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Efforts To Access To Medicine (ATM)
4
Ad
optio
n
Ava
ilab
ility
Affo
rda
bility
Architecture: fundamental strategy/framework to improve access to medicine
Access Improvement of Access To Medicine
Efforts to focus on Neglected Tropical Diseases; NTD (filariasis), and
Non-Communicable Diseases; NCD (neurology, oncology, and
liver/GI franchises) Reference: Reich & Frost
Efforts Toward Affordability
5
Started to supply Aricept (brand name in India
“Aricep”) and Pariet (brand name in India “Parit”)
at affordable prices suitable to the social,
economic, and healthcare environments of India in
2005.
Aricep achieved the status of No.1 brand in India
in spite of severe competitive environment.
Launched Revovir (generic name: clevudine)
for chronic hepatitis B in the Philippines at an
affordable price in February 2010; achieved
year-on-year growth of 313 %*1 further
contributing to patients.
India Philippines
Continued supply of medicines at “affordable prices” suitable to the social, economic, and healthcare environments in each country
Efficient manufacturing is essential to realize affordable pricing in a sustainable manner
Strive for reduction of manufacturing cost by optimization of global production and supply
Revised the price of Aricept in April 2010 aimed for affordable pricing. Captured more than 40% *2 of
the market share while it increased almost 4 times *3 on a volume basis in FY2010 and FY2011
(cumulative as of January 2012) to increase patient coverage (compared to the FY2009 actual results) .
Indonesia
*1 Comparison between cumulative sales from April 2010 to January 2011 and April 2011 to January 2012 (on local currency basis) *2 Copyright 2012 IMS Health Incorporated or its affiliates. All rights reserved. *3 Comparison between actual sales of FY2009 and actual sales of FY2010 and FY2011 (cumulative as of January 2012) respectively (on local currency basis)
To Realize Affordability By Leveraging The Vizag Plant (India)
Strategically leverage as the supply base of
high-quality
pharmaceutical products
based on distinguished
cost-competitiveness
For Japan Started exporting Aricept 5mg and Myonal 50mg tablets; transferring formulation technology for Pariet
For U.S. Obtained timely approvals from the FDA (in 3 months) for Aricept API and formulation
For Europe Additionally submitted the application for India-origin Aricept API
Based on the agreement with the WHO, Eisai to supply 2.2 billion tablets of DEC
(diethylcarbamazine) for the treatment of lymphatic filariasis as a Eisai’s product from 2013 to 2020
(million tablets) Production Plan at Vizag Plant
6
0
500
1,000
1,500
2,000
FY2011estimate
FY2012target
FY2013target
FY2014target
FY2015target
DEC
Warfarin 1mg
Pariet 20mg
Pariet 10mg
Myonal 50mg
Aricept 5mg
7
London Declaration To Eliminate
Neglected Tropical Diseases (NTDs) The largest international public-private partnership to eliminate NTDs
Realizing “price zero” model as a form of long-term investment
Signed a statement
of intent with the
World Health
Organization (WHO) in
November 2010. Supply medicine free
of charge to the
WHO’s lymphatic
filariasis elimination
program.
January 30, 2012 Established the largest international public-private
partnership with the Bill & Melinda Gates Foundation, the WHO, the U.S. and U.K.
governments, the World Bank and governments from neglected tropical disease-
endemic countries A coordinated effort to eliminate 10 NTDs by 2020 Eisai is the only Japanese company to join the coordinated program; the “London
Declaration.”
