[英文調查報告書] Astellas 製藥：製藥企業分析

Abstract

Astellas Pharma aims to secure a top share in the Japanese pharmaceutical market. This report provides a full review of the company's activities together with sales forecasts for key products to 2010.

Astellas Pharma (Fujisawa and Yamanouchi) recorded consolidated net sales for the first nine months of fiscal 2005/6 of ¥678,848 million, a 2% increase over the same period in 2004/5. This result was negatively impacted by various factors related to the merger, including product transfers and divestiture of non-ethical pharmaceutical businesses, which combined to reduce consolidated net sales by approximately ¥29.2 billion. Sales of ethical pharmaceuticals rose by 2% to ¥653.2 billion and R&D expenditure amounted to ¥92,590 million, an increase of 3%.

R&D Pipeline Overview

FK506 is an asthma treatment in Phase II in the US and Europe.
YM060, an oral agent to treat diarrhoea-predominant irritable bowel syndrome (IBS), is currently in Phase II in Europe and Phase III in Japan with launch expected in 2006.
YM150 is an oral antithrombotic agent for the treatment of venous thromboembolism.
RSD1235 is an anti-arrhythmic agent and is being co-developed with Cardiome in Canada, US and Mexico, as an iv formulation for the treatment of atrial fibrillation and atrial flutter.
CVT-3146: Astellas is co-developing regadenoson (CVT-3146), a short-acting, selective A2A adenosine-receptor agonist, with CV Therapeutics. CV Therapeutics advanced CVT-3146 into a Phase III trial in 2003.

In all, Astellas Pharma has 15 late stage compounds expected to enter the market over the next 5 years.

Major Products Forecast to 2010

Gaster/Pepcid (Gastrointestinal)
Nasea (Anti-emetic)
Ketek (Antibiotic)
Cefzon (Antibiotic)
Lipitor (Cardiovascular)
Perdipine (Cardiovascular)
Hypoca/Cyress (Cardiovascular)
Micardis (Cardiovascular)
Protopic (Transplantation/Arthritis)
Starsis (Diabetes)

EXECUTIVE SUMMARY

Introduction
Financial Performance 2005
- Sales and Market Position
- Income
  - Sales, Costs and Operating Income
  - Operating Income By Business Area
  - Operating Income By Business Area
- Expenditure
  - Capital Expenditure
  - Capital Expenditure By Business Area
  - Capital Expenditure By Business Area
  - R&D Expenditure
  - R&D Expenditure
- Divisional Performance
  - Sales By Business Area
  - Sales By Business Area
  - Total Assets By Business Area
  - Total Assets By Business Area
- Geographic Performance
  - Sales By Destination
  - Sales By Destination
  - Sales By Origin
  - Sales By Origin
  - Operating Income (Loss) By Geographic Area
  - Operating Income (Loss) By Geographic Area
  - Total Assets By Geographical Area
  - Total Assets By Geographical Area
Company Strategy
- Objectives for FY2006-FY2008 (April 2005-March 2008):
- OTC Pharmaceuticals Business
- Key Mergers, Acquisitions and Divestitures
- Key Agreements
- Production
- Employees
  - Employees
  - Employees
  - Employees and Productivity
Product/R&D Overview
- Key Products
  - Recent Product Launches
  - Recent Product Approvals
  - Products Withdrawn
- R&D Strategy
- Key R&D Projects
- R&D Pipeline Overview
- Sales Forecasts
  - Sales of Current Top Ten Products (2000A-2010E)
Other Factors Affecting the Bottom Line
Conclusions

