Pipeline Insight: Alzheimer's Disease - The ultimate high-risk, high-reward therapy market

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Pipeline Insight: Alzheimer's Disease - The ultimate high-risk,
high-reward therapy market
Published on August 2009

Report Summary

Introduction

Driven by the launch of disease modifying treatments and an expanding patient population, the Alzheimer's disease market will more
than double over the next 10 years. Late-stage pipeline products such as Pfizer/Medivation's Dimebon (latrepirdine) and Johnson &
Johnson/Wyeth's bapineuzumab hold blockbuster potential. However, the risk of clinical trial failure remains high in this indication.

Scope

*Forecasts to 2018 for Alzheimer's disease, total dementia, and mild cognitive impairment for novel disease-modifying agents in the
seven major markets

*Forecasts to 2018 of current brand reformulations targeting the symptomatic relief market.

*Provides a global Alzheimer's disease market snapshot, and analysis of patient population growth trends in the seven major markets
and BRIC nations.

*Discusses the requirement for biomarker development and targeting patients earlier in the course of their disease.

Highlights

With impressive Phase II data, a strong marketing partner, and broad target population, Datamonitor forecasts multi-billion dollar
sales for Pfizer and Medivation's Dimebon (latrepirdine) over the forecast period 20092018.

Driven by prescribing in non-ApoE4 allele patients, Datamonitor forecasts lucrative sales for Johnson & Johnson/Wyeth's
bapineuzumab. Off-label prescribing for pre-dementia/prodromal Alzheimer's disease type mild cognitive impairment patients will add
significant revenue towards the end of the 10-year outlook.

It is unlikely that a treatment will be developed which completely halts, or reverse, the cognitive decline observed in Alzheimer's
disease over the 10 year time horizon. Therefore, a symptomatic market will remain active in this disease over the forecast period.

Reasons to Purchase

*Quantify the current size of the global Alzheimer's disease market.

*Appreciate the demographic changes leading to anticipated growth in the Alzheimer's disease market.

*Quantify the market to 2018 in the US, Japan, and five key European markets while identifying the major drivers, resistors, and risks.

Pipeline Insight: Alzheimer's Disease - The ultimate high-risk, high-reward therapy market Page 1/13


Table of Content

Overview 1
Catalyst 1
Summary 1
ABOUT DATAMONITOR HEALTHCARE 2
About the Central Nervous System pharmaceutical analysis team 2
Executive Summary 3
Strategic scoping and focus 3
Datamonitor insight into the Alzheimer's disease market 3
Related reports 5
Table of Contents 6
1. Pipeline Overview and Dynamics 7
Key findings 7
Pipeline overview 8
Interest remains strong in this high risk/high reward indication 8
Clinical trial attrition is very high in Alzheimer's disease 8
Movement towards more targeted drugs 8
Trends in the current pipeline 10
Comparative forecasts - Pfizer's Dimebon best positioned for commercial success 11
Datamonitor Pipeline Assessment Summary - disease modification enhances clinical attractiveness 12
Key companies involved in the Alzheimer's disease pipeline 13
Big Pharma companies partner their way into Alzheimer's pipeline 13
Elan Pharmaceuticals 14
Pfizer and Wyeth 15
Key R&D company strategies 16
Diverse drug discovery approaches 16
Beta-amyloid is the primary drug discovery target 16
Secondary indications are possible but not yet under development 17
2. Alzheimer's Disease: Market Potential 18
Key findings 18
Definition 19
Overview 19
World Health Organization classification and scope 21
1) Alzheimer's disease-specific sales 21
2) Other dementia-specific sales 22
3) Mild cognitive impairment 22
Syndrome description and patient segmentation 22
Dementia 22
Alzheimer's disease 23
Mild cognitive impairment 24
Mild cognitive impairment subtypes 25
Mild cognitive impairment subtypes and their links to Alzheimer's disease 26
Alzheimer's disease is the most frequent outcome of mild cognitive impairment 27
Epidemiology 28
Seven major markets 28
Alzheimer's disease prevalence and patient population 28
Alzheimer's disease prevalence estimates methodology 30



