The special year to achieve a series of our milestones

Information Meeting
March 4, 2008
Eisai Co., Ltd.

1

Forward Looking Statement•

Materials and information provided during this presentation may contain socalled “forward-looking statements.” These statements are based on current
expectations, forecasts and assumptions that are subject to risks anduncertainties which could cause actual outcomes and results to differ materiallyfrom these statements.

•

Risks and uncertainties include general industry and market conditions, andgeneral domestic and international economic conditions such as interest rateand currency exchange fluctuations. Risks and uncertainties particularly apply
with respect to product-related forward-looking statements. Product risks anduncertainties include, but are not limited to, technological advances and patents
attained by competitors; challenges inherent in new product development,
including completion of clinical trials; claims and concerns about product safety
and efficacy; obtaining regulatory approvals; domestic and foreign healthcare
reforms; trends toward managed care and healthcare cost containment; andgovernmental laws and regulations affecting domestic and foreign operations.

•Also, for products that are approved, there are manufacturing and marketingrisks and uncertainties, which include, but are not limited to, inability to build
production capacity to meet demand, unavailability of raw materials, and failure
to gain market acceptance.

•

The Company disclaims any intention or obligation to update or revise any
forward-looking statements whether as a result of new information, future eventsor otherwise.
2

Agenda
1. Strategy Based on Cash Generating Capability, the Ultimate
Measure of Corporate Value
Executive Vice President ＆CFO, Eisai Co., Ltd.

Hideaki Matsui

2. MGI’s Products, Commercial Capabilities and Strength
Vice Chairman, Eisai Corporation of North America

Lonnie Moulder

3. MGI R&D and Pipeline
Executive Vice President, Eisai Corporation of North America

Mary Lynne Hedley

4. Robust US Operation Strengthened by Integration with MGI
PHARMA
President and COO, Eisai Corporation of North America

Lonnel Coats5. Our Future
President and CEO, Eisai Co., Ltd.

Haruo Naito

3

1. Strategy Based on Cash Generating
Capability, the Ultimate Measure of
Corporate Capability

4

Dramatic Leap ofFinancial Platform
Maintain Multi A-rating and increase DOE•••

Expansion in scale(Globalization)
Focus on pharmaceuticals
business
Rich retained earnings••

Growth potential
Return to shareholders

Anticipate A credit rating based on the leverage strategy••••

Maintain high corporate credit and decrease cost of capital
Optimize capital structure
Improve ROE
Maintain or increase dividend payout ratio

Moving to the Era of Cash EPS
5Trend of Cash & GAAP EPS (Proforma)（%） Cash EPS = (Net income + Amortization of Tangible & Intangible Assets
300+ IPR&D + Amortization of Goodwill)/ Number of Shares

Set Cash EPS of FY2006 as 100
Total Amortization in FY2006 :26.8B yen

Cash EPS
Eisai + MGI

200
Cash EPS
Eisai Standalone
GAAP EPS
Eisai + MGI

100

2006

2007

2008

2009

2010

2011

2012

GAAP EPS
Eisai Standalone

2013

2014

2015
2016
(Fiscal year) 6

Accounting Procedure of MGI PHARMA’s
Acquisition Cost
- Summary of amortization period - Based on U.S. GAAP (FAS141) Japan GAAP to be applied for goodwill
In Process R&D
Assets used forspecific research
applications which
will not be used forother purposes.
To be booked as
one-time R&D
expenses.

Acquisition

Fair Valueof Assets

Cost

Goodwill

Fair Valueof Other
AssetsTo be booked inbalance sheet

In Process
R&D

One-time booking ofexpenses in FY2007

Intangible
AssetsSet the amortization
period for eachproduct

Expect 20-year
amortization
7

(%)

Trend of GAAP EPS (Proforma)

400

Set GAAP EPS of FY2006 as 100
300
GAAP EPS
Eisai + MGI

200

GAAP EPS
Eisai Standalone

100

2006

2007

2008

2009

2010

2011

2012

2013

2014

2015
2016
(Fiscal year)
8

(%)
400

Trend of Cash EPS (Proforma)
Cash EPS = (Net income + Amortization of Tangible & Intangible Assets+ IPR&D + Amortization of Goodwill)/ Number of Shares

Set Cash EPS of FY2006 as 100
300
Cash EPS
Eisai+MGI

200
Cash EPS
Eisai Standalone

100
2006

2007

2008

2009

2010

2011

2012

2013

2014

2015
2016
(Fiscal Year)
9

Trend of Cash & GAAP EPS (Proforma)（%） Cash EPS = (Net income + Amortization of Tangible & Intangible Assets
300+ IPR&D + Amortization of Goodwill)/ Number of Shares

Set Cash EPS of FY2006 as 100
Total Amortization in FY2006 :26.8B yen

Cash EPS
Eisai + MGI

200
Cash EPS
Eisai Standalone
GAAP EPS
Eisai + MGI

100

2006

2007

2008

2009

2010

2011

2012

GAAP EPS
Eisai Standalone

2013

2014

2015
2016
(Fiscal year)10

Cashflow
Outstanding Debt
(Billions yen)

6,000
600

Ex Dividend Free Cash Flowand Total Dividend (Proforma)

Dividends(Billions yen)

1,800
180

Total Dividends
Eisai Standalone
Eisai + MGI
Repayment Amount

500
5,000

1,500
150

Eisai + MGI(After Debt Repayment)