PRODUCT PORTFOLIO / RESEARCH & DEVELOPMENT

Major Products, Therapeutic Areas and Sales
R&D Pipeline

Cardiovascular - Products
- Major Launched Products
- Adenocard
  - Mode of Action
  - Patents/Licensees
  - Key Markets/Indications/Formulations
  - Generic Competition
- Adenoscan
  - Mode of Action
  - Sales
  - Key Markets/Indications
  - Lawsuits
  - Sales Forecast
- Adenoscan Sales (2000A-2010E)
- Carperitide
  - Mode of Action
  - Key Markets/Indications/Further Development
  - Further Development
- Cibenol
- Dorner
  - Mode of Action
  - Sales
  - Key Markets/Indications
  - Further Development
  - Competitor Products
  - Sales Forecast
- Dorner Sales (2000A-2010E)
- Frandol
  - Sales Forecast
- Fransol Sales (2000A-2010E)
- Hypoca/Cyress
  - Mode of Action
  - Sales
  - Key Markets/Indications
  - Competitor Products
  - Further Development
  - Sales Forecast
- Hypoca Sales (2000A-2010E)
  - Clinical Trial Results
- Lipitor
  - Mode of Action
  - Sales
  - Key Markets/Indications/Formulations
  - Competitor Products
  - Sales Forecast
- Lipitor Sales (2000A-2010E)
- Micardis
  - Mode of Action
  - Sales
  - Key Markets/Indications/Formulations
  - Further Development
  - Competitor Products
  - Sales Forecast
- Micardis Sales (2003A-2010E)
  - Clinical Trial Results
- Milrila
  - Mode of Action
  - Key Markets/Indications/Formulations
- Nivadil
  - Mode of Action
  - Sales
  - Key Markets/Indications/Formulations
  - Sales Forecast
- Nivadil Sales (2000A-2010E)
- Perdipine
  - Mode of Action
  - Sales
  - Key Markets/Indications/Formulations
  - Sales Forecast
- Perdipine Sales (2000A-2010E)
- Solinase
  - Mode of Action
  - Key Markets
- Vaprisol
  - Mode of Action
  - Key Markets/Indications
  - Further Development
Cardiovascular - R&D
- Regadenoson
  - Mode of Action/Indication
  - Clinical Trial Results
- RSD1235
  - Patents/Licensees
  - Development/Launch Schedule
  - Clinical Trial Results
- YM150
Cardiovascular - Summary
- Growth Potential
- Limiting Factors
Urology - Products
- Major Launched Products
- Harnal/Omnic/Flomax
  - Mode of Action
  - Sales
  - Key Markets/Indications/Formulations
  - Further Development
  - Lawsuits
  - Sales Forecast
  - Flomax/Harnal Sales (2000A-2010E)
    - Clinical Trial Results
- Vesicare
  - Mode of Action
  - Sales
  - Key Markets/Indications/Formulations
  - Further Development
  - Clinical Trial Results
Urology - R&D
- Prodel
  - Mode of Action
- YM155
  - Mode of Action
- YM178
- YM672 (IPD-1151T)
  - Mode of Action
  - Licensing
  - Development/Launch Schedule
Urology - Summary
- Growth Potential
Inflammation & Immunology - Products
- Major Launched Products
- Atock/Foradil
  - Mode of Action
  - Key Markets/Indications/Formulations
- Intal
  - Mode of Action
  - Sales
  - Key Markets/Indications/Formulations
  - Sales Forecast
- Intal Sales (200A-2010E)
- Prograf
  - Mode of Action
  - Sales
  - Licensing Agreements
  - Key Markets/Indications
  - Further Development
- New Indications
  - Discontinued Formulations
  - Safety Issues/Labelling
  - Sales Forecast
- Prograf Sales (2000A-2010E)
Inflammation & Immunology - R&D
- AGI-1096
- Celecoxib
  - Mode of Action
  - Development Status
- FK-778
- Parecoxib
  - Mode of Action
  - Key markets
- For the short-term treatment of post-operative pain
- Valdecoxib (YM974)
  - Mode of Action
  - Key Markets
Inflammation & Immunology - Summary
- Growth Potential
- Limiting Factors
Gastrointestinal - Products
- Major Launched Products
- Colonel (HSR 237)
  - Mode of Action
  - Key Markets/Indications/Formulations
- Ganaton
  - Mode of Action
  - Key Markets/Indications/Formulations
- Gaster/Pepcid
  - Mode of Action
  - Sales
  - Key Markets/Indications/Formulations
  - Further Development
  - Lawsuits/Patents
  - Competitor Products
  - Sales Forecast
- Gaster/Pepcid Sales (2000A-2010E)
- Nasea
  - Mode of Action
  - Sales
  - Key Markets/Indications/Formulations
  - Further Development
  - Sales Forecast
- Nasea Sales (2000A-2010E)
Gastrointestinal - R&D
- YM443
  - Mode of Action
  - Patents/Licensees