Alternative US patient population estimates 31
Patient population projections across the seven major markets 32
Rest of the world 36
Lower current prevalence rates than in more developed markets 36
Projected demographic changes drive growth in Alzheimer's disease population 37
Diagnosis rate of cognitive disorders 40
Dementia (including Alzheimer's disease) 40
Mild cognitive impairment 42
Current treatment options 42
Brand dynamics and key past events 42
Drug profiles 42
Historical sales and off-label prescribing 43
Current gold standard and comparator therapies 47
Gold standard or comparator therapy: Aricept 47
Leading Alzheimer's disease therapy 48
Superior efficacy did not drive the success of Aricept 50
Current market overview 53
Global Alzheimer's disease market 53
Alzheimer's disease-specific sales across the seven major markets 54
Unmet need in Alzheimer's disease 56
Disease modifying/slowing treatments 56
Early treatment with disease slowing drugs should produce a better outcome 58
Improved symptomatic efficacy 59
Better diagnostic tools 60
Current diagnostic techniques are subjective 61
Better diagnostics required for early treatment and a better outcome 61
Better understanding of the disease etiology 62
Current level of attainment vs. target product profile 62
Different efficacy expectations for symptomatic or disease modifying treatments 63
Safety and tolerability 63
Formulation/dosing 63
Target population 64
Price 64
3. R&D Approach 66
Key findings 66
Clinical trial design in Alzheimer's disease 67
What constitutes disease modification' 68
Determination of disease modification 68
Clinical trial endpoints 71
Alzheimer's Disease Assessment Scale-cognitive portion (ADAS-Cog) 71
Alzheimer's Disease Cooperative Study: Activities of Daily Living (ADCS-ADL) 71
Mini-Mental Status Exam 72
Clinician's Interview-Based Impression of Change 72
Neuropsychiatric Inventory 72
Utilization in Dementia 72
Neuropsychological Test Battery 73
Severe Impairment Battery 73
Clinical Dementia Rating 73
4. Pipeline Analysis & Forecasts: Drugs targeting beta-amyloid 74
Key findings 74



Overview for drugs targeting beta-amyloid 75
Pipeline summary 75
Beta-amyloid theory 77
Better understand of the role of beta-amyloid is still required 78
Passive immunotherapy and vaccines 80
Secretase modulation 82
Aggregation inhibition 83
Comparative forecasts 83
Bapineuzumab - passive immunotherapy 84
Drug overview 84
Drug profile 85
SWOT analysis 85
Clinical trial data 86
Clinical outcome 87
MRI measure of cerebral volume change 88
Ongoing clinical trials 89
Clinical attractiveness 89
Patient potential 89
Regular monitoring 90
Commercial attractiveness 90
Price of bapineuzumab and influencing factors 90
Bapineuzumab market penetration 91
Marketing resources and expertise unprecedented 91
Competition in passive immunization 92
Datamonitor drug assessment score card for bapineuzumab 92
Satisfaction of unmet needs 94
Forecasts to 2018 94
Gammagard - passive immunotherapy 100
Drug overview 100
Drug profile 101
SWOT analysis 101
Baxter Phase II clinical trial 102
Other studies investigating the use of immunoglobulin in Alzheimer's disease 103
Ongoing Phase III clinical trial 104
Competing immunoglobulin is in development 104
Large scale production may represent a challenge 104
Datamonitor drug assessment score card for Gammagard 105
Other drugs targeting beta-amyloid 110
LY450139 - gamma secretase 110
Drug overview 110
Datamonitor's comment 113
PBT2 - aggregation inhibition 114
Drug overview 114