Acquisition of MGI
Outstanding Balance of Debt

120
1,200

400
4,000

Eisai
Standalone

3,000
300

200
2,000

60
600

den
Divi

1,000
100

ds
300
30

FY
20
16

FY
20
14

FY
20
12

FY
20
11

FY
20
10

FY
20
08

FY
20
06

FY
20
04

0

FY
20
02

0

FY
20
00

90
900

11

Governance Accounting of FY2007
Balance Sheet
As of 1H FY2007

Balance Sheet
As of end of January, 2008

Total Assets: 817.6 Billion Yen

Total Assets: 1.2382 Trillion Yen

Financial Assets
239.5 B

Customers,
Business Partners
174.3 B
Employees

43.4 B

Government

24.8 B

Account
Receivable
172.8 B
Inventory Assets 53.4 B
Plants, Property andEquipment
115.8 B

Intangible Assets
121.6 B

Shareholders575.1 B

Financial Assets
285.3 B

Account
Receivable
164.5 B
Inventory
Assets 53.6 B
Plants, Property
and Equipment
119.9 B

Customers,
Business Partners
173.2 B

Creditors
443.3 B

Employees 39.9 B
Government 16.3 B

Deferred Tax
Assets 72.3 B

Other 20.4 B
Intangible Assets
495.9 B
Shareholders
565.5 B

Deferred Tax
Assets 73.9 B
Other 23.8 B

12Balanced yet Aggressive Financing Strategy<Transition of Strategy>
Management with focus on retained earnings
Solid investment with appropriate ceiling cap
Focus on return to shareholders aiming at increasing DOE
 Maintain high credit rating
 Business expansion through debt
 Decrease in capital cost

Enhancement in Cash Generating Capabilities
Need to maintain

TargetSoundness of financials

Pursue optimal capital structure
appropriate for a pharmaceuticalcompany

・Aims to maintain A credit-rating
Flexibility of financials
・Preserve liquidity in hand
Proactive and stable return toshareholders

Reduce capital cost and pursue
growth13

2. MGI’s Products, Commercial
Capabilities and Strength14

Oncology and Institutional Care

Building a Franchise

9Aloxi® (CINV) market share growth accelerating
9Dacogen® revenue expansion continues
9Aloxi® (PONV) approved on February 29, 2008
9Aquavan® NDA FDA action date: July 26, 2008
9Advancing the science– Amolimogene, AKR-501, ZYC 300, PARP, GCPII
Oncology and Institutional Care Portfolio
A Global Platform for Growth
15
15

Aloxi® Injection

Best-in-Class for CINV

• Only serotonin subtype-3 (5-HT3) receptor antagonist (RA)approved by the FDA for the prevention of both acuteAND delayed Chemotherapy Induced Nausea andVomiting (CINV)• Efficacy demonstrated in head-to-head clinical trials– Strong Day 1 efficacy for N&V– Unique efficacy for delayed N&V• Large U.S. 5-HT3 RA CINV market opportunity– >6 million IV Day-of-Chemotherapy doses annually– Opportunity for significant growth beyond
current 40% market share– Greatest share-of-voice within market place• Franchise expansion opportunity– Aloxi® injection for PONV approved February 29, 2008
– Aloxi® Oral Capsule FDA action date of August 22, 2008

• Patent Protection into 2015

16

Aloxi® Injection

Improved Efficacy;
Differentiated Pharmacology
Aloxi® vs. Ondansetron (n=374)
Complete Response(No Emesis, No Rescue)(% of Patients)
10080

p=0.0085

p<0.001

81.0

74.1

68.6

55.1

60

• Much longer plasma halflife compared to older 5HT3 RAs– 40 hours vs. 4-8 hours

40
20
0

The Science of Aloxi®

Acute: 0-24
(Day 1)• Significantly higher
binding affinity; binds
tighter and stays longer at
Delayed: 24-120(Days 2-5)
the 5-HT3 receptor

TIME (hr)– 10 – 100 times greater

Aloxi 0.25 mg IV (n=189)
Ondansetron 32 mg IV (n=185)
Gralla R, et al. Ann Oncol. 2003;14:1570-7

17

Aloxi® Injection

Market Share Growth in CINV
Aloxi® share increasing; share of Zofran / ondansetron decreasing18

Dacogen® for Injection

A Rapidly Growing Hematology
Franchise• A novel, highly potent hypo-methylating agent– An Epigenetic Therapy that induces cell-differentiation by
reducing DNA methylation• Broad indication for patients with myelodysplastic
syndromes (MDS)– All subtypes (FAB)– Int-1, Int-2, and High Risk WHO IPSS groups– De novo & secondary MDS– Previously treated & untreated• Over 30 ongoing clinical trials– Phase III acute myeloid leukemia (AML) survival program– Phase III MDS survival program– Phase II alternative dosing for outpatient treatment
19

Dacogen® for Injection

Dacogen® Launch Doubles
Market Size
50% of the market yet to be penetrated; number of cycles oftherapy per patient could double

20Dacogen® for Injection

Basis for Market Share
Performance
Clinicians report faster time to response andconsistently observe similar levels of tolerability
Vidaza

RevlimidMedian RBC Count

4.0

3.45

3.5
3.0

2.95
2.60

2.5
2.0
1.5
1.0
0.5
0.0

Baseline
N = 54
Feinberg B et al. ASCO, 2007

DacogenMedian % Change in RBC Count

DacogenVidaza

Revlimid

20.0
15.0
10.0
5.0
0.0
-5.0
-10.0

1

2
After Cycle
N = 54

3

21

MGI Oncology Capabilities

U.S. Commercial Success• Full coverage of the oncology customer
base with a team of 200+ field-based
professionals targeting:Oncology
Practitioners– ~2500 oncology clinics