Gastrointestinal - Summary
- Growth Potential
- Limiting Factors
Infectious Disease - Products
- Major Launched Products
- Aimmugen
  - Mode of Action
  - Patents
  - Key Markets
- AmBisome
  - Mode of Action
  - Sales
  - Key Markets/Indications/Formulations
  - Labelling Issues
  - Sales Forecast
- AmBisome Sales (2000A-2010E)
- Cefamezin
  - Mode of Action
  - Sales
  - Key Markets/Indications/Formulations
  - Sales Forecast
- Cefamezin Sales (2000A-2010E)
- Cefspan
  - Mode of Action
  - Sales
  - Key Markets/Indications/Formulations
  - Further Development
  - Sales Forecast
- Cefspan Sales (2000A-2010E)
- Cefzon/Omnicef
  - Mode of Action
  - Sales
  - Key Markets/Indications/Formulations
  - Lawsuits
  - Sales Forecast
- Cefzon Sales (2000A-2010E)
- Funguard
  - Mode of Action
  - Key Markets/Indications/Formulations
  - Further Development
  - Sales
  - Competitor Products
  - Sales Forecast
- Funguard Sales (2003A-2010E)
- Infergen/Advaferon
  - Mode of Action
  - Sales
  - Patents
  - Key Markets/Indications/Formulations
  - Further Development
- Ketek
  - Mode of Action
  - Sales
  - Key Markets/Indications/Formulations
  - Further Development
  - Competitor Products
- Targocid
  - Mode of Action
  - Sales
  - Key Markets/Indications/Formulations
Infectious Disease - R&D
- Garenoxicin
- Telavancin
  - Mode of Action
  - Licensing
  - Clinical Trial Results
- TD-1792
  - Mode of Action
  - Licensing
Infectious Disease - Summary
- Growth Potential
- Limiting Factors
Central Nervous System - Products
- Major Launched Products
- Dogmatyl
  - Sales
  - Key Markets
  - Sales Forecast
- Dogmatyl Sales (2002A-2010E)
- Luvox
  - Mode of Action
  - Sales
  - Key Markets
  - Further Development
  - Sales Forecast
- Luvox Sales (2000A-2010E)
- Myslee
  - Mode of Action
  - Sales
  - Patents/Licensees
  - Key Markets/Indications/Formulations
  - Further Development
  - Competitor Products
  - Sales Forecast
- Myslee Sales (2000A-2010E)
- Seroquel
  - Mode of Action
  - Sales
  - Key Markets/Indications/Formulations
  - Further Development
  - Competitor Products
  - Sales Forecast
- Seroquel Sales (2000A-2010E)
Central Nervous System - R&D
- ACR16
  - Mode of Action
- FK962
  - Mode of Action
  - Development Status
- XP13512
  - Mode of Action
  - Patents
  - Clinical Trial Results
Central Nervous System - Summary
- Growth Potential
Dermatology - Products
- Major Launched Products
- Protopic
  - Mode of Action
  - Sales
  - Licensing Agreements
  - Key Markets/Indications
  - Further Development
  - Discontinued Indications/Formulations
  - Safety Issues/Labelling
  - Competitor Products
  - Sales Forecast
- Protopic Sales (2000A-2010E)
Dermatology - R&D
Dermatology - Summary
Metabolic - Products
- Major Launched Products
- Starsis
  - Mode of Action
  - Sales
  - Key Markets/Indications/Formulations
  - Further Development
  - Sales Forecast
- Starsis Sales (2000A-2010E)
  - Clinical Trial Results
Metabolic - R&D
Metabolic - Summary
- Growth Potential
Bone Disorders - Products
- InductOs (YM484; rhBMP-2, dibotermin alpha)
  - Mode of Action
  - Key Markets/Indications/Formulations
Bone Disorders - R&D
- Minodronate
  - Mode of Action
- Strontium ranelate (FK481)
  - Mode of Action
Bone Disorders - Summary
- Growth Potential
Oncology - Products
- Eligard
  - Mode of Action
  - Key Markets/Indications/Formulations
  - Lawsuits
- SMANCS
  - Mode of Action
  - Key Markets/Indications/Formulations
Oncology - R&D
- Degarelix
- Oprelvekin
  - Mode of Action
  - Development Status
- FK-228
  - Mode of Action
Oncology - Summary
- Growth Potential
- Limiting Factors
Discontinued
- Atrisone
  - Mode of Action
- Bisphonal
  - Mode of Action
- Cholebine
  - Mode of Action
- Farom
  - Mode of Action
- FK-352B
- FK-614
- MBI 226
- PYM50028
  - Mode of Action
  - Licensees
- ReoPro
  - Mode of Action
- Rescula Eye Drops
  - Mode of Action
  - Japanese Withdrawal
- Selodenoson/DTI-0009
- Tilmacoxib
- TRK-820
  - Mode of Action
- YM337
- YM454
  - Mode of Action
  - Further Developments
  - Patents
- YM598

