軽度認識障害と痴呆の市場：アリセプトは未開拓市場の先駆けとなるか？

INTRODUCTION

While 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 OF THE REPORT

• 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.

KEY REASONS TO BUY THIS REPORT

• 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

TABLE 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