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Pipeline Insight: Depression - Novel therapies key to market penetrationPublished by: Datamonitor Published: Sep. 15, 2003 - 168 Pages Table of ContentsTABLE OF CONTENTS CHAPTER 1 EXECUTIVE SUMMARY 3 Scope of the analysis 3 Datamonitor insight into the depression market 3 Duloxetine, Eli Lilly’s follow-up compound to Prozac, is set to become the next drug to enter the antidepressant market. However, convincing physicians that it is an improvement on Wyeth’s Effexor may prove challenging. Lilly needs to position duloxetine as an alternative first-line therapy to SSRIs. Datamonitor forecasts revenues of $2.1 billion by 2011. 4 Merck’s NK1 receptor antagonist, aprepitant, is expected to be the first drug from another completely new class of antidepressants to hit the market. Its launch in 2006 will precipitate an influx of similar compounds to the market, presenting a major threat to the leading position of first-line therapy SSRIs 5 Despite the looming patent expiries of several leading antidepressants by 2008, pharmaceutical companies are finding it increasingly difficult to develop novel compounds to replace these products. New strategies are needed to prevent a decline in the antidepressant market. Companies need to begin focusing on the development of compounds with new modes of action and targeting treatment resistant patients. 7 Key metrics 9 CHAPTER 2 PATIENT POTENTIAL 23 Introduction 23 Definition of depression 23 Segmentation of depression 24 Epidemiology of depression 25 MDD prevalence in the major markets 25 Diagnosis and treatment 27 Comorbid disorders 27 Generalized anxiety disorder 28 Social anxiety disorder 28 Panic disorder 29 Obsessive compulsive disorder 29 Post-traumatic stress disorder 30 Unmet need in depression 30 Introduction 30 Efficacy 31 Improved side-effect profile 32 Onset of action 33 Other unmet needs 33 Treatment-resistant depression 33 Remission 34 Compliance 35 Comorbid disorders 35 CHAPTER 3 R&D APPROACH 36 Classification of pipeline products 36 Serotonergics 36 Noradrenergics 38 NK receptor antagonists 39 Reversible monoamine oxidase inhibitors 40 Novel therapies 41 Clinical trial design in depression 42 Patient population 42 Placebo effect 43 Duration 44 Endpoints 45 Clinical trial endpoints in depression 46 Hamilton Rating Scale for Depression 46 Hamilton Rating Scale for Anxiety 46 Montgomery-Asberg Depression Rating Scale 46 Clinical Global Impression Scale 47 The Beck Depression Rating Scale 47 The Zung Self-Rating Depression Scale 47 CHAPTER 4 DEPRESSION PIPELINE ANALYSIS 48 Pipeline overview 48 Preregistration overview 48 Phase III overview 49 Phase II overview 50 Phase I overview 52 Key companies involved in the depression pipeline 53 Organon 53 Organon’s CNS franchise 54 Organon’s antidepressant portfolio 54 R&D pipeline 55 Strategy for success 56 Dov Pharmaceutical 56 Dov’s CNS franchise 57 Dov’s antidepressant portfolio 57 R&D pipeline 57 CHAPTER 5 SEROTONERGIC LATE-STAGE DRUG ANALYSIS & FORECASTS 59 Overview for serotonergics 59 Pipeline summary 59 Definition of current comparator therapy 59 Variza (gepirone) 60 Profile 60 Drug overview 60 Clinical trial data 60 Patient potential 67 Marketing factors 67 Satisfaction of unmet needs 68 Forecasts to 2011 69 Competition from Lexapro 70 Use in niche markets within depression 71 Generic competition 71 Other serotonergics 71 Alnespirone (S-20499) 71 Elzasonan (CP 448,187) 72 YKP-10A 72 Late-stage development compounds recently discontinued 73 DU-125530 74 Flibanserin (Ectris) 74 Robalzotan (NAD 299) 75 Vilazodone (EMD 68843 or SB659746A) 75 CHAPTER 6 NORADRENERGIC LATE-STAGE DRUG ANALYSIS AND FORECASTS 76 Overview for noradrenergics 76 Pipeline summary 76 Definition of current comparator therapy 76 Cymbalta (duloxetine) 78 Profile 78 Drug overview 78 Clinical trial data 78 Patient potential 84 Marketing factors 84 Satisfaction of unmet needs 86 Forecasts to 2011 88 Lilly's experience in antidepressants market, added marketing strength of Quintiles sales representatives 89 Competition from Effexor and Effexor XR 89 European launch for depression in 2004/05 89 Japan launch for depression in 2006 90 Generic competition 90 Additional indications 90 CHAPTER 7 NK RECEPTOR ANTAGONISTS LATE-STAGE DRUG ANALYSIS AND FORECASTS 92 Overview for NK receptor antagonists 92 Pipeline summary 92 Aprepitant (MK869) 92 Profile 92 Drug overview 92 Clinical trial data 94 Patient potential 96 Marketing factors 96 Satisfaction of unmet needs 97 Forecasts to 2011 98 First in class 99 Launch of Roche's R673 99 Anxiety indications 99 Concerns over safety profile 99 Launch in Japan 100 Other NK receptor antagonists 100 GW 597599 100 R637 101 TAK637 101 Saredutant (SR 48968) 101 Osanetant (SR 142801) 102 Late-stage development compounds recently discontinued 