Aducanumab launch insights, 2018 sample pages

2018Aducanumab, Launch Insights

T A B L E O F C O N T E N T S
A D U C A N U M A B O V E R V I E W
3
A D U C A N U M A B I N A L Z H E I M E R ’ S D I S E A S E
A L Z H E I M E R ’ S D I S E A S E I N S I G H T S - U S
Key insights from primary research
A D U C A N U M A B M A R K E T E V O L U T I O N
18
24 Aducanumab Sales Forecast and key market insights
C O M P E T I T I V E L A N D S C A P E O F A D U C A N U M A B
I N A L Z H E I M E R ’ S D I S E A S E42
A D U C A N U M A B M A R K E T P O S I T I O N I N G
48
Detailed Profiling of Phase III products in this space
including product description, research and development
and regulatory milestones
Analysis and comparison of different pipeline products
and determining the market potential and size
of Aducanumab
51 M A R K E T D R I V E R S A N D B A R R I E R S
A P P E N D I X
53
A D U C A N U M A B M E C H A N I S M O F A C T I O N
4
5
Pre-clinical Characterization and Detailed Clinical Studies
*Note: The page number might vary upon the recent update

BIOGEN’S
ADUCANUMAB
Aducanumab (BIIB037) is being developed for the treatment of early
Alzheimer’s disease. Aducanumab is a human recombinant monoclonal
antibody (mAb) derived from a de-identified library of B cells collected
from healthy elderly using Neurimmune’s technology platform called
Reverse Translational Medicine (RTM). Biogen licensed Aducanumab
from Neurimmune under a collaborative development and license
agreement.
Further information in detailed report….
Clinical Development
────
Alzheimer's
disease
Phase III
────
DESIGNATION
Key Points Information in detailed report….
General
Description
 Alias Name: Anti-beta amyloid monoclonal antibody-Biogen Idec;
BART; BIIB 037; NI-10
Fast track Drug
Designation

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DelveInsight’s, “Aducanumab, Launch Insights, 2018” report provides comprehensive insights about
Aducanumab launch. The report covers detailed overview of Alzheimer’s disease for which the drug is
being developed and provides the competitive landscape in this space. The report further contains patent
details, forecasted sales till 2027 and post launch market positioning.
The report is built using data and information sourced from proprietary databases, primary and secondary
research and in-house analysis by DelveInsight team of industry experts.
Secondary sources information and data has been collected from various printable and non-printable sources
like search engines, News websites, Government Websites, Trade Journals, White papers, Magazines, Trade
associations, Books, Industry Portals, Industry Associations and access to available databases.
Scope
 Aducanumab’s detailed product description including its chemical properties, molecule type and
mechanism of action
 Detailed description of non-clinical and clinical studies for Alzheimer’s disease
 Patent expiry analysis of Aducanumab
 Forecasted Sales till 2027
 Aducanumab market positioning analysis
Introduction

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Alzheimer’s disease is an irreversible, progressive brain disorder that slowly destroys memory and thinking
skills and, eventually, the ability to carry out the simplest tasks. In most people with the disease those with
the late-onset type symptoms first appear in their mid-60s. Early-onset Alzheimer’s occurs between a
person’s 30s and mid-60s and is very rare. Alzheimer’s disease is the most common cause
of dementia among older adults. Symptoms of Alzheimer's, including early-onset Alzheimer's, include
problems with memory, judgment, and thinking. Memory loss and dementia will progress as the stages of
Alzheimer's advance. Symptoms can be treated with medication, but there is no cure.
The likelihood of having Alzheimer's disease increases substantially after the age of 70 and may affect
around 50% of persons over the age of 85. Symptoms may be present in varying degrees of severity. The
treatment and management of Alzheimer's disease consists of medications and non-medication based
treatments.
Further information is in detailed report…
Alzheimer’s disease Overview

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Aducanumab in Alzheimer's Disease

