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Pipeline Insight: Antipsychotics - Novel Antipsychotics Driving Market EvolutionPublished by: Datamonitor Published: Nov. 13, 2003 - 166 Pages Table of ContentsTABLE 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 AbstractIntroductionThe 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 Report 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. Reasons to Purchase 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 Get Full Details About This Report >> |
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