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Astellas Growth Strategy -Leveraging Our Strengths to Grow- Masafumi Nogimori President & CEO Astellas Pharma Inc. J.P. Morgan HealthCare Conference January 2011

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Page 1: 20110111_en

Astellas Growth Strategy-Leveraging Our Strengths to Grow-

Masafumi NogimoriPresident & CEOAstellas Pharma Inc.

J.P. Morgan HealthCare ConferenceJanuary 2011

Page 2: 20110111_en

Target figures in this material are not forecasts of business results. In addition, any description relating to the future in this material is subject to known or unknown risks and uncertainties, although it is based on management’s current assumptions and beliefs in light of the information currently available to it. Please be cautioned that a number of important factors could cause actual results to differ significantly from the description in the material.

Such risks and uncertainties include adverse economic conditions, currency exchange rate fluctuations, adverse legislative and regulatory developments, delays in new product launch, pricing and product initiatives of competitors, the inability of the company to market existing and new products effectively, interruptions in production, infringements of the company’s intellectual property rights and the adverse outcome of material litigation.

This material contains information on pharmaceuticals (including compounds under development), but this information is not intended to make any representations or advertisements regarding the efficacy or effectiveness of these preparations nor provide medical advice of any kind.

Cautionary statement regarding forward-looking information

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Business Model of Astellas

VISION 2015で掲げた指針・目標を継続するConcentration on Proprietary

Ethical Pharmaceutical Business

新薬ビジネス

Establish a competitive edge as a Global Category Leader (GCL)

A “GCL” shows higher competitiveness by providing value-added products ‘globally’ in several ‘categories’where a high degree of expertise is required. And takes over the position of ‘leader’ in the categories

Strengthen In-house R&D capabilities

Concentrate proprietary ethical pharmaceutical business Innovative

pharmaceutical business approach

Proprietary ethical pharmaceuticalbusiness approach

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Landing of Science

Landing of Science

H2 receptor antagonists Beta receptor blockers etc.

HMG-CoA

Nucleic acid drugs

Molecularly-targeted drugs

Antibodies etc.

Current Market

Tissue engineering(ES cell, iPS cell, Somatic cell )

System biologyPharmacogenomics ToxicogenomicsDeciphering the human genome

Drug discovery research utilizing drug target moleculeand disease related gene (HTS, structural biology, CADD)DNA recombination technology

PCR

Technology innovation sustaining drug discovery

NSAIDs etc.Market Size

Drug Discovery and Science Progress

4

~1950 1950~1990 latter half

Pharmaceutical market grew as science progresses

Future Market

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Current GCL Area and Future GCL Candidates

Establish a GCL model in the five focus therapeutic areas utilizing multiple NME platforms

Current GCL areas Future GCL candidates

Oncology

Neuroscience

DM Complications & Metabolic Diseases

Immunology & Infectious

DiseasesTransplantationUrology

Small molecule synthesis

NME platform

Fermentation Antibody Protein

NME platform

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Actively Approach to Precision Medicine Drug Discovery

Astellas aims to establish a leading position in Precision Medicineby leveraging translational science and biomarker research

“One-size fits all” prescription

Past

Highly effective drugs for defined patients

Future

Higher efficacy and fewer side effectsSmaller-scale clinical trials targeting specific population of patientsPharmacoeconomical advantages by prescribing for responders only

Precision Medicine:Offering highly effective therapeutic options for precisely defined patient populations based on molecular targeting and precise diagnosis

Mass Medicine Precision Medicine

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FY2010-FY2014 Mid-term Management Plan- Basic Policy and Strategy

長期成長

Growth strategy• Therapeutic area strategy

• Regional strategy

• R&D innovation strategy

Efficiency strategy• Improve cost efficiency

Overcome decrease in sales and earnings from U.S. patent expiry of Prograf and Harnal and accelerate growth to a new stage

