Pipeline Insight: Antipsychotics - Novel Antipsychotics Driving Market Evolution

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Publication Date: 2003-11-13

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Introduction
The antipsychotic market is worth an estimated $10.7 billion and is led by Eli Lilly's blockbuster Zyprexa. After 2007, the market is expected to plateau due to the genericization of Janssen's Risperdal and Pfizer's Geodon. However, Bristol-Myers Squibb's dopaminergic modulator Abilify, launched in 2002. has acheived good uptake and is predicted to reach blockbuster status by 2009.

Scope

Detailed coverage of the patient potential, unmet needs, and clinical trial design of antipsychotics across the seven major markets
Overview of drugs in preregistration, Phase III, II, I and preclinical development, with in-depth profiles of Organon and Sanofi-Synthelabo
Profiles of compounds undergoing development for schizophrenia, with sales forecasts to 2011
Insight into current research for novel diagnostic tests and the genetic basis of psychosis

Highlights
The current late stage antipsychotic pipeline is unlikely to yield a blockbuster product over the forecast period. Novartis has discontinued research of Zomaril with the drug now available for out-licensing, leaving Novartis' antipsychotic pipeline empty.

Lundbeck's Serdolect is set for relaunch in 2005, with post-marketing studies demonstrating that the drugs efficacy and safety profile is comparable to current frontline antipsychotics. However, Datamonitor is unsure whether this is enough to dispel the negative association with heart problems.

Novel neurotransmitter receptor ligands form the majority of drugs in Phase II and below. Due to the predicted high specificity and narrowed spectrum of efficacy, Datamonitor believes these compounds will be investigated as adjuncts, as a precursor to the predicted future of polytherapy.

Why you should buy this report

Understand unmet needs in the antipsychotics market to identify new opportunities
Assess the commercial potential of new products entering the market
Identify in-licensing and co-promotional opportunities