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Aducanumab (BIIB037) is an investigational drug being developed for the treatment of early Alzheimer’s
disease. It is a high-affinity, fully human IgG1 monoclonal antibody against a conformational epitope found
on A . BIIB037 binds aggregated forms of A , not monomer. In the brain, BIIB037 preferentially binds
parenchymal over vascular amyloid. It was originally derived by the biotech company Neurimmune in
Schlieren, Switzerland, from healthy, aged donors who were cognitively normal but later licensed to Biogen.
Aducanumab is currently being evaluated in two global Phase III studies, ENGAGE and EMERGE, which
are designed to evaluate its safety and efficacy in slowing cognitive impairment and the progression of
disability in people with early Alzheimer’s disease.
In October 2017, Eisai and Biogen announced that the companies have expanded their existing agreement to
jointly develop and commercialize investigational Alzheimer’s disease treatments. Under the terms of the
agreement Eisai has exercised its option to co-develop and co-promote Aducanumab, Biogen’s
investigational anti-amyloid beta (A ) antibody for patients with Alzheimer’s disease.
In August 2016, Aducanumab was accepted into the European Medicines Agency’s PRIME program.
In September 2016, the U.S. Food and Drug Administration accepted Aducanumab into its Fast Track
program and in April 2017 Aducanumab was accepted into the Japanese Ministry of Health, Labour and
Welfare’s (MHLW) Sakigake Designation System.
In May 2015, development began in Japan with a Phase I study of increasing doses up to 6 mg/kg in 25
patients with mild to moderate AD.
In December 2014, Biogen announced it would move into Phase III based on interim data suggesting target
engagement and a cognitive benefit.
Aducanumab - Overview

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In Pre-clinical studies, transgenic mouse model of Alzheimer’s disease were studied. Aducanumab was
shown to enter the brain, bind parenchymal A , and reduce soluble and insoluble A in a dose-
dependent manner. In patients with prodromal or mild AD, one year of monthly intravenous infusions
of aducanumab reduces brain A in a dose- and time-dependent manner. This was accompanied by a
slowing of clinical decline measured by Clinical Dementia Rating-Sum of Boxes and Mini Mental State
Examination scores. Thirteen-week chronic dosing in old APP-transgenic mice reduced plaques of all
sizes; vascular amyloid stayed unchanged. Brain-exposure studies in mice suggest that
microhemorrhages start at 500 mg/kg, more than 100 times the minimally effective dose for plaque
clearance, 3 mg/kg. The main safety and tolerability findings were amyloid related imaging
abnormalities. These results justify further development of Aducanumab for the treatment of
Alzheimer’s disease.
Pre-clinical Characterization

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ReRe
Trial Identifier: NCT02477800
Start Date: August 2015
Completion Date: March 2022 In August 2015, company initiated Phase III
multicenter, randomized, double-blind, placebo-
controlled, parallel-group study to evaluate the
efficacy of monthly doses of Aducanumab in slowing
cognitive and functional impairment as measured by
changes in the Clinical Dementia Rating-Sum of
Boxes (CDR-SB) score as compared with placebo in
participants with early AD.
Phase III Trial
Indication: Alzheimer's Disease
Intervention: Aducanumab
Primary Endpoint:
 Change from baseline in CDR-SB score
Secondary Endpoint:
 Change from baseline in MMSE score
 Change from baseline in Alzheimer's Disease
Assessment Scale-Cognitive Subscale (13
items) (ADAS-Cog 13)
 Change from baseline in Alzheimer's Disease
Cooperative Study-Activities of Daily Living
Inventory (Mild Cognitive Impairment
version) (ADCS-ADL-MCI) score
Further information in detailed report…
1350 Phase IIIActive, Recruiting
Results
Clinical Studies

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Trial Identifier:
Start Date:
Completion Date:
Trial II
Indication:
Intervention:
Primary Endpoint:
Secondary Endpoints:
Results

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Aducanumab Milestones
Designation
In December 2017, Biogen announced that Aducanumab, its investigational treatment for early
Alzheimer’s disease (AD), was granted Fast Track designation by the U.S. Food and Drug
Administration (FDA). The FDA’s Fast Track program supports the development of new
treatments for serious conditions with an unmet medical need such as Alzheimer’s disease.

