Last Update June. 21, 20131

「日本におけるケミカルバイオロジー研究新展開」

研究開発専門委員会第6回定例会

2013. 8. 5, ホテル京阪京都

Last Update June. 21, 20132

Meiji Group Overview

Last Update June. 21, 20133

Meiji Group

Ethical Pharmaceutical Business

Agricultural Chemicals and Veterinary Drugs Business

Unit for Confectionary Business

Unit for Dairy Products Business

Unit for Healthcare and Nutrition Business

Unit for International Business

Consolidated Sales$11.2B (Apr. 2012 – Mar. 2013)Consolidated Number of Employees15,338 (as of March 31st, 2012)

Last Update June. 21, 20134

Meiji Group Financial Overview

Consolidated Sales$11.2B

Operating Incomes$258M

*Based on the sales before intergroup elimination**Apr. 2012 - Mar. 2013

Confectionary and Healthcare

$4.07B30%

Pharmaceuticals$1.27B

10%

Others$1.84B

14%

Dairy Products$170M66%

Confectionary and Healthcare

$21M8%

Pharmaceuticals$64M25%

Others$2M1%

Dairy Products$6.17B

46%

1USD=100JPY

Last Update June. 21, 20135

Meiji Seika Pharma Co., Ltd.

Last Update June. 21, 20136

2020 Vision

• Business Expansion through Proactive R&D

Investment

• Further Expansion of the Generic Drugs Business

• Proactive Expansion of International Business,

mainly in Asia and Emerging Countries

Contributing to the well-being of people worldwide through the research and development of ethical pharmaceuticals, agricultural chemicals and veterinary drugs, and by providing high-quality, low-priced generic drugs.

Last Update June. 21, 20137

R&D Administration

Non-consolidated Employees: 2,071 ( as of March, 2012)

R&D Expenditure: $150M (FY2012)

Intellectual PropertyPharmaceutical Research Center

M. MatsuoPresident & Representative Director

Agricultural & Veterinary Div.

Reliability & QA Center

K. Mori General Manager

International Headquarters

Production Div.

R&D Div.

Marketing Div.H. Uchida Senior Managing Executive Officer

Organization of Meiji Seika Pharma

Generics Development

Corporate Development

CMC Labs. Bioscience Labs.

S. Kurokawa Executive Officer

HR & General Affairs

Financial & Accounting

Audit

Drug Information Center

K. Noda General Manager

R. AsadaSenior Executive Officer Y. Murai Senior Executive Officer

Portfolio Management

New Product Planning and Creation

Partnering Strategy and Business Development

H. Yamaguchi Executive Officer

M. Egawa Executive Officer

Y. Sasaki Executive Officer

Last Update June. 21, 20138

Task : Drug Discovery & Research Operation, External Research Collaboration

New Product Planning and Creation Partnering Strategy and Business Development

Task : Agro-Vet Licensing, Generic Product Licensing,R&D Contract

Task : R&D Strategy, Portfolio Analysis & Optimization, Business Assessment and Valuation

New Product Planning and CreationGeneral Manager

Licensing and Product AcquisitionGroup Manager

Research Planning and Operation Group Manager

Licensing and Alliance ManagementGroup Manager

Business Development and Alliance ManagementGroup Manager

Executive Officer: Mr. Yuji Sasaki

Task : Strategic Alliance (incl. M&A),Business Development, Product & Technology Out-Licensing

Partnering Strategy and Business DevelopmentGeneral Manager

Portfolio Management General Manager

Task : Product In-Licensing, Marketing Alliance

Last Update June. 21, 20139

Employees (As of March, 2013)12 Branches and 76 Sales Offices

MR ca. 780(CNS specialized MR ca. 170 )R&D ca. 360

Headquarters (Kyobashi Tokyo)- Domestic Marketing Div.- Production Div.- International Div.- Reliability & QA Center- R&D Div.