CHAPTER 1 EXECUTIVE SUMMARY - page 3
- 1.1 Scope of the analysis - page 3
- 1.2 Datamonitor insight into the antipsychotics pipeline - page 3
  - Following safety concerns with key late stage products, namely Novartis' Zomaril (iloperidone) and Lundbeck's Serdolect (sertindole), Datamonitor believes that the antipsychotic pipeline is unlikely to provide a blockbuster drug over the forecast period, 2003-2011. Datamonitor believes out-licensing is the best option for Novartis and Lundbeck, although finding a buyer will prove difficult. - page 4
  - The remaining Phase III drugs include Lundbeck/Solvay's bifeprunox, Dainippon's Lonasen, and Organon/Pfizer's asenapine, all of which are MNRAs. Datamonitor believes that bifeprunox has the greatest market potential, based upon the drugs superior efficacy and side effect profile; although the recent collaboration of Organon and Pfizer over the development of asenapine, indicates that the drug has strong therapeutic and commercial capabilities. - page 5
  - The majority of antipsychotics in Phase II development and below demonstrate a paradigm shift from the traditional D2 dopamine and 5-HT2 serotonin receptor antagonism to alternative dopaminergic and serotonergic receptor targeting, in addition to a plethora of novel neurotransmitter receptors. Datamonitor believes that although this demonstrates a transition towards the potential future treatment strategy of polytherapy, a number of hurdles have to be approached first. - page 7
  - Summary - page 9
- 1.3 Key metrics - page 10
TABLE OF CONTENTS - page 11
CHAPTER 2 PATIENT POTENTIAL - page 23
- 2.1 Introduction: antipsychotic indications - page 24
- 2.2 Schizophrenia - page 25
  - Disease definition - page 25
  - Epidemiology - page 27
  - Comorbid disorders - page 28
  - Segmentation of schizophrenia - page 31
  - Diagnosis, treatment and compliance - page 33
- 2.3 Bipolar disorder - page 35
  - Disease definition - page 35
  - Epidemiology - page 36
  - Comorbidity disorders - page 39
  - Segmentation of bipolar disorder - page 41
  - Diagnosis, treatment and compliance - page 41
- 2.4 Future prevalence trends of schizophrenia and bipolar disorder - page 42
- 2.5 Unmet needs - page 44
- 2.6 Efficacy - page 44
  - Compliance - page 45
  - Onset of action - page 46
  - Side-effect profile - page 46
  - Refractory patients - page 46
CHAPTER 3 R&D APPROACH - page 48
- 3.1 Classification of pipeline products - page 49
  - Dopamine antagonists - page 49
  - Mixed neurotransmitter receptor antipsychotics - page 50
  - Novel antipsychotics - page 50
- 3.2 Clinical trial assessment tools - page 51
  - Positive and Negative Syndrome Assessment - page 51
  - Brief Psychiatric Rating Scale - page 52
  - Other tests - page 52
- 3.3 Side effects of antipsychotics - page 52
  - Extrapyramidal symptoms - page 53
  - Prolactin serum levels - page 53
  - Sexual dysfunction - page 53
  - Weight gain - page 53
  - Diabetes - page 54
  - QTc prolongation - page 55
  - Agranulocytosis - page 55
- 3.4 Clinical trial design in psychosis - page 56
  - Randomization - page 56
  - Double blind and placebo controlled - page 56
  - Placebo effect in clinical trials - page 57
  - Comparator drugs: equivalence and non-inferiority trials - page 58
  - Comparator drugs: doses - page 59
CHAPTER 4 ANTIPSYCHOTIC PIPELINE ANALYSIS - page 60
- 4.1 Pipeline overview - page 61
  - Registered and Phase III overview - page 61
  - Phase II overview - page 62
  - Phase I overview - page 64
  - Preclinical overview - page 65
- 4.2 Key companies involved in the antipsychotic pipeline - page 71
- 4.3 Organon and Cortex - page 72
- 4.4 Sanofi-Synthélabo - page 74
  - Collaboration between Sanofi and Organon? - page 78
- 4.5 Strategies for success - page 78
  - Antipsychotic delivery systems - page 78
  - Polytherapy - page 82
CHAPTER 5 MIXED NEUROTRANSMITTER RECEPTOR ANTAGONISTS - page 85
- 5.1 Pipeline overview - page 86
- 5.2 Definition of current gold standard for MNRA class - page 86
  - Zyprexa (olanzapine) - page 87
- 5.3 Zomaril (iloperidone) - page 89
  - Profile - page 89
  - Forecast to 2011 - page 94
- 5.4 Serdolect (sertindole) - page 95
  - Profile - page 95
  - Forecast to 2011 - page 100
- 5.5 Bifeprunox (DU127090) - page 102
  - Profile - page 102
  - Forecast to 2011 - page 105
- 5.6 Lonasen (blonanserin) - page 107
  - Profile - page 107
  - Forecast to 2011 - page 111
- 5.7 Other MNRA drugs in late-stage development - page 112
  - Asenapine (ORG-5222) - page 112
  - SM-13496 - page 114
  - SLV 310/313 - page 115
- 5.8 Comparison of mixed neurotransmitter receptor antagonists - page 115
  - Efficacy - page 116
  - Compliance - page 116
  - Side-effect profile - page 116
  - Marketing strength - page 117
  - MNRA market forecast to 2011 - page 118
- 5.9 Recently discontinued MNRAs - page 118
  - Eplivanserin - page 119
CHAPTER 6 DOPAMINERGIC ANTIPSYCHOTICS - page 120
- 6.1 Pipeline overview - page 121
- 6.2 Definition of gold standard - page 121
- 6.3 Abilify (aripiprazole) - page 122
- 6.4 Drug analysis - page 123
  - PNU-170413 - page 123
CHAPTER 7 NOVEL LATE-STAGE ANTIPSYCHOTICS - page 125
- 7.1 Pipeline overview - page 126
- 7.2 Definition of gold standard - page 126
- 7.3 Clozaril (clozapine) - page 126
- 7.4 CX-516 - page 127
  - Profile - page 127
- 7.5 LAX-101 - page 131
  - Profile - page 131
- 7.6 ORG-24448 - page 133
- 7.7 ABT-089 - page 134
- 7.8 Osanetant - page 134
  - Profile - page 134
- 7.9 Talnetant (SB-223412) - page 135
- 7.10 Recently discontinued novel antipsychotics - page 135
- 7.11 E-5826 - page 136
  - Profile - page 136
CHAPTER 8 INNOVATIVE EARLY-STAGE PROJECTS - page 137
- 8.1 Current research strategies - page 138
  - Niacin skin test - page 138
  - Susceptibility genes for schizophrenia - page 139
  - Bipolar and schizophrenia genetic link - page 140
- 8.2 Key antipsychotics in Phase I and preclinical development - page 141
  - 5-HT receptor targeting: ACP-103 - page 141
  - Dopamine receptor targeting - page 143
  - Novel receptor targets - page 145
- 8.3 Contributing experts - page 147
- 8.4 List of tables - page 148
- 8.5 List of figures - page 149
- 8.6 Bibliography - page 149
  - Patient potential - page 149
  - R&D approach - page 152
  - Clinical trial data - page 153
  - Websites - page 158
  - Other sources - page 159
- 8.7 R&D research methodology - page 159
- 8.8 About Datamonitor - page 160
  - About Datamonitor Healthcare - page 160
  - Datamonitor Healthcare's research and analysis methodologies - page 161
- 8.9 Datamonitor Healthcare's therapy area capabilities - page 161
  - About CNS analysis team - page 162
  - Datamonitor Healthcare's Consulting expertise - page 163
  - Key therapy team members - page 164
  - Disclaimer - page 165

