The beta-amyloid hypothesis has so far failed to deliver a viable candidate, contributing to an absence of new market entrants over the past decade. However, given the weight of candidates with disease-modifying potential in the pipeline, new drugs are expected to emerge that will satisfy one of the biggest unmet needs in the industry – a treatment that slows Alzheimer’s disease neurodegeneration.Market Research Reports, Market Research, Industry Analysis, Market Share, Market Size, marketing research,
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Product profiles alzheimer's disease immunotherapies can revolutionize treatment paradigm
1. Product Profiles: Alzheimer's Disease - Immunotherapies can revolutionize
treatment paradigm
Published:November 2011
No.Of Pages:150
Price:US $ 11400
Introduction
The beta-amyloid hypothesis has so far failed to deliver a viable candidate, contributing to
an absence of new market entrants over the past decade. However, given the weight of
candidates with disease-modifying potential in the pipeline, new drugs are expected to
emerge that will satisfy one of the biggest unmet needs in the industry – a treatment that
slows Alzheimer’s disease neurodegeneration.
Features and benefits
* Understand Datamonitor’s independent appraisal of marketed brands and key pipeline
agents indicated for treating Alzheimer’s disease.
* Illustrate how pipeline and marketed drugs compare to one another in terms of clinical
and commercial attributes.
* Review important clinical developments for key pipeline agents with analysis of the latest
clinical trial data.
* Understand how marketed brands are positioned in the Alzheimer’s disease treatment
algorithm.
* Determine to what extent future therapies satisfy the main clinical unmet needs in
Alzheimer’s disease treatment.
Highlights
* Datamonitor’s physician survey reveals that Aricept finds widespread use across all lines
of therapy and severities, from mild cognitive impairment to severe Alzheimer’s disease.
However, Eisai faces a steep decline in revenues as generic donepezil take hold in the US,
marketed competition heightens in Japan, and European patents near expiry.
* Bapineuzumab and solanezumab have the potential to revolutionize Alzheimer’s disease
treatment and become future market leaders. However, each program carries a caveat.
J&J/Pfizer are relying on post-hoc analyses of bapineuzumab in a subpopulation while Lilly is
betting on solanezumab’s Phase II biomarker effect translating into tangible benefits.
* A precedent already exists for neurotransmitter mechanisms, ensuring a higher likelihood
of navigating through clinical trials. Late-stage symptomatic drugs include Eisai’s Aricept
patch and GSK’s 5-HT6 receptor agonist SB-742457, although the potential rewards on offer
for these candidates are lower than for the immunotherapies.
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2. Table Of Contents
OVERVIEW
Catalyst
Summary
EXECUTIVE SUMMARY
Strategic scoping and focus
Datamonitor key findings
Related reports
PRODUCT OVERVIEW
Product Overview
Marketed Alzheimer’s Disease Product Profiles
Aricept (donepezil; Eisai/Pfizer)
Drug profile
Development overview
SWOT analysis
Product positioning
Clinical and commercial attractiveness
Exelon (rivastigmine; Novartis)
Drug profile
Development overview
SWOT analysis
Product positioning
Clinical and commercial attractiveness
Razadyne (galantamine; Johnson & Johnson/Shire)
Drug profile
Development overview
SWOT analysis
Product positioning
Clinical and commercial attractiveness
Namenda (memantine; Forest/Merz/Lundbeck)
Drug profile
Development overview
SWOT analysis