Specialized
Sales Force– ~1500 hospitals• Concentrated focus on ~10,000
Physicians– All oncology subspecialties targeted• Integrated strategy to differentiate our
products– Scientific features– Clinical benefits– Economic advantages

Corporate AccountManagement

Private Care
PayersGovernment Affairs& Reimbursement

Government
Payers 22

MGI Oncology Capabilities

U.S. Commercial Success• Commercial involvement throughout
all phases of product development

Medical & Scientific
Meetings• Research and clinical medicine
involvement throughout entire
commercial lifecycle• A concentrated focus on developmentof Key Opinion Leader (KOL)Key
Opinion Leaders(KOL’s)• Integrated strategy to differentiate
our products– Scientific features– Clinical benefits– Economic advantages

Education &Publications

Clinical Trial
Involvement
23

Future Global Franchise

Combined Oncology
Pipeline and Know-how
MGI compounds with global rights
IrofulvenSemi-synthetic derivative of toxin illudin S

Aquavan®

Eisai’s ability to develop
and market globally

Sedation for brief therapeutic and diagnostic procedures

SaforisTM
Oral mucositis＋

Amolimogene
DNA Vaccine for Cervical Dysplasia

MGI’s oncology
business Know-how

AKR-501
Thrombocytopenia

ZYC300Cancer Therapeutic DNA Vaccine Against CYP1B1

Sales & Marketing
Research
Development
Production

GPI 21016 (PARP inhibition)
Chemotherapy, radiotherapy sensitizer

GCPII inhibitor
Chemotherapy-induced neuropathy
24

3.

MGI R&D and Pipeline25Advancing The Product Portfolio
Preclinical

Phase 1

Phase 2Phase 3

Regulatory
Review

Marketed

Aloxi® Injection (CINV)
Dacogen® for Injection (MDS)
Gliadel® Wafer
Aloxi® Injection (PONV)

Approved

Aquavan® Injection (sedation)
Aloxi® Oral Capsule (CINV)
Saforis (oral mucositis)
AKR-501 (ITP)
Amolimogene Bepiplasmid (cervical dysplasia)
Dacogen® for Injection (AML)
Dacogen® for Injection (MDS Survival)
Dacogen® for Injection (other)
Irofulven (prostate cancer)
ZYC300 (solid tumors)
PARP Inhibitors (cancer therapy sensitizers)
GCPII Inhibitors (chemo-induced neuropathy)
Decitabine Analogs

26

AQUAVAN®

(fospropofol disodium) Injection• Sedative Agent for Brief Therapeuticand Diagnostic Procedures– Intended for intravenous injection– Water soluble pro-drug of propofol– Clear, colorless liquid in glass vial
– Target product profile• Can safely be administered by nonanesthesiologists toprovide:• Consistent pharmacokinetic/pharmacodynamics profile• Predictable level of sedation• Minimal and expected adverse events• Amnesia lasting only for the duration of the procedure
27

AQUAVAN®:
A Unique PK/PD Profile
6000
4000

Propofol2000– Water soluble prodrug of propofol– Metabolism by alkaline
phosphatases liberates propofol
for a gradual increase in plasma
propofol concentration followed bya gradual decrease

AQUAVAN® 10 mg/kg bolus0• AQUAVAN®: Fospropofol
Disodium Injection

Median Propofol Concentration (ng/mL)– Lipid based emulsion– PK is characterized by sharp peakand drop in serum concentration

8000• Original Propofol Injectable
Emulsion

0

10

20

30

40

50

60

Time (minutes)

Fechner J, et al. Anesthesiology. 2003;99:303-1313.
Shah A, et al. Anesthesiology. 2007;107:A46.
28

Clinical Development:
Pivotal Efficacy Summary
Phase III Colonoscopy Study

Phase III Bronchoscopy Study

Sedation SuccessSedation Success87%

p=0.001p=0.00289%

p < 0.001

69%

28%

26%

Aquavan
6.5 mg/kg
N = 158

Trial Endpoints

Aquavan
2.0 mg/kg
N = 102

Midazolam0.02 mg/kg
N = 52−Treatment success (p <0.001)−Amnestic effect (p <0.001)−Reduced analgesic use (p <0.001)−Willingness to use study drug again(p <0.188)−Median Time to Fully Alert: 5 min−HVLT-R (recall)−6.5mg/kg: 67%−Midazolam: 41%

Aquavan
6.5 mg/kg
N = 150Aquavan
2.0 mg/kg
N = 102

Trial Endpoints−Treatment success (p <0.001)−Amnestic effect (p <0.001)−Reduced analgesic use (p <0.001)−Willingness to use study drug again( p <0.001)−Median time to fully alert: 5.5 min

29

®
AQUAVAN : Summary• Administration of Standard Aquavan® Dose Titration Regimen*– Provides ease of titration with the benefit of propofol sedation– Multiple measures of sedation success and clinical benefit have been
demonstrated– Sedation related adverse event profile in line with expectations based onliterature– Optimum balance between efficacy and safety• NDA Package under active review by U.S. FDA– 21 clinical studies; 1611 subjects and 1338 patients– 10 Clinical Pharmacology studies (healthy subjects) and 11 Phase II or III
studies (patients)– ICH compliant clean QT study– PDUFA action date: July 26, 2008
*Standard dose: 6.5mg/kg with 1.6mg/kg supplements; upper weight boundary 90kg;
lower weight boundary 60kg, reduce to 25% of standard dose for age >65 year and
ASA P3 and P4.