Pharmaceutical Research Center &CMC Labs. (Yokohama)

Bioscience Labs. (Ashigara)

Business Locations & Group companies: Japan

Odawara Plant (Drug Formulation)

Kitakami Plant (API)Gifu Plant (API)

Group companies

・Ohkura Pharmaceutical

Manufacturing & sales of ethical pharmaceuticals

・Kitasato Pharmaceutical Industry

Sales of ethical vaccines

Ohkura Pharmaceutical (Kyoto)

Kitasato Pharmaceutical Industry (Tokyo)

Last Update June. 21, 201310 Beijing Office

Overseas Employees : 1,963

Business Locations: World

Shantou Meiji Pharmaceuticals Co., Ltd. (1989)

Production & Distribution

P.T. Meiji IndonesianPharmaceutical Industries (1974)Production, Distribution & Export

Thai Meiji Pharmaceuticals Co., Ltd. (1979)Production, Distribution & ExportTedec-Meiji

Farma, S.A. (1991)Production, Distribution & Export

Los Angeles Office

Meiji Pharma (Shandong) Co., Ltd. (2004)

Fermentation Production

Dong-A Meiji Bio Limited. (2012)Monoclonal Antibody Production

Meiji Pharma Korea Co., Ltd. (2012)Distribution (Agrochemicals)

Last Update June. 21, 201311

Consolidated basis$1,273M

Ethical Pharmaceuticals$1,056M

- domestic sales- overseas sales- export

AgrochemicalsAnimal Health$217M

Segment Sales

Apr. 2012 - Mar. 2013

83%

17%

1USD=100JPY

Last Update June. 21, 201312

Ethical Pharmaceutical Sales by Therapeutic Area in the Japanese market ( Apr.2012―Mar.2013 )

Meiact®Fosmicin®

Isodine®

Habekacin®

Omegacin®

Orapenem ®

Sword®

Meilax® ( Ethyl Loflazepate ) : AnxietyDepromel® ( Fluvoxaime ) : Depression, OCD, SADReflex® ( Mirtazapine ) : DepressionDiacomit ®( Stiripentol ) : Antiepileptic

Ebastel® ( Ebastin ): Urticaria, RhinitisDaunomycin: Acute LeukemiaTherarubicin® ( Pirarubicin ) : Malignant LymphomaLaserphyrin （Talaporfin Sodium ）: Lung CarcinomaOxis® 9µg Turbuhaler® ( Formoterol ) : COPD

Infection (33%)$280M

CNS (26%)$219M

Others (10%)$82M

Generics (31%)$265M

Total$846M

Last Update June. 21, 201313

Brand Name Activity/Indication Sales in Japan Partner（Date of Launch）

Meiact (’94.6) Oral cephem $167M Reflex (’09.9) NaSSA* : Depression $136M MSD

Depromel (’99.5) SSRI: Depression, OCD, SAD $48M Abbott

Vancomycin MEEK (’02.7) Antibiotic $38M Kobayashi Kako

Amlodipine (’08.7) Ca antagonist $38MFosmicin (’80.12) Fosfomycin $36MMeilax (’88.12) Benzodiazepine: Anxiety $34M Sanofi-Aventis

Sulbacillin (’06.9) Antibiotic $22MOrapenem （’09.8） Oral carbapenem $21M Pfizer

Isodine (’61.11) Anti-septic $21M Mundipharma

Donepezil (’11.11) Anti-Alzheimer’s disease $19MEbastel (’96.6) H1antagonist: Urticaria, Rhinitis $18M Dainippon Sumitomo

Omegacin (’02.3) Carbapenem $14M Pfizer

Habekacin (’90.12) Aminoglycoside: MRSA $13M

Ethical Pharmaceutical Leading Products in the Japanese Market ( Apr.2012―Mar.2013 )

* NaSSA : Noradrenergic and Specific Serotonergic Antidepressant

【Infectious Disease】

Compound Activity Indication Status Partner

ME1111 Antifungal Onychomycosis Phase I

Sym006 Polyclonal human antibodies

Pseudomonas aeruginosa infection

Preclinical

Research Collaboration with Symphogen

Last Update June. 21, 201314

Product Pipeline : Infection Disease

Developing outside Japan Meiji Seika Pharma original compound

【CNS】

Compound Activity Indication Status Partner

ME2136(Asenapine)

SDA Schizophrenia Phase IIIMSD(in-license)

Depromel(Fluvoxaime)