Eisai has signed an agreement with the WHO to extend its support to the WHO’s
lymphatic filariasis elimination program until 2020 to supply free of charge 2.2
billion tablets of the medicine DEC (diethylcarbamazine) in line with the WHO
elimination goals
goals. Contributions to the economic development and expansion of the
middle-income class through enhancement of health and welfare
A form of long-term investment for future market growth
London Declaration:
Global Prevalence of WHO-defined 10 NTDSs
Disease Global prevalence Population at risk
Blinding Trachoma 84 million approx. 600 million
Leprosy 0.4 million
-
Human African trypanosomiasis 0.3 million 60 million
Dracunculiasis
(guinea-worm disease) 10,000 -
Lymphatic Filariasis 120 million approx. 1.3 billion
Chagas disease 8-9 million 25 million
Visceral Leishmaniasis 12 million 350 million
Onchocerciasis
(River Blindness) 37 million 90 million
Schistosomiasis 207 million approx. 800 million
Soil-transmitted Helminthes consisting
of ascariasis, trichuriasis and hookworm infection
approx. 800 million (for ascariasis)
approx. 4.2 billion (only for ascariasis)
Reference: Hotez et al., NEJM357: 1010-1027, 2007
Working Together To Treat Chagas Disease
With New Medicines Licensing agreement with DNDi for the clinical development of E1224
(Product Development Partnership; PDP)
9
Dr. Urbina in
Venezuela
discovered that
ravuconazole has
potent activity both
in vitro and in vivo
against Chagas
disease
Chagas disease is transmitted by the bite of the
assassin bug or vinchuca; it is one of the 10 NTDs on
which the WHO is focusing to eliminate by 2020 as with
lymphatic filariasis .
Ravuconazole is an azole anti-fungal drug discovered and developed
by Eisai. Phase I study of E1224 (in oral administration), a prodrug or
salt form change of ravuconazole, was conducted. The study
demonstrated good ADME properties and safety profile.
Proposed by DNDi (Drugs for Neglected Disease initiative; an
independent non-profit foundation), which has been working to develop
a treatment for Chagas disease, Eisai and DNDi entered into a
collaboration and licensing agreement in September 2009 for the
clinical development of a new drug for the treatment of Chagas Disease
In the London Declaration, in particular, 11 pharmaceutical
companies including Eisai pledged their commitment to the
joint development of new drugs to treat 5 NTDs with DNDi
Contributing to new drug development of these diseases in developing countries
through PDP to support R&D for treatment of neglected tropical diseases
Joined World Intellectual Property Organization (WIPO)
sponsored global consortium for neglected tropical
disease research and development
(Public-Private Partnership; PPP)
10
WIPO Re:Search is a
new consortium in
partnership with non-profit
organizations, research
institutions, and
pharmaceutical
companies with the
objective of improving
health level in developing
countries, including least
developing countries
Eisai and other member organizations promote open innovation to
develop new drugs by voluntarily providing intellectual property and
expertise under royalty-free licenses with global research community for
drugs and candidate compounds for WHO-defined NTDs, malaria, and
tuberculosis, via a public database managed by WIPO
All intellectual property, know-how, and compound library licensed through
this consortium are required to be provided on a royalty-free basis for all
research and development of each disease, as well as for supply and sale
of final products in least developing countries.
Eisai is the only Japanese pharmaceutical company to have joined WIPO
sponsored global consortium “WIPO Re:Search” launched on October 26,
2011 with the aim of supporting research and development for NTDs.
Eisai has provided seven candidate compounds to the database, including
a compound that shows potential as a leishmania treatment, an infectious
disease that is endemic in developing countries.
With the aim of improving access to medicine, contributing to realize a sustainable
healthcare solution through sharing intellectual property and know-hows with
pharmaceutical companies
Eisai invites TDR Clinical Research Fellows from developing countries
Training programs for researchers and physicians from developing
countries are provided at Eisai’s facilities in the U.S.