Product positioning
Clinical and commercial attractiveness
PIPELINE PRODUCT PROFILES
Bapineuzumab (Johnson & Johnson/Pfizer)
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Clinical and commercial attractiveness
Solanezumab (LY2062430; Eli Lilly)
Drug profile
Development overview
SWOT analysis
3. Satisfaction of unmet needs
Clinical and commercial attractiveness
Gammagard (intravenous immunoglobulin; Baxter)
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Clinical and commercial attractiveness
Aricept patch (transdermal donepezil; Eisai/Teikoku Seiyaku)
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Clinical and commercial attractiveness
SB-742457 (GlaxoSmithKline)
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Clinical and commercial attractiveness
Other key disease-modifying drugs in development for Alzheimer’s disease
ACC-001 (conjugate beta-amyloid vaccine; Johnson & Johnson/Pfizer)
AD02 (beta-amyloid vaccine; GlaxoSmithKline/Affiris)
Avagacestat (BMS-708163; Bristol-Myers Squibb)
CAD106 (beta-amyloid vaccine; Novartis/Cytos Biotechnology)
CERE-110 (AAV2-NGF; Ceregene)
CHF5074 (Chiesi Pharmaceuticals)
Crenezumab (R7412/MABT5102A; Roche/AC Immune)
Davunetide (AL-108; Allon Therapeutics)
ELND005 (scyllo-inositol; Elan)
EHT 0202 (etazolate; ExonHit Therapeutics)
Gantenerumab (R1450; Roche/MorphoSys)
Masitinib (AB1010; AB Science)
NIC5-15 (Humanetics)
Nypta (tideglusib; Noscira)
Octagam (intravenous immunoglobulin; Octapharma)
PF-04494700 (Pfizer/TransTech Pharma)
PBT2 (Prana Biotechnology)
Rember (methylthioninium chloride; TauRx Pharmaceuticals)
T-817MA (Toyama Chemical)
Other key symptomatic drugs in development for Alzheimer’s disease
ABT-288 (Abbott Laboratories)
Dimebon (latrepirdine; Pfizer/Medivation)
EVP-6124 (EnVivo Pharmaceuticals)
GSK239512 (GlaxoSmithKline)
Ispronicline (AZD3480; AstraZeneca/Targacept)
Lu AE58054 (Lundbeck)
BIBLIOGRAPHY
Journal papers
Websites
Datamonitor reports
4. APPENDIX A – SURVEY INFORMATION
Physician research methodology
Physician sample breakdown
The survey questionnaire
Screener
Section 10: Alzheimer’s disease regimens
Section 11: Treated disease stages
Section 12: Treatment flow – mild cognitive impairment due to Alzheimer’s disease
Section 13: Treatment flow – mild Alzheimer’s disease
Section 14: Treatment flow – moderate Alzheimer’s disease
Section 15: Treatment flow – severe Alzheimer’s disease
APPENDIX B
PharmaVitae Explorer database
Datamonitor drug assessment scorecard
Contributing experts
Conferences attended
Report methodology
LIST OF TABLES
Table: Key marketed and pipeline products for Alzheimer’s disease, 2011
Table: Aricept (donepezil; Eisai/Pfizer) – drug profile in Alzheimer’s disease, 2011
Table: Overview of pivotal trial data for Aricept (donepezil; Eisai/Pfizer) in Alzheimer’s
disease, 2011
Table: Datamonitor’s drug assessment scorecard for Aricept (donepezil; Eisai/Pfizer) in
Alzheimer’s disease, 2011
Table: Exelon (rivastigmine; Novartis) – drug profile in Alzheimer’s disease, 2011
Table: Overview of pivotal trial data for Exelon (rivastigmine; Novartis) in Alzheimer’s
disease, 2011
Table: Datamonitor’s drug assessment scorecard for Exelon (Novartis) in Alzheimer’s
disease, 2011
Table: Razadyne (galantamine; Johnson & Johnson/Shire) – drug profile in Alzheimer’s
disease, 2011
Table: Overview of pivotal trial data for Razadyne (galantamine; Johnson & Johnson/Shire)
in Alzheimer’s disease, 2011
Table: Datamonitor’s drug assessment scorecard for Razadyne (galantamine; Johnson &
Johnson/Shire) in Alzheimer’s disease, 2011
Table: Namenda (memantine; Forest/Merz/Lundbeck) – drug profile in Alzheimer’s disease,
