Disease Analysis: Alzheimer’s disease
Author: Pammy Spicer
Publisher: Datamonitor Healthcare
- Description
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Latest key takeaways
- Datamonitor Healthcare estimates that in 2018, there were 74.5 million prevalent cases of Alzheimer’s disease in adults aged 65 years and older worldwide, and forecasts that number to increase to 102.5 million prevalent cases by 2027.
- The US Alzheimer’s disease market only includes four marketed products that are well established. The anticipation of growth has faded with the failure of immunotherapies to produce efficacious results on cognitive outcomes. The acetylcholinesterase class of drugs will continue to dominate the treatment of mild Alzheimer’s disease, while NMDA receptor antagonist memantine is used primarily as an add-on or second-line therapy in more severe disease stages.
- In the first half of 2020, an FDA approval decision is expected for Adlarity, a once-weekly transdermal formulation of gold-standard Alzheimer’s disease treatment donepezil. In late 2019, China granted a conditional approval for GV-971, an oligosaccharide derived from brown algae, representing the first novel drug approved for Alzheimer’s disease in nearly two decades.
- Biogen’s unexpected decision to pursue FDA approval for its previously discontinued amyloid-targeting biologic aducanumab in Alzheimer’s disease was met with skepticism given the surprising nature of the turnaround. It is by no means clear the drug will skate through the FDA approval process. Even if the drug is approved, it is uncertain how patients, physicians, and payers might weigh the potential cost of the drug against what could be viewed as incremental efficacy.
- Trial data from the Phase III clinical trials for remaining beta amyloid-targeting antibodies BAN2401 and gantenerumab are expected in 2022. Other Phase III products targeting additional pathways have not produced sufficient clinical evidence to suggest a high likelihood of approval.
- Generic erosion in Japan will contract the overall Alzheimer’s disease market. This may be slightly offset by the increased prevalence owing to an aging population and advances in screening for the earliest phases of Alzheimer’s disease that may lead to improved diagnosis rates.
- The likelihood of approval of a Phase III Alzheimer’s disease asset is 15%, compared to 51% in the overall neurology space.
CONTENTS
8 OVERVIEW
8 Latest key takeaways
9 DISEASE BACKGROUND
9 Definition
9 Symptoms
9 Risk factors
9 Patient segmentation
12 TREATMENT
12 Cholinesterase inhibitors are recommended for mild-to-moderate Alzheimer’s disease
12 Memantine is reserved for moderate-to-severe disease
12 Despite lacking efficacy, cholinesterase inhibitors are still used off-label for MCI
13 EPIDEMIOLOGY
17 MARKETED DRUGS
20 PIPELINE DRUGS
35 KEY REGULATORY EVENTS
35 Biogen Aducanumab BLA Plan Is In Line With US FDA Neurology Division Precedent
35 China Alzheimer’s Approval Raises Hope But Also Questions
35 AARP-Funded Researchers Say Forget About Supplements To Improve Memory
36 PROBABILITY OF SUCCESS
37 LICENSING AND ASSET ACQUISITION DEALS
37 Shionogi Set To Acquire R&D Partner Tetra After Raising Stake
37 Biogen Doubles Down On Alzheimer’s and Neuroscience With Sangamo Gene Regulation Deal
37 Pfizer Licenses Asset With Potential In Alzheimer’s, Parkinson’s To Biogen
37 Biogen Licenses Potential Neurodegenerative Therapy From Ionis
38 Alkermes Invests In Novel CNS Targets With Rodin Acquisition
39 CLINICAL TRIAL LANDSCAPE
40 Sponsors by status
41 Sponsors by phase
42 Recent events
45 DRUG ASSESSMENT MODEL
47 MARKET DYNAMICS
48 FUTURE TRENDS
48 Generic therapies will continue to dominate the Alzheimer’s disease market
48 Mixed results from aducanumab cloud the outlook
50 CONSENSUS FORECASTS
52 RECENT EVENTS AND ANALYST OPINION
52 Vafidemstat for Alzheimer’s Disease (April 3, 2020)
53 Vafidemstat for Alzheimer’s Disease (April 3, 2020)
54 Multiple Drugs for Alzheimer’s Disease (February 10, 2020)
56 Aducanumab for Alzheimer’s Disease (December 5, 2019)
57 SUVN-502 for Alzheimer’s Disease (November 30, 2019)
58 Neflamapimod for Alzheimer’s Disease (November 7, 2019)
60 GV-971 for Alzheimer’s Disease (November 2, 2019)
61 Aducanumab for Alzheimer’s Disease (October 22, 2019)
63 Xanamem for Alzheimer’s Disease (October 1, 2019)
65 AVP-786 for Alzheimer’s Disease (September 27, 2019)
67 Elenbecestat for Alzheimer’s Disease (September 13, 2019)
68 AADvac1 for Alzheimer’s Disease (September 9, 2019)
69 Bryostatin for Alzheimer’s Disease (September 9, 2019)