Human Development Programs For Developing Countries Special Program for Research and Training in Tropical Diseases (TDR)
11
Activities of Dr. Ogunfowokan (Nigeria)
after the TDR:
1. Explore new research areas with a
view to develop vaccines to prevent
tropical diseases
2. Promote collaboration between
pharmaceutical companies and clinical
researchers in Nigeria
3. Advocate for stronger regulatory roles
of the clinical research regulatory
authorities in Nigeria
Dr. Mestra (Colombia):
Directly involved in phase II clinical trial
that Eisai and DNDi are conducting for the
treatment of Chagas disease; expected to
put the experience to use immediately after
he returns to Colombia
He is expected to join the early phase of
development of an antimalarial compound
as well
1st TDR Fellow
(2010-2011)
2nd TDR Fellow
(2011-2012)
Through capacity-building programs for researchers and physicians of
developing countries, Eisai contributes to the development of multilateral
activities to improve the access to medicine
Improvement of Access To Medicine
will contribute to the resolution of
health issues in developing countries
thereby creating potential middle-
income class in the future
12
DCHQ
Demand Chain
Patients
Biologics
DCU
Oncology
DCU
New
Chemical
Entity
DCU
Global
Brand
DCU
Stable
Brand
DCU
Quality
Assurance
CFU
Partnership
Management
CFU
Provide inter-unit coordination and support
Provide common functional excellence
14
Transformation from Mass Production Model
To Global Adaptive Model by Product Line
DCU: Demand Chain Unit that has ownership of product and its accountability
CFU: Core Functional Unit that provides common functional excellence to DCUs
DCHQ: Demand Chain Headquarters that maintains integrity of organization
Site-specific production
by local sites
Implementing end-to-end (from procurement to patient satisfaction)
management on a global basis
API API
Formulation
Packaging
Formulation
Packaging
Formulation
Packaging
Kashima Domestic
plants:
Misato
Kawashima
Sannova
Vizag Overseas
plants:
EML
RTP
Tainan
Bogor
Suzhou
EML:Hatfield plant (UK)
RTP:North Carolina plant (U.S.) 15
Improvement of convenience such as formulation, packaging,
and others based on patient needs
Establishment of optimal supply chain that realizes affordable
price
Improvement of decision-making speed and execution capability
Oncology DCU
New Chemical Entity DCU
Global Brand
DCU
Biologics DCU
Stable Brand
DCU
Procure API
Formulation Packaging
Procure API
Formulation Packaging
Procure API Formulation Packaging
Procure API
Formulation Packaging
Procure API Formulation Packaging
Transformation from Mass Production Model
To Global Adaptive Model by Product Line P
atie
nt S
atis
factio
n
18
Regional Structure That Enables Knowledge Sharing
New regional structure to freely exchange
knowledge in the regions
Globally-shared knowledge
hhc (first thoughts to patients)
ATM (Access To Medicine)
Compliance
Regionally-shared knowledge
Regulatory Science
Medical Knowledge
Pricing and Reimbursement Strategies
Marketing Informatics (Product, HTA etc.)
Talent Development
19
HQs Locations
Japan
US
UK
Singapore
Regions
East Asia
Americas
Europe, Middle East, Africa
Indo-Pacific
Regional Structure That Enables Knowledge Sharing
New regional structure to freely exchange
knowledge in the regions
20
*
HQs
Japan
China
Korea
Taiwan
Hong Kong
Steady progress of East Asia (EA) Framework
HQs Location: Japan
East Asia region already achieved the target sales composition
of 63% set forth in the plan “HAYABUSA”
Growth prospects of
prescription drug market
“Knowledge” interaction in East Asia region
- Japanese-Chinese-Korean sales force exchange programs/
physician exchange programs
- Promotion of mutual understanding through interaction of key
opinion leaders of Japan and China
- Transmitting hhc knowledge accumulated in Japan
- Promotion of global clinical trials in East Asia; progress of
regulatory harmonization
(CAGR: internal estimates)
Americas
HQs Location: U.S.
21
“Knowledge” interaction in Americas region - Promotion of mutual understanding through
interactions of key opinion leaders in the region
- Utilization of U.S CPP (Certificate of
Pharmaceutical Product) for regulatory
submissions in Latin American countries
- Mexico functions as a major hub of other Spanish-
speaking Latin American countries
- Brazil aims to be the operational base for South-to-
South business
Growth prospects of
prescription drug market
(CAGR: internal estimates)
U.S.
Canada
Mexico
Brazil
Argentina
Venezuela
・ ・ ・
HQs
22
HQs
Europe Middle East Africa (EMEA)
HQs Location: U.K.
