APPENDIXES Appendix 1 The Drug Development Process Clinical trials Early FDA 14 research/ Preclinical review process/ On market Testing Phase 1 Phase 2 Phase 3 approval Years 6.5 1.5 2 3.5 1.5 15 years to bring products on market Test Population Purpose/ Aims Success Rate Test tube 20 to 80 100 to 1000 to and healthy 300 3000 animal studies volunteers patients patients Look for Determine Evaluate Confirm safety, desired safety and effective dosage for ness, effective ness, activity the next look for look for phase potential toxic side effects side effects from long term use 5000 5 evaluated compound s enter clinical trials 1 compou nd approval Phase 4 Patients Post-ma rket surveilla nce of the patients to look for potential problem s Source: Pharmaceutical Research and Manufacturing Association, Robbins-Roth, (2001) 14 Food and Drug administration 109
Appendix 2 The Investment in Taiwan Biotechnology Industry Fields Biomedicine Aid-industry Clinical Test Bio-foods Agricultural Biotechnology Regeneration Medicine Bioenvironmental Biochip Biomedical Materials The main firms 太景 基亞 國光 亞聯國際精鼎 佳生 汎球藥理 水昕 國內法人研究機構毒理實驗室五鼎 台岳 喬聯 台醫生技英橋 美蔘 加特福台花 萬蘊 國聯 陸仕生寶 訊聯 再生緣偉盟 丹海 生物鋅華聯 台灣基因 晶宇台鹽 台糖 和康 雙美 Amount Average R&D invested in R&D intensity investment R&D (%) ( ten thousand ( ten thousand NTD) NTD ) 81758 24.2 3555 7946 34.4 1683 9401 31.7 1990 63671 0.6 1599 23371 2.6 660 5160 77.0 5843 62374 9.0 710 28361 77.7 1880 13499 16.9 1135 Source:Development Center of Biotechnology, DCB 110
Appendix 3 Approbated Development Project of Biotechnology Industry in 2003 公司名稱黑松 ( 股 ) 公司永信藥品工業 ( 股 ) 公司台灣基因科技 台灣神隆 神隆生物科技晶宇生物科技實業 ( 股 ) 公司聯亞生技開發 ( 股 ) 公司國際威林生化科 ( 股 ) 公司佳生科技顧問 仁山生化科技 杏輝藥品 科苗生物 泰宗生物科技 鴻亞生物科技五鼎生物技術 ( 股 ) 公司台灣醣聯生技醫藥 ( 股 ) 公司基亞生物科技 ( 股 ) 公司華肝基因 ( 股 ) 公司永昕生物醫藥 ( 股 ) 公司進階生物科技 ( 股 ) 公司 計畫名稱姬松茸高活性多醣特性研究及分離生產技術開發計畫新藥候補物質 1-Benzy1-3-(5'-hydroxymethy 1-2'-fury1)indazole(YC-1) 及其衍生物開發計畫以中草藥開發影響人類疾病相關基因及其應用整合計畫微流體快速雜交晶片系統計畫治療愛滋病病毒血症單株抗體產程技術之開發新穎鉑化物作為抗癌與 DNA 切割藥物之研發植物藥國際法規策略平台計畫用於測定血糖之奈米電化學生物感測技術之開發抗癌細胞醣抗原人類單株抗體之開發抗癌藥物 PI-88 國際聯合開發計畫基因抗體服務的技術平台開發計畫生物藥 cgmp 委託開發服務中心 (CMO) 之建立計畫基因轉殖鼠與胚胎幹細胞科技開發計畫 資料來源 : 經濟部技術處業界科專辦公室 111
Appendix 4 The Distribution of sample firms Appendix 4.1 The Distribution of sample firms in USA Industry Sample Size in USA Industry Biotech & Health Care Biohemistry Number of Company 134 68 Distribution of Sample Firms in US 34% 66% Biotech& Health Care Biochemistry 112
Appendix 4.2 The distribution of Sample Firms in Taiwan Industry Sample Size in Taiwan Industry Health Care & Biotechnology Chemicals Number of Company 24 49 Distribution of Sample Firms in Taiwan 33% 67% Biotech& Health Care Biochemistry 113
