[英文調查報告書] 大塚製藥：製藥企業分析報告書

Abstract

Otsuka Pharmaceutical Company (OPC) is one of the largest healthcare companies in Japan and one of the largest privately-held firms in the world. This report provides a full review of the company's activities together with sales forecasts for key products to 2010.

In fiscal 2005, (YE 31st March 2005) Otsuka reported consolidated pharmaceutical sales of ¥434,100 million. Operating income totalled ¥65,865 million, an increase of 202.2% on the previous year, and net income totalled ¥37,025 million, an increase of 123.72% on the previous year.

Otsuka Pharmaceuticals has eight divisions in total including the Pharmaceutical business division and the Consumer Products business division. Expansion of the Pharmaceutical division has been concentrated on Asia and the Middle East, with the establishment of new clinical R&D laboratories in China and Thailand, and new drugs launches in South Korea and Vietnam.

R&D Pipeline Overview

Acalas is for hypertension, angina pectoris and renoparenchymal hypertension.
Fijurin for the syndrome of inappropriate secretion of ADH.
Last-F for the treatment of stomach, breast and lung cancers.
Toborinone for acute and chronic heart failure, and circulation insufficiency.
Vitrase is indicated for diabetic retinopathy.
Tolvaptan, a non-peptide vasopressin V2-receptor antagonist for the treatment of congestive heart failure (CHF) and hyponatraemia.

EXECUTIVE SUMMARY

Introduction
Financial performance 2005
- Sales and Market Position
- Income
  - Sales, Costs and Operating Income
- Expenditure
  - Capital Expenditure
- Divisional Performance
  - Global Sales by Business Area
  - Global Sales by Business Area
  - Total Assets by Business Area
- Geographic Performance
  - Sales by Destination
  - Sales by Destination
  - Sales by Origin
  - Sales by Origin
Company strategy
- Mergers, Acquisitions and Divestitures
- Production
- Employees
- Key Agreements
Product/R&D overview
- Key Products
  - Recent Product Launches
  - Recent Product Approvals
- R&D Strategy
  - Key R&D Projects
Conclusions

PRODUCT PORTFOLIO/RESEARCH & DEVELOPMENT

R&D Pipeline
Respiratory - Products
- Major Launched Products
- IPD-1151T
  - Key Markets/Indications
  - Further Development
- Meptin
  - Key Markets/Indications/Formulations
  - Competitor Products
- Synaclyn
- UNIPHYL
  - Key Markets
Respiratory - summary
Cardiovascular - Products
- Major Launched Products
- Arkin-Z
  - Mode of Action
  - Key Markets/Indications/Formulations
- Hi-Z
  - Key Markets/Indications/Formulations
- Lorelco
  - Mode of Action
  - Key Markets/Indications
- Mikelan
  - Key Markets/Indications/Formulations
  - Further Development
- Pleetal/Pletal
  - Mode of Action
  - Key Markets/Indications/Formulations
  - Further Development
  - Competitor Products
  - Generic Competition
  - Clinical Trial Results
- Sapresta/Bec
Cardiovascular - R&D
- Acalas
- OPC-28326
- Toborinone
- Tolvaptan
Cardiovascular - Summary
- Growth Potential
- Limiting Factors
Gastrointestinal - Products
- Mucosta
  - Mode of Action
  - Key Markets/Indications/Formulations
  - Licensees
Central Nervous System - Products
- Abilify
  - Mode of Action
  - Key Markets/Indications/Formulations
  - Competitor Products
  - Safety Issues
  - Clinical Trial Results
- Myocalm
Central Nervous System - R&D
- OPC-14523
- Rotigotine CDS
Central Nervous System - Summary
- Growth Potential
- Limiting Factors
Dermatology - Products
- Acuatim
  - Mode of Action
  - Key Markets/Indications/Formulations
- Urepearl
  - Mode of action
  - Key Markets/Indications/Formulations
Dermatology - SUMMARY
Anticancer - Products
- Abraxane
  - Clinical Trial Results
- Futraful
- Lentinan
- O-gamma 100
- OIF
  - Mode of Action
  - Key Markets/Indications/Formulations
- S-1 (TS-1)
  - Mode of Action
  - Key Markets/Indications/Formulations
  - Further Development
- Stogar
- UFT
  - Key Markets/Indications
Anticancer - R&D
- Last-F
- TAS-108
Anticancer - Summary
- Growth Potential
Anti-infective - Products
- Herzer
- Kenicef
- Meropen
  - Mode of Action
  - Licensees
- Miridacin
- Otsuka CEZ Injection-MC
- Palavale
Anti-infective - R&D
- OPC-2045
- TN-3262a
Anti-infective - Summary
Others - Products
- Aminoleban/Aminoleban EN/Kidmin
- BUP-4
- FerriSeltz
- Lepetan
- Neophagen
- Solcoseryl Injection
  - Licensee
- Others
OTHERS - R&D
- OPC-51803
- OPC-6535
- Vitrase
Others - Summary

APPENDIX 1 - FINANCIAL PERFORMANCE

Full year results 2005
- Sales, Costs and Operating Income
- Operating Margin (%)
- Capital Expenditure
- Current Assets, Liabilities and Ratio
- Assets, Cash and Liquidity
- Employees and Productivity

APPENDIX 2 - KEY CORPORATE EVENTS

APPENDIX 3 - KEY AGREEMENTS

Abraxis Bioscience Inc
- November 2005
Astellas Pharma Inc
- 23rd January 2003
Bristol-Myers Squibb
- Oncology agreements
- 17th April 1995
- 6th August 1997
- Aripiprazole Agreement
- 20th September 1999
Galenea Corporation
- 17th February 2005
GlaxoSmithKline
- 25th July 2000
Innovata Biomed Limited
- 20th March 2003
- 5th May 2004
ISTA Pharmaceuticals Inc
- 20th December 2001
Merck KGaA
- 14th July 2005
Methylgene Inc
- October 2003
Novartis Ophthalmics
- 12th January 1999
- 7th February 2005
Pfizer
- 30th July 1998
- 28th April 1999
Prasco Laboratories
- 18th October 2004
Schwarz Pharma AG
- 14th November 2002
Sosei Co Ltd
- 22nd February 2005
SRI International
- 8th June 1999
Toyama Chemical Co Ltd/Nidek Co Ltd
- 18th March 2003
Vela Pharmaceuticals Inc
- 1st April 2004
Others

APPENDIX 4 - INFRASTRUCTURE

Research and development facilities
Manufacturing facilities

APPENDIX 5 - MAJOR PHARMACEUTICAL

SUBSIDIARIES/JOINT VENTURES

Subsidiaries
Joint-venture Companies

大塚製藥：製藥企業分析報告書

Otsuka: Pipeline, Products, Performance, Potential