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Transplantation :Maintain and Reinforce Global Leading Position

n ASKP1240 P2 (US), P1(JP)Antibody- CD40 antagonistic monoclonal antibody

n ASP0485 P2 (EU/US)Protein

- LFA3-IgG fusion protein

n ASP015K P2 (US), P1 (JP)Small molecule

- Immunosuppressant

20%

13%

29%

38%FY2009 FY2010

ForecastFY2014 Target

JapanEurope

AsiaAmericas

Over 160.0*154.7

186.7(billion yen)

Maintain and Maximize Prograf Business

Suppression of Organ rejection in organ transplant

Prevention of DGF in Kidney transplant

n Diannexin P2 (EU/US)Protein-Phosphatidylserine binding inhibition

Unique Candidates in Clinical Phase

Aim to contribute further to the transplantation community

*Revised sales target which was announced in May, 2010 due to revise expected FX rate.

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Urology:Maximize Global Sales

20%

13%

29%

38%

154.1

Growth Driver :Vesicare and Mirabegron

Vesicare

Over 215.0 *

BPHOAB

(billion yen)

Over 155.0

FY2010Forecast

FY2014Target

Strengthen Global Leading Position in OAB

Vesicare+Mirabegron

89.5

Harnal/Omnic

OABn Vesicare OD Approval (JP) LCM of Vesicare n ASP3652 P1 NME

BPH n EC905 P3(EU) LCM of Harnal

/Vesicaren AKP0306 P1 NMEn AKP-002 P1 NME

Nocturian ASP7035 P1

Mirabegron NDA filing Japan: June, 2010 US/EU: 2Q/ FY2011

Harnal/Omnic+EC905

*Revised sales target which was announced in May, 2010 due to revise expected FX rate.

64.6Approx.60.0

Maximize Global Sales in OAB and BPH

LCM and NME Candidatesin Clinical Phase

Aim for continuous high sales growth

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October 2010Submit NDA of Degarelix

June 2010Acquisition of OSI-Acquire fully integratedoncology capabilities in the U.S. -Expand clinical stage oncologypipeline

-Access to small molecule discovery research platform in oncologyDecember 2009

AC220 (AML)Licensed fromAmbit

October 2009MDV3100 (Prostate cancer)Licensed from Medivation

December 2007Acquisition of Agensys-Generation of fully human monoclonalantibodies

-Gain target molecules in the oncology field

-Therapeutic antibodies in R&D pipeline

Oncology:Reinforcement of Oncology Business Base

Select “oncology” as a focus therapeutic areaPromote in-house research system(Initiate antibody research headed by Molecular Medicine Research Labs.)

March 2007 MorphoSys: Phage antibody library

March 2007 Regeneron: VelocImmuneⓇ generating fully human monoclonal antibodies

2006 2010

July 2010Extend license agreement

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Oncology Pipeline ExpansionProject

Product name Target cancer P1 P2 P3 Filing

Small molecule

MDV3100 Prostate cancer EU/USA/JP

AC220 Acute myeloid leukemia EU/USA

ASP3550degarelix Prostate cancer 1M formulation: JP

3M: JP

YM155 Breast cancer, Non-Hodgkin's lymphoma, Melanoma EU/USA/JP

ASP1707 Prostate cancer, Endometriosis

Tarceva (Extension)

NSCLC (1st line for patients with EGFR mutation, adjuvant), Hepatocellular carcinoma USA

OSI-906 Adrenocortical carcinoma, Ovarian cancer, NSCLC, Hepatocellular carcinoma

Adrenocortical: USAOvarian etc: USA

OSI-027 Renal cell cancer

Antibody

AGS-1C4D4 Pancreatic cancer EU/USAASP6183

(AGS-8M4) Ovarian cancer USA

AGS-16M18 Cancer

AGS-16M8F Renal cancer

ASG-5ME Prostate cancer, Pancreatic cancer11

* Development suspended

OSI

OSI

OSI

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Achieved many alliances that have helped bolster the pipeline and products

Qutenza Peripheral neuropathic pain

in non-diabetic adults

VIBATIV cSSTI: Complicated Skin and Soft Tissue Infection

telavancinHAP: Hospital-acquired

Pneumonia

ASP8825(XP13512)

Restless legs syndrome

GeninaxOral quinolone antibiotic

Degarelix Prostate cancer

AmevivePsoriasis

YM311 ASP1517 etc.(FG-2216 FG-4592, etc.)