Appendix 5 List of the Sample Firms Appendix 5.1 List of the Sample Firms in US Biotechnology Biotech & Health Care Company Name Ticker Business ABBOTT LABORATORIES ABT Medical Diagnostic Instruments And Tests AFFYMETRIX INC AFFX Genechip System Such As Assays & Reagents ALBANY MOLECULAR RESH INC AMRI Biocatalysis Technology And Medicinal Chemistry Services ALLOS THERAPEUTICS INC ALTH Small Molecule Drugs For The Treatment Of Cancer AMEDISYS INC AMED Home Health And Hospice Services AMERICAN MEDICAL SYSTMS HLDS AMMD Surgical Products AMSURG CORP AMSG Operating Ambulatory Surgery Centers In Partnership With Physician Practice Groups AMYLIN PHARMACEUTICALS INC AMLN Medicines For Diabetes And Obesity ANTIGENICS INC/DE AGEN Personalized Cancaer Vaccine APRIA HEALTHCARE GROUP INC AHG Home Respiratory/Infusion Therapy And Home Medical Equipment ARADIGM CORP ARDM.PK Drug Delivering Tech By Inhalation ARIAD PHARMACEUTICALS INC ARIA Medicines To Treat Cancers ARMOR HOLDINGS INC AH Security Products And Vehicle Armor Systems ARQULE INC ARQL R&D Of Cancer Therapeutic ARRHYTHMIA RESEARCH TECH HRT Licenses Medical Software That Detect Potentially Lethal Arrhythmias ARTHROCARE CORP ARTC Medical Devices For Use In Soft-Tissue Surgery Primarily ASPECT MEDICAL SYSTEMS INC ASPM Anesthesia Monitoring System ATS MEDICAL INC ATSI Medical Devices Primarily Used In Cardiac Surgery AVANT IMMUNOTHERAPEUTICS INC AVAN Vaccines That Harness The Human Immune Response System AVIGEN INC AVGN Small Molecule Therapeutics To Treat Neuromuscular Disorders. BARD (C.R.) INC BCR Vascular, Urology, Oncology, And Surgical Specialty Products BAXTER INTERNATIONAL INC BIOCRYST PHARMACEUTICALS INC BIOGEN IDEC INC BAX BCRX BIIB Medical Devices And Pharmaceuticals For Immune Disorders And Cancer Research And Development Of Novel Drugs That Block Jet Enzymes Involved In Cancer R&D Of Novel Therapies Primarily In The Areas Of Oncology, Neurology, And Immunology BIOLASE TECHNOLOGY INC BLTI Dental, Cosmetic, And Surgical Lasers And Related Products BIOMARIN PHARMACEUTICAL INC BMRN Biopharmaceuticals For Serious Diseases BIOSITE INC BSTE Immunoassay Diagnostic Products 114
BOSTON LIFE SCIENCES INC BLSI Biopharmaceutical Products For The Treatment And Diagnosis Of Cns Disorders BOSTON SCIENTIFIC CORP BSX Medical Devices For Interventional Medical Specialties BRITESMILE INC BSMLD Dental Health And Aftercare Products CELL THERAPEUTICS INC CTIC Developing Cancer Teatments And Drugs CELSION CORP CLN Developing Treatment Systems For Cancer And Other Chronic Diseases CERUS CORP CERS Products For Blood Safety And Immunotherapy COMMUNITY HEALTH SYSTEMS INC CYH Hospital Healthcare Services CONMED CORP CNMD Surgical Devices And Equipment For Minimally Invasive Procedures CONNETICS CORP CNCT Effective Skin Care Product CRYOLIFE INC CRY Biomaterials And Implantable Medical Devices CURAGEN CORP CV THERAPEUTICS INC CYTOGEN CORP CRGN CVTX CYTO Protein, Antibody, And Small Molecule Therapeutics For The Treatment Of Cancer Small Molecule Drugs For The Treatment Of Cardiovascular Diseases Drugs For The Treatment Of Pain In Patients Whose Cancer Has Spread To The Bone