30

DACOGEN®:A Novel Anti-Cancer Agent••

Cytosine nucleoside analoguethat reverses DNA methylation
Incorporates into DNA & traps
DNA-methyltransferase(DNMT)
Inhibition of cell proliferation athigh doses– Blocks DNA synthesis– Cytotoxic•

Silenced

Promoterdeoxyribose

Methylation Low
Methylation High
Log-Rank=8.3, P=0.004

80
60
40
20

MMMM M

Hypomethylation at low doses
leads to:– Cell differentiation– Re-expression of tumor
suppressor genes– Suppression of tumor growthdecitabine

100

Percent of Survival•

Overall survival of MDS
patients correlates with
global methylation levelsX

M M MM M

Promoter0X

0Silenced
Expression

5

10

15

20

25

MonthsCancer cell differentiation and cell death

Leone G, et al. Haematologica. 2002;87:1324-1341
Hannahan & Weinberg 200031

DACOGEN®: Clinical Strategy• Myelodysplastic Syndromes (MDS)– Seek new labeling for 5 day dosing regimen (DACO-020)•

Convenient, outpatient, commonly used

– Support approval for use in MDS patients in EU and generate data
to support survival indication in US label (EORTC)• Acute myeloid leukemia (AML) in elderly– Support approval in AML patients (DACO-017 and DACO-016)• Pediatrics– Evaluate potential to treat pediatric patients• Oral Dacogen®
– Improved administration flexibility and patient convenience,and extend product life cycle
32

DACOGEN®:
Life Cycle Managementlock• Development

CDA
N– AML indication– Pediatric uses
– Oral decitabine program

HO*CDA: cytidine deaminase

O
O

N
N
Inactive
Metabolite

OH• Research

L1210 model (CDA inhibitor + Decitabine)
Percent survival– Proprietary oral second
generation decitabine
prodrugs– Proprietary oral CDA*
inhibitors

NH2 CDA B

100
80
60
40
20

0 0.0

2.5

5.0

7.5

Days

10.0

12.5

15.0

17.5

Vehicle control
CDA inhibitor (10mg/kg)
Dacogen (0.1mg/kg)
Dacogen + CDA inhibitor

33

AKR-501:

A Novel Compound Being Evaluatedfor Treatment of Thrombocytopenia•

Blood disease characterized by abnormally low level of circulatingplatelets•

Thrombopocytopenia results when:– The liver is damaged by viral infection– Bone marrow is damaged or abnormal– Platelets are sequestered in the spleen and destroyed•

Relevant to the following patients:– Idiopathic thrombocytopenic purpura (ITP)– Cancer patients being treated with chemotherapy– Patients with Chronic Hepatitis-C Viral Infection– Patients with MDS

34

AKR-501: Phase I Clinical Data
Data indicate that:••

AKR-501 induces differentiation andproliferation of megakaryocytes fromhuman CD34+ precursor cells.
AKR-501 increases platelet counts inhealthy subjects when administered once
daily for up to 14 days

500
Mean Change from Baseline
Platelet Count (X1000)

•

400
300
200
100
0

0
3
10
20
Daily Dose (mg/day X 10-14 days)

AKR-501 is well tolerated and no drug
related SAEs have been reported to date35

AKR-501:
Clinical Development Program• Idiopathic Thrombocytopenic Purpura– Phase II trial ongoing– 1st Phase III pivotal program to initiate in FY2009• Hepatitis-C-Related Thrombocytopenia– Phase II trial to begin in first half of FY2008 in patients with cirrhosis
related to HCV• Chemotherapy-Induced Thrombocytopenia– Phase II trial in planning in patients with lymphoma• Myelodysplastic Syndromes– Clinical strategy is currently under evaluation with key opinion leadersin the field of hematology
36

Amolimogene:

Targeted DNA Vaccine forTreating HPV Mediated Diseasez Human Papillomavirus (HPV) infection
can result in pre-cancerous diseasez Non-invasive disease treatment optionthat does not damage healthy tissue

Amolimogene:z A non-replicating, non-integrating DNA
z Expresses a HPV polyprotein (based on E6
and E7 proteins) to activate an immune
responsez Encapsulated in PLG particles
z Lyophilized formulation

z If approved, amolimogene: would
represent the first DNA vaccine therapy
available for human use.
Normal

HPV Lesion

Amolimogene

Immune cells

37

Amolimogene:

Treatment vs. Prophylaxis for Cervical Dysplasia

Prophylactic Vaccine

Medical TherapeuticYY• Goal: elicit antibody response • Goal: elicit immune response• Antibody binds and neutralizes • Immune cells migrate tovirus
cervix; recognize pre-cancer
cells• Prevents infection• Eliminate diseased cells ÆHPVcleared lesion
Y
Antibody
Y
Y

Y

Y

Y
Y

Y

Immune cells

Prevent infection

Treat women with disease38

Amolimogene Clinical Development:
Cervical Dysplasia• Phase I trials– Demonstrated biologic activity– Clinical response in 100% of <25 year olds

• Phase II investigator study– Well tolerated; 67% clinical response overall and 100%
clinical response in patients <25 years old• Phase II company sponsored trial– 161 patients, randomized, controlled– Safe and well-tolerated– Resolution of CIN2/3 (all patients): 43% vs. 27%– Resolution of CIN2/3 (< 25 years old): 70% vs 23%;
(p =0.001)• Pivotal program underway– 2 pivotal trials– First trial (n=250) completed enrollment
CIN: cervical intraepithelial neoplasia

39

ZYC300:

A Targeted Approach to Cancer Therapy
Cytochrome P450 1B1 (CYP1B1):––––

Expressed at high levels in tumor cells
Limited expression in normal healthy tissues
T cells that target CYP1B1 kill tumor cells
Goal: activate T cells in the body to target andkill tumor cells expressing CYP1B1
ZYC300:z A non-replicating, non-integrating DNA
z Expresses CYP1B1 to activate an immune
responsez Encapsulated in PLG particles
z Lyophilized formulation

CYP1B1 Expression (Immunohistochemistry)ALL
AML
Breast cancer
Colon carcinoma
Renal carcinoma
Lung cancer
Lymphoma
Multiple myeloma
Melanoma
Ovarian carcinoma
Prostate cancer

+++
+++
+++
+++
+++
+++
+++
+++
+++
+++
+++

Normal ovary

Serous carcinoma

ZYC30040

ZYC300 Clinical Development:
Solid Tumors• Phase I/II (17 patients with late stage metastatic disease)– Safe and well-tolerated– 6/17 immune responders: all responders had clinical benefit (1 CR, 2 PR,
3 SD) w/ subsequent salvage therapy• Phase I/II (20 patients with late stage metastatic disease)– Enrollment complete– Continued safe and well-tolerated– Elevated levels of CYP1B1 immune responses observed in 11/19 patients• 7/11 of these responders completed all 6 cycles and could be tested for Treg activity• 5/7 showed a reduction in Treg activity– Preliminary evidence of activity in patients with Breast cancer, Colorectal cancer,
Renal cell carcinoma– Clinical signals correlate with CYP1B1 immune response• 3 of 3 patients with CYP1B1 immune responses

41

4. Robust US Operation Strengthened byIntegration with MGI PHARMA

42

“To accomplish great things we mustfirst dream, then visualize, thenplan…believe…act!”
Alfred Montapert

43

Enhancement in Seamless Value Chainwith Morphotek and MGI PHARMA
Strengthen collaboration between functions, simplify decision making
process, and clarify roles & responsibilities
Discovery

Develop-ment

Corporate
R&D
Ridgefield Park, NJ
Andover, MA
Lexington, MA
Exton, PA•Discovery•Preclin. Research•Clinical Research•Regulatory Affairs

Production Distribution Marketing

Pharmaco-vigilance

Woodcliff Lake, NJ, U.S. Headquarters
Executive Staff, Legal, Finance, HR, BD
Manufacturing Distribution
Research Triangle
Park, NC
Baltimore, MD•Pharmaceutical
Production•Clinical Supply
Production•Formulation
Research

Patients

Sales/Marketing

Memphis, TN

Woodcliff Lake, NJ•Distribution of
Aricept as of
Jan 2003•Distribution of
AcipHex as of
Jan 2004•Sales Mgt & Admin•Marketing•Managed Care Mgt• Speed up business operation• Accelerate R&D• Commitment in R&D projects

44

Eisai Dramatic Leap Plan U.S.
(2006 -2011)• Sustain Double Digit Growth• Create Strong Presencein Oncology• Strengthen Independent Marketing
Covered Area
To be covered45

U.S. Market growth slowed…

46

…while Oncology grew atdouble-digit

47

Global Oncology market is growing
rapidly, with large growth insupportive and targeted therapies

48

CNS Market Trend

Alzheimer’s disease market is growing with double digit

49

Eisai Evolution/Transformation
to Pharma+Bio Company (1)Transfer to advanced value chain from discovery to marketing ofboth small molecules + biologics,
utilizing our expertise in small molecules in growing markets
MarketedMarketed
Products
Products(US)(US)

Small Molecules
Aricept®, AcipHex®, Zonegran®,
Aloxi®, Dacogen®, Gliadel® Wafer,
Targretin® Capsules and Gel,
Panretin®, etc.

Pipeline
Pipeline
Candidates
Candidates(Global)(Global)E2007, E7389, E5564, E5555,
E2012, Aquavan®, SaforisTM,
AS-3201, E7820, E6201,
E7080, E7107, E7974, E6020,
AKR-501, etc.

MORAb003, MORAb009,
MORAb004, MORAb028,
MORAb022, Amolimogene,
ZYC300, BAN2401, etc.

• Andover, MA, (U.S.)• Baltimore, MD, (U.S.)• Tsukuba, Japan• Hatfield / London, (U.K.)
etc.

• Exton, PA (U.S.) (Morphotek)• Lexington, MA (U.S.) (MGI)• Kobe, Japan• BioArctic Collaboration(Sweden)50
etc.

ResearchResearch
Sites
Sites
(Global)(Global)

Biologics
ONTAK, Fragmin

Eisai Evolution/Transformation
to Pharma+Bio Company (2)Increasing Presence among Oncologists, Hematologists,
Neurologists, Critical Care Specialists, etc.
• Oncology growing at double-digit growth• US launch plans heavily weighted towards oncology, institutionalcare and specialty markets
NME and New Indication/Formulation:
US Potential Launch and Submission Plans<Potential Launch>
FY2008

Aloxi® PONV (approved), Aquavan®, rufinamide,
Aloxi® Oral

<Submission Plan>
FY2008E2007

FY2009-2011

E7389, E5564, Aricept® Sustained Release Formulation,
Aricept® Patch, Dacogen® AML, E2012, etc.

FY2012-2016

E6201, E7107, AS-3201, MORAb-003, MORAb-009,
Amolimogene, AKR-501, ZYC300, etc.

