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Pipeline Insight: Alzheimer's Disease - A Busy Future, with Diagnosis, Disease Modification and Prevention Key to Growing MarketPublished by: Datamonitor Published: Jul. 2, 2004 - 234 Pages Table of ContentsTABLE OF CONTENTS CHAPTER 1 EXECUTIVE SUMMARY 3 Scope of the analysis 3 Datamonitor insight into the Alzheimer’s disease market 4 The major unmet need in this market is for disease modification and disease prevention. Currently marketed products are perceived to only provide partial and temporary relief from Alzheimer’s symptoms. In the short to medium term opinion leaders are looking to Axonyx’s phenserine and Neurochem’s Alzhemed in anticipation of successful modification of disease progression. This high level of awareness and positivity bodes well for the launches of these products, which could challenge the market domination of Pfizer/Eisai’s Aricept (donepezil) if supported by sufficient marketing strength. 5 Current diagnosis by specialists, albeit of ‘probable’ Alzheimer’s, is relatively accurate as verified on post mortem analysis. However, an increasing focus on early identification and prevention, in addition to a growing aging population being managed by primary care physicians, highlights a need for simpler diagnostic tools and robust biological markers. Improved identification of both ‘at risk’ and early clinical groups would aid trial design and assist patient segmentation and product positioning strategies, which will become key as more players enter the market. 8 Prevention is better than cure. Over the longer term physicians, and sections of the pharmaceutical industry, are searching for options to prevent Alzheimer’s disease. The large number of mechanisms hypothesized to contribute to the etiology and progression of the disorder complicates this quest. As these hypotheses are refined and scientific rationale is demonstrated, the substantial opportunity provided by prevention may become more attainable, however Industry will need to pay careful consideration to the challenges of a prophylactic market. 10 Although neuroprotective and neurotrophic drugs offer significant potential commercial benefit, they are also associated with problematic development. Companies with little threshold tolerance for pipeline failure may look to balance their risk across a number of potential pathways to Alzheimer’s treatment. This approach will increase the likelihood of providing a marketable product and could provide a veritable suite of drugs for Alzheimer’s management across the patients’ range of needs. 14 Summary 16 Key metrics 17 CHAPTER 2 PATIENT POTENTIAL 32 Definition of Alzheimer’s disease 33 Segmentation of Alzheimer’s disease 35 Mild cognitive impairment (MCI) 35 Comorbidities 36 Treatments for comorbidities 37 Drugs for treating depression 37 Drugs for treating agitation, aggression and psychotic symptoms 37 Drugs for treating anxiety 38 Drugs for treating sleep disturbances 38 Commercial analysis of AD comorbidities 39 Epidemiology of Alzheimer’s disease 40 Diagnosis and treatment rates 41 Future trends 42 Unmet needs in Alzheimer’s disease 43 Disease modification 43 Improved efficacy 43 Fewer side effects 44 Reducing numbers of treatment unresponsive patients 45 Patient compliance 45 CHAPTER 3 R&D APPROACH 46 Classification of pipeline products 47 ACh modulators 47 Neuroprotective and neurotrophic drugs 49 Beta-amyloid modulators 50 Beta-secretase (BACE) inhibitors 50 Protein deposition inhibitors 50 Other compounds in development 50 Clinical trial design in Alzheimer’s disease 51 Patient population 51 Design 52 Duration 52 Gold standard 53 Clinical trial endpoints in Alzheimer’s disease 53 Alzheimer’s disease assessment scale 55 Mini-Mental Status Exam 55 Clinician’s Interview-Based Impression of Change 56 Severe Impairment Battery 56 Alzheimer’s Disease Cooperative Study: Activities of Daily Living 56 Clinical Dementia Rating 57 Cambridge Neuropsychological Test Automated Battery (CANTAB) 57 Global Deterioration Scale 59 Functional Assessment Staging 60 Clinical Global Impression of Change 61 Clinical Global