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PHASE I PHASE II PHASE III UNKNOWN
Alzheimer's
Disease
Recruiting
Active, not Recruiting
Completed
Not Available
Aducanumab Heat Map

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Phase Indication Trial ID Enrollment Status
Phase III Alzheimer's Disease NCT02477800 1350 Active, recruiting

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Aducanumab Market Evolution

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2023E 2024E 2025E 2026E 2027E
SALESINUSDMILLION
Sales are
estimated to
be XXXX
million in
2025
Information is in detailed report…
Aducanumab Forecasted Sales
YOY Growth %
XX
XX
XX
XX
XX

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Competitive Landscape for Aducanumab

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Drug Name Company Name
Phase III
Lanabecestat AstraZeneca
Other drugs are in the detailed report…..

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Lanabecestat (AZD3293) is an orally administered drug in development by AstraZeneca along with Eli Lilly.
It is an inhibitor of BACE1, the -secretase sheddase that cleaves the APP protein to release APP's C99
fragment. This fragment then becomes a substrate for subsequent -secretase cleavage and A peptide
generation. The rationale of BACE inhibition is that it represents an upstream interference with the amyloid
cascade, regardless of which species or aggregation states of A then exert toxicity in the brain. The drug is
currently in Phase III stage of development for Alzheimer's Disease.
Lanabecestat Overview

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Information is in detailed report…
Pre-clinical Characterization

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Information in detailed report…
Trial Identifier:
Start Date:
Completion Date:
Phase III Trial
Indication:
Intervention:
Primary Endpoint:
Secondary Endpoints:
Results
Clinical Studies

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Patent Expiry Analysis
2015 2017 2019 2021 2023 2025 2027 2029
PATENT EXPIRY ANALYSIS
Aducanumab
Lanabecestat
XXXX
Note: The details of Aducanumab on Alzheimer's Disease are in the detailed
report

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Aducanumab vs Lanabecestat vs XXX
DelveInsight has performed an attribute analysis to understand the potential of upcoming drugs for
Alzheimer's Disease. We have compared the drugs under development and scored them based on their
results for all selected attributes. The product with higher scores on basis of attributes is estimated to have a
bigger say in the market post its launch. Please note that DelveInsight assumes that these drugs would not
face any failure prior to approval.
Alzheimer's Disease Market Positioning
Aducanumab Scores Lanabecestat Scores

APPENDIX
METHODOLOGY
DelveInsight is a cutting-edge market and
pipeline analysis and API intelligence service
provider for the Pharma and Biotech sector,
helping clients to quantify market events and
evaluate their impact on the valuation of
products, portfolios and companies.
SECONDARY RESEARCH
PRIMARY RESEARCH
The secondary research on internal and external sources is
being carried out to source qualitative and quantitative
information relating to each market.
• Company websites, annual reports, financial reports,
broker reports, investor presentations and SEC filings
• Industry trade journals and other literature
• National government documents, statistical databases
and market reports
• News articles, press releases and web-casts specific to
the companies operating in the market
DelveInsight conducts primary research by interacting with
the healthcare professionals, doctors, industry’s experts
and industry participants and commentators in order to
validate its data and analysis.

salessupport@delveinsight.com
About
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clients to quantify market events and evaluate their impact on the valuation of
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and Drug’s research and development. We help Drug developing companies,
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The pharmaceuticals market is in its growth stage and we are uniquely
positioned to successfully endeavour the dimensions of the fast growing
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clients.
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Building Commercial Excellence, and Growing Businesses in an increasingly
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