SSRI Obsessive Compulsive Disorder ( Pediatric )

Phase IIILine Extension

Abbvie(in-license)

ME2112(Ziprasidone) SDA Schizophrenia Phase II

RaQualia(in-license)

Reflex(Mirtazapine)

NaSSA FibromyalgiaPhase IILine Extension

MSD(in-license)

ME2125(Safinamide)

MAO-B inhibitor Parkinson’s Disease Phase INewron(In-license)

Last Update June. 21, 201315

New Product Pipeline : CNS

Developing in Japan

Last Update June. 21, 201316

New Product Pipeline : Unmet Medical Needs

【Unmet Medical Needs】

Compound Activity Indication Status Partner

ME2906 PhotosensitizerGlioma

Esophagus Cancer

NDAClinical Research

ME3113(Udenafil)

Phosphodiesterase V inhibitor

Benign Prostatic Hyperplasia Phase IIb

Dong-A(In-license)

DMB-3111(Biosimilar)

Monoclonal Antibody Breast Cancer Preclinical Dong-A

Developing in JapanDeveloping outside Japan

Last Update June. 21, 201317

Partners’ Development Activities

【International Development】

Compound Activity Indication Status Partner

LS11(ME2906) Photosensitizer

Hepatocellular CarcinomaMetastatic Colorectal CancerBenign Prostatic Hyperplasia

Phase IIIPhase IIIPhase I

Light Sciences Oncology(out-license)

ME3301 Anti-inflammatory IBD, Allergic Rhinitis Phase II Amalyte(out-license)

CP8816 & CP8863

Progesterone receptor modulator Endometriosis Preclinical

Tokai(out-license)

MN-447 (CP4715)

GPⅡbⅢa & αvβ3 receptor dual antagonist

Acute Ischemic Heart Disease Cerebral Infarction

PreclinicalMediciNova(out-license)

Developing in JapanDeveloping outside Japan

Meiji Seika Pharma original compound

Recent Alliance Deals

Last Update June. 21, 201318

Year Partner Type of CollaborationApr/2013 MSD In license of Asenapine / Schizophrenia in Japan

Oct/2012 OHKURA Distribution of Check hMPV / Diagnostic reagent kit in Japan

May/2012 AstraZeneca Distribution of Oxis® 9µg Turbuhaler®28doses / COPD in Japan

May/2012 OHKURA Distribution of Check AD / Diagnostic reagent kit in Japan

Apr/2012 R-Pharm Out license and Distribution of MEIACT MS® and ADANT® in Russia

Apr/2012 Thien Thao Distribution partnership of Meiji products in Viet Nam

Jan/2012 Newron In license of Safinamide / Parkinson’s Disease In Asia

Dec/2011 OHKURA Distribution of Check RSV/ Diagnostic reagent kit in Japan

Sep/2011 Dong-A Pharm Strategic Partnership for global R&D of Biosimilars

Sep/2011 Dong-A Pharm In license of Udenafil / Benign Prostatic Hyperplasia in Japan

Jul/2011 Alere Medical Distribution of Clearline®InfluenzaA/B/(H1N1)2009 / Diagnostic product for Influenza in Japan

Mar/2011 RaQualia In license of Ziprasidone / Schizophrenia in Japan

Jan/2011 Fresenius KabiJapan Strategic Partnership of oncologic generic products in Japan

Last Update June. 21, 201319

Strategic Alliance to Strengthen Generic Business

Global Alliance with Dong-A Pharmaceutical

（September 14th, 2011）

Collaboration on Monoclonal Antibody of Biosimilars

・ DMB-3111 selected for development for oncology indications

・Two more to be selected within a year

Joint Venture established for global supply and commercialization

c-GMP manufacturing facility to be constructed in Incheon Free Economic Zone

Last Update June. 21, 201320

Partnering Interest

• Product In-license & Research Collaboration• Infectious and respiratory diseases• CNS diseases• Diseases with unmet medical needs

(Oncology, Inflammatory & rare diseases)• Marketing Collaboration

• ENT• Pediatric• Psychiatry & Neurology• Respiratory• Hematology

Last Update June. 21, 201321

Current Partnerships

Last Update June. 21, 201322