DAVITA INC DVA It Operates Kidney Dialysis Centers DAXOR CORP DXR Developing Instruments That Are Used For Diagnosing And Treating Patients With Heart Failure DECODE GENETICS INC DCGN Develop Drugs And Diagnostics For Common Diseases DENTSPLY INTERNATL INC XRAY Dental Consumables DJO INC DJO Rigid Knee Braces EDWARDS LIFESCIENCES CORP EW Tissue Heart Valves For Repairing A Patient'S Valve Defective Heart ENCYSIVE PHARMACEUTICALS INC ENCY Small Molecule Compounds For The Treatment Of Cardiovascular And Vascular ENDOCARE INC ENDO.OB Health Care Products That Use The Ice To Destroy Tumors EXELIXIS INC EXEL R&D Of Therapies For Cancer Diabetic Nephropathy GENE LOGIC INC GLGC Provides A Database That Examine The Interrelationship Between The Human Genome GEN-PROBE INC GPRO Develops Nucleic Acid Testing GENTA INC GNTA Dna/Rna Medicines:Using Modifications Of Either Dna Or Rna As Drugs GENZYME CORP GENZ Products For Renal Diseases,Gaucher Disease, Anemia. GERON CORP GERN Telomerase Inhibitors Based Anti-Cancer Therapies 115
GILEAD SCIENCES INC GILD Drugs For Human Immunodeficiency Virus Infection GTC BIOTHERAPEUTICS INC GTCB Human Therapeutic Proteins Through Transgenic Technology HCA INC HCA Healthcare Services HEALTHSOUTH CORP HLS Ambulatory Surgery And Rehabilitative Health Care Services HOOPER HOLMES INC HH Medical-Related Outsourced Risk Assessment Services HUMAN GENOME SCIENCES INC HGSI Antibody Drugs To Treat Cancer Hepatitis C, Lupus, Anthrax Disease And ICOS CORP ICOS Clinical Products Such As Various Antibodies ICU MEDICAL INC ICUI Disposable Medical Connection Systems IDEXX LABS INC IDXX Point-Of-Care Veterinary Diagnostic Products IMCLONE SYSTEMS INC IMCL Providing Treatment Such As Antibody For Cancers; Conducting Clinical Studies For Cancer IMCOR PHARMACEUTICAL CO ICRP.PK An Ultrasound Imaging Contrast Agent For Echocardiograms IMMUCELL CORP IMMUNE RESPONSE CORP/DE ICCC 3IMNR Products For Therapeutic And Preventive Use Against Infectious Diseases Developing Novel Treatments For Autoimmune And Infectious Diseases INTEGRA LIFESCIENCES HLDGS IART Surgical Implants And Medical Instruments INTERMUNE INC ITMN Products That Address Ipf And Hcv INTRABIOTICS PHARMACEUTICALS INTRICON CORP IBPI IIN Pharmaceutical Products For The Treatment Of Hiv, Cancer, And Inflammatory Diseases INTUITIVE SURGICAL INC ISRG Micro-Miniature Components For The Hearing Instrument INVACARE CORP IVC Power Wheelchairs And Custom Manual Wheelchairs INVITROGEN CORP JOHNSON & JOHNSON IVGN JNJ Kit Forms For Gene Acquisition, Cloning, Expression, And Analysis Techniques Providing Various Products And Services For Health Care Such As Caregiver Services KINDRED HEALTHCARE INC KND Hospital, Health Services, Rehabilitation, And Pharmacy KOS PHARMACEUTICALS INC KOSP Drugs Of Chronic Cardiovascular Diseases LCA VISION INC LEXICON GENETICS INC LCAV LXRX Laser Technologies To Correct Nearsightedness, Farsightedness, And Astigmatism Providing Treatement Of Congnitive Impairment Associated With Disorders LIFEPOINT HOSPITALS INC LPNT A Hospital LINCARE HOLDINGS INC LNCR Home Oxygen Equipment, Nebulizers And Associated Respiratory Medications MANOR CARE INC HCR Home Health Care, And Rehabilitation Therapy Services 116