2011
Table: Overview of pivotal trial data for Namenda (memantine; Forest/Merz/Lundbeck) in
Alzheimer’s disease, 2011
Table: Datamonitor’s drug assessment scorecard for Namenda in Alzheimer’s disease, 2011
Table: Bapineuzumab (Johnson & Johnson/Pfizer ) – drug profile in Alzheimer’s disease,
2011
Table: Clinical trial summary for bapineuzumab (Johnson & Johnson/Pfizer) in Alzheimer’s
disease
Table: Ongoing clinical development program for bapineuzumab (Johnson & Johnson/Pfizer)
in Alzheimer’s disease, 2011
Table: Bapineuzumab (Johnson & Johnson/Pfizer) versus comparator therapy Aricept
(donepezil; Eisai/Pfizer), the minimum acceptable product profile, and the target product
profile in Alzheimer’s disease, 2011
5. Table: Datamonitor’s drug assessment scorecard for bapineuzumab (Johnson &
Johnson/Pfizer) in Alzheimer’s disease, 2011
Table: Solanezumab (LY2062430; Eli Lilly ) – drug profile in Alzheimer’s disease, 2011
Table: Ongoing clinical development program for solanezumab (LY2062430; Eli Lilly) in
Alzheimer’s disease, 2011
Table: Solanezumab (LY2062430; Eli Lilly) versus comparator therapy Aricept (donepezil;
Eisai/Pfizer), the minimum acceptable product profile, and the target product profile in
Alzheimer’s disease, 2011
Table: Datamonitor’s drug assessment scorecard for solanezumab (Eli Lilly) in Alzheimer’s
disease, 2011
Table: Gammagard (intravenous immunoglobulin; Baxter ) – drug profile in Alzheimer’s
disease, 2011
Table: Key facts: Phase III trial of Gammagard, 2011
Table: Gammagard (intravenous immunoglobulin; Baxter) versus comparator therapy
Aricept (donepezil; Eisai/Pfizer), the minimum acceptable product profile, and the target
product profile in Alzheimer’s disease, 2011
Table: Datamonitor’s drug assessment scorecard for Gammagard (intravenous
immunoglobulin; Baxter) in Alzheimer’s disease, 2011
Table: Aricept patch (transdermal donepezil; Eisai/Teikoku Seiyaku ) – drug profile in
Alzheimer’s disease, 2011
Table: Aricept patch (transdermal donepezil; Eisai/Teikoku Seiyaku) versus comparator
therapy Aricept (donepezil; Eisai/Pfizer), the minimum acceptable product profile, and the
target product profile in Alzheimer’s disease, 2011
Table: Datamonitor’s drug assessment scorecard for the Aricept patch (transdermal
donepezil; Eisai/Teikoku Seiyaku) in Alzheimer’s disease, 2011
Table: SB-742457 (GlaxoSmithKline ) – drug profile in Alzheimer’s disease, 2011
Table: Clinical trial summary for SB-742457 (GlaxoSmithKline) in Alzheimer’s disease
Table: SB-742457 (GlaxoSmithKline) versus comparator therapy Aricept (donepezil;
Eisai/Pfizer), the minimum acceptable product profile, and the target product profile in
Alzheimer’s disease, 2011
Table: Datamonitor’s drug assessment scorecard for SB-742457 in Alzheimer’s disease,
2011
Table: ACC-001: ongoing studies for the treatment of Alzheimer’s disease, 2011
Table: Key facts: Phase II trial of AD02 (GlaxoSmithKline/Affiris), 2011
Table: Key facts: Phase II trial of avagacestat (BMS-708163; Bristol-Myers Squibb), 2011
Table: Key facts: Phase II trial of CERE-110, 2011
Table: Key facts: Phase II trial of crenezumab (Roche/AC Immune), 2011
Table: Key facts: Phase II trial of gantenerumab (R1450; Roche/MorphoSys), 2011
Table: Key facts: Phase II trial of Nypta (tideglusib; Noscira), 2011
Table: Key facts: Phase II trial of Octagam, 2011
Table: Key facts: Phase II trial of PF-04494700, 2010
Table: Key facts: Phase II trial of T-817MA, 2011
Table: Key facts: Phase II trial of ABT-288, 2011
Table: Key facts: Phase II trial of EVP-6124, 2011
Table: Key facts: Phase II trial of GSK239512, 2010
Table: Key facts: Phase II trial of Lu AE58054, 2010