102 Compound A 103 CP-122721 103 CHAPTER 8 REVERSIBLE MONOAMINE OXIDASE INHIBITORS LATE-STAGE DRUG ANALYSIS AND FORECASTS 105 Overview for reversible monoamine oxidase inhibitors 105 Pipeline summary 105 Selegiline (EMSAM) 105 Profile 105 Drug overview 105 Clinical trial data 106 Patient potential 108 Marketing 108 Satisfaction of unmet need 109 Efficacy 109 Side effects 109 Onset of action 110 CHAPTER 9 NOVEL THERAPIES 111 Overview of ‘other’ novel therapies 111 Wellbutrin XL (bupropion) 111 Profile 111 Drug overview 111 Patient potential 112 Marketing factors 112 Satisfaction of unmet needs 113 Vagus nerve stimulation (VNS) 113 Profile 113 Drug overview 113 Clinical trial data 114 Patient potential 120 Marketing factors 120 Satisfaction of unmet needs 121 Efficacy 121 Side effects 121 Onset of action 121 Nemifitide (INN 00835) 122 Profile 122 Drug overview 122 Clinical trial data 123 Patient potential 127 Marketing factors 128 Satisfaction of unmet needs 129 Efficacy 129 Side effects 129 Onset of action 130 Forecasts to 2011 130 Added experience of Quintiles 131 Novel delivery system and use in niche markets 131 OPC-14523 132 Dov 216,303 133 AMPAKINE (Org 24448) 134 Org 34517 134 Triacetyluridine (RG-2133) 135 CHAPTER 10 INNOVATIVE EARLY-STAGE PROJECTS 136 Key Phase I and preclinical compounds in depression 136 Corticotrophin releasing factors (CRF) 137 Companies developing CRF compounds 138 NB 34041 138 Potential advantages and disadvantages of CRF 138 APPENDIX A 140 Contributing experts 140 List of tables 140 List of figures 141 Bibliography 142 Patient potential 142 R&D approach 145 Clinical trial data 147 Serotonergic late-stage pipeline 147 Noradrenergic late-stage pipeline 148 NK receptor antagonists late-stage pipeline 149 Reversible monoamine oxidase inhibitors 149 Novel antidepressants 150 Innovative early stage 151 Websites 151 R&D research methodology 154 Introduction 154 Hypothesis formulation 154 Hypothesis testing 155 Ongoing information update 155 Product specific primary research 155 Data verification and quality control 156 Quantification of data reliability 156 Confidence ratings 156 Date of research completion 157 Introduction to Datamonitor Healthcare forecasting 157 Methodology 157 Market events 158 Validation 159 Pipeline-drug forecast methodology 160 Predicting initial market share 161 Clinical competitiveness attributes 161 Order of entry 161 Pre-launch awareness 161 Market composition 161 Marketing plan 162 Marketing strength 162 Forecasting future growth 162 Influencing factors 162 APPENDIX B 163 About Datamonitor 163 About Datamonitor Healthcare 163 Datamonitor Healthcare’s research and analysis methodologies 164 Datamonitor Healthcare’s therapy area capabilities 164 About Disease analysis team 165 Datamonitor Healthcare’s Consulting expertise 166 Datamonitor’s Therapeutic Consulting expertise 167 Key therapy team members 167 David Abramson, Therapeutic Lead Consultant 167 Disclaimer 169 AbstractIntroduction:With the global antidepressant market valued at $16.6 billion in 2002, drugs for the treatment of depression have historically provided huge returns on investment. However, several of the leading brands are expecting patent expiries over the next five years. New strategies are needed to prevent a decline in the antidepressant market. Scope: * Detailed coverage of the patient potential, unmet needs, and clinical trial design of antidepressants across the seven major markets * Overview of the drugs in preregistration, Phase III, II, I and preclinical development, with in-depth profiles of Organon and Dov Pharmaceutical * Profiles of compounds undergoing development for depression, with sales forecasts to 2011, and insight into innovative early stage products * Evaluation of key clinical trials in the treatment of depression, with revenue forecasts to 2011 Report Highlights: Duloxetine, Eli Lilly’s follow-up compound to Prozac, is set to become the next drug to enter the antidepressant market. However, convincing physicians that it is superior to Wyeth’s Effexor may prove challenging. Lilly needs to position duloxetine as an alternative first-line therapy to selective serotonin reuptake inhibitors (SSRIs). Merck’s NK1 receptor antagonist, aprepitant, is expected to be the first drug from another completely new class of antidepressants to hit the market. Its launch in 2006 will precipitate an influx of similar compounds to the market, presenting a major threat to the leading position of first-line therapy SSRIs. Reasons to Purchase: * Understand the depression market unmet needs to devise market-penetrating strategies * Analyze the competitive environment at the time of product launch * Identify in-licensing and co-promotional opportunities Get Full Details About This Report >> |
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