APPENDIX 1 - FINANCIAL PERFORMANCE

Astellas Proforma Results
- Sales, Costs and Operating Income
- Profitability and Research Ratios
- R&D Expenditure and Capital Expenditure
- Current Assets, Liabilities and Ratio
- Assets, Cash and Liquidity
- Employees and Productivity
Fujisawa Data
- Sales By Business Area - Fujisawa
- Sales By Business Area - Fujisawa
- Operating Income (Loss) By Business Area - Fujisawa
- Capital Expenditure By Business Area - Fujisawa
- Total Assets By Business Area - Fujisawa
- Total Assets by Business Area - Fujisawa
- Sales By Destination - Fujisawa
- Sales By Destination - Fujisawa
- Sales By Origin - Fujisawa
- Sales By Origin - Fujisawa
- Operating Income (Loss) By Geographic Area - Fujisawa
- Total Assets By Geographical Area - Fujisawa
Yamanouchi Data
- Operating Income By Business Area - Yamanouchi
- Operating Income By Business Area - Yamanouchi
- Capital Expenditures By Business Area - Yamanouchi
- Capital Expenditures By Business Area - Yamanouchi
- Sales By Business Area - Yamanouchi
- Sales By Business Area - Yamanouchi
- Total Assets By Business Area - Yamanouchi
- Total Assets by Business Area - Yamanouchi
- Sales By Destination - Yamanouchi
- Sales By Destination - Yamanouchi
- Sales By Origin - Yamanouchi
- Sales By Origin - Yamanouchi
- Operating Income (Loss) by Geographical Area - Yamanouchi
- Total Assets By Geographical Area - Yamanouchi

APPENDIX 2 - KEY CORPORATE EVENTS

APPENDIX 3 - KEY AGREEMENTS

Adir Et Cie
- 18th May 2001
Ajinomoto Co Inc
American BioScience Inc (ABS)
- 1997
AtheroGenics Inc
- 12th January 2004
- 2nd February 2006
Boehringer Ingelheim (BI)
- 1994
- 24th January 2002
- 16th August 2004
Cardiome Pharma Corp
- 16th October 2003
- 23rd February 2005
- 19th October 2005
Carlsson Research AB
- 7th February 2005
CV Therapeutics Inc (CVT)
- 11th July 2000
Daiichi Sankyo Co Ltd
- 27th August 2004
Gilead Sciences Inc
- 7th April 1995
- 7th April 1999
GlaxoSmithKline
- 21st May 1998
- 20th December 1999
- 7th June 2000
- November 2000
- 4th June 2003
- 8th August 2003
Gloucester Pharmaceuticals Inc
- 15th April 2004
Ferring Pharmaceuticals
- 31st January 2006
Merck KGaA
- 11th May 1998
- November 2000
Metabolex Inc
- 20th March 2002
- 18th March 2003
- 2nd May 2005
- 8th November 2005
Nippon Kayaku Co Ltd
- 7th February 2005
Novartis
- December 2000
- 1st September 2001
Ono Pharmaceutical Co Ltd
- January 1999
Pfizer
- December 1997
- April 1998
- 13th July 1998
- 28th March 2001
- 31st May 2004
Pharmagenesis Inc
- 17th September 2002
sanofi-aventis
- 13th April 1998
- 4th September 2000
- 8th December 2000
- 10th July 2001
- 14th November 2001
- 19th April 2002
- 13th February 2003
- 20th November 2003
- 16th December 2005
Senju Pharmaceutical Co Ltd
- January 2005
Taiho Pharmaceuticals Co Ltd
- 23rd January 2003
Taisho Toyama Pharmaceutical Co Ltd
- 26th January 2006
TAP Pharmaceutical Products Inc
- 9th November 2000
Tercica Inc
- 29th April 2004
Wyeth
Zeria Pharmaceutical Co Ltd
- 1st July 2002

Astellas 製藥：製藥企業分析報告

Astellas Pharma: Performance, Products, Pipeline, Potential

Abstract

R&D Pipeline Overview

Major Products Forecast to 2010

Table of Contents

EXECUTIVE SUMMARY

PRODUCT PORTFOLIO / RESEARCH & DEVELOPMENT

APPENDIX 1 - FINANCIAL PERFORMANCE

APPENDIX 2 - KEY CORPORATE EVENTS

APPENDIX 3 - KEY AGREEMENTS

APPENDIX 4 - INFRASTRUCTURE

APPENDIX 5 - KEY PHARMACEUTICAL SUBSIDIARIES/JOINT VENTURES

APPENDIX 6 - PRODUCT INDEX

Astellas 製藥 ：製藥企業分析報告

Astellas Pharma: Performance, Products, Pipeline, Potential

Abstract

R&D Pipeline Overview

Major Products Forecast to 2010

Table of Contents

EXECUTIVE SUMMARY

PRODUCT PORTFOLIO / RESEARCH & DEVELOPMENT

APPENDIX 1 - FINANCIAL PERFORMANCE

APPENDIX 2 - KEY CORPORATE EVENTS

APPENDIX 3 - KEY AGREEMENTS

APPENDIX 4 - INFRASTRUCTURE

APPENDIX 5 - KEY PHARMACEUTICAL SUBSIDIARIES/JOINT VENTURES

APPENDIX 6 - PRODUCT INDEX

Astellas 製藥：製藥企業分析報告