Table: Neurologists surveyed regarding Alzheimer’s disease across the seven major
markets, 2011
Table: Datamonitor’s drug assessment parameters for key Alzheimer’s disease therapies
6. LIST OF FIGURES
Figure: Datamonitor’s drug assessment summary for Alzheimer’s disease, 2011
Figure: Aricept (donepezil; Eisai/Pfizer) – SWOT analysis for Alzheimer’s disease, 2011
Figure: Aricept (donepezil; Eisai/Pfizer) use by line of therapy and disease severity in the
seven major markets, 2011
Figure: Datamonitor’s drug assessment summary for Aricept (donepezil; Eisai/Pfizer) in
Alzheimer’s disease, 2011
Figure: Exelon (rivastigmine; Novartis) – SWOT analysis for Alzheimer’s disease, 2011
Figure: Exelon (rivastigmine; Novartis) use by line of therapy and disease severity in the
seven major markets, 2011
Figure: Datamonitor’s drug assessment summary for Exelon (rivastigmine; Novartis) in
Alzheimer’s disease, 2011
Figure: Razadyne (galantamine; Johnson & Johnson/Shire) – SWOT analysis for Alzheimer’s
disease, 2011
Figure: Razadyne (galantamine; Johnson & Johnson/Shire) use by line of therapy and
disease severity in the seven major markets, 2011
Figure: Datamonitor’s drug assessment summary for Razadyne i(galantamine; Johnson &
Johnson/Shire) n Alzheimer’s disease, 2011
Figure: Namenda (memantine; Forest/Merz/Lundbeck) – SWOT analysis for Alzheimer’s
disease, 2011
Figure: Namenda (memantine; Forest/Merz/Lundbeck) use by line of therapy and disease
severity in the seven major markets, 2011
Figure: Datamonitor’s drug assessment summary for Namenda in Alzheimer’s disease, 2011
Figure: Bapineuzumab (Johnson & Johnson/Pfizer) – SWOT analysis for Alzheimer’s disease,
2011
Figure: Datamonitor’s drug assessment summary for bapineuzumab (Johnson &
Johnson/Pfizer) in Alzheimer’s disease, 2011
Figure: Solanezumab (LY2062430; Eli Lilly) – SWOT analysis for Alzheimer’s disease, 2011
Figure: Datamonitor’s drug assessment summary for solanezumab (Eli Lilly) in Alzheimer’s
disease, 2011
Figure: Phase II Gammagard clinical trial design and results
Figure: Gammagard (intravenous immunoglobulin; Baxter) – SWOT analysis for Alzheimer’s
disease, 2011
Figure: Datamonitor’s drug assessment summary for Gammagard (intravenous
immunoglobulin; Baxter) in Alzheimer’s disease, 2011
Figure: Aricept patch (transdermal donepezil; Eisai/Teikoku Seiyaku) – SWOT analysis for
Alzheimer’s disease, 2011
Figure: Datamonitor’s drug assessment summary for the Aricept patch (transdermal
donepezil; Eisai/Teikoku Seiyaku) in Alzheimer’s disease, 2011
Figure: Phase II SB-742457 dose-ranging trial design and results
Figure: Phase II SB-742457 comparator trial with donepezil design and results
Figure: SB-742457 (GlaxoSmithKline) – SWOT analysis for Alzheimer’s disease, 2011
Figure: Datamonitor’s drug assessment summary for SB-742457 in Alzheimer’s disease,
2011
Figure: Phase II masitinib clinical trial design and results
Figure: Phase II Dimebon clinical trial design and results
Figure: Q12.1 First line treatment of mild cognitive impairment due to Alzheimer’s disease
Figure: Q12.2 Second line treatment of mild cognitive impairment due to Alzheimer’s
disease
Figure: Q13.1 First line treatment of mild Alzheimer’s disease
7. Figure: Q13.2 Second line treatment of mild Alzheimer’s disease
Figure: Q14.1 First line treatment of moderate Alzheimer’s disease
Figure: Q14.2 Second line treatment of moderate Alzheimer’s disease
Figure: Q15.1 First line treatment of severe Alzheimer’s disease
Figure: Q15.2 Second line treatment of severe Alzheimer’s disease
Figure: The PharmaVitae Explorer
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