LY2062430 - passive immunotherapy 116
Drug overview 116
PF-04494700 - other beta-amyloid 117
Drug overview 117
Phase IIa clinical results 118
Ongoing clinical trial program 119
Posiphen - other beta-amyloid 119
Drug overview 119
Previous clinical trial failure with the negative enantiomer of phenserine 120
Amyloid vaccines ACC-01 and CAD106 120
ACC-001 121
CAD106 121
Good antibody response but no clinical efficacy signal 122
Octagam - passive immunization 122
Drug overview 122
ELND005 - beta-amyloid aggregation inhibitor 123
Drug overview 123
ACI91 - beta-secretase inhibition 123
Drug overview 123
EHT0202 - alpha-secretase activator 124
Drug overview 124
NIC515 - gamma-secretase inhibitor 124
Drug overview 124
ARC029 - other beta-amyloid 124
Drug overview 124
PF4360365 - passive immunization 125
Drug overview 125
Late-stage development compounds recently discontinued 125
Flurizan 125
Alzhemed 125
5. Pipeline Analysis & Forecasts: Drugs targeting tau hyperphosphorilation 126
Key findings 126
Overview for drugs targeting tau tangles 127
Pipeline summary 127
Rember - tau hyperphosphorylation inhibitor 127
Drug overview 127
Datamonitor's comments 130
Patient potential 131
Potential pricing 131
Other drugs targeting tau tangles 131
AL108 - tau hyperphosphorylation inhibitor 131
NP-12 - Glycogen synthase kinase-3 beta inhibitor 133
Drug overview 133
GSK-3 beta hypothesis of Alzheimer's disease 134
Basic research identifies the GSK-3 beta target 134
Preclinical in vivo analysis conducted with NP-12 134



Phase I safety trial 135
Ongoing Phase II clinical trial 135
6. Pipeline Analysis & Forecasts: General neuroprotective drugs 137
Key findings 137
Overview for general neuroprotective drugs 138
Dimebon - MPTP, NMDA, cholinesterase inhibitor 138
Drug overview 139
Drug profile 139
SWOT analysis 140
Estimation of disease modifying effects with Staggered Start and Natural History Staggered Start approach 142
Preclinical animal studies suggest beta-amyloid modulation 143
Clinical significance of Dimebon's various mechanisms of action yet to be established 146
Inconvenient dosing regime 147
Broad cognitive disorder patient potential 147
Potential for combination therapy with Aricept 148
Pfizer partnership greatly expands the drug's commercial potential 148
Lifecycle management planning 148
Cost of Dimebon 149
Datamonitor drug assessment score card for Dimebon 149
Other drugs with general neuroprotective characteristics 157
Memryte - Gonadotrophin releasing hormone 157
Drug overview 157
HF0220 - endogenous human steroid 158
Drug overview 158
Cogane - neurotrophic factor inducer 159
Drug overview 159
T817MA - neurotrophic agent 160
Drug overview 160
7. Pipeline Analysis & Forecasts: Symptomatic Relief 161
Key findings 161
Overview for drugs targeting symptomatic relief 162
Acetylcholinesterase inhibitors 163
NMDA receptor antagonism 164
Neuronal nicotinic receptor agonism 165
5-HT6 receptor antagonist 165
Other targets 165
Comparative forecasts 165
Aricept SR - acetylcholinesterase inhibitor 166
Drug overview 166
Drug profile 167



SWOT analysis 167
Switching between brands 169
Price for Aricept SR 170
Datamonitor drug assessment score card for Aricept SR 170
Aricept patch - acetylcholinesterase inhibitor 175
Drug overview 176
Drug profile 176
SWOT analysis 176
Price for Aricept patch 179
Datamonitor drug assessment score card Aricept patch 179
Memantine extended-release -NMDA receptor antagonist 185
Drug overview 186
Drug profile 186
SWOT analysis 186
Datamonitor drug assessment score card for memantine extended-release 189
Other drugs targeting symptomatic relief 193
Huperzine A - acetylcholinesterase inhibitor 193
Drug overview 193
Chinese clinical trial investigating the efficacy of Huperzine A 195
Small-scale trial investigating the efficacy and safety of Huperzine A 196
Mimopezil/Debio9902 SR - acetylcholinesterase inhibitor 196
Drug overview 196
Ispronicline/AZD3480 - neuronal nicotinic receptor agonist 197
Drug overview 197
Pozanicline/ABT-089 - neuronal nicotinic receptor agonist 198
Drug overview 198
R3487 - neuronal nicotinic receptor agonist 198
Drug overview 198
EVP6124 - neuronal nicotinic receptor agonist 199
Drug overview 199