Renal anemia

ASP1585(AMG223)

Hyperphosphatemia

CD40 antagonistic monoclonal antibody

Transplantation

CTS-21166, etc.Alzheimer's disease

MAXY-4Transplantation,

rheumatoid arthritis and otherautoimmune diseases

febuxostatHyperuricemia in gout

Sumavel DosePro Acute treatment of migraine

and cluster headache episodes

Caduet Combination TabletsHypercholesterolemia and

hypertension treatment

Symbicort TurbuhalerTreatment of

adult bronchial asthmaMDV3100

Prostate cancerLinaclotide

IBS and chronic constipation

AC220Acute myeloid leukemia

IsavuconazoleFungal infections

Joint venturewith Maxygen

Licensed in Regeneron ’sVelocImmune technology

Utilizing MorphoSys AG’s antibody library

Agensysacquisition

Strengthened antibody drug business

Seattle Genetics and Agensys Expand

antibody-drug conjugate (ADC) collaboration

Alliance Achievements Between FY2005 and FY2010

Technology in-licensing

FY2005 FY2006 FY2007 FY2008 FY2009 FY2010UMN-0501/-0502

Influenza

AKP-002Functional symptoms

of benign prostate hyperplasia

DiannexinPrevention of DGF

in kidney transplantation

Regeneron ’sVelocImmune technology

Extension of license agreement

Strategic equity agreement with Cytori

Technology in-licensing

OSIacquisition

Technology in-licensing

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: In-house global :Local, licensed-in, new Indication, or new formulation

MDV3100 (JP)AGS-16M18AGS-16M8FASG-5MEYM155 (JP)ASP1707

Oncology

ASP0777FK949ECNS

telavancin (JP)Anti-

Infective

ASKP1240 (JP)ASP015K (JP)ASP3291ASP4058

TransplantImmunologyInflammation

P2

ASP0456Others

YM311 (JP)#ASP1517 (JP) #ASP4178ASP5034

DiabetesCardiologyRenal

ASP3652, ASP7035ASP0306, AKP-002Urology

P1P3Filed

ASP8825 (Restless legs syndrome, JP)

YM177 (Acute pain, JP)

ASP1585 (Hyperliphosphatemia, JP)

YM178 (OAB, EU/USA)

YM150 (VTE, JP)

solifenacin/tamuslosin (EU)

YM529 (1M, JP)YM443 (FD, JP)

telavancin (NP, USA)

RSD1235 (AF, USA)

ASP0485 (Transplant, EU/USA)

ASP9831 (Hepatitis, EU)ASP015K (Transplant, USA)

ASP3550 (1M, JP)

telavancin (cSSTI/NP, EU)

ASP1941 (DM, JP) YM150 (VTE:EU/USA, AF:EU/JP/Asia, ACS:EU)

YM311 (USA), ASP1517 (USA)#

ASP1941 (EU/US)YM533 (Chronic renal failure, JP/Asia)

ASP2151* (USA/JP)

ASKP1240 (Transplant, USA)

isavuconazole (Aspergillosis, candidemia, EU/USA)

YM178 (OAB, JP)

YM060 (IBS, EU)YM060 (IBS Female, JP)

MDV3100 (EU/USA)

elrotinib (USA)

OSI-906 (Adrenocortical, USA)

YM155 (EU/USA)

AGS-1C4D4 (EU/USA)AC220 (EU/USA)

ASP6183* (AGS-8M4) (USA)ASP3550 (3M, JP)

YM905 (Pediatric, EU/USA)

Diannexin (DGF, USA)