Impression of Severity 61 Neuropsychiatry Inventory 62 Behavioral Rating Scale for Geriatric Patients 62 Resource Utilization in Dementia 63 Disability Assessment for Dementia 63 Progressive Deterioration Scale 63 Clinical Dementia Rating 64 Summary 64 CHAPTER 4 ALZHEIMER’S DISEASE PIPELINE ANALYSIS 66 Pipeline overview 67 Phase III overview 68 Phase II overview 70 Phase I overview 72 Preclinical overview 74 Key companies involved in the Alzheimer’s disease pipeline 77 Eli Lilly 77 Pfizer 78 Sanofi-Synthélabo 79 Companies specializing in Alzheimer’s disease 81 Axonyx 81 Mindset 83 Nymox 85 Prana 87 Strategies for success 88 High risk, high profit versus low risk, low return 88 Diagnosis of Alzheimer’s disease 89 Ethics and trial design 92 CHAPTER 5 ACETYLCHOLINE MODULATORS - LATE-STAGE DRUG ANALYSIS & FORECASTS 93 Overview for ACh modulators 94 Pipeline summary 94 Definition of current comparator therapy 94 Phenserine 95 Profile 95 Drug overview 95 Clinical trial data 96 Phase III 96 Phase II 96 Patient profile 98 Marketing factors 98 Satisfaction of unmet needs 100 Efficacy 101 Disease modification 101 Safety 102 Treatment response 102 Forecasts to 2014 102 Other ACh modulator drugs 103 ZT-1 (Huperzine A) 103 NS-2330 106 P58 110 TC-1734 113 SIB-1553A 114 ABT-089 115 Ganstigmine 116 CI-1017 (PD-151832) 117 MKC231 117 Late-stage development compounds recently discontinued 118 TAK-147 (PIII) 118 Comparison of key AChE modulator compounds 119 Disease modification 119 Better efficacy than marketed drugs 120 Side-effect profile 120 Treatment unresponsive patients 120 Marketing strength 120 CHAPTER 6 BETA-AMYLOID MODULATORS LATE-STAGE DRUG ANALYSIS AND FORECASTS 122 Overview for beta-amyloid modulators 123 Pipeline summary 123 Definition of current comparator therapy 123 Alzhemed (NC 531) 123 Profile 123 Drug overview 123 Clinical trial data 124 Phase I 124 Phase II 125 Phase III 126 Patient potential 127 Marketing factors 127 Satisfaction of unmet need 127 Efficacy 127 Disease modification 128 Safety 128 Treatment response 128 Forecasts to 2014 129 PBT-1 (clioquinol) 130 Profile 130 Drug overview 130 Clinical trial data 131 Patient potential 134 Marketing factors 134 Satisfaction of unmet need 135 Efficacy 135 Disease modification 135 Safety 135 Treatment response 135 Forecasts to 2014 136 Other drugs 138 Egb-761 (Tanakan) 138 Comparison of key compounds in the beta-amyloid modulator class 140 Disease modification 140 Better efficacy than marketed drugs 140 Side-effect profile 140 Treatment unresponsive patients 141 Marketing strength 142 Comparative forecasts 142 CHAPTER 7 NEUROPROTECTIVE AND NEUROTROPHIC DRUGS—LATE-STAGE DRUG ANALYSIS AND FORECASTS 143 Overview for neuroprotective and neurotrophic drugs 144 Pipeline summary 144 Definition of current comparator therapy 144 Xaliproden 144 Profile 144 Drug overview 144 Clinical trial data 145 Patient potential 146 Marketing factors 146 Satisfaction of unmet need 147 Efficacy 147 Disease modification 148 Safety 148 Treatment response 148 Forecasts to 2014 148 Other drugs 148 SR-57667 148 SGS111 149 KA-672 150 T-588 151 Late-stage development compounds recently discontinued 152 CX516 (AMPAKINE) (PII) 152 FK960 (PII) 153 Neotrofin (PII) 153 CHAPTER 8 OTHER DRUGS - LATE-STAGE DRUG ANALYSIS AND FORECASTS 155 Overview for other drugs 156 Pipeline summary 156 Definition of current comparator therapy 156 Antioxidants 157 Colostrinin 157 Drug profile 157 Clinical trial data 158 Patient potential 160 Marketing factors 160 Satisfaction of unmet needs 160 Forecasts to 2014 162 Bacosides 163 Vitamin E 163 PREADVISE 163 Vitamin E and donepezil 164 Anti-inflammatory drugs 165 R-Flurbiprofen (MPC7869) 166 Dapsone 167 Statins 169 Lipitor (atorvastatin) 170 Zocor (simvastatin) 171 Comment 171 B vitamins 172 Hormones 172 Estrogen 173 Drug overview 173 Clinical trial data 175 Datamonitor conclusions 176 Leuprolide 177 Testosterone 177 Rasagiline 179 Avandia (rosiglitazone) 180 SGS-742 181 SL-65.0155 181 S-8510 182 COGNIShunt 183 Late-stage development compounds recently discontinued 185 NSAIDs (Vioxx, Naprelan) (PIII) 185 Lovastatin (ADX-159) (PII) 185 