• Meiji Group Overview• Meiji Seika Pharma Co., Ltd.
Last updated January 21, 2015 2
◆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$11.5B (Apr. 2013 – Mar. 2014)Consolidated Number of Employees14,819 (as of March 31st, 2014)
Last updated January 21, 2015 3
Consolidated Sales Operating Incomes
* Growth vs. previous business year1USD=100JPY
Based on the sales before intergroup eliminationApr. 2013 - Mar. 2014
R&D Expenditure
$364M(+41.1% *)
$11.5B(+1.9% *)
$260M
◆Financial Overview
Last updated January 21, 2015 4
• Meiji Group Overview• Meiji Seika Pharma Co., Ltd.
Last updated January 21, 2015 5
R&D Administration
Intellectual Property
D. KobayashiPresident & Representative Director
Marketing Div.Y. Umeki, Managing Executive Officer
Generics Development
Bioscience Labs.
HR & General Affairs
Financial & Accounting
Audit
Drug Information Center
Executive Committee
Partnering Strategy and Business Development
◆Organization
Consolidated Number of Employees : 4,035 (As of April, 2014)
Last updated January 21, 2015
Production Div.T. Nagasato, Executive Officer
International HeadquartersK. Noda, Executive Officer
External Affairs
Pharmaceutical Research Div.T. Kikkoji, Executive Officer
Reliability & Quality Assurance CenterK. Mori, General Manager
Agricultural & Veterinary Div.S. Hashimoto, Executive Officer
Pharmaceutical Development Div.H. Yamaguchi, Managing Executive Officer
Corporate Development
Research Planning
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Corporate DevelopmentGeneral Manager: Dr. Hiromasa Takizawa
Licensing and Alliance ManagementGroup Manager : Mr. Toru Kawahatsu
Managing Executive Officer: Mr. Yuji Sasaki
Partnering Strategy and Business DevelopmentGeneral Manager:Mr. Kenshi Murase
Task : Product In-Licensing, Alliance ManagementProduct Out-Licensing
◆Business Development & Licensing
Last updated January 21, 2015
Licensing and Product AcquisitionGroup Manager : Mr. Kazuyoshi Kataha
Task : Alliance Management, Agro-Vet LicensingGeneric Product Licensing, R&D Contract
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Employees (As of October, 2014)12 Branches and 72 Sales Offices (10 CNS Sales Offices)
MR ca. 810(CNS specialized MR ca. 200 )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)
Odawara Plant (Drug Formulation)
Kitakami Plant (API)Gifu Plant (API)
Group companies・Ohkura PharmaceuticalManufacturing & sales of ethical pharmaceuticals and diagnostics
・Kitasato Pharmaceutical IndustrySales of ethical vaccines
Ohkura Pharmaceutical (Kyoto)
Kitasato Pharmaceutical Industry (Tokyo)
◆Business Locations : Japan
Last updated January 21, 2015 8
Beijing Office
Shantou Meiji Pharmaceuticals Co., Ltd. (1989)
Production & Distribution
P.T. Meiji IndonesianPharmaceutical Industries (1974)Production, Distribution & Export
Thai Meiji Pharmaceutical 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
DM Bio Limited. (2013)
Monoclonal Antibody Production
Meiji Pharma Korea Co., Ltd. (2012)
Distribution (Agrochemicals)
◆Business Locations : World
Last updated January 21, 2015 9
Consolidated basis$1,351M (+6.1% *)
Ethical Pharmaceuticals$1,135M
‐ domestic sales‐ overseas sales‐ export
Agrochemicals & Animal Health$215M
84%
16%
◆Segment Sales
* Growth vs. previous business year1USD=100JPY
Apr. 2013 - Mar. 2014
Last updated January 21, 2015 10
Ethical Pharmaceutical Sales /Japan(Apr.2012‐Mar.2013)
Meiact®Fosmicin®Isodine®Habekacin®Omegacin®Orapenem ®
Sword®
Meilax® (Ethyl Loflazepate) : AnxietyDepromel® (Fluvoxamine) : Depression, OCD, SADReflex® (Mirtazapine) : DepressionDiacomit ®(Stiripentol) : Antiepileptic
Ebastel® (Ebastin): Urticaria, RhinitisDaunomycin ® : Acute LeukemiaTherarubicin® (Pirarubicin) : Malignant LymphomaLaserphyrin ® (Talaporfin Sodium ): Lung Carcinoma, Brain TumorOxis® 9µg Turbuhaler® (Formoterol) : COPD
Infection (29%)$266M
CNS (26%)$239M
Others (9%)$85M
Generics (35%)$321M
Total$911M
◆Sales by Therapeutic Area
Last updated January 21, 2015 11
* NaSSA : Noradrenergic and Specific Serotonergic Antidepressant