PSN821 (Diabetes, obesity, USA)

*Development suspended, # Licensed territory: EU and JP etc.,

OSI-027(USA)

Robust Pipeline

OSI-906 (Ovarian, USA)

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Well-Balanced Business Expansion in 4 Regions

179.8 billion yen18.4%

Americans

Consolidated Net Sales(FY2009):974.8 billion yen

529.2 billion yen54.3%235.8 billion yen

24.2%

29.9 billion yen3.1%

Europe

Japan

Group HQ/Regional HQ

Sales Affiliate/Promotion Base (EUR)

R&D Base

Manufacturing Base

5,600 MRsSales through own affiliatesin more than 40 countriesWide coverage including emerging countries such as BRICs

Sales by Geographical Areas (FY2009)

Asia

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Strength for Each Area

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Americas

nBusiness model focused on specialty areasnSales affiliates

in USA, Canadaand Brazil

nRealize high growth by expanding sales in each country nMain Asia market cover

-Sales affiliates in 8 countries/areas

nNo.1 sales among Japanese pharmaceutical companies*n Extensive geographic coverage

-20 sales affiliates/9 promotion offices

n Top ranked sales forcen Rich product lineup

(Therapeutic areas and product numbers)

*Copyright 2010 IMS health. All rights reserved. Source: World Review Preview 2010 (2009 YR) Reprinted with permission.

Japan

Asia

Americas

Europe

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Europe

Growth Drivers for Each Area

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Japan Americasn Vesicare n Lexiscann Mycaminen Protopicn VIBATIVn Sumavel DosePron Tarceva revenue

n Prografn Harnaln Vesicaren Mycaminen Protopic

n Vesicaren Prografn Micardis family

(Micombi, Micamulo)n Celecoxn Geninax n Symbicortn Bonoteon Irribow

n Vesicaren Eligardn Mycaminen Protopicn Qutenza n Bendamstine royalty income

Asia

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Business Expansion in Emerging CountriesExpect High growth

Europe

n Russia -Established the affiliate in 1994

• High growth rate (2Q/FY10 +42%)• The 5th largest sales among

European countries • Further expanding in CIS

n Brazil -Established the affiliate in 2009 -Expect high sales growth

Americas

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n India-Established the affiliate in

2008

n Expanding intoother countries

n China -Established the affiliate in 1994

• High growth rate (2Q/FY10 +19%)• Aim for sales of more than double of

FY2010 in FY2014• Increase MRs to expand customer

coverage• No.1 in sales among Japanese Companies

Brazil

n Turkey / Poland- High growth rate (2Q/FY10 +30%)

n Romania/Bulgaria-Recent Regal entity for promotion

n Expanding into other countries

(Source: IMS MIDAS®, CY2009.3QYTD)

ブラジル

FY2010Forecast

FY2009

China

Russia

China

Russia

Brazil

Approx. 30 billion yen

Asia

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Growth Realization to FY2014

Continuous growth in both net sales and operating income after FY2010

Symbicort (JP)Bonoteo(JP)

Qutenza (EU)Sumavel

DosePro (US)VIBATIV (US)

FY2009 New Products

ASP8825 (JP)

Launches

Mirabegron (JP/US/EU)

Launches

Japan New Product Lineup (Degarelix, YM150VTE,

YM529, YM443, ASP1585)telavancin (EU)

EC905 (EU)

LaunchesMDV3100 (US,EU)

ASP1941 (JP)RSD1235 (US)AC220 (EU,US)

isavuconazole (EU,US)

Launches

910.9

OSI ImpactSales +56.0 OP +5.0

FY2010 FY2011 FY2012 FY2013FY2014

FY2010 Forecast

Sales 942.0 OP 124.0

(billion yen)

FY2014 Target

Sales 1,096.0 OP 226.0

(billion yen)

OSI ImpactSales +31.0 OP -11.0

FY2014

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Further strengthen the orientation to patients and make the best efforts to meet unmet medical needs for

patients all over the world.