MAXYGEN INC MAXY Protein Pharmaceuticals For Treatment Of Neutropenia, Hepatitis C MEDAREX INC MEDX Human Antibody-Based Therapeutic Products To Treat Cancer MEDIMMUNE INC MEDI Products For Prevention And Treatment In Therapeutic Areas Of Infectious Diseases MEDTOX SCIENTIFIC INC MTOX Medical Laboratories MERIT MEDICAL SYSTEMS INC MMSI Coronary Control Syringes; Inflation Devices And Monitors MICROVISION INC MVIS Light Scanning Technologies MILLENNIUM PHARMACEUTICALS MINE SAFETY APPLIANCES CO NABI BIOPHARMACEUTICALS MLNM MSA NABI Manufacturing Velcade That Can Prevent Protein From Decomposing And Against Cancer Cells Respiratory Protection Products; Hand-Held And Permanent Instruments Medical For Transplantation, Infectious Disease And Nicotine Addiction NANOGEN INC NGEN Advanced Diagnostic Products To Research, Clinical Laboratory NATIONAL HEALTHCARE CORP NHC Long-Term Health Care Centers NOVOSTE CORP NOVT.PK Therapeutic Solutions For The Prevention And Treatment Of Vascular Diseases NPS PHARMACEUTICALS INC NPSP Therapeutic Small Molecule Drugs And Recombinant Proteins NUVELO INC NUVO Drugs For Acute Cardiovascular And Cancer Therapy OAKLEY INC OO Sunglasses, Prescription Eyewear, Goggles, And Electronically Enabled Eyewear ODYSSEY HEALTHCARE INC ODSY Manage Pain And Other Discomforting Symptoms ORASURE TECHNOLOGIES INC OSUR Oral Fluid Specimen Collection Devices ORCHID CELLMARK INC ORCH Dna Testing Service OSI PHARMACEUTICALS INC OSIP Pharmaceutical Products For Oncology, Diabetes, And Obesity OSTEOTECH INC OSTE Provides Osteo-Biologic Solutions PALOMAR MED TECHNOLOGIES INC PDL BIOPHARMA INC PMTI PDLI Laser And Light Based Systems For Medical And Cosmetic Treatments Providing A Technology Of Transplantation For Chronic Myelogenous Leukemia PEDIATRIX MEDICAL GROUP INC PDX Provide Pediatric Physician Services PHARMACEUTICAL PROD DEV INC PPDI Drug Discovery And Development Service PHARMOS CORP PARS Focus On Specific Diseases Of The Nervous System PONIARD PHARMACEUTICALS INC PARD Cancer Therapy Products PRAECIS PHARMACEUTICALS INC PRCS R&D Of A Drug Candidate For Cancer And Autoimmune Diseases PSYCHEMEDICS CORP PMD Provides Testing And Confirmation By Mass Spectrometry To Detect Presence Of Drugs REHABCARE GROUP INC RHB A Hospital 117