51

New U.S. Commercial Structure
Oncology &Institutional Care

Sales

Oncology Marketing

Medical &Scientific Affairs

Government Affairs
Reimbursement

Commercial
Operations•Marketing Research•Sales Training•Sales & Marketing Operations•Trade & Pharmacy Relations
Sales

Marketing

Medical Affairs

ManagedMarketAlliance
Management

Primary Care &Specialty52

A Strong, Adaptive, Flexible
and Competitive Organization
Oncology&
Institutional Care

Specialty&
Primary Care

Current
Products

Aloxi® CINV
Fragmin®
Dacogen®
Gliadel® Wafer
ONTAK®
Targretin®
Targretin® gel
Panretin® gel

Aricept®
AcipHex®
Zonegran®
Fragmin®

Product
Candidates

E7389
Aloxi® PONV
E7820
Aquavan®
MORAb-003 E5564
MORAb-009 AKR-501
Amolimogene etc.

E2007
E5555
E2012
E6201

Approx. 400 FTES (Sales
Force of Approx. 280 FTEs)

E3710
AS-3201
rufinamideetc.

Over 800 FTES (Sales Forceof Over 640 FTEs)

53

Maintain AcipHex® Value throughExecuting Account Strategy& Scientific Pursuit• Account Strategy– Ensure patient access to benefits of AcipHex®
• Gained net trade sales growth in the last three years in the face of genericand OTC omeprazole• Provide discounts with contracted customers who can impact AcipHex®
share & volume• Selling activity and higher share of voice will drive formulary pull through• Scientific Pursuit– Advance the science to provide greater patient benefit• Based on appropriate data, promote AcipHex® extended release formulation
as superior PPI in Erosive Gastroesophageal Reflux Disease (GERD)• At market introduction, potential for only AcipHex® and Nexium brands toexist– Drive value of AcipHex® extended release formulation on improved patient
benefit– Use account strategy to ensure patients have access to improvements
in benefits• Prepare AcipHex® OTC to compete in consumer market
54

Maximize Aricept® Value through Pursuitof Patient-centric New Indication and
New Formulation in Growing Market• Continue to contribute to Alzheimer’s disease therapy by
Aricept® and optimize return on sales & marketing activity– Gold standard of care in mild, moderate and severe AD• Pursue the proof of Aricept® benefit to pediatric unmet
medical needs including cognitive impairment due to Down’s
syndrome and to brain cancer chemotherapy• Launch potential new patient-centric formulations– Aricept® Patch (Goal: superior convenience)• Reduction of caregivers’ and patients’ burden - without titration, easy toapply• Target: once a week

– Aricept® sustained release formulation (Goal: superior efficacy)• Target: Increase of drug exposure (AUC) without sacrificing safety profile• Maintain market leadership position in Alzheimer’s to ensure
future opportunities with potential success of E2012
Top Priority, Full Commitment, Multiple Strategies

55

U.S. Business

Drastic Transformation of Business Structure• Evolution to Pharma + Bio Company
Small Molecule＋

Biologics
Fragmin®, ONTAK®
MORAb-003, MORAb-009
Amolimogene, ZYC300

Aricept®, AcipHex®, Zonegran®, Targretin®
Panretin®, Aloxi®, Dacogen®, Gliadel® Wafer,
Aquavan®, E2007, E7389, E5564 …

• Shift from mature products to growing products/areas

Aricept®
AcipHex®

Mature products

Oncology / Institutional
E7820
MORAb-003
E7389
Aquavan
MORAb-009
E7080
DacogenAmolimogene
Aloxi
Alzheimer’s Disease

New Anti-Platelet

E2012

E5555
Growing market
Growing products• Improved the likelihood of achieving DLP U.S. sales target of
440 billion yen in FY2011 and growth beyond FY2012 through
MGI PHARMA acquisition56

5. Our Future

57

Progress of the First 2 Years ofDramatic Leap Plan¾：

World Headquarters
Concept

R&D Strategy• Organized Global Policy & Strategy Council• Launched Japan Business Headquarters (JBHQ)• Started investment in European Knowledge Center¾ Formulated 5-region structure by making China business independent(Japan, U.S., EU, China, Asia, Oceania and Middle East)¾ Relocated Asian headquarters (exclu. China) to Singapore in January 2008
• Established Eisai R&D Management Ltd.
- Instituted R&D Management Committee as the top decision-making body for
R&D function¾ Acquired antibody drug technology and pipeline through acquisition of Morphotek¾ Established Asian clinical research center in Singapore•••

Oncology Strategy

Independent
MarketingTransformation
Strategy
Global Human
Resource Strategy

Events in FY2007

Acquired 4 oncology-related products and oncology expertise from Ligand Pharmaceuticals
Started construction of oncology production facility at RTP, North Carolina manufacturing site
Started operation of API oncology production building (PI building) at Kashima Plant¾ Acquired antibody drug technology and pipeline through acquisition of Morphotek¾ Completed MGI Pharma acquisition: Enhanced Eisai’s commercial infrastructurein the U.S., the most important market for Eisai where the largest pharmaceuticalcluster is formed• Established Global Medical & Marketing Services in the U.S.
• Internalized the ordering system in the U.S.
¾ Number of sales force: U.S.: 1000+ (as of end of Feb. 08), Japan: 1290, Europe: 500, Asia: 980 (as of Sep. 07)¾ Enhancing Eisai’s commercial infrastructure in the U.S. through the acquisition of
MGI Pharma•

Established an API research and production company in Vizag, India and started construction on
new facility in December 2007
¾ Entered agreement to outsource global clinical data management at Chennai India
Started full operation from February 2008

• Established Global HRM Strategy Section• Developed and implemented Global HRM Policy¾ Developed and implemented Global Executive Leadership Development Program58

