENTIAL - page 21
- Etiology of schizophrenia - page 21
- DSM-IV defined symptoms of schizophrenia - page 22
- A - Characteristic symptoms - page 22
- B - Social/occupational dysfunction - page 23
- C - Duration - page 23
- D - Schizoaffective and mood disorder exclusion - page 23
- E - Substance/general medical condition exclusion - page 23
- F - Relationship to a pervasive developmental disorder - page 24
- DSM-IV defined symptoms of schizophrenia - page 22
- Classification of schizophrenia - page 24
- Epidemiology of schizophrenia - page 25
- Schizophrenia affects 1% of the population - page 25
- Comorbidities of schizophrenia - page 25
- Anxiety is the most prevalent comorbidity of schizophrenia - page 26
- Substance and alcohol abuse is frequently observed in schizophrenia - page 28
- Depression affects a third of schizophrenia patients - page 28
- Diagnosis rates of schizophrenia - page 30
- Unmet needs in schizophrenia - page 31
- Improving patient compliance is key - page 31
- Lack of insight into schizophrenia, and the management thereof, are the most frequent reasons for patient noncompliance - page 36
- Increased public and physician awareness and education - page 36
- The importance of identifying a market niche before launch - page 39
- Greater efficacy with fewer side-effects - page 40
- A need for drugs targeting negative and cognitive symptoms, and partial-responders - page 41
- Long-acting depots and patch technology are favored to improve patient compliance - page 43
- Improving patient compliance is key - page 31
- Etiology of schizophrenia - page 21
- CHAPTER 3 R&D APPROACH - page 47
- Classification of marketed and pipeline products - page 47
- Serotonergic and dopaminergic receptor antipsychotics - page 48
- Dopaminergic antipsychotics - page 49
- Dopamine antagonists - page 49
- Dopamine agonists - page 49
- Serotonergic antipsychotics - page 50
- Serotonin antagonists - page 50
- Serotonin agonists - page 51
- Novel antipsychotics - page 52
- Alpha 2 adrenoceptor antagonists - page 53
- Glutamate (AMPA and NMDA) and glycine receptor modulators - page 53
- Cannabinoids - page 54
- Cyclooxygenase-2 inhibitors - page 55
- Monoaminergic antipsychotics - page 55
- Muscarinic M(1) receptor agonists - page 55
- Neurokinin 3 (NK3) receptor antagonists - page 56
- Nicotinic acetylcholine receptor modulators - page 56
- Secretin - page 56
- Clinical trials and drug development - page 57
- Clinical trial endpoints and schizophrenia rating scales - page 57
- Positive and Negative Syndrome Scale - page 57
- Brief Psychiatric Rating Scale - page 57
- Brief Assessment of Cognition in Schizophrenia - page 57
- Neuropsychological Assessment Battery - page 58
- Other tests - page 58
- A number of other tests are used in the diagnosis and monitoring of patients during general treatment management and for the duration of clinical trials: - page 58
- Clinical trial design guidance - page 59
- MATRICS recommendations for the clinical trial design for cognition enhancing drugs in schizophrenia - page 59
- Key research recommendations - page 62
- Increased focus on cost containment - page 63
- Improved quality of life - page 64
- Clinical trial endpoints and schizophrenia rating scales - page 57
- Classification of marketed and pipeline products - page 47
- CHAPTER 4 PIPELINE DRUG ANALYSIS - page 66
- Pipeline overview - page 66
- Approved drugs yet to be launched - page 66
- Drugs in pre-registration - page 67
- Pipeline drugs in Phase III - page 68
- Pipeline drugs in Phase II - page 69
- Pipeline drugs in Phase I - page 70
- Key companies involved in the development of novel schizophrenia therapeutics - page 71
- J&J's schizophrenia franchise will decline from 2008 onwards despite the launch of paliperidone - page 71
- Lundbeck's experience with marketing sertindole will provide a strong base from which to launch bifeprunox - page 74