SAM-531 - 5-HT6 receptor antagonist 199
Drug overview 199
SB-742457 - 5-HT6 receptor antagonist 200
Drug overview 200
PRX03140 - 5-HT4 receptor agonist 200
Drug overview 200
CX717 - AMPA receptor agonist 201
Drug overview 201
MK-0249 202
Drug overview 202
8. Innovative Early-Stage Approaches 203
Key findings 203
Delivery across the blood-brain barrier 204
Carniotomy-based drug delivery 204
EC Biodelivery, NSgene 204
Molecular Trojan horse 205
ArmaGen's neurotrophin and AGT-160 205
Tau immunotherapy 205
The future of treatment in Alzheimer's disease 206
Prophylactic treatment 208
Biomarkers significantly expand the patient population 209
Structural imaging - MRI 210
Functional imaging - PET and SPECT 210
Radiotracer fluorodeoxyglucose 210
Beta-amyloid radioligands using PET scans 211
Tau neurofibrillary tangles 212
Urine and serum biomarkers 212
Bibliography 214
Journals 214
Web-site 218
APPENDIX 224
Methodology 224
Datamonitor forecast methodology 224
Contributing experts 224
About Datamonitor 225
About Datamonitor Healthcare 225
About the Disease analysis team 225
Datamonitor consulting 226
Disclaimer 226
List of Tables
Table 1: Products in Phase II/III clinical development for Alzheimer's disease, 2009 9
Table 2: Sales forecasts ($m) for each pipeline drug, 2010-18 12
Table 3: Elan's Alzheimer's disease late-stage pipeline, 2009 15
Table 4: Pfizer/Wyeth Alzheimer's disease late-stage pipeline, 2009 16



Table 5: DIAG4 (ICD-10 derived) codes constituting >1% of total brand sales for drugs approved for Alzheimer's disease, 2008 20
Table 6: Dementia ICD-10 codes 22
Table 7: Forms of dementia 23
Table 8: Common clinical features in Alzheimer's disease 24
Table 9: Population size and prevalence rate of Alzheimer's disease and other cognitive disorders across the seven major
pharmaceutical markets, 2009 29
Table 10: Age-group trends in Alzheimer's disease prevalence 31
Table 11: Current and projected patient populations (millions) for cognitive disorders, 2008-18 35
Table 12: Alzheimer's disease prevalence and patient population comparison across the seven major pharmaceutical markets and
BRIC countries, 2009 37
Table 13: Projected Alzheimer's disease population across the seven major pharmaceutical markets, the 5EU and the BRIC nations,
2008-18 39
Table 14: Leading treatments for Alzheimer's disease, 2009 43
Table 15: Total brand and indication-specific sales for drugs approved for Alzheimer's disease, ($m), 2008 45
Table 16: Percentage of total brand sales attributed to each indication group, 2004-08 47
Table 17: Aricept (donepezil) - drug profile, 2009 48
Table 18: Efficacy of acetylcholinesterase inhibitors as measured by change in ADAS-Cog above placebo 52
Table 19: Head-to-head clinical trials of Aricept and other acetylcholinesterase inhibitors 53
Table 20: Comparison of acetylcholinesterase inhibitor treatment response outcomes, according to a meta-analysis of clinical trials 60
Table 21: Minimum acceptable product profile and target product profile 64
Table 22: Typical Phase III clinical trial design in Alzheimer's disease, 2009 67
Table 23: Key products in late-stage R&D pipeline targeting beta-amyloid, 2009 76
Table 24: Sales forecasts ($m) for beta-amyloid focused pipeline drugs across the seven major pharmaceutical markets, 2012-18 84
Table 25: Bapineuzumab - drug profile, 2009 85
Table 26: Bapineuzumab vs. the minimum acceptable product profile and target product profile 94
Table 27: Impacting factors on the revenues of bapineuzumab, 2009-18 95
Table 28: Bapineuzumab forecast methodology, US, 2012-18 96
Table 29: Bapineuzumab forecast methodology, 5EU, 2012-18 97
Table 30: Bapineuzumab forecast methodology, Japan, 2012-18 98
Table 31: Bapineuzumab forecast across the seven major markets ($m), 2012-18 99
Table 32: Gammagard - drug profile, 2009 101
Table 33: Gammagard vs. minimum acceptable product profile and target product profile 106
Table 34: Gammagard forecast methodology, US, 2012-18 107
Table 35: Gammagard forecast methodology, 5EU, 2012-18 108
Table 36: Gammagard forecast methodology, Japan, 2012-18 109
Table 37: Gammagard forecast across the seven major markets ($m), 2012-18 110
Table 38: Ongoing LY450139 clinical trials 113
Table 39: Key products in late-stage R&D pipeline targeting tau tangles, 2009 127
Table 40: Clinical trial results for high dose of AL-108 (15mg twice a day) in mild cognitive impairment subjects 133
Table 41: Key products in late-stage R&D pipeline with a general neuroprotective mechanism, 2009 138
Table 42: Dimebon - drug profile, 2009 139
Table 43: Mean change from baseline on the ADAS-Cog at weeks 12 and 26 in the intention-to-treat population 141
Table 44: Estimates from Dimebon Staggered Start and NHSS 143
Table 45: Ongoing Dimebon clinical trials, 2009 145
Table 46: Dimebon vs. the minimum acceptable product profile and target product profile 150
Table 47: Dimebon forecast methodology, US, 2012-18 151
Table 48: Dimebon forecast methodology, 5EU, 2012-18 153
Table 49: Dimebon forecast methodology, Japan, 2012-18 155
Table 50: Dimebon forecast across the seven major markets ($m), 2012-18 157
Table 51: Key products in late-stage R&D pipeline providing symptomatic relief, 2009 163