Dramatic Leap Plan
3rd Year’s Resolution

The four high priority issues to be tackledwith a unified effort by the Company
E7389: Pursue approvals as the 2nd & 3rd line treatment
for breast cancer in U.S, Europe and JapanE5564: Pursue approval as treatment for severe sepsis in U.S.,
Europe, and Japan
E2007: Pursue approvals as treatment for Parkinson’s disease andneuropathic pain in U.S. and Europe
Aricept®: Pursue proof of Aricept benefit to pediatric unmet medical needs
Pursue approval of new formulation (sustained releaseformulation, transdermal patch formulation)
59Selection of Eisai Corporate Programs
Target approval/launch of four focused global projects during DLPCEO Office• Allocate and concentrate global talent onthese programs• Invest with highest priority• Report directly to CEO Office
Eisai
Global ClinicalEisai Corporate Programs Office

E2007
Office
Chair

E7389
Office
Chair

E5564
OfficeChair

ART-LCM
OfficeChair

Dedicatedmembers

Dedicatedmembers

Dedicatedmembers

Dedicatedmembers

Projects

60

Increase the Likelihood of Achieving Sales of
1 Trillion Yen and ROE of 16% in FY2011
Sales mix by products in FY2011, the final fiscal
year of Dramatic Leap Plan
¥1 trillion
New Products/
Business
Development

New Products/
Business Development

Aricept®

Aricept®

AcipHex®/Pariet®

AcipHex®/Pariet®

Other current
products

Other current
products

ＤＬＰOriginal

ＤＬＰUpdate

MGI

61

Increased the Likelihood of Achieving
the Dramatic Leap Plan (1)Contribution of MGI PHARMA($ millions)

1200
1000

Net Sales

Operating Income

800

900+

750 +

600
400

1,000-1,100

550+
412*

200

1C
07-1

A

-28%
5
2
GR
220+

270+

300-330100+

0CY2007

FY2008FY2009FY2010FY2011

Cost Synergy

60+

90+

100+

100+

Aloxi®:$550-600m
Dacogen®:$300- 350m
Gliadel® Wafer:$50-70m®
Aquavan :
$100m
.
.
.

*: 2007 figures aren't audited yet

Contribution of MGI PHARMA to Sales and Profits
will be continuously growing after FY2011

62

Increased the Likelihood of Achieving
the Dramatic Leap Plan (2)Japan sales expansion
Sales mix target ratio for Japan, U.S., Europe and Asia of:

36:44:14:6 → 42:43:10:5
Japan sales target in FY2011:¥360 Billion → ¥420 Billion
Growth drivers for Japan•

Rapid growth of Aricept® and Pariet®
•••

Aricept®’s rapid
expansion in Japan

Recorded top-class growth ratio according to market
research
Pariet® steadily expand into No.1 PPIPlan to launch new products by FY2011
D2E7(Humira® /adalimumab):Rheumatoid arthritis, Psoriasis, Crohn's diseaseT-614 (iguratimod): Rheumatoid arthritis
KES-524 (sibutramine): Obesity management
E2014 (Botulinum Toxin Type B): Cervical dystonia

90.0

85.0
62.0
42.3

49.7

2005 2006 2007 2008 2009 2010 2011

DLP

Results, New forecast

63

Growth Strategy
towards FY2016
1. Regional Strategy
2. R&D Strategy

64

1. Regional Strategy
Japan

Integrate the four businesses - prescription pharmaceuticals, consumer
health products, diagnostic products, and generics – under Japan
Business Headquarters (JBHQ), covering“ prevention, intervention
and innovation”

U.S.

Shift to growing products/areas from mature products
Oncology and Alzheimer’s Area, New Anti-Platelet
Roll out small molecule along with biologics
Target to become a multiple Pharma + Bio Company

EuropeTarget to become a Neurology/Oncology/Critical Care House
Consolidate key functions such as information, services andmanufacturing at European Knowledge Center, currently underconstruction
One unified European territory
Target to grow in new EU member countries

China(5th in the World)

Seek to enrich the product portfolio that matchesdisease structure and income structure

Asia, Oceania
and Middle East

Nurture business in India (10th market in the world)to the core of this area65

2. R&D Strategy
1) Eisai R&D Structure characterized with Global Talents
Hatfield/London
Andover (MA)
Lexington (MA)Ridgefield Park (NJ)
Exton (PA)Baltimore (MD)• Organizational structure creating the champions(therapeutic disease area and discovery basic
technology)• Science / Technology excellence, Enhanced
translational research– Expand capability of Bio-marker with reinforcementof Proteomics, Genome science & technology,
cellular biology, and image analyses– Set up “Translational Medicine Group” to strengthen
cooperating with basic research group andaccelerate POC process• Use of clusters for discoveries in U.S., U.K., Singapore,
India and Japan

Tsukuba
Tokyo
Kobe
Vizag
Chennai
Singapore

Clinical ResearchDiscovery
Clinical Researchand Discovery

66

2. R&D Strategy
2) Discover New Molecular Entities, small moleculeand biologics, in three focused areas• Integrative Neuroscience, Oncology & Critical Care, andImmunology/Vascular Biology• Enforce capability in discovering new antibodies throughexpanding Morphotek• Improve DNA Vaccine Technologies at MGI• Pursue beta amyloid Antibody program for Alzheimer’s
Disease with Bioarctic Neuroscience• Pursue additional indication of Humira®(D2E7) in Japan
Rheumatoid arthritis, Psoriasis, Crohn's disease, Ankylosing spondylitis,
Juvenile rheumatoid arthritis, and Ulcerative colitis