- Organon's asenapine will be an exciting entrant to the schizophrenia market - page 78
- Pfizer's schizophrenia franchise will continue to grow through 2011 - page 81
- Dainippon-Sumitomo's blonanserin will first launch in Japan, despite competing with the recently launched Abilify - page 84
- GSK's antipsychotic pipeline drugs are unlikely to have a significant impact on the schizophrenia market - page 85
- Methodology of Datamonitor's competitive positioning analysis - page 88
- Gold standard antipsychotic - page 90
- The market value is calculated using IMS diagnosis value - page 92
- Forecast caveats - page 94
- Pipeline overview - page 66
- CHAPTER 5 LATE-STAGE PIPELINE DRUG ANALYSIS AND FORECASTS - page 95
- Paliperidone - page 95
- Clinical trial data - page 95
- Study 1 - page 95
- Study 2 - page 96
- Study 3 - page 97
- Study 4 - page 98
- Study 5 - page 98
- Study 6 - page 99
- Completed trials - page 100
- Ongoing clinical trials - page 101
- Physicians not overly impressed with paliperidone therapeutic profile - page 103
- Paliperidone IM - an improvement over Risperdal Consta? - page 105
- Risperdal patent expiry and switch to paliperidone over generic risperidone - page 107
- How will J&J price paliperidone IM compared to Risperdal Consta - page 109
- Paliperidone ER will be the next entrant to the US market in H2 2006 - page 111
- Clinical trial data - page 95
- Intramuscular Zyprexa - page 114
- Clinical trial data - page 114
- Ongoing clinical trials - page 114
- Zyprexa's undesirable side-effect profile will limit the uptake of the long-acting IM formulation - page 114
- Clinical trial data - page 114
- Intramuscular Abilify - page 118
- Clinical trial data - page 118
- Study 1 - page 118
- Study 2 - page 119
- Study 3 - page 120
- Study 4 - page 121
- Study 5 - page 121
- Completed clinical trials - page 122
- Abilify IM may lead to increased use of Abilify as a first-line maintenance therapy - page 123
- Abilify needs to demonstrate strong efficacy in a head-to-head study - page 124
- Multiple IM doses within a 24-hour period may limit use of Abilify IM compared to other IM formulations - page 125
- How will Abilify IM be priced? - page 126
- BMS/Otsuka should consider a long-acting IM version of Abilify - page 128
- Clinical trial data - page 118
- Sertindole - page 130
- Clinical trial data - page 130
- Study 1 - page 130
- Study 2 - page 131
- Study 3 - page 132
- Study 4 - page 133
- Study 5 - page 133
- Other clinical studies - page 134
- Physicians not impressed with sertindole's tolerability despite new data - page 135
- Sertindole will be the next entrant to the EU market in H2 2006 - page 139
- Clinical trial data - page 130
- Asenapine (Org-5222) - page 142
- Clinical trial data - page 142
- Study 1 - page 142
- Study 2 - page 143
- Study 3 - page 144
- Study 4 - page 146
- Ongoing clinical trials - page 146
- Asenapine's potential in treating negative symptoms will be a key therapeutic and commercial advantage - page 147
- Twice daily dosing of asenapine may limit uptake - page 149
- Asenapine will be the leading market entrant in terms of revenue value by 2015 - page 152
- Clinical trial data - page 142
- Bifeprunox - page 155
- Clinical trial data - page 155
- Study 1 - page 155
- Additional clinical trial data - page 156
- Completed clinical trials - page 156
- Ongoing clinical trials - page 156
- Bifeprunox's tolerability is a key therapeutic and commercial attribute - page 157
- Bifeprunox unlikely to be used for acute psychosis, but may have a niche in first episode psychosis - page 159
- Bifeprunox's pharmacokinetic profile is suitable for once-daily dosing, with a potential for numerous reformulation strategies - page 161
- Solvay and Wyeth's experience in psychiatry and Lundbeck's launch of sertindole will provide a strong base for the commercialization of bifeprunox - page 162
