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Pipeline Insight: Antipsychotics - Novel Antipsychotics Driving Market Evolution
Datamonitor, Nov 2003, Pages: 166
TABLE OF CONTENTS
Chapter 1 Executive summary 3
1.1 Scope of the analysis 3
1.2 Datamonitor insight into the antipsychotics pipeline 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. 4
Discontinuation and out-licensing of Zomaril 4
Lundbeck’s crowded pipeline means uncertain future of Serdolect 5
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. 5
Bifeprunox 5
Lonasen 6
Asenapine 7
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. 7
Summary 9
1.3 Key metrics 10
Chapter 2 Patient potential 23
2.1 Introduction: antipsychotic indications 24
Indications targeted by manufacturers 24
2.2 Schizophrenia 25
Disease definition 25
Epidemiology 27
Comorbid disorders 28
Anxiety 28
Depression 29
Substance abuse 30
Parkinson’s disease and Alzheimer’s disease 31
Segmentation of schizophrenia 31
Age 31
Gender 32
Social class 32
Diagnosis, treatment and compliance 33
Treatment 34
Compliance 34
2.3 Bipolar disorder 35
Disease definition 35
Types of mood episodes associated with BD 35
Bipolar I disorder 35
Bipolar II disorder 36
Epidemiology 36
Comorbidity disorders 39
Depression 39
Anxiety 39
Substance abuse 40
Migraine 40
Segmentation of bipolar disorder 41
Bipolar class 41
Gender 41
Diagnosis, treatment and compliance 41
Diagnosis 41
Treatment and compliance 42
2.4 Future prevalence trends of schizophrenia and bipolar disorder 42
2.5 Unmet needs 44
2.6 Efficacy 44
Compliance 45
Onset of action 46
Side-effect profile 46
Refractory patients 46
Chapter 3 R&D approach 48
3.1 Classification of pipeline products 49
Dopamine antagonists 49
Mixed neurotransmitter receptor antipsychotics 50
Novel antipsychotics 50
3.2 Clinical trial assessment tools 51
Positive and Negative Syndrome Assessment 51
Brief Psychiatric Rating Scale 52
Other tests 52
3.3 Side effects of antipsychotics 52
Extrapyramidal symptoms 53
Prolactin serum levels 53
Sexual dysfunction 53
Weight gain 53
Diabetes 54
QTc prolongation 55
Agranulocytosis 55
3.4 Clinical trial design in psychosis 56
Randomization 56
Double blind and placebo controlled 56
Placebo effect in clinical trials 57
Comparator drugs: equivalence and non-inferiority trials 58
Comparator drugs: doses 59
Chapter 4 Antipsychotic pipeline analysis 60
4.1 Pipeline overview 61
Registered and Phase III overview 61
Phase II overview 62
Phase I overview 64
Preclinical overview 65
4.2 Key companies involved in the antipsychotic pipeline 71
4.3 Organon and Cortex 72
Organon’s CNS franchise 72
Cortex’s AMPAKINE technology 72
Organon/Cortex antipsychotic portfolio 73
Strategy for success 73
4.4 Sanofi-Synthélabo 74
Sanofi’s CNS franchise 74
Threats to Solian 75
Sanofi’s antipsychotic portfolio 76
Strategy for success 77
Collaboration between Sanofi and Organon? 78
4.5 Strategies for success 78
Antipsychotic delivery systems 78
IM depots 79
Liquid and dissolvable formulations 80
Late-stage antipsychotics with reformulation potential 81
Future reformulation strategies 81
Polytherapy 82
Chapter 5 Mixed neurotransmitter receptor antagonists 85
5.1 Pipeline overview 86
5.2 Definition of current gold standard for MNRA class 86
Zyprexa (olanzapine) 87
Efficacy 87
Compliance 87
Side-effect profile 88
Marketing factors 88
5.3 Zomaril (iloperidone) 89
Profile 89
Drug overview 89
Clinical trial data 89
Patient potential and marketing factors 92