Table 52: Sales forecasts for pipeline symptomatic treatments across the seven major pharmaceutical markets, ($m), 2010-18 166
Table 53: Aricept SR (donepezil sustained release) - drug profile, 2009 167
Table 54: Aricept SR vs. the minimum acceptable product profile and target product profile 171
Table 55: Aricept SR forecast methodology, US, 2010-18 172
Table 56: Aricept SR forecast methodology, 5EU, 2011-18 173
Table 57: Aricept SR forecast methodology, Japan, 2012-18 174
Table 58: Aricept SR forecast across the seven major markets, 2010-18 175
Table 59: Aricept patch - drug profile, 2009 176
Table 60: Aricept patch vs. the minimum acceptable product profile and target product profile 181
Table 61: Aricept patch forecast methodology, US, 2010-18 182
Table 62: Aricept patch forecast methodology, 5EU, 2010-18 183
Table 63: Aricept patch forecast methodology, Japan, 2012-18 184
Table 64: Aricept patch forecast across the seven major markets, 2010-18 185
Table 65: Memantine extended release - drug profile, 2009 186
Table 66: Memantine extended-release vs. the minimum acceptable product profile and target product profile 190
Table 67: Memantine extended-release forecast methodology, US, 2010-18 191
Table 68: Memantine extended-release forecast methodology, 5EU, 2010-18 192
Table 69: Memantine extended-release forecast across the seven major markets, 2010-18 193
Table 70: Tracers for beta-amyloid plaques and other hallmarks of Alzheimer's disease 212
Table 71: Example of alternative tests to cerebrospinal fluid biomarkers in neurological conditions 213
List of Figures
Figure 1: Late-stage pipeline Alzheimer's disease drugs by class, 2009 11
Figure 2: Datamonitor Pipeline Assessment Summary for Alzheimer's disease, 2009 13
Figure 3: Companies with more than one late-stage product in development of Alzheimer's disease, 2009 14
Figure 4: Potential relation between symptom classification and outcomes in mild cognitive impairment patients 27
Figure 5: Prevalence of mild cognitive impairment (MCI) symptom and outcome subtypes 28
Figure 6: Patient population estimates derived from different US Alzheimer's disease estimates, 2009 32
Figure 7: Projected patient population for all cognitive disorders across the seven major markets, 2005-18 33
Figure 8: Demographic changes in the general US population, 2005-18 34
Figure 9: Alzheimer's disease patient population across the seven major pharmaceutical markets and BRIC nations, 2005-18 38
Figure 10: Percentage change in elderly population (65 years and older), 2009-18 40
Figure 11: Percentage of total brand sales Aricept, Namenda, Exelon and Razadyne (inc ER version sales) for Alzheimer's disease,
other dementia, and mild cognitive impairment across the seven major markets, 2008 46
Figure 12: Alzheimer's disease-specific sales revenue generated by Aricept across the seven major pharmaceutical markets, ($m),
2009 49
Figure 13: Percentage of total Aricept brand sales for each indication group, 2004-08 50
Figure 14: Regional distribution of global Alzheimer's disease-specific sales for the four drugs approved for Alzheimer's disease, 2008
54
Figure 15: Alzheimer's disease-specific sales revenue across the seven major markets, ($m), 2004-08 55
Figure 16: Percentage of total brand sales for each indication group, 2004-08 55
Figure 17: Unmet need in Alzheimer's disease treatment, 2009 56
Figure 18: Cognitive decline of untreated Alzheimer's disease patients and patients treated with a symptomatic drug 57
Figure 19: Alzheimer's disease symptom progression in the presence of a disease slowing therapy 58
Figure 20: Alzheimer's disease symptom progression in the presence of a disease modifying treatment administered at an early stage
of the disease due to better diagnostic tools 59
Figure 21: Alzheimer's disease symptom progression in the presence of a disease modifying treatment administered at an early stage
of the disease due to better diagnostic tools 62
Figure 22: Clinical trial designs proposed to determine disease modification 70
Figure 23: Amyloidogenic pathway: formation of toxic beta-amyloid 78
Figure 24: Proposed passive immunization mechanism of action in Alzheimer's disease 82