67

Oncology Area Pipeline Strategy
Comprehensive Therapeutic Approaches to Cancer and its Medical Needs,
Small Molecules to Biologics, and Supportive Care
Late Phase
Clinical ResearchPreclinical Research

Early Phase
Clinical Research

GPI21016 Cancer therapy,

E7070 Cell Cycle G1 Phase

E7389

Radiotherapy sensitizer

Targeting Agent

Microtubule Growth Suppressor

E7974 Hemiasterlin TypeTubulin Polymerization Inhibitor

Irofulven Semi-synthetic

Novel Cytotoxic
Anti-cancer

Derivative of Toxin Illudin S

E7107
RNA Splicing Modulator

E6201
Novel natural product-inspired
MEK-1/MEKK-1 kinase inhibitor

Anti-Angiogenesis,
Anti-proliferation

E7820 Alpha-2 Integrin
Expression Inhibitor

E7080 VEGF receptor
tyrosine kinase inhibitor

MORAb-004

MORAb-009

MORAb-003 Anti Folate

Antibody

Anti Mesothelin mAb

Receptor Alpha mAb

Vaccine Adjuvant

ZYC300 Cancer
Therapeutic DNA Vaccine

HPV Therapeutic DNA Vaccine

GCPII Inhibitor

AKR-501

AquavanTMProcedural Sedation

Nerve Disorder by Chemotherapy

Thrombocytopenia

for Minor Surgery/Diagnostics

Monoclonal
Antibody

MORAb-028
Antibody

E6020

VaccineSupportive Care

Amolimogene

SaforisTM
Oral Mucositis：

Biologics

：

MGI

68

Neuroscience Area Pipeline Strategy
Aiming to Discover Next-generation AD Therapeutic Drug with Application of Biologics
and Gene Technology
Exploratory Research Preclinical Research
Alzheimer's
diseaseDementia

Clinical Research

Alliance with DNAVEC

Alliance with BioArctic

Aricept® New formulations

Beta-amyloid vaccine

Anti-beta amyloid Antibody

Sustained Release and Patch Formulation

Alliance with TorreyPines Gamma-Secretase Modulator
Genes responsible for LOAD

E2012

ProgramGamma-Secretase Modulator

Novel
Mechanism of Action

AMPA Receptor Antagonist

Novel
Mechanism of Action

Parkinson’s
DiseaseE2007
Zonegran®
New Indication (Generalized Seizure)

Epilepsy

E2007
AMPA Receptor Antagonist

GCPII Inhibitor

Neuropathic Pain

Novel
Mechanism of Action

AS-3201
Aldose Reductase Inhibitor

E2007
AMPA Receptor Antagonist

Depression

E2508

Sleep Disorder

Lunesta®

：

Biologics

：

MGI

69

Immunology and Vascular Disease Pipelines
Creating the First-in-class Small Molecules and Antibodies Based on the Cell and
Vascular Biology in Japan, the U.S., and Europe
Exploratory/Pre-clinicalResearch

Rheumatoid
Arthritis

Vascular andThrombus

Psoriasis
Crohn’s Disease：

Biologics

Clinical Research

D2E7／Humira®

MORAb-022
Monoclonal Antibody

Fully human monoclonalanti-TNF-alpha antibody

T-614／Careram®

Novel
Mechanism of Action
Novel
Mechanism of Action

Submission

Rheumatoid Arthritis Treatment

E5555
Thrombin Receptor Antagonist

Novel
Mechanism of Action
E6201

D2E7／Humira®

Novel natural product-inspired
MEK-1/MEKK-1 kinase inhibitor

Fully human monoclonalanti-TNF-alpha antibody

D2E7／Humira®
Fully human monoclonalanti-TNF-alpha antibody

70Rich Pipeline Will Drive Growth
During and Beyond DLP
E2012 Alzheimer’s disease
MORAb-003 Antibody, ovarian cancer
E5555 Acute Coronary Syndrome
AS-3201 Diabetic complication
MORAb-009 Antibody, pancreatic cancer
E7080 VEGF receptor TK inhibitor
E7820 Alpha-2 expression integrin inhibitor
E3710 Acid-related disease/new PPI
E7974 Tubulin polymerization inhibitor
E7107 RNA splicing modulator
E6201 Psoriasis, Cancer
E3210 IBS
E5555 Acute Coronary Syndrome

E7389
E2007

Breast cancer
Parkinson’s disease,
Neuropathic Pain
E5564 Severe sepsis
D2E7
Rheumatoid arthritis, Psoriasis
T-614 Rheumatoid arthritis
KES524 Obesity Management
SEP190 Sleep disorder
Clevudine Hepatitis B
Aloxi® CINV, PONV
Dacogen® Myelodysplastic syndrome
Gliadel® Wafer Implant treatment for
malignant glioma®
Salagen Dry mouth
Hexalen® Ovarian cancer
Aquavan® Sedation
SaforisTM Oral Mucotitis

FY2007

FY2008FY2009FY2010FY2011

Dramatic Leap Plan (FY2006-2011)
Blue Letters: MGI PHARMA

Amolimogene Therapeutic DNA vaccine
AKR-501 Thrombocytopenia
Irofulven Prostate cancer
ZYC300 Therapeutic DNA vaccine

FY2012FY2013

FY2014FY2015FY2016Further Leaping (FY2012 - )71

Next Mid-term Strategic Plan
(FY2012-2016)

Target Sales of 1.5+ Trillion Yen and ROE of 20+%72