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Stakeholder Perspectives: Mild Cognitive Impairment and Dementia - Aricept in race to pioneer unexplored marketsPublished by: Datamonitor Published: Aug. 18, 2003 - 101 Pages Table of ContentsTABLE OF CONTENTS About Datamonitor healthcare 2 About the CNS pharmaceutical analysis team 2 CHAPTER 1 Executive summary 3 1.1 Scope 3 1.2 Datamonitor insight into the MCI and dementia markets 3 MCI, the prodromal disease of AD, affects nearly 15 million people in the seven major markets. There are no approved drugs for MCI, although companies currently manufacturing AD products, Aricept (donepezil), Exelon (rivastigmine) and Reminyl (galantamine) are expected to file NDA’s during 2004. 4 VaD is the second most common cause of dementia and affects nearly four million people in the seven major markets, although opinion leaders expect the figure to be significantly higher as only 15% of patients are accurately diagnosed. There are currently no drugs approved for VaD, and Pfizer/Eisai’s Aricept, believed to have the best chance of first-to-market status, failed to gain FDA approval in July 2003. 5 Severe AD represents 20% of the total AD population, accounting for nearly one million people in the US alone. Memantine is currently the only treatment approved for severe AD in the EU, and is currently awaiting FDA approval in the US. Forest, which is memantine’s US marketing company, has an additional NMDA antagonist, neramexane, in Phase III development. Datamonitor believes neramexane will help reduce the impact to Forest’s share price if memantine fails to launch in the US. 5 1.3 Key metrics 6 CHAPTER 2 Mild Cognitive Impairment 15 Disease overview 16 Symptomology 16 Predictive factors of conversion to AD 17 Diagnosis 18 2.1 Epidemiology 19 Prevalence 19 Diagnosis rates 20 2.2 Unmet needs 21 Delayed progression to AD 21 Approval of disease modifying drugs 22 Drugs that improve memory 22 More accurate diagnosis 22 Non-drug treatments 23 2.3 Pharmacotherapy 23 Current treatment 23 Pharmacological Treatment 23 Over the counter drugs 23 2.4 Key late stage clinical trial analysis 25 Acetylcholinesterase inhibitors 26 Aricept 27 Trial analysis 27 Satisfaction of unmet needs 28 Other indications 29 Strength of Aricept within the MCI market 30 Exelon 31 Trial analysis 31 Satisfaction of unmet needs 31 Other indications 32 Strength of Exelon within the MCI market 32 Reminyl 33 Trial analysis 33 Satisfaction of unmet needs 34 Other indications 34 Strength of Reminyl within the MCI market 35 2.5 Drugs in Phase I & II trials for MCI 35 Ampalex 35 2.6 Summary of trials 37 2.7 Commercial perspectives 37 The need for improved early and accurate diagnosis 37 Reformulations 39 Potential for disease modifying therapy 39 Standardized clinical trial design 40 CHAPTER 3 Vascular Dementia 42 3.1 Introduction 43 Disease overview 43 Symptomology 43 Predictive factors 44 Diagnosis 44 3.2 Epidemiology 45 Prevalence 45 Diagnosis rates 46 3.3 Unmet needs 47 Improved prevention of cardiovascular disease 48 Improved diagnosis of people at risk 48 Increased awareness 48 Approval of symptomatic drugs 48 3.4 Pharmacotherapy 49 Current treatment 49 Preventative treatment 49 Supportive treatments 49 3.5 Key clinical trial analysis 50 Late stage R&D pipeline overview 50 Aricept 52 Trial analysis 52 Satisfaction of unmet needs 53 Strength of Aricept within the VaD market 54 Failure to gain FDA approval for VaD 54 Reminyl 54 Trial analysis 54 Satisfaction of unmet needs 55 Strength of Reminyl within the VaD market 56 Exelon 57 Trial analysis 57 Memantine 58 Trial analysis 59 Satisfaction of unmet needs 60 Other indications 61 Strength of memantine within the VaD market 61 Drugs in Phase I & II trials for VaD 61 3.6 Summary of trials 61 3.7 Commercial perspectives 62 Future of VaD therapy 62 Implications of Aricept trial failure 62 Stroke prevention 