List of Tables
Table 1: Key parameters of psychosis, 2003-2011 - page 10
Table 2: Forecast key pipeline products in psychosis to 2011 ($m) - page 10
Table 3: Range of 12-month prevalence between regions, 2003 - page 27
Table 4: Adult schizophrenia patient potential in the seven major markets, 2003 - page 28
Table 5: Prevalence of BD between countries, 2003 - page 36
Table 6: Adult prevalence rates of BDI and BDII in the seven major markets, 2003 - page 38
Table 7: Adult prevalence rates of BDI and BDII in the seven major markets using the MDQ prevalence rate, 2003 - page 38
Table 8: Trends in the combined adult prevalence of schizophrenia and BD, 2003-2011 (000s) - page 43
Table 9: Registered antipsychotics, 2003 - page 61
Table 10: Phase III antipsychotics pipeline, 2003 - page 61
Table 11: Phase II antipsychotics pipeline, 2003 - page 63
Table 12: Phase I antipsychotic pipeline, 2003 - page 64
Table 13: Preclinical MNRA pipeline, 2003 - page 66
Table 14: Preclinical serotonergic antipsychotic pipeline, 2003 - page 67
Table 15: Preclinical dopaminergic antipsychotic pipeline, 2003 - page 68
Table 16: Preclinical novel antipsychotics pipeline, 2003 (originators A-M) - page 69
Table 17: Preclinical novel antipsychotics pipeline, 2003 (originators N-U) - page 70
Table 18: Sanofi's marketed CNS portfolio - page 75
Table 19: Sanofi's antipsychotic pipeline, 2003 - page 76
Table 20: Reformulations of antipsychotic brands, 2003 - page 79
Table 21: MNRAs in late-stage R&D antipsychotic pipeline - page 86
Table 22: Marketed antipsychotics considered for MNRA gold standard, 2003 - page 86
Table 23: Global sales forecasts for Serdolect, 2003-11 - page 100
Table 24: Impacting factors on the sales of Serdolect, 2004-11 - page 101
Table 25: Global sales forecasts for bifeprunox, 2003-11 - page 105
Table 26: Impacting factors on the sales of bifeprunox, 2005-11 - page 105
Table 27: Global sales forecasts for Lonasen, 2003-11 - page 111
Table 28: Impacting factors on the sales of Lonasen, 2004-11 - page 111
Table 29: Global sales forecasts for MNRAs, 2003-2011 ($m) - page 118
Table 30: Recently discontinued MNRAs, 2003 - page 118
Table 31: Late-stage dopamine antagonists, 2003 - page 121
Table 32: Marketed antipsychotics considered for dopaminergic gold standard, 2003 - page 121
Table 33: Late-stage R&D pipeline antipsychotics, 2003 - page 126
Table 34: Recently discontinued MNRAs, 2003 - page 135
Table 35: Candidate susceptibility genes for schizophrenia - page 139

List of Figures
Figure 1: Summary of major antipsychotic market events, 2003-2011 - page 9
Figure 2: Unmet needs in the treatment of psychosis, 2003 - page 44
Figure 3: Zomaril's satisfaction of unmet needs, 2003 - page 93
Figure 4: Serdolect's satisfaction of unmet needs, 2003 - page 99
Figure 5: Bifeprunox's satisfaction of unmet needs, 2003 - page 104
Figure 6: Lonasen's satisfaction of unmet needs, 2003 - page 110
Figure 7: Satisfaction of unmet needs of MNRAs in late-stage development, 2003 - page 115
Figure 8: Datamonitor's Healthcare Consultancy - page 163
Figure 9: Datamonitor Healthcare's Therapeutic Consulting capabilities - page 164

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Pipeline Insight: Antipsychotics - Novel Antipsychotics Driving Market Evolution

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