Progress and Status of
5th Mid-term Strategic Plan
‘Dramatic Leap Plan’
Haruo Naito
President & CEO
Eisai Co., Ltd.
1Contents
New Globalization Era
Integrative Oncology Approach
Pipeline
Shareholders’ Return2

New Globalization Era
1. Good Balance of Global Sales(Unit: %)Japan

NorthAmerica

EuropeAsia

Market Growth
CAGR FY05-11

2879Eisai FY2005

474283Eisai FY2011

354515532. Clear View for Regional Headquarters
as well as Global Functional Initiativein the Best Location− Eisai R&D Management Company (Japan)
Integrative R&D Management, Project Management− Eisai Global Clinical Development (U.S.)− Global Medical & Marketing Services (U.S.)− Asia, Oceania and Middle East Business Headquarters(Japan)4

3. Capability of Global Policy/ Strategy
Building− Start up Global Policy & Strategy Committee− Regional and Functional Representation, Chair: CEO
US, Japan, Europe, Asia, Discovery, Clinical,Marketing, Manufacturing, Regulatory,Compliance, Safety etc.

5

4. Discovery Research
Enlargement of the capacity in the U.S. and Europe

Eisai Research Institute of Boston

European Knowledge Center (Image)

Number of Scientists: 140 Æ200

Number of Scientists: 50 Æ100

6Integrative Oncology Approach
1. Areas

Cancer Therapies
Cytotoxics
Anti-angiogenesis
Antibodies
Vaccines

Supportive Therapies
AnemiaThrombosis
Pain
Nausea/vomiting
Oral mucositis
Neuropathy7

2. Our Pipeline & Acquisition
Our Pipeline
StatusResearch
CodeFilingSchedule

Development
Area

Subpart H
application/Phase III

E7389

Microtubule Growth
Suppressor

Tumor
Regression

Novel Antimitotic

FY2006

US, Europe,Japan

Phase III

E0167

Prevention of
Hepatocellular Carcinoma
Recurrence by Vitamin K2

Life-span
Prolongation

Prevention ofRecurrence

FY2008Japan

Phase II

E7070

Cell Cycle G1 Phase
Targeting Agent

Tumor
RegressionNovel
Mechanism

FY2010US, Europe,Japan

Phase I

E7820

Integrin Alpha-2
Expression Inhibitor

Tumor
Suppression

AntiAngiogenesis

FY2011

US

Phase I

E7080

VEGF Receptor Tyrosine
Kinase Inhibitor

Tumor
Suppression

AntiAngiogenesis

FY2012

US, Europe,Japan

Phase I

E7974

Hemiasterlin Type Tubulin
Polymerization Inhibitor

Tumor
Regression

Novel Antimitotic

FY2012US

Pre-Clinical

E7107

Novel Anti-tumor Agent
Derived from Fermentation

Tumor
Regression

Novel
Mechanism

FY2013-Mechanism of Action

Therapeutic Strategy

8Product Acquisition
ProductFragmin
dalteparin sodium
Prialtziconotide acetate

ONTAKdenileukin diftitox

Indication

PatentSales ‘05

Prevention of deep vein thrombosis (DVT), which
may lead to pulmonary embolism (PE)Prophylaxis of ischemic complications resulting
from unstable angina and non-Q-wave myocardial
infarction (heart attack), when used with aspirin.

—$35 (6mo)

Treatment of severe, chronic pain in patients who
require intrathecal analgesia

Feb 2015*—

Treatment of patients with persistent or recurrent
cutaneous T-cell lymphoma, whose malignant cells
express the CD25 component of the Interleukin-2
receptor

Dec 2014$31 mil

Targretin capsulebexarotene

Targretin gel 1%

Treatment of cutaneous manifestations ofcutaneous t-cell lymphoma in patients who are
refractory to at least one prior systemic therapy$19milOct 2016

bexarotene

Panretin gel
alitretinoin

Treatment of cutaneous lesions in patients withAIDS-related Kaposi’s sarcoma$3 milOct 2016*data protection period––Acquisition from Ligand Pharmaceuticals (subject to closing of the transaction):
ONTAK, Targretin capsule & gel, Panretin gel at $205 million
Fragmin got positive recommendation for extended use in patients with cancer toreduce the recurrence of venous thromboembolism at Oncology Drug Advisory
Committee on 2006/9/693. Discovery Capability– Molecular/Cellular Biology to find new target
molecules for: novel cytostatics, novel cytotoxics,
novel diagnostics, novel agents for prevention– Antibodies– Vaccines– Gene/RNA targeting technologies– Biomarkers

4. Cohesive Alignment of Oncology
Functions as One Business Unit
Discovery ClinicalRegistration Medical(Regulatory) Affairs

Reimbursement

Specialty
Reps10Pipeline– Large Unmet Medical Needs Coverage:
Four Key Global Projects’ Phase III studies arefully ongoing
Japanese Projects are progressing as well as
starting to join in the global developments– Extensive new indications/formulations
programs are ongoing

11

Current Status ofGlobal NME Development (1)– E7389: Microtubule Growth Suppressor (target Subpart-H NDA
submission in FY2006)––––