Figure 25: SWOT analysis for bapineuzumab, 2009 86
Figure 26: Bapineuzumab Phase II clinical trial design and results 87
Figure 27: Datamonitor's competitive positioning analysis of bapineuzumab in Alzheimer's disease, 2009 93
Figure 28: Sales forecasts for bapineuzumab in the seven major markets ($m), 2010-18 99
Figure 29: SWOT analysis for Gammagard, 2009 102
Figure 30: Datamonitor's competitive positioning analysis of Gammagard in Alzheimer's disease, 2009 105
Figure 31: Sales forecasts for Gammagard (immunoglobulin) in the seven major markets ($m, 2012-18 110
Figure 32: LY450139 Phase II clinical trial design and results 111
Figure 33: SWOT analysis forDimebon, 2009 140
Figure 34: Datamonitor's competitive positioning analysis of Dimebon in Alzheimer's disease, 2009 149
Figure 35: Sales forecasts for Dimebon in the seven major markets ($m), 2012-18 156
Figure 36: SWOT analysis for Aricept SR, 2009 168
Figure 37: Datamonitor's competitive positioning analysis of Aricept SR in Alzheimer's disease, 2009 170
Figure 38: Sales forecasts for Aricept SR in the seven major markets, ($m), 2010-18 175
Figure 39: SWOT analysis for Aricept patch, 2009 177
Figure 40: Percentage of total sales for Exelon oral and Exelon patch in the US, 2008 179
Figure 41: Datamonitor's competitive positioning analysis of Aricept patch in Alzheimer's disease, 2009 180
Figure 42: Sales forecasts for Aricept patch in the seven major markets. 2010-18 ($m) 185
Figure 43: SWOT analysis for memantine extended-release, 2009 187
Figure 44: Efficacy of memantine extended-release in moderate-to-severe Alzheimer's disease 188
Figure 45: Datamonitor's competitive positioning analysis of memantine extended-release in Alzheimer's disease, 2009 189
Figure 46: Sales forecasts for memantine extended-release in the seven major markets. 2010-18 ($m) 193



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Pipeline Insight: Alzheimer's Disease - The ultimate high-risk, high-reward therapy market