63 CHAPTER 4 Severe Alzheimer’s Disease 64 4.1 Introduction 65 Disease overview 65 Symptomology 65 Diagnosis 65 4.2 Epidemiology 66 Prevalence 66 Diagnosis rates 67 Unmet needs 67 Improved drugs/increased quality of life 68 Reduced caregiver burden 68 4.3 Pharmacotherapy 68 Current treatment 68 Memantine 68 Trial analysis 68 4.4 Key clinical trial analysis 70 Late stage R&D pipeline overview 70 Memantine 72 Trial analysis 72 Satisfaction of unmet needs 73 Strength of memantine within the severe AD market 74 Neramexane 75 4.5 Summary of trials 75 4.6 Commercial perspectives 75 Approval of memantine 75 Off-label use of AChEIs 76 Drug approval and reimbursement 76 CHAPTER 5 Appendix A 78 5.1 Contributing experts 78 5.2 List of tables 78 5.3 List of figures 79 5.4 Bibliography 80 References 80 Websites 83 Interviewed opinion leaders 83 5.5 R&D research methodology 84 Introduction 84 Hypothesis formulation 84 Hypothesis testing 85 Ongoing information update 85 Product specific primary research 85 Data verification and quality control 86 5.6 Introduction to Datamonitor Healthcare forecasting 86 5.7 Current drug forecast methodology 87 Methodology 87 Market events 89 Validation 90 5.8 Pipeline drug forecast methodology 91 Predicting initial market share 92 Clinical competitiveness attributes 92 Order of entry 92 Pre-launch awareness 92 Market composition 92 Marketing plan 93 Marketing strength 93 Forecasting future growth 93 Influencing factors 93 CHAPTER 6 Appendix B: About Datamonitor 94 6.1 About Datamonitor 94 About Datamonitor Healthcare 94 Datamonitor Healthcare’s research and analysis methodologies 95 6.2 Datamonitor Healthcare’s therapy area capabilities 95 About Disease analysis team 96 Datamonitor Healthcare’s Consulting expertise 97 Datamonitor’s Therapeutic Consulting expertise 98 Key therapy team members 98 Simon Hemsworth, Director of Therapy Area Analysis 98 Dr. Susanne Begley, Head of CNS Business Unit 99 David Abramson, Therapeutic Lead Consultant 100 John Freeman, US Lead Consultant 100 Nick Alcock, Managing Analyst, Central Nervous System 101 Disclaimer 102 AbstractIntroductionWhile the mild to moderate Alzheimer’s disease (AD) market grew strongly over 2002 to exceed $1.5 billion, drug manufacturers are now recognizing opportunities in other areas of the dementia population. Of particular interest is the treatment of mild cognitive impairment (MCI), treatment of severe AD, and treatment of vascular dementia. Scope * Epidemiology: including prevalence split by the seven major markets, diagnosis rates, and treatment rates * Analysis of unmet needs as identified by opinion leaders * Discussion of current drug treatments * Analysis of drugs in late stage development for these areas, including Aricept, Exelon, Reminyl and memantine Report Highlights There are no approved drugs for MCI, VaD with only memantine approved for severe AD in the EU. Companies currently manufacturing of AD products, Aricept, Exelon and Reminyl are expected to file NDA’s for treatment of MCI during 2004. Despite Aricept’s failure to gain FDA approval for VaD in July 2003, Datamonitor predicts it will be approved during 2005 and will experience the benefits of first to market status. Memantine is currently the only treatment approved for sever AD in the EU, and is expected to be launched in the US during 2004. Datamonitor predicts strong uptake in this niche market with see sales nearing blockbuster figures over the next 8 years. Reasons to Purchase * Identify hot areas of the dementia and MCI market that are not being targeted by competitors * Improve knowledge of important issues, such as neuroprotection, as identified by respected experts in these fields * Increase future revenue potential of an MCI product by understanding what is needed to improve low diagnosis rates Get Full Details About This Report >> |
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