“Knowledge” interaction in EMEA region - Transmitting the medical and marketing
knowledge
- Submissions utilizing the EU regulatory dossiers
- Sharing the pricing/reimbursement strategies
EU 27 countries
Switzerland
Turkey
Russia
Central and Eastern Europe
(Estonia, Latvia, and other countries)
Middle East (Saudi Arabia and other countries)
Africa (Egypt, Algeria, Morocco, South Africa, and other
countries)
Growth prospects of
prescription drug market
(CAGR: internal estimates)
23
Indo-Pacific
HQs Location: Singapore
HQs
“Knowledge” interaction in Indo-Pacific region
- Sharing the disease solution model, PPP (Public-
Private Partnership), affordable pricing, and capacity
building and others, which started in India
- Focusing on India, Indonesia, and Indo-China
- Collaboration for regulation, registration, and etc. in
pan-Pacific including ASEAN countries
Singapore
India
Indonesia
Thailand
Cambodia
Laos
Myanmar
Vietnam
Malaysia
Philippines
Australia
New Zealand
・ ・ ・
Growth prospects of
prescription drug market
(CAGR: internal estimates)
0.50
1.00
1.50
2.00
2.50
3.00
1950 1960 1970 1980 1990 2000 2010 2020 2030 2040 2050
Brazil
China
India
Indonesia
Japan
U.S.
(year)
24
Demographic Structures Of Emerging Countries
That Lead The Economic Growth
*1 working population: population of age 15 – 65 *2 dependent population: population of age less than15 + 65 and above
Transition of [working population*1 ÷ dependent population*2]
Peaks of productive-age population ratio
Brazil 2020 China 2015 India 2040 Indonesia 2025
(Japan 1970 U.S. 1985)
Actual
Reference:
United Nations World Population Prospects, The 2010 Revision
Sato, Yuri (2011) Keizai Taikoku Indonesia, Chuokoron-shinsha, Inc.
Forecast
0.0
20.0
40.0
60.0
80.0
100.0
1950 1960 1970 1980 1990 2000 2010 2020 2030 2040 2050
population ratio of age 0~14
population ratio of age 15~64
population ratio of age 65 and above
dependent population ratio
(%)
(year)
25
Emerging Country Expected For Future Growth
- Indonesia -
*1 dependent population ratio: dependent population ÷ working population
Transition of demographic structure in Indonesia
Productive population ratio to increase
in the next 20 years to sustain economic activities
Forecast Actual
Reference:
United Nations World Population Prospects, The 2010 Revision
Sato, Yuri (2011) Keizai Taikoku Indonesia, Chuokoron-shinsha, Inc.
*1
Realize more proactive interaction of
global and regional knowledge
under the new regional structure
26
Premise
Any remarkable therapeutic
hypothesis will not hold true
without the compound to prove it
28
29
A RECEPTOR
Perceiv ing what is go ing on
in the sc ience wor ld
How we can break down
the in f in i te amount of in format ion
to ident i fy the target
To be equipped with
“sophist icated insights” and
“hunter ’s vis ion”
Name Title
(Chair)
Professor
Yoshito Kishi
Morris Loeb Professor of Chemistry, Emeritus, Harvard University
Professor
Christopher Walsh
Hamilton Kuhn Professor, Department of Biological Chemistry and
Molecular Pharmacology, Harvard Medical School
Professor
Stuart L. Schreiber
Director of Chemical Biology and a Founding Member of the Broad
Institute of Harvard and MIT, Morris Loeb Professor of Chemistry
and Chemical Biology, Harvard University
Professor
David Altshuler
Deputy Director and Chief Academic Officer at the Broad Institute
of MIT and Harvard, Professor of Genetics and Medicine at
Harvard Medical School and Department of Medicine and
Molecular Biology at Massachusetts General Hospital
Professor
Phil S. Baran
Department of Chemistry, Skaggs Institute for Chemical Biology,
The Scripps Research Institute
Professor
Benjamin Cravatt
Department of Chemical Physiology, Skaggs Institute for Chemical
Biology, The Scripps Research Institute
30
Origin of RECEPTOR
Eisai Scientific Advisory Board
31 PCU: Product Creation Unit
A Good RECEPTOR To Internal & External
Knowledge, Inventions, and Discoveries
Examples in oncology and immunology therapeutic areas
Oncology PCU Morphotek Inc.