Satisfaction of unmet needs 93
Forecast to 2011 94
5.4 Serdolect (sertindole) 95
Profile 95
Drug overview 95
Clinical trial data 95
Patient potential and marketing factors 97
Satisfaction of unmet needs 99
Forecast to 2011 100
QTc negative publicity 101
Launch of bifeprunox and asenapine 101
5.5 Bifeprunox (DU127090) 102
Profile 102
Drug overview 102
Clinical trial data 102
Patient potential and marketing factors 103
Satisfaction of unmet needs 104
Efficacy 104
Compliance 104
Side-effect profile 104
Forecast to 2011 105
FDA approval of Abilify 106
Geodon and Zyprexa short-term IM depot 106
Risperdal Consta and Zyprexa long-term IM depot 106
FDA approval of Serdolect and asenapine 106
5.6 Lonasen (blonanserin) 107
Profile 107
Drug overview 107
Clinical trial data 107
Patient potential and marketing factors 109
Satisfaction of unmet needs 110
Forecast to 2011 111
Launch market 112
Global launch 112
5.7 Other MNRA drugs in late-stage development 112
Asenapine (ORG-5222) 112
Drug overview 112
Clinical trial data 112
Patient potential and marketing factors 114
SM-13496 114
SLV 310/313 115
5.8 Comparison of mixed neurotransmitter receptor antagonists 115
Efficacy 116
Compliance 116
Side-effect profile 116
Marketing strength 117
MNRA market forecast to 2011 118
5.9 Recently discontinued MNRAs 118
Eplivanserin 119
Chapter 6 Dopaminergic antipsychotics 120
6.1 Pipeline overview 121
6.2 Definition of gold standard 121
6.3 Abilify (aripiprazole) 122
Efficacy 122
Side-effect profile 122
Compliance 122
Marketing factors 123
6.4 Drug analysis 123
PNU-170413 123
Drug overview 123
Clinical trial data 123
Datamonitor comment 124
Chapter 7 Novel late-stage antipsychotics 125
7.1 Pipeline overview 126
7.2 Definition of gold standard 126
7.3 Clozaril (clozapine) 126
Efficacy 127
Compliance 127
Side-effect profile 127
7.4 CX-516 127
Profile 127
Drug overview 127
Clinical trial data 128
Patient potential and marketing factors 129
7.5 LAX-101 131
Profile 131
Drug overview 131
Clinical trial data 131
Patient potential and marketing factors 132
7.6 ORG-24448 133
7.7 ABT-089 134
7.8 Osanetant 134
Profile 134
Drug overview 134
Clinical trial data 135
7.9 Talnetant (SB-223412) 135
7.10 Recently discontinued novel antipsychotics 135
7.11 E-5826 136
Profile 136
Drug overview 136
Datamonitor comment 136
Chapter 8 Innovative early-stage projects 137
8.1 Current research strategies 138
Niacin skin test 138
Susceptibility genes for schizophrenia 139
Bipolar and schizophrenia genetic link 140
8.2 Key antipsychotics in Phase I and preclinical development 141
5-HT receptor targeting: ACP-103 141
Drug overview 141
Research data 141
Datamonitor comment 142
Dopamine receptor targeting 143
Novel receptor targets 145
Datamonitor comment 146
APPENDIX A 147
8.3 Contributing experts 147
8.4 List of tables 148
8.5 List of figures 149
8.6 Bibliography 150
Patient potential 150
R&D approach 153
Clinical trial data 154
Websites 159
Other sources 160
8.7 R&D research methodology 160
Appendix B 161
8.8 About Datamonitor 161
About Datamonitor Healthcare 161
Datamonitor Healthcare’s research and analysis methodologies 162
8.9 Datamonitor Healthcare’s therapy area capabilities 162
About CNS analysis team 163
Datamonitor Healthcare’s Consulting expertise 164
Datamonitor’s Therapeutic Consulting expertise 164
Key therapy team members 165
David Abramson, Therapeutic Lead Consultant 165
Disclaimer 166
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