Studies for 3rd line breast cancer Subpart H NDA submission ongoing
Initiated Phase III study for 2nd line breast cancer
Phase II POC study for prostate cancer ongoing
Initiated Phase I study in Japan– E2007: AMPA Receptor Antagonist (target submission for PD inFY2007)– PD: Phase III study in Europe ongoingCompleted End-of-Phase II meeting with US FDA, initiate Phase III study in theUS– Migraine Prophylaxis: Phase II POC study in progress– Epilepsy: Phase II POC study in progress– E5564: Endotoxin Antagonist (target submission in FY2009)– Phase III study for severe sepsis started– Plan to sequentially initiate study at approx. 250 sites in Americas, Europe, Japan,Asia, Oceania, etc.
– Preparing Phase I study with Japanese participants– Target simultaneous submission in the US, Europe and Japan in FY2009
12Current Status ofGlobal NME Development (2)– AS-3201: Aldose Reductase Inhibitor (target submission inFY2009)– Diabetic Neuropathy– Phase II/III in progress by Dainippon Sumitomo Pharma– Eisai will conduct its Phase III study upon outcomes of End-of-Phase II meeting tobe held in FY2006– E5555: Thrombin Receptor Antagonist (target submission inFY2010)– Prevention of major adverse cardiac events in acute coronary syndrome (unstableangina, non-ST elevation myocardial infarction)– Confirmed safety, PK and pharmacological action in Phase I– Phase II in progress in US and Europe– Phase I in progress in Japan– E2012: Gamma-secretase Modulator (target submission inFY2010)––––Alzheimer’s disease
IND submitted in March 2006 to US FDA
Phase I study started
To establish Proof of Principle in Phase I by measuring beta amyloid in blood andspinal fluids
13Global NME Projects

E2080

E7389

Project CodeNa channel modulator+Microtubule growth suppressor

Target Indication
Epilepsy (rufinamide)

Progress
Filed (US & EU)

Breast cancer

Subpart H study
Phase III (US)

Submission Target
FiledFY2006(Subpart Hsubmission)

Non-small cell lung cancer

Phase II (US)FY2010

Prostate cancer

Phase II (US)-Parkinson’s disease

Phase IIin preparation
Phase III (US & EU)

Migraine prophylaxis
Epilepsy
Multiple sclerosis

Phase II (US)Phase II (US & EU)
Phase II (US & EU)

Severe sepsis

Phase III (US)clevudine Antiviral agent
AS-3201 Aldose reductase inhibitor

Chronic hepatitis B
Diabetic neuropathy

Phase III (Asia)
Phase II/III (US)FY2008FY2009FY2009(JP, US, EU)
Start from FY2006
FY2009

E5555

Thrombin receptor antagonist

Phase II (US)FY2010

E7070

Cell cycle G1 phase targeting

Phase II (JP)Phase I

FY2010

E2012
E1224
E7820

Gamma-secretase modulator
Anti-fungal agent
Alpha 2 integrin expression inhibitor

Prevention of major adverse cardiac
events in acute coronary syndrome
Gastric cancer (Japan)
Small cell lung cancer (combinationwith irinotecan)
Alzheimer’s disease
Fungal infectioncancers

Phase I (US)Phase I (US)Phase I (US)FY2010FY2011FY2011

E7974

Tubulin polymerization inhibitor

cancers

Phase I (US)FY2012

E7080

VEGF receptor tyrosine kinase inhibitor cancers

Phase I(US, EU & JP)

FY2012

Sarcoma, ovarian cancer

E2007

AMPA receptor antagonist

E5564

Endotoxin antagonist

FY200714

Development Projects in Japan
Project CodeProgress

Submission
TargetT-614

Rheumatoid arthritis (RA)Filed for the treatment of RA

Filed

D2E7

Rheumatoid arthritis (RA)Filed for the treatment of RA

Filed

E2014

Cervical dystonia

Phase II/III ongoing

FY2006

KES524

Obesity management

Phase III ongoing

FY2007

E0167

Vitamin K2 preparation

Recurrence of hepatocellular carcinoma
Phase II/III ongoing

FY2008

E7389

Cancers

Enrolled the first patient in Phase I study

FY2009

E5564

Endotoxin antagonist

Phase I in preparation

FY2009E7070

Cancers

Gastric cancer, Phase II ongoing

FY2010E2007

AMPA receptor
antagonist

Phase II for Parkinson’s disease
in preparation

FY2010E5555

Thrombin receptor
antagonist

Single-dose Phase I completed

FY2011

E7080

Cancers

Phase I ongoing

FY2012
15

New Indication/Formulation Programs
ProductAricept®

Pariet®

Zonegran ®

Acetylcholinesterase Inhibitor

Anti-ulcer agent(PPI)

Anti-epileptic
Agent

Severe Alzheimer’s disease

Submission
TargetFiled(JP, US & EU)

Sustained release formulation

FY2009Transdermal patch formulation

FY2009H. pylori eradication

Filed (JP)Symptomatic GERD

Filed (JP)Extended release formulation

FY2009Pediatric use

FY2009

Monotherapy

FY2010Target Indication

16Enriching Return to Shareholders
Target DOE approx. 8% and DPR approx. 50% in FY2011(DPS:Yen)(DOE: %)

7150
DPS

5.9

DOE

6

5.3
110

100

50

3.7

2.4

2.5

29

32

2.6

590

4356

2.0

236

23

100
FY2000FY2001

FY2002

Share buyback

vol.
Yen

FY2003

FY20044 mil.
11.4 bil.

1.97 mil.
6.1 bil.

DOE = Dividends On Equity (= ROE x Dividend Payout)
DPR = Dividend Payout Ratio

FY2005FY2006(est)
4 mil.
22.0 bil.

DPS = Dividends Per Share17