Small molecule
compound
Biologics
Epizyme Cancer epigenetics
Collaboration
with
Quintiles
PRISM Biolab Protein-protein
interaction inhibitor
H3 Biomedicine Inc. KAN Research Institute
Antibody
MORPHODOMA
Introduction of
seeds from
academia
Antibody/biologics
Cell biology
FORMA Therapeutics
Diversity-oriented
synthesis
compound library
Cancer genomics Scientific founders
Anaeropharma
Science Inc.
Novel cancer drugs
Drug delivery system
technologies
Next-
generation
treatment
approach
TransMolecular Targeting in cancer
Kagoshima
University fulminant hepatitis
Keio University Inflammatory
bowel diseases
Scientific
Advisors
33
CHEMISTRY Strength:
World-Class Lead Generation System
Utilize information of human biology to find the properties of library compounds Patients
Drugs
Lead
compounds
Efficient lead
generation
High-quality
leads
leading to drugs
Focused screening
Unique creation system
for lead compounds
Original
compounds
Neurology
-focused DOS
Natural
products
GPCR
-focused
Product creation library
Matching analysis for disease target group utilizing human biology
Oncology
-focused
GPCR: G protein-coupled receptor
Screening based on
patient information
・Omics
・Human Cell Culture
.
.
.
34
World-Class CHEMISTRY Strength
Oncology
Natural
products
Diversity-
oriented
synthesis
(DOS)
Neuroscience
Basic
chemistry
Process
chemistry
Excellent Biologics
Monoclonal antibody
in oncology
Morphotek Inc.
Monoclonal antibody
in immunology
KAN Research Institute
Peptide-drug conjugates
Antibody-drug conjugates
Innovative small molecule compounds
e.g., farletuzumab e.g., KANAb001 (E6011) e.g., TM tumor targeting peptide
TM: TransMolecular, Inc.
35
Optimizing Development Strategy With
Maximum Utilization Of Human Biology
Lenvatinib
VEGFR
FGFR
RET
SF3b MEK
FLT3 Chemokine
・・・・
Root-cause targets
Good RECEPTORによる ベスト・マッチング
ターゲットの継続探索
BACE
E7107 E6201 Farletuzumab KANAb001
(E6011) E2609 Golvatinib BAN2401 Ontecizumab
Endosialin Beta amyloid
protofibril
c-MET
VEGFR2
Target
molecules
Human Biology space Chemical space • Search for chemical structures
that have potential to be
effective for challenging
disease targets
• Optimization and maximization
of potency for unique
compounds derived from
collective effort of chemistry
Best matching by a good RECEPTOR
Continued discoveries for potential targets
Gene translocation is
recently identified in some
lung adenocarcinoma
Variation specific to a certain type of
hematological cancer cell is recently identified
in SF3b and its surrounding splicing factors
Diseases
Folate receptor
alpha
36
Combining the RECEPTOR and CHEMISTRY Strength
Halaven
RECEPTOR
CHEMISTRY
INNOVATION
Professor Hirata and Dr. Uemura of Nagoya University and their team of
scientists were able to isolate and identify the full structure of halichondrin B
Success of total synthesis of halichondrin B by a team of scientists led by
Professor Yoshito Kishi from Harvard University
Success in creating promising anticancer agent with high-level organic
synthetic chemistry
Controlled 19 chiral carbons with 64 synthesizing steps
Halaven
Microtubule dynamics inhibitor with a unique mechanism
of action
- Overall survival benefit in metastatic breast cancer
- Ease of administration
- Manageable tolerability profile : Chiral carbon
37
BAN2401 Aricept E2609
Symptomatic Treatment Disease Modifier
J-ADNI: Japanese Alzheimer's Disease Neuroimaging Initiative
Johns Hopkins
University
University