RES-CARE INC RSCR Job Training, And Educational Support Services RESEARCH FRONTIERS INC REFR Suspended Particle Technology And Devices SIRNA THERAPEUTICS INC RNAI Developedrna Interference-Based Therapies For Diabetes, Cancer, Hepatitis C SONIC INNOVATIONS INC SNCI Digital Hearing SONOSITE INC SONO Hand-Carried Ultrasound Systems SPECTRASCIENCE INC SCIE.OB A Laser Induced Fluorescence Spectrophotometry System To Determine If Tissue Is Mormal ST JUDE MEDICAL INC STJ Medical Devices For Heart-Related And Neurological Conditions STAAR SURGICAL CO STAA Ntraocular Lenses And Other Ophthalmic Products STRYKER CORP SYK Orthopedic Reconstructive, Trauma,Spinal, And Craniomaxillofacial Implant Systems SUN HEALTHCARE GROUP INC SUNH Specialty Healthcare Services Primarily To The Senior Population SYMYX TECHNOLOGIES INC SMMX Research Software For The Chemicals, Energy And Life Science TARGETED GENETICS CORP TGEN Gene Therapy Products And Technologies THERAGENICS CORP TGX Theraseed, A Cancer Treatment Device THORATEC CORP THOR Circulatory Support Products For Use By Patients With Heart Failure TRIAD HOSPITALS INC TRI Hospitals And Ambulatory Surgery Centers TRIMERIS INC TRMS Drugs That Called Fusion Inhibitors Impair Viral Fusion UNITED SURGICAL PARTNERS INTL USPI Health Care Delivery And Management Of Ambulatory Surgery Centers UNIVERSAL HEALTH SVCS UHS Acute Care Hospitals UTAH MEDICAL PRODUCTS INC UTMD Neonatal Intensive Care:Fetal Monitoring Accessories VENTANA MEDICAL SYSTEM INC VMSI Drug Discovery Systems VIASYS HEALTHCARE INC VAS Medical Devices, Instruments, And Medical And Surgical Products VICAL INC VICL Dna-Based Vaccines ZIMMER HOLDINGS INC ZMH Orthopaedic, Dental And Spinal Implants Total Number:134 118
Biochemistry Company Name Ticker Businesses ACURA PHARMACEUTICALS INC ACUR. Manufacture Of Abuse Deterrent, Abuse Resistant ALBEMARLE CORP ALB Provides Chemistry Services For The Pharmaceutical Use ALLERGAN INC AGN Dermal Filter Products ALPHARMA INC ALO Active Pharmaceutical Ingredients AMGEN INC AMGN Human Therapeutic Products In Supportive Cancer Care ARCH CHEMICALS INC ARJ Biocides And Personal Care Specialty Ingredients; And Wood Treatment And Industrial Coatings Chemicals BALCHEM CORP BCPC Specialty Performance Ingredients And Products For The Food BENTLEY PHARMACEUTICALS BNT Active Pharmaceutical Ingredients And Drug Delivery Technologies BRADLEY PHARMACEUTICL BDY Dermatologic And Podiatric Products BRISTOL-MYERS SQUIBB CO BMY Cardiovascular Products,Virology Products CAMBREX CORP CBM Active Pharmaceutical Ingredients CARRINGTON LABORATORIES INC CARN Wound And Skin Care Medical Products CELGENE CORP CELG Innovative Therapies To Treat Cancer CELL GENESYS INC CEGE Biological Therapies For Cancer Such As Cell-Based Immunotherapies CEPHALON INC CEPH Drugs To Treat Human Diseases CHEMTURA CORPORATION CEM Crop Protection Products COLUMBIA LABORATORIES INC CBRX Pharmaceutical Products That Treat Women'S Healthcare CUBIST PHARMACEUTICALS INC CBST Pharmaceutical Products For The Anti-Infective Market CYTEC INDUSTRIES INC CYT Mining Chemicals DOW CHEMICAL DOW Pest Management, Agricultural, And Crop Biotechnology Products DU PONT DE NEMOURS DD