Astellas Pharma: Performance, Products, Pipeline and Potential

Transcription

1 Brochure More information from Astellas Pharma: Performance, Products, Pipeline and Potential Description: Astellas Pharma Inc was formed on 1st April 2005 from the merger of Yamanouchi and Fujisawa. The aim of Astellas is to secure a top share in the Japanese pharmaceutical market; the combined company now has 5,000 medical representatives, the largest among domestic pharmaceutical companies, and it aims to develop an even stronger sales and marketing infrastructure. The company also expects to be able to provide broad coverage for both primary care physicians and specialty markets in the US by leveraging the existing infrastructures to accelerate expansion of the US business. The merger of Yamanouchi and Fujisawa brought together two very complementary R&D pipelines, putting Astellas in a very strong position in the domestic Japanese market. The combined company has concentrated its core business on pharmaceuticals and related products, split into six key franchise fields and priority research areas; urology, inflammation, diabetes, infectious diseases, gastrointestinal disease and the central nervous system. Astellas has a number of licensed-in products, which have been proven overseas by partner companies. These products, such as Micardis, Luvox, Seroquel, Eligard and Myslee, are regarded as "Synergy Products'" by Astellas and should provide the foundation for future growth. Astellas is throwing its weight behind these products with support from all of its medical sales representatives and Area Marketing Supporters. For other key products Astellas has divided up its sales force into two: GA, which markets Yamanouchi products and CF, which markets the former Fujisawa products. The merger also enhanced the global reach of Astellas and it now has a strong base from which to begin to increase overseas sales without relying too heavily on partners to market its products. Most Japanese pharmaceutical companies are still struggling to achieve this aim, despite setting up overseas subsidiaries and sales offices. Astellas now has a significant global sales network that spans Japan, Europe and North America, and it can finally begin to make inroads in foreign markets through its own sales channels. Although recent years have seen declining sales in a number of its older products, Astellas' broad portfolio has enabled the accelerated transition of its late-stage products to regulatory submission in time to offset these declines. The greatest challenge for the company is expected to arise in fiscal 2009, when the US patent expiry in April 2008 of its blockbuster product Prograf is predicted to severely impact total company revenue. Losses incurred by the loss of exclusivity for this product are expected to be partially buffered by increasing sales of Vesicare and mainstay products such as Micardis. Contents: EXECUTIVE SUMMARY 5 Introduction 5 Current Financial Position 6 Company Performance 6 Business Segment Performance 6 Geographic Segment Performance 8 Company Strategy 14 R&D Strategy 14 Mergers, Acquisitions and Divestitures 15 Key Agreements 17 Production 18 Employees 18 Product Performance Forecasts 20 Pipeline Analysis 22 Key R&D Projects 22

2 Discontinued Projects 23 Conclusions 25 THERAPEUTIC ARE A FOCUS 29 R&D PIPELINE 30 CARDIOVASCULAR 32 Marketed Products 32 Adenocard 32 Adenoscan 33 Cibenol 34 Dorner 35 Frandol 37 Hypoca/Cyress 38 Lexiscan 39 Lipitor 40 Micardis 42 Milrila 46 Nivadil 47 Perdipine 48 Solinase 49 Vaprisol 50 R&D Projects 52 ASP ASP Vernakalant 52 YM YM Growth Forecast 56 UROLOGY 57 Marketed Products 57 Harnal/Omnic/Flomax 57 Vesicare 61 R&D Projects 63 YM Growth Forecast 64 INFLAMMATION & IMMUNOLOGY 65 Marketed Products 65 Atock/Foradil 65 Celecox 66 Intal 68 Prograf 69 R&D Projects 75 AGI ASK ASP015K 75 Growth Forecast 76 GASTROINTESTINAL 77 Marketed Products 77 Colonel (HSR 237) 77 Ganaton 77 Gaster/Pepcid 78 Nasea 81 R&D Projects 83 YM Growth Forecast 84 INFECTIOUS DISEASE 85 Marketed Products 85

3 Aimmugen 85 AmBisome 85 Cefamezin 87 Cefspan 88 Cefzon/Omnicef 89 Funguard/Mycamine 91 Geninax 94 Infergen/Advaferon 95 Targocid 96 R&D Projects 97 ASP Telavancin 97 Growth Forecast 100 CENTRAL NERVOUS SYSTEM 101 Marketed Products 101 Dogmatyl 101 Luvox 102 Myslee 104 Seroquel 105 R&D Projects 109 ACR ASP ASP ASP ASP Growth Forecast 112 DERMATOLOGY 113 Marketed Products 113 Amevive 113 Protopic 114 R&D Projects 119 Growth Forecast 120 METABOLIC 121 Marketed Products 121 Starsis 121 R&D Projects 123 ASP YM Growth Forecast 124 BONE DISORDERS 125 Marketed Products 125 InductOs 125 R&D Projects 127 Minodronate 127 Growth Forecast 129 ONCOLOGY 130 Marketed Products 130 Eligard 130 SMANCS 131 R&D Projects 133 AGS-16M AGS-8M4 133 ASP Degarelix 133 YM Growth Forecast 135 APPENDIX 1 - FINANCIAL PERFORMANCE 139