71 PTI-125 for Alzheimer’s Disease (September 9, 2019)
73 GRF6019 for Alzheimer’s Disease (August 5, 2019)
75 CNP520 for Alzheimer’s Disease (July 11, 2019)
76 Azeliragon for Alzheimer’s Disease (June 28, 2019)
77 Masitinib for Alzheimer’s Disease (June 26, 2019)
78 Multiple Drugs for Alzheimer’s Disease (June 25, 2019)
79 Xanamem for Alzheimer’s Disease (May 7, 2019)
81 KEY UPCOMING EVENTS
82 KEY OPINION LEADER INSIGHTS
82 Meaningful changes on clinical endpoints are essential
82 Generics are entrenched in current treatment strategies
82 Alzheimer’s heterogeneity requires a diverse treatment approach
83 Individual treatment paradigms
84 UNMET NEEDS
84 Currently approved therapies display modest efficacy at best
84 Current treatments are only palliative and do not prolong survival
84 Beyond cognition and function, Alzheimer’s disease also involves behavioral deficits
85 BIBLIOGRAPHY
85 Prescription information
86 APPENDIX
LIST OF FIGURES
16 Figure 1: Trends in prevalent cases of Alzheimer’s disease, 2018–27
20 Figure 2: Overview of pipeline drugs for Alzheimer’s disease in the US
20 Figure 3: Pipeline drugs for Alzheimer’s disease, by company
21 Figure 4: Pipeline drugs for Alzheimer’s disease, by drug type
21 Figure 5: Pipeline drugs for Alzheimer’s disease, by classification
36 Figure 6: Probability of success in the Alzheimer’s disease pipeline
39 Figure 7: Clinical trials in Alzheimer’s disease
39 Figure 8: Top 10 drugs for clinical trials in Alzheimer’s disease
40 Figure 9: Top 10 companies for clinical trials in Alzheimer’s disease
40 Figure 10: Trial locations in Alzheimer’s disease
41 Figure 11: Alzheimer’s disease trials status
42 Figure 12: Alzheimer’s disease trials sponsors, by phase
45 Figure 13: Datamonitor Healthcare’s drug assessment summary for Alzheimer’s disease
47 Figure 14: Market dynamics in Alzheimer’s disease
48 Figure 15: Future trends in Alzheimer’s disease
53 Figure 16: Vafidemstat for Alzheimer’s Disease (April 3, 2020): Phase IIa – REIMAGINE-AD (Spain)
57 Figure 17: Aducanumab for Alzheimer’s Disease (December 5, 2019): Phase III – EMERGE (Early AD), Phase III – ENGAGE (Early AD)
60 Figure 18: Neflamapimod for Alzheimer’s Disease (November 7, 2019): Phase IIb – REVERSE-SD
63 Figure 19: Aducanumab for Alzheimer’s Disease (October 22, 2019): Phase III – EMERGE (Early AD), Phase III – ENGAGE (Early AD)
65 Figure 20: Xanamem for Alzheimer’s Disease (October 1, 2019): Phase I – XanaHES (Elderly)
69 Figure 21: AADvac1 for Alzheimer’s Disease (September 9, 2019): Phase II – ADAMANT
71 Figure 22: Bryostatin for Alzheimer’s disease (September 9, 2019): Phase II – Confirmatory Study
73 Figure 23: PTI-125 for Alzheimer’s Disease (September 9, 2019): Phase IIa – Mild to Moderate AD
81 Figure 24: Key upcoming events in Alzheimer’s disease
LIST OF TABLES
10 Table 1: Alzheimer’s disease severity, by rating scale
11 Table 2: FDA stages by disease attributes
14 Table 3: Prevalent cases of Alzheimer’s disease, 2018–27
18 Table 4: Marketed drugs for Alzheimer’s disease
22 Table 5: Pipeline drugs for Alzheimer’s disease in the US
50 Table 6: Historical global sales, by drug ($m), 2014–18
51 Table 7: Forecasted global sales, by drug ($m), 2020–24
52 Table 8: Vafidemstat for Alzheimer’s Disease (April 3, 2020)
54 Table 9: Vafidemstat for Alzheimer’s Disease (April 3, 2020)
55 Table 10: Multiple Drugs for Alzheimer’s Disease (February 10, 2020)
56 Table 11: Aducanumab for Alzheimer’s Disease (December 5, 2019)
58 Table 12: SUVN-502 for Alzheimer’s Disease (November 30, 2019)
59 Table 13: Neflamapimod for Alzheimer’s Disease (November 7, 2019)
60 Table 14: GV-971 for Alzheimer’s Disease (November 2, 2019)
61 Table 15: Aducanumab for Alzheimer’s Disease (October 22, 2019)
63 Table 16: Xanamem for Alzheimer’s Disease (October 1, 2019)
66 Table 17: AVP-786 for Alzheimer’s Disease (September 27, 2019)
67 Table 18: Elenbecestat for Alzheimer’s Disease (September 13, 2019)
68 Table 19: AADvac1 for Alzheimer’s Disease (September 9, 2019)
70 Table 20: Bryostatin for Alzheimer’s Disease (September 9, 2019)
71 Table 21: PTI-125 for Alzheimer’s Disease (September 9, 2019)
74 Table 22: GRF6019 for Alzheimer’s Disease (August 5, 2019)
75 Table 23: CNP520 for Alzheimer’s Disease (July 11, 2019)
76 Table 24: Azeliragon for Alzheimer’s Disease (June 28, 2019)
77 Table 25: Masitinib for Alzheimer’s Disease (June 26, 2019)
78 Table 26: Multiple Drugs for Alzheimer’s Disease (June 25, 2019)
79 Table 27: Xanamem for Alzheimer’s Disease (May 7, 2019)
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