Hybrid Seed Corn And Soybean Seed DUSA PHARMACEUTICALS INC DUSA Products For Common Skin Conditions EASTMAN CHEM EMN Eastacryl Emulsion 30D,7-Dehydrocholesterol EMISPHERE TECHNOLOGIES INC EMIS Specializes In The Oral Delivery Of Therapeutic Macromolecules ENDO PHARMACEUTICALS HLDGS ENDP Drugs To Relieve The Pain Of Postherpetic Neuralgia ENTREMED INC ENMD Engagin In Clinical Trials Such As A Monotherapy For Treatment Of Ovarian Cancer FMC CORP FMC Drug Tablet Binder And Disintegrant, And Food Ingredient GENENTECH INC DNA Avastin For Treating Metastatic Cancer Of The Colon HERCULES INC HPC Pharmaceutical Ingredients IGI INC IG Semi Solid And Liquid Products For Pharmaceutical Applications Total Number: 68 Total Number of Biotechnology Companies in USA: 202 119
Appendix 5.2 List of the Sample Firms in Taiwan Biotechnology Biotech & Health Care Company Name Ticker Businesses 精華 1565 醫療器材 : 拋棄隱形眼鏡鏡片 ; 車削式鏡片 必翔 1729 醫療器材 : 殘障用車, 電動代步車 五鼎 1733 醫療器材 : 尿酸試鏡片, 尿酸測試儀套件 喬山 1736 醫療器材 : 心肺復甦健身機 合世 1781 醫療器材 : 電子血壓計 訊聯 1784 擠帶血, 間質幹細胞, 基因檢測 露絲科 1794 醫療儀器設備, 保養品 紅電醫 1799 醫療器材 : 電子體溫計 進階 3118 培養用耗材, 抗體 / 試劑類, 儀器設備 大學光 3218 醫療器材 : 光學儀器, 眼鏡 熱映光電 3373 醫療器材 : 紅外線溫度測量儀, 血糖尿酸測次儀器, 高精度耳膜溫度計 百略 4103 醫療器材 : 血壓, 體溫及氣喘等相關檢測器材 東貿 4104 醫療器材 : 血液透析相關耗材, 心臟科相關醫療器材 雃博 4106 醫療器材 : 褥瘡氣墊床組, 醫療電子產品 邦拓 4107 醫療器材 : 血液迴路管,TPU 導管之製造買賣及代理 聯上生技 4113 醫療器材 : 毒品檢測劑, 驗孕檢測計, 部分美容產品 三豐醫 4116 醫療器材 : 嬰兒照顧, 特殊手術用產品等 優盛 4121 醫療器材 : 數位式血壓計 期美 4124 醫療器材 : 室內醫療保健器材 喬聯 4125 床邊生理監護儀製造業務, 臨床生化電解質分析 太醫 4126 醫療氣體用儀器 儀表, 中央氣體工程之加工買賣 聯合 4129 人工關節 人工骨板 骨釘 骨針等 晶宇生技 4131 生物晶片之開發製造及銷售 康齡醫 4727 牙醫生技醫療服務及醫療器材批發 Total Number: 24 120
Biochemistry Company Name Ticker Businesses 中化 1701 一般錠劑膠囊, 醫療用藥品 榮化 1704 甲醇及其下游製品 ( 用於保養品和醫藥 ) 葡萄王 1707 藥品及藥品原料, 機能性食品 東鹼 1708 生產用於製藥 食品的原料 東聯 1710 醫藥中間體, 化妝保養品, 醫療用氣體 永光 1711 特用化學品 : 醫藥化學品及電子化學品 興農 1712 農藥及肥料 國化 1713 保險粉, 鋅氧粉 : 常與其他藥物配成複方制劑 永信 1716 人用錠劑, 人用膠囊 生達 1720 人用及動物藥品, 試劑 三晃 1721 特用化學品及合成樹脂, 可用於醫藥中間體 台肥 1722 農藥, 複合肥料 台硝 1724 化學試藥及化工產品 中華化 1727 醫藥中間體 血管擴張劑 ; 酸鹼化學品 : 有機合成藥劑 美吾華 1731 醫藥品, 美髮品 毛寶 1732 清潔用品, 西藥及環境衛生用藥 杏輝 1734 西藥 : 抗生素, 藥品原料合成 台鹽 1737 藥品, 機能性食品, 微生物製劑 台蠟 1742 凡士林, 特用化學品之開發 南光 1752 大型注射液, 人用錠劑類, 小型注射液 寶齡 1760 西藥及化妝品代理代工 生泰 1777 肌肉鬆弛劑原料藥, 局部麻醉劑原料藥 杏昌 1788 生化試藥, 人工腎臟, 紅血球生成素 美時 1795 西藥製造 精鼎科 3109 生物技術服務, 藥品檢驗及藥品批發 景岳生技 3164 發酵菌粉及發酵菌液 基亞 3176 生物製藥研發及中西藥批發, 動物用藥批發 天騵 3205 生化科技產品及中西藥品研發零售, 健康食品 弘如洋 3266 錠劑類, 注射類 永日 4102 化學藥品, 醫藥品, 工業藥品 東洋 4105 口服製劑, 軟膏類 懷特 4108 天然植物中藥草, 生物科技研發 加捷 4109 藥品, 機能性食品, 酵素 濟生 4111 抗生素藥品及注射類 健喬 4114 錠劑, 液劑, 膜衣錠 121
普生 4117 B 型肝炎試劑,C 型肝炎試劑 旭富 4119 原料藥, 原料藥中間體 友華 4120 西藥系列, 食品, 化妝品之製造進出口及代理經銷 晟德 4123 西藥製造批發, 水劑, 錠劑 天良 4127 西藥, 中藥及食品製造批發 中天 4128 新藥開發, 機能性食品 健亞 4130 藥品製造代工, 藥品臨床試驗服務 中美實 4702 醫藥中間體, 檢測用精密化學品, 染料及胡蘿蔔素 磐亞 4707 聚乙二醇烷基胺醚 : 用於製藥 ; 聚乙二醇 : 用於保養品 永捷 4714 生產可用於環保產品, 醫療產品之原料 信昌化 4725 醫藥及防腐劑用酚 新力美 6507 動物用藥中間體, 環境用藥, 多官能機單體 惠光 6508 農藥及肥料, 植物保護劑 聚和 6509 醫藥合成中間物, 藥品製劑, 保養品, 食物乳化劑等 Total Number: 49 Total Number of Biotechnology Companies in Taiwan: 73 122