4 Full Year Results APPENDIX 2 - KEY CORPORATE EVENTS 142 APPENDIX 3 - KEY AGREEMENTS 143 Ajinomoto Co Inc 143 American BioScience Inc (ABS) 143 AtheroGenics Inc 143 Biogen Idec 144 Boehringer Ingelheim (BI) 144 Cardiome Pharma Corp 144 Carlsson Research AB 146 Cephalon Inc 146 CoMentis Inc 146 CV Therapeutics Inc (CVT) 146 Ferring Pharmaceuticals 147 FibroGen Inc 147 Gilead Sciences Inc 148 GlaxoSmithKline 148 Gloucester Pharmaceuticals Inc 149 Icagen Inc 150 Ilypsa Inc 150 Immuno-Biological Laboratories 151 Kirin Brewery 151 Metabolex Inc 151 MorphoSys AG 153 Mundipharma International 153 Nippon Kayaku Co Ltd 154 Novartis 154 Ono Pharmaceutical Co Ltd 154 Pfizer 154 Pharmagenesis Inc 155 Regeneron Pharmaceuticals Inc 155 sanofi-aventis 155 Senju Pharmaceutical Co Ltd 157 SymBio Pharmaceuticals Ltd 157 Taiho Pharmaceuticals Co Ltd 158 Taisho Toyama Pharmaceutical Co Ltd 158 TAP Pharmaceutical Products Inc 158 Tercica Inc 159 Theravance Inc 159 Wyeth 160 XenoPort Inc 160 Zeria Pharmaceutical Co Ltd 161 APPENDIX 4 - INFRASTR UCTURE 162 Research and Development Facilities 163 Manufacturing Facilities 164 APPENDIX 5 - KEY PHARMACEUTICAL SUBSIDIARIES /JOINT VENTURES 166 Subsidiaries 166 Joint Ventures 169 APPENDIX 6 - PRODUCT INDEX 170 Index of Tables Principal Operating Results 1 Sales By Business Area 7 Sales By Destination 10 Sales By Origin 11 Operating Income (Loss) By Geographic Area 12 Total Assets By Geographical Area 13 Employees By Geographic Area 19 Recent Product Approvals 21 Major Products, Therapeutic Areas and Sales 29 Major Cardiovascular Products, Major Urology Products,

5 Major Inflammation & Immunology Products, Major Gastrointestinal Products, Major Infectious Disease Products, Major Central Nervous System Products, Major Dermatology Products, Major Metabolic Products, Major Oncology Products, Index of Charts Sales By Business Area 7 Sales By Destination 10 Sales By Origin 11 Operating Income (Loss) By Geographic Area 12 Total Assets By Geographical Area 13 Employees By Geographic Area, Sales of Current Top Ten Products (2003A-2013E) 20 Adenoscan Sales (2003A-2013E) 34 Cibenol Sales (2005A-2013E) 35 Dorner Sales (2003A-2013E) 37 Frandol Sales (2003A-2013E) 38 Regadenoson Sales (2009E-2015E) 40 Lipitor Sales (2003A-2013E) 42 Micardis Sales (2003A-2013E) 44 Nivadil Sales (2002A-2012E) 48 Perdipine Sales (2003A-2013E) 49 Vernakalant Sales (2009E-2015E) 54 Flomax/Harnal/Omnic Sales (2003A-2013E) 61 Vesicare Sales (2005A-2013E) 62 Celecox Sales (2008A-2015E) 67 Intal Sales (2003A-2013E) 69 Prograf Sales (2003A-2013E) 73 Gaster/Pepcid Sales (2003A-2013E) 80 Nasea Sales (2003A-2013E) 82 AmBisome Sales (2003A-2013E) 87 Cefamezin Sales (2003A-2013E) 88 Cefspan Sales (2003A-2013E) 89 Cefzon Sales (2003A-2013E) 91 Funguard Sales (2003A-2013E) 93 Geninax Sales (2008E-2015E) 95 Telavancin Sales (2009E-2014E) 98 Dogmatyl Sales (2003A-2013E) 102 Luvox Sales (2003A-2013E) 103 Myslee Sales (2003A-2013E) 105 Seroquel Sales (2003A-2013E) 108 Protopic Sales (2003A-2013E) 117 Starsis Sales (2003A-2013E) 122 Minodronate Sales (2009E-2015E) 128 Eligard Sales (2006A-2013E) 131 Sales, Costs and Operating Income 140 Profitability and Research Ratios 140 R&D Expenditure and Capital Expenditure 140 Current Assets, Liabilities and Ratio 141 Assets, Cash and Liquidity 141 Employees and Productivity 141 Ordering: Order Online - Order by Fax - using the form below Order by Post - print the order form below and sent to

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