Comparison of key compounds in the other drugs class 186 Disease modification 186 Better efficacy than marketed drugs 187 Side-effect profile 187 Marketing strength 187 CHAPTER 9 INNOVATIVE EARLY-STAGE PROJECTS 188 Key Phase I and preclinical compounds in Alzheimer’s disease 189 Chelators 189 Gene therapy 191 HCT 1026 193 Lithium 194 Ketone bodies 195 AMPAKINES 195 CX-717 196 S-18986 196 Vaccines 196 Neurochem 197 Elan and Wyeth: ACC-001 198 Mindset: Amyrex 198 Pharmexa and Lundbeck: PX-106 199 Cytos and Novartis: AD Immunodrug 200 Other vaccines 200 Comments 200 Key research impacts on Alzheimer’s disease 202 Amyloid and blood vessels in the brain 202 APPENDIX A 205 Contributing experts 205 Bibliography 205 General information 205 Epidemiology 212 Clinical trial data 212 Websites 216 Report methodology 220 Introduction 220 Hypothesis formulation 220 Hypothesis testing 221 Ongoing information update 221 Product specific primary research 221 Data verification and quality control 222 Quantification of data reliability 222 Confidence ratings 222 Date of research completion 223 Introduction to Datamonitor Healthcare forecasting 223 Methodology 223 Market events 224 Validation 225 Pipeline-drug forecast methodology 226 Predicting initial market share 227 Clinical competitiveness attributes 227 Order of entry 227 Pre-launch awareness 227 Market composition 227 Marketing plan 228 Marketing strength 228 Forecasting future growth 228 Influencing factors 228 APPENDIX B 230 About Datamonitor 230 About Datamonitor Healthcare 230 Datamonitor Healthcare’s therapy area capabilities 231 About the CNS analysis team 232 Key therapy team members 233 Disclaimer 234 AbstractIntroductionOver the next ten years the Alzheimer's disease market will become increasingly competitive as potentially disease modifying drugs vie for approval. Companies will need to scrutinize their plans to ensure implementation of appropriate launch strategies, achieving clear positioning and differentiation in a changing environment. What is right for launch in 2005 may not be effective at a later date. Scope Epidemiology of Alzheimer's Disease across the 7 major markets, as well as analysis of the main unmet needs in the current treatment of the disease Overview of drugs in Phase III, II, I and pre-clinical development, plus analysis of key companies involved in the R&D pipeline: Pfizer, Lilly & Sanofi Comprehensive analysis of key late-stage products phenserine, Alzhemed, PBT-1 and Colostrinin, with Datamonitor forecasts of drug revenues to 2014 Insight into innovative early stage products, including vaccines, as well as analysis of key research impacts concerning beta-amyloid Highlights Marketed products only provide temporary partial symptomatic relief: disease modification and prevention are major unmet needs. Opinion leaders consider phenserine (Axonyx) and Alzhemed (Neurochem) to have potential for successful disease modification which could challenge Aricept's market domination if supported by sufficient marketing strength. Physicians and sections of the pharmaceutical industry are searching for options to prevent Alzheimer's disease. The large number of mechanisms contributing to the etiology and progression of the disorder add complications. There is substantial opportunity but the industry will need to carefully consider the challenges of a prophylactic market. An increasing focus on disease prevention and early identification highlights a need for simple diagnostic tools and biological markers. Identification of 'at risk' and early clinical groups would aid trial design and assist patient segmentation and product positioning strategies, key factors as more players enter the market Reasons to Purchase Enhance your sales forecasting ability and future product positioning through identification of market drivers and key competitors Optimize your knowledge of company strategies in the AD market Identify areas of the market that are not being targeted by competitors and gain an objective view of potential in-licensing opportunities Get Full Details About This Report >> |
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