◆Leading ProductsBrand Name(Date of Launch)
MOA/Indication Sales in Japan Partner
Reflex (’09.9) NaSSA* : Depression $167M MSD
Meiact (’94.6) Oral cephem $162M
Amlodipine (’08.7) Ca antagonist $43M
Depromel (’99.5) SSRI: Depression, OCD, SAD $40M AbbVie
Vancomycin MEEK (’02.7) Glycopeptide: MRSA $37M Kobayashi Kako
Meilax (’88.12) Benzodiazepine: Anxiety $31M Sanofi
Fosmicin (’80.12) Fosfomycin $30M
Sulbacillin (’06.9) Penicillin $29M
Donepezil (’11.11) Anti‐Alzheimer’s disease $26M
Orapenem (’09.8) Oral Carbapenem $23M Pfizer
Isodine (’61.11) Anti‐septic $19M Mundipharma
Ebastel (’96.6) H1antagonist: Urticaria, Rhinitis $14M Dainippon Sumitomo
Omegacin (’02.3) Carbapenem $12M Pfizer
Habekacin (’90.12) Aminoglycoside: MRSA $10M
Ethical Pharmaceutical Sales /Japan(Apr.2013‐Mar.2014)
Last updated January 21, 2015 12
◆Product Pipeline : Infectious Diseases
Compound MOA Indication Status Partner Territory
ME1111 Antifungal Onychomycosis <US>Phase II
Global
ME1100(Arbekacin)
Aminoglycoside(Inhalation)
Hospital Acquired Bacterial Pneumonia;Ventilator Associated Bacterial Pneumonia
<US>Phase I
PARI Pharma Global
OP0595 β‐lactamase inhibitor
Bacterial Infection <Australia>Phase I
Roche Japan
Last updated January 21, 2015 13
◆Product Pipeline : CNS Diseases
Compound MOA Indication Status Partner Territory
ME2136(Asenapine)
SDA Schizophrenia Phase III MSD(in‐license)
Japan
Depromel(Fluvoxamine)
SSRI Obsessive Compulsive Disorder (Pediatric)
Phase IIILine Extension
AbbVie(in‐license)
Japan
ME2112(Ziprasidone)
SDA Schizophrenia Phase II RaQualia(in‐license)
Japan
Reflex(Mirtazapine)
NaSSA Fibromyalgia Phase IILine Extension
MSD(in‐license)
Japan
ME2125(Safinamide)
MAO‐Binhibitor
Parkinson’s Disease Phase I Newron(in‐license)
Asia
Last updated January 21, 2015 14
◆Product Pipeline : New Fields
Compound MOA Indication Status Partner Territory
ME2906(Talaporfin)
Photosensitizer
Esophagus Cancer Filed Japan
ME3113(Udenafil)
PDE‐Vinhibitor
Benign Prostatic Hyperplasia
Phase IIb Dong‐A ST(in‐license)
Japan
DMB‐3111(Herceptin)
MonoclonalAntibody(Biosimilar)
Breast Cancer Phase I Dong‐A Socio(Researchcollaboration)
Darinaparsin Mitochondrial‐targeted agent
Relapsed and Refractory PTCL*
Phase I SolasiaPharma(in‐license)
Japan
Last updated January 21, 2015
* PTCL: Peripheral T‐Cell Lymphoma
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◆Out‐Licensing Activities
Compound MOA Indication Status Partner Territory
OP0595 β‐lactamase inhibitor
Bacterial Infection Phase I Roche Global(exc. JP)
LS11(ME2906; Talaporfin)
PhotosensitizerHepatocellular CarcinomaMetastatic Colorectal CancerBenign Prostatic Hyperplasia
Phase IIIPhase IIPhase I
Light SciencesOncology
Global(exc. JP)
ME3301 Anti‐inflammatory
IBD, Allergic Rhinitis Phase II Amalyte Global
CP8816 &CP8863
Progesterone receptor modulator
Endometriosis Pre‐clinical
Tokai Global
MN‐447(CP4715)
GpⅡbⅢa & αγβ3 receptor dual antagonist
Acute Ischemic Heart DiseaseCerebral Infarction
Pre‐clinical
MediciNova
Global
Last updated January 21, 2015 16
◆Recent Alliance DealsMon./Year Partner Type of Collaboration
Jan. 2015 Solasia Pharma Commercialization partnership of Darinaparsin / PTCL in Japan
Jan. 2015 Roche License Agreement regarding OP0595 / beta‐lactamase Inhibitor
Sep. 2014 Takeda Co‐Promotion partnership of Ramelteon / Insomnia in Japan
Jul. 2014 Ono Pharmaceutical
Development and Commercialization partnership of Limaprost alfadex in Thailand and Indonesia
Jul. 2013 PARI Pharma In‐license of eFlow® Technology inhalation device for ME1100
Apr. 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 partnership 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 JapanLast updated January 21, 2015 17
◆In‐licensing fields
Marketing Collaboration• ENT• Pediatric• Respiratory• Psychiatry & Neurology• Hematology
Research Collaboration• Infectious Diseases• Inflammatory Diseases• Unmet Medical Needs
Last updated January 21, 2015 18
◆Current Partnerships
Last updated January 21, 2015 19
Last updated January 21, 2015 20