- Bifeprunox will be the second-highest new entrant in terms of cash value to the schizophrenia market by 2015 - page 163
- Clinical trial data - page 155
- Blonanserin - page 166
- Clinical trial data - page 166
- Study 1 - page 166
- Study 2 - page 166
- Blonanserin demonstrates no clear advantages over marketed or pipeline schizophrenia drugs - page 167
- Almirall's limited commercial presence in the EU, and lack of presence in the US will limit uptake of blonanserin outside of Japan - page 169
- Blonanserin will receive its strongest uptake in the Japanese market - page 170
- Clinical trial data - page 166
- Seroquel SR - page 173
- Clinical trial data - page 173
- Ongoing clinical trials - page 173
- Seroquel SR unlikely to provide significant differentiation from Seroquel - page 174
- Seroquel will retain patent protection until 2011, safeguarding the initial uptake of Seroquel SR from generic quetiapine - page 176
- Will US health insurers pay the increased costs for the SR formulation? - page 177
- Seroquel SR is not expected to receive a strong uptake, and revenues will decline from 2012 onwards - page 178
- Clinical trial data - page 173
- Iloperidone - page 180
- Clinical trial data - page 180
- Ongoing clinical trials - page 181
- If approved, QT will limit iloperidone uptake as a first-line therapy - page 182
- Iloperidone offers no therapeutic advantage over marketed or pipeline schizophrenia drugs - page 183
- Iloperidone will receive limited uptake in the US - page 185
- Clinical trial data - page 180
- Paliperidone - page 95
- CHAPTER 6 PHASE II PIPELINE DRUG ANALYSIS - page 187
- Introduction - page 187
- ABT-089 - page 187
- Clinical trial data - page 187
- Nicotinic agonists which improve cognitive functioning and smoking cessation would be valuable in the management of schizophrenia - page 188
- ACP-103/ACP-104 - page 189
- ACP-103 clinical trial data - page 190
- Study 1 - page 190
- Study 2 - page 191
- Study 3 - page 192
- Other trial data - page 192
- Ongoing clinical trials - page 193
- There is little need for an adjunct to improve positive symptoms, as marketed drugs already treat this domain of schizophrenia - page 193
- ACP-104 clinical trial data - page 195
- Study 1 - page 195
- Other trial data - page 196
- Ongoing clinical trials - page 197
- ACP-104 would be a significant treatment advance if it can demonstrate cognitive enhancement without the side effects of clozapine - page 198
- ACP-103 clinical trial data - page 190
- AVE-1625 - page 200
- Dihydrexidine - page 202
- Idazoxan - page 203
- Clinical trial data - page 203
- Study 1 - page 203
- Idazoxan is unlikely to be a standalone therapy, but may have a niche in treatment-resistant schizophrenia - page 204
- Clinical trial data - page 203
- Lurasidone - page 205
- Clinical trial data - page 206
- Completed clinical trials - page 206
- Ongoing clinical trials - page 206
- Lurasidone - another me-too atypical, and therefore of limited therapeutic and commercial potential - page 206
- Clinical trial data - page 206
- LY2140023 - page 207
- Ocaperidone - page 207
- Clinical trial data - page 207
- Study 1 - page 207
- Other clinical trial data - page 209
- J&J may choose to relicense ocaperidone from Neuro3d if ocaperidone performs well in Phase II trials - page 209
- Clinical trial data - page 207
- Org-24448 - page 210
- Org-24448 may have potential in treating cognitive functioning - page 210
- RG1068 - page 213
- Clinical trial data - page 213
- Study 1 - page 213
- Other clinical trial data - page 214
- Ongoing clinical trials - page 214
- The subcutaneous formulation is unlikely be well received by patients - page 214
- Clinical trial data - page 213
- Sabcomeline - page 216
- 773812 (SB-750093A) - page 218
- Clinical trial data - page 218
- Completed clinical trials - page 218
- Ongoing clinical trials - page 218
- Clinical trial data - page 218
- SCA-136 - page 219
- Clinical trial data - page 219
