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Disease Analysis: Alzheimer's disease

  • ID: 4895485
  • Report
  • September 2020
  • Region: Global
  • 91 pages
  • Datamonitor Healthcare
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FEATURED COMPANIES

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Disease Overview

Alzheimer’s disease is an irreversible, progressive, neurodegenerative disease that slowly affects memory, cognition, and function. It is a continuum of pathological changes in the brain that begin well before clinical symptoms emerge. The hallmark abnormalities of Alzheimer’s disease are beta-amyloid deposits and tau tangles in the brain, while it is also characterized by the loss of neuronal connections. These pathological changes are thought to occur years in advance of the onset of dementia in patients with Alzheimer’s disease. Studies indicate that people aged 65 years and over survive an average of four to eight years after a diagnosis of Alzheimer’s disease, yet some live as long as 20 years or more, indicating the slow, insidious progression of the disease.

Latest Key Takeaways
  • The publisher 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 franchised 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 2020, a US 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. The company has received FDA approval to start a Phase III trial to be conducted in North America, Europe, and Asia.
  • 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 has led to the contraction of the overall Alzheimer’s disease market. This may be slightly offset by 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, with potential growth also possible from the anticipated anti-amyloid antibodies.
  • The likelihood of approval of a Phase III Alzheimer’s disease asset is 17%, compared to 50% in the overall neurology space.
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Overview
  • Latest key takeaways
Disease Background
  • Definition
  • Symptoms
  • Risk factors
  • Patient segmentation
Treatment
  • Cholinesterase inhibitors are recommended for mild-to-moderate Alzheimer’s disease
  • Memantine is reserved for moderate-to-severe disease
  • Despite lacking efficacy, cholinesterase inhibitors are still used off-label for MCI
Epidemiology

Marketed Drugs

Pipeline Drugs

Key Regulatory Events
  • Adu-CAN-umab? Reading The Tea Leaves For Biogen’s US Filing For Alzheimer’s Drug
  • Biogen/Eisai Hit ‘Send’ On High Stakes BLA For Aducanumab In Alzheimer’s Disease
  • China’s First Alzheimer’s Drug Enters US Trials To Much Fanfare
  • Biogen Aducanumab BLA Plan Is In Line With US FDA Neurology Division Precedent
  • China Alzheimer's Approval Raises Hope But Also Questions
Probability of Success

Licensing and Asset Acquisition Deals
  • Roche Partners With UCB On Anti-Tau Alzheimer’s Drug
  • Shionogi Set To Acquire R&D Partner Tetra After Raising Stake
  • Biogen Doubles Down On Alzheimer’s and Neuroscience With Sangamo Gene Regulation Deal
  • Pfizer Licenses Asset With Potential In Alzheimer’s, Parkinson’s To Biogen
  • Biogen Licenses Potential Neurodegenerative Therapy From Ionis
  • Alkermes Invests In Novel CNS Targets With Rodin Acquisition
Clinical Trial Landscape
  • Sponsors by status
  • Sponsors by phase
  • Recent events
Drug Assessment Model
  • Genericized symptomatic treatments
  • Disease-modifying candidates
  • Other pipeline drugs
Market Dynamics

Future Trends
  • Generic therapies will continue to dominate the Alzheimer’s disease market
  • Mixed results from aducanumab cloud the outlook
Consensus Forecasts

Recent Events and Analyst Opinion
  • Aducanumab for Alzheimer’s Disease (August 7, 2020)
  • BPN14770 for Alzheimer’s Disease (May 26, 2020)
  • AXS-05 for Alzheimer’s Disease (April 27, 2020)
  • Vafidemstat for Alzheimer’s Disease (April 3, 2020)
  • Vafidemstat for Alzheimer’s Disease (April 3, 2020)
  • Multiple Drugs for Alzheimer’s Disease (February 10, 2020)
  • Aducanumab for Alzheimer’s Disease (December 5, 2019)
  • SUVN-502 for Alzheimer’s Disease (November 30, 2019)
  • Neflamapimod for Alzheimer’s Disease (November 7, 2019)
  • GV-971 for Alzheimer’s Disease (November 2, 2019)
  • Aducanumab for Alzheimer’s Disease (October 22, 2019)
  • Xanamem for Alzheimer’s Disease (October 1, 2019)
  • AVP-786 for Alzheimer’s Disease (September 27, 2019)
  • Elenbecestat for Alzheimer’s Disease (September 13, 2019)
  • AADvac1 for Alzheimer’s Disease (September 9, 2019)
  • Bryostatin for Alzheimer’s Disease (September 9, 2019)
  • Sumifilam for Alzheimer’s Disease (September 9, 2019)
Key Upcoming Events

Key Opinion Leader Insights
  • Meaningful changes on clinical endpoints are essential
  • Generics are entrenched in current treatment strategies
  • Alzheimer’s heterogeneity requires a diverse treatment approach
  • Individual treatment paradigms
Unmet Needs
  • Currently approved therapies display modest efficacy at best
  • Current treatments are only palliative and do not prolong survival
  • Beyond cognition and function, Alzheimer’s disease also involves behavioral deficits
Bibliography
  • Prescription information
Appendix