College London Keio University
Imaging
Bexarotene J-ADNI
Neurodegenerative disorders
due to aging
Target for new
mechanism Recent
findings
Neurology-Focused Library
Biomarker
Discovery Research
ADME/toxicity
Prediction
Technology
CSF, blood biomarkers
Brain metabolic imaging
Beta-amyloid imaging
Imaging response to indicate hippocampal degeneration
RECEPTOR
CHEMISTRY
INNOVATION
Eisai pioneered the avenue for medicinal therapy:
continue leading as the First Runner
Alzheimer’s disease
Target for new
mechanism
Utilizing the network of high-level expertise with excellent researching
environment for neurology at UCL (University College London)
38
Unique functional assays of rat primary cultured neurons and
identified the seeds by HTS with compound library
Candidate compounds created with
excellent medicinal chemistry at astonishing speed
・ Synthetic development targeting highly active compounds with unique scaffold structures
perampanel
HTS: High Throughput Screening
CHEMISTRY
RECEPTOR
INNOVATION Creation of first-in-class
AMPA receptor antagonist
Combining the RECEPTOR and CHEMISTRY Strength
Perampanel (investigational agent for epilepsy)
39
DOS library Cancer genomics Cancer drugs aimed for
personalized medicines
+ =
CHEMISTRY
RECEPTOR
Take full advantage of the location in Cambridge
where cutting-edge technology and scientific talent exist
INNOVATION
Control functions of cancer-causing genes identified with genomics analysis through following
approaches:
1. Directly control causative gene
2. Block factors that locate in the downstream of signaling system
3. Control oncogenes that synchronize with other oncogenes
4. Control the dependency of non-oncogenes that synchronize with oncogenes
H3 Biomedicine Inc. strives to create cancer drugs aimed for
personalized medicines combining high-level, extensive library
and genomics to challenging target molecules
Personalized Medicine with Advanced Genomics and
Biomarker Application
Lenvatinib
AD Disease Modifier
E2609 BAN2401 ・ ・ ・ ・ ・ ・ ・ ・
Unique Compound Based On Novel Target
Ontecizumab KANAb001 (E6011) ・ ・ ・ ・ ・ ・ ・ ・
Natural Product Derivatives
Halaven E6201 E7107 ・ ・ ・ ・ ・ ・ ・ ・
More
INNOVATION = RECEPTOR CHEMISTRY
Strength +
Farletuzumab Golvatinib ・ ・ ・ ・ ・ ・ ・ ・
40
Financial Strategy Map
To Maximize Shareholder Value
Corporate governance
Viewpoints of shareholders and investors
IR
Strategy ROE
Management
Shareholder
return
DOE ≥ 8%
Compensating cost
of equity via cash
dividend
Maximizing shareholder value
Allocating 1/3 of cash income
in the midterm
Maintain/increase
dividend
Accountability
Achieving
fair valuation
Independent board of
directors: representing the
best interest of shareholders
×
×
Margin
Leverage
Turnover
42
ROE≥20%
43
Linkage of Value Creation
Four factors to realize shareholder value
EPS Growth
Midterm target: to aim for
nearly 500 yen
FY2011 estimate: 212.3 yen
FY2012 target: Increase
FY2013 target: Increase
Strong Balance Sheet
Midterm target Net DER: 0.3 or below
FY2011 estimate: 0.4
FY2012 target: 0.35
FY2013 target: 0.3 or below
Valuation Increase intrinsic
corporate value through
implementation of the
plan “HAYABUSA” Equity Spread* as a source of
shareholder value: 15% (target)
ROE- cost of equity
Value Creation
Further Globalization ROE
Midterm target: 20%+
FY2011 estimate: 15.1%
FY2012 target: Improve
FY2013 target: Improve
*Equity Spread = ROE – cost of equity (%)
Assuming 8% level of cost of equity
More Innovation