- Ongoing clinical trials - page 219
- Clinical trial data - page 219
- SGS518 - page 220
- Clinical trial data - page 220
- Study 1 - page 220
- Study 2 - page 221
- Commercial and patient potential - page 221
- Clinical trial data - page 220
- Talnetant - page 222
- Clinical trial data - page 223
- Study 1 - page 223
- Other study data - page 223
- Completed clinical trials - page 224
- Ongoing clinical trials - page 224
- Pharmacokinetic profile may hamper talnetant's clinical development - page 224
- Clinical trial data - page 223
- CHAPTER 7 FUTURE TREATMENT OF SCHIZOPHRENIA - page 226
- Future treatment of schizophrenia - page 226
- APPENDIX A - page 227
- Forecast revenues - page 227
- Competitive positioning analysis of pipeline schizophrenia drugs - page 228
- Bibliography - page 230
- Websites - page 230
- Journal articles and conference abstracts - page 235
- APPENDIX B - page 244
- Report methodology - page 244
- Datamonitor forecast methodology - page 244
- Sales calculations - page 245
- Datamonitor forecast methodology - page 244
- About Datamonitor - page 246
- About Datamonitor Healthcare - page 246
- Datamonitor Healthcare's therapy area capabilities - page 247
- Report methodology - page 244
- List of Tables
- Table 1: Diagnostic criteria for schizophrenia and its subtypes - page 24
- Table 2: Prevalence of patients with schizophrenia exhibiting comorbid psychiatric disorders across the US, EU and Japan (%), 2005 - page 26
- Table 3: Risk factors for non-compliance to follow-up appointments and/or antipsychotics in patients with schizophrenia - page 33
- Table 4: Potential strategies for improving compliance in patients with schizophrenia - page 35
- Table 5: Novel antipsychotic drug classes in development for the treatment of schizophrenia,2006 - page 52
- Table 6: Approved drugs yet to be launched in the US, EU and Japan for the treatment of psychosis and schizophrenia, 2006 - page 66
- Table 7: Pipeline drugs in pre-registration for the treatment of psychosis and schizophrenia, 2006 - page 67
- Table 8: Pipeline drugs in Phase III development for psychosis and schizophrenia, 2006 - page 68
- Table 9: Pipeline drugs in Phase II development for psychosis and schizophrenia, 2006 - page 69
- Table 10: Pipeline drugs in Phase I development for psychosis and schizophrenia, 2006 - page 70
- Table 11: J&J's pipeline schizophrenia drugs, 2006 - page 72
- Table 12: Lundbeck's pipeline schizophrenia drugs, 2006 - page 75
- Table 13: Organon's pipeline schizophrenia drugs, 2006 - page 78
- Table 14: Pfizer's pipeline schizophrenia drugs, 2006 - page 81
- Table 15: Dainippon-Sumitomo's pipeline schizophrenia drugs, 2006 - page 84
- Table 16: GSK's pipeline schizophrenia drugs, 2006 - page 86
- Table 17: Commercial strength/weakness factors - weightings and scoring definitions - page 88
- Table 18: Product-specific strength/weakness factors - weightings and scoring definitions - page 89
- Table 19: Proportion of total molecule volume (SU and sales) of antipsychotics, accounted for by schizophrenia diagnoses in the US, EU and Japan, 2005 - page 93
- Table 20: Comparison of paliperidone IM versus Risperdal Consta - page 106
- Table 21: Price of different formulations of Risperdal ($), 2001-05 - page 109
- Table 22: Revenues of the rapid-acting atypical antipsychotic IMs ($m), 2002-05 - page 126
- Table 23: Price points for the rapid-acting atypical antipsychotic IMs ($), 2004-06 - page 127
- Table 24: Asenapine can address most of the unmet needs for the treatment of schizophrenia - page 145
- Table 25: Datamonitor's forecast schizophrenia revenues of marketed and pipeline schizophrenia drugs across the US, EU and Japan ($m), 2006-2015 - page 227
- Table 26: Datamonitor's competitive positioning analysis of pipeline schizophrenia drugs according to product-specific strength/weakness factors, 2006 - page 228