List of Figures
  • Figure 1: Trends in prevalent cases of Alzheimer’s disease, 2018–27
  • Figure 2: Overview of pipeline drugs for Alzheimer's disease in the US
  • Figure 3: Pipeline drugs for Alzheimer's disease, by company
  • Figure 4: Pipeline drugs for Alzheimer's disease, by drug type
  • Figure 5: Pipeline drugs for Alzheimer's disease, by classification
  • Figure 6: Probability of success in the Alzheimer's disease pipeline
  • Figure 7: Clinical trials in Alzheimer's disease
  • Figure 8: Top 10 drugs for clinical trials in Alzheimer's disease
  • Figure 9: Top 10 companies for clinical trials in Alzheimer's disease
  • Figure 10: Trial locations in Alzheimer's disease
  • Figure 11: Alzheimer's disease trials status
  • Figure 12: Alzheimer's disease trials sponsors, by phase
  • Figure 13: The publisher's drug assessment summary for Alzheimer's disease
  • Figure 14: Market dynamics in Alzheimer's disease
  • Figure 15: Future trends in Alzheimer's disease
  • Figure 16: BPN14770 for Alzheimer’s Disease (May 26, 2020): Phase II - PICASSO AD
  • Figure 17: Sumifilam for Alzheimer’s Disease (May 15, 2020): Phase IIb - Mild-to-Moderate AD
  • Figure 18: AXS-05 for Alzheimer’s Disease (April 27, 2020): Phase II/III - ADVANCE-1 (w/Agitation)
  • Figure 19: Vafidemstat for Alzheimer’s Disease (April 3, 2020): Phase IIa - REIMAGINE-AD (Spain)
  • Figure 20: Aducanumab for Alzheimer’s Disease (December 5, 2019): Phase III - EMERGE (Early AD), Phase III - ENGAGE (Early AD)
  • Figure 21: Neflamapimod for Alzheimer’s Disease (November 7, 2019): Phase IIb - REVERSE-SD
  • Figure 22: Aducanumab for Alzheimer’s Disease (October 22, 2019): Phase III - EMERGE (Early AD), Phase III - ENGAGE (Early AD)
  • Figure 23: Xanamem for Alzheimer’s Disease (October 1, 2019): Phase I - XanaHES (Elderly)
  • Figure 24: AADvac1 for Alzheimer’s Disease (September 9, 2019): Phase II - ADAMANT
  • Figure 25: Bryostatin for Alzheimer’s disease (September 9, 2019): Phase II - Confirmatory Study
  • Figure 26: Sumifilam for Alzheimer’s Disease (September 9, 2019): Phase IIa - Mild to Moderate AD
  • Figure 27: Key upcoming events in Alzheimer's disease
List of Tables
  • Table 1: Alzheimer’s disease severity, by rating scale
  • Table 2: FDA stages by disease attributes
  • Table 3: Prevalent cases of Alzheimer’s disease, 2018–27
  • Table 4: Marketed drugs for Alzheimer's disease
  • Table 5: Pipeline drugs for Alzheimer's disease in the US
  • Table 6: Historical global sales, by drug ($m), 2015–19
  • Table 7: Forecasted global sales, by drug ($m), 2020–24
  • Table 8: Aducanumab for Alzheimer’s Disease (August 7, 2020)
  • Table 9: BPN14770 for Alzheimer’s Disease (May 26, 2020)
  • Table 10: Sumifilam for Alzheimer’s Disease (May 15, 2020)
  • Table 11: AXS-05 for Alzheimer’s Disease (April 27, 2020)
  • Table 12: Vafidemstat for Alzheimer’s Disease (April 3, 2020)
  • Table 13: Vafidemstat for Alzheimer’s Disease (April 3, 2020)
  • Table 14: Multiple Drugs for Alzheimer’s Disease (February 10, 2020)
  • Table 15: Aducanumab for Alzheimer’s Disease (December 5, 2019)
  • Table 16: SUVN-502 for Alzheimer’s Disease (November 30, 2019)
  • Table 17: Neflamapimod for Alzheimer’s Disease (November 7, 2019)
  • Table 18: GV-971 for Alzheimer’s Disease (November 2, 2019)
  • Table 19: Aducanumab for Alzheimer’s Disease (October 22, 2019)
  • Table 20: Xanamem for Alzheimer’s Disease (October 1, 2019)
  • Table 21: AVP-786 for Alzheimer’s Disease (September 27, 2019)
  • Table 22: Elenbecestat for Alzheimer’s Disease (September 13, 2019)
  • Table 23: AADvac1 for Alzheimer’s Disease (September 9, 2019)
  • Table 24: Bryostatin for Alzheimer’s Disease (September 9, 2019)
  • Table 25: Sumifilam for Alzheimer’s Disease (September 9, 2019)
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