- Table 27: Datamonitor's competitive positioning analysis of pipeline schizophrenia drugs according to commercial strength/weakness factors, 2006 - page 229
- Table 28: Schizophrenia market definition by ICD10 code - page 244
- List of Figures
- Figure 1: Forecast schizophrenia revenues of marketed and pipeline schizophrenia drugs across the US, EU and Japan, 2006-2015 - page 7
- Figure 2: Datamonitor's competitive positioning analysis of pipeline schizophrenia drugs compared to marketed comparators, 2006 - page 8
- Figure 3: Reasons for non-compliance among schizophrenia patients receiving antipsychotic therapy - page 34
- Figure 4: Drug classes in development for the treatment of schizophrenia, 2006 - page 47
- Figure 5: NICE measurement of cost-effectiveness of drug treatment - page 63
- Figure 6: Forecast revenues for J&J's schizophrenia franchise (Risperdal and paliperidone), 2006-2015 - page 73
- Figure 7: Datamonitor's competitive positioning analysis of J&J's marketed and pipeline schizophrenia drugs, 2006 - page 73
- Figure 8: Datamonitor's competitive positioning analysis of Lundbeck's pipeline schizophrenia drugs, 2006 - page 75
- Figure 9: Forecast revenues of Lundbeck's schizophrenia franchise(Serdolect and bifeprunox (Lundbeck's share - EU only), 2006-2015 - page 77
- Figure 10: Datamonitor's competitive positioning analysis of Pfizer's marketed and pipeline schizophrenia drugs, 2006 - page 80
- Figure 11: Forecast revenues of Organon's schizophrenia franchise (asenapine), 2006-2015 - page 80
- Figure 12: Datamonitor's competitive positioning analysis of Pfizer's marketed and pipeline schizophrenia drugs, 2006 - page 82
- Figure 13: Forecast revenues of Pfizer's schizophrenia franchise (Geodon and asenapine), 2006-2015 - page 83
- Figure 14: Paliperidone ER only meets one of the criteria for a therapeutically and commercially successful drug reformulation - page 104
- Figure 15: Datamonitor's competitive positioning analysis of paliperidone ER and IM, 2006 - page 111
- Figure 16: Datamonitor's forecast of paliperidone's revenues across the US, EU and Japan ($m), 2006-2015 - page 113
- Figure 17: Zyprexa's declining US revenues, and plateauing EU revenues - page 115
- Figure 18: Datamonitor's competitive positioning analysis of Zyprexa IM, 2006 - page 117
- Figure 19: Datamonitor's competitive positioning analysis of Abilify IM, 2006 - page 128
- Figure 20: Datamonitor's competitive positioning analysis of sertindole, 2006 - page 139
- Figure 21: Datamonitor's forecast of sertindole's revenues across the five major EU markets ($m), 2006-2015 - page 141
- Figure 22: Datamonitor's competitive positioning analysis of asenapine, 2006 - page 152
- Figure 23: Datamonitor's forecast of asenapine's revenues across the US, EU and Japan ($m), 2006-2015 - page 154
- Figure 24: Datamonitor's competitive positioning analysis of bifeprunox, 2006 - page 163
- Figure 25: Datamonitor's forecast of bifeprunox's revenues across the US, EU and Japan ($m), 2006-2015 - page 165
- Figure 26: Datamonitor's competitive positioning analysis of blonanserin, 2006 - page 170
- Figure 27: Datamonitor's forecast of blonanserin's revenues across the US, EU and Japan, 2006-2015 - page 172
- Figure 28: Seroquel SR meets two out of three criteria for a therapeutically and commercially successful drug reformulation - page 176
- Figure 29: Datamonitor's competitive positioning analysis of Seroquel SR, 2006 - page 177
- Figure 30: Datamonitor's forecast of Seroquel SR's revenues across the US, EU and Japan, 2006-2015 - page 179
- Figure 31: Datamonitor's competitive positioning analysis of iloperidone, 2006 - page 184
- Figure 32: Datamonitor's forecast of iloperidone's revenues across the US, EU and Japan, 2006-2015 - page 186
- Figure 33: Polypharmacology affinity of atypical antipsychotics for serotonergic, dopaminergic, adrenergic, muscarinic and histaminergic receptors - page 223
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