Contents:

EXECUTIVE SUMMARY.........................................................................................................................................I SECTION 1 INTRODUCTION................................................................................................................................ 1 INVESTIGATION........................................................... 1 1.2 METHODOLOGY OF INVESTIGATION................................................................................................ 2 1.3 LIMITATIONS OF INVESTIGATION ..................................................................................................... 3 SECTION 2 DELPHI PANEL AND THOUGHT LEADER INTERVIEW: DISCUSSION AND SUMMARY OF DIABETES INNOVATION.................................................................................................... 5 2.1 INTRODUCTION ..................................................................................................................................... 5 2.2 RESULTS OF DELPHI PANEL INTERVIEWS....................................................................................... 6 2.3 DELPHI SUMMARY.............................................................................................................................. 18 SECTION 3 TYPE I DIABETES BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITIES . 21 3.1 INTRODUCTION TO THE DISEASE STATE AND ITS EPIDEMIOLOGY ....................................... 21 3.2 EVALUATION OF INNOVATION ACTIVITIES UNDER WAY......................................................... 24 3.3 PRODUCT TECHNOLOGY ANALYSIS ............................................................................................... 26 3.4 MARKET ANALYSIS AND FORECAST .............................................................................................. 33 3.5 BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITY IDENTIFICATION ................ 35 SECTION 4 TYPE II DIABETES BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITIES 39 4.1 INTRODUCTION TO THE DISEASE STATE AND ITS EPIDEMIOLOGY ....................................... 39 4.2 EVALUATION OF INNOVATION ACTIVITIES UNDER WAY......................................................... 44 4.3 PRODUCT TECHNOLOGY ANALYSIS ............................................................................................... 48 4.4 MARKET ANALYSIS AND FORECAST .............................................................................................. 60 4.5 BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITY IDENTIFICATION ................ 64 SECTION 5 DIABETIC NEPHROPATHY BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITIES...................................................................................................................... 71 5.1 INTRODUCTION TO THE DISEASE STATE AND ITS EPIDEMIOLOGY ....................................... 71 5.2 EVALUATION OF INNOVATION ACTIVITIES UNDER WAY......................................................... 75 5.3 PRODUCT TECHNOLOGY ANALYSIS ............................................................................................... 76 5.4 MARKET ANALYSIS AND FORECAST .............................................................................................. 82 5.5 BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITY IDENTIFICATION ................ 83 SECTION 6 DIABETIC NEUROPATHY BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITIES...................................................................................................................... 87 6.1 INTRODUCTION TO THE DISEASE STATE AND ITS EPIDEMIOLOGY ....................................... 87 6.2 EVALUATION OF INNOVATION ACTIVITIES UNDER WAY......................................................... 91 6.3 PRODUCT TECHNOLOGY ANALYSIS ............................................................................................... 91 6.4 MARKET ANALYSIS AND FORECAST .............................................................................................. 96 6.5 BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITY IDENTIFICATION ................ 97 ii SECTION 7 DIABETIC RETINOPATHY BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITIES.................................................................................................................... 101 7.1 INTRODUCTION TO THE DISEASE STATE AND ITS EPIDEMIOLOGY ..................................... 101 7.2 EVALUATION OF INNOVATION ACTIVITIES UNDER WAY....................................................... 105 7.3 PRODUCT TECHNOLOGY ANALYSIS ............................................................................................. 105 7.4 MARKET ANALYSIS AND FORECAST ............................................................................................ 111 7.5 BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITY IDENTIFICATION .............. 112 SECTION 8 TECHNOLOGY PLATFORMS PRODUCT TECHNOLOGIES IMPACTING DIABETES THERAPEUTICS ...................................................................................................................... 115 8.1 INTRODUCTION TO PRODUCT TECHNOLOGIES IMPACTING DIABETES THERAPEUTICS 115 8.2 ANGIOGENISIS INHIBITORS............................................................................................................. 116 8.3 ANTIHYPERTENSIVE AGENTS......................................................................................................... 117 8.4 CELL THERAPY .................................................................................................................................. 118 8.5 ENZYME INHIBITORS ........................................................................................................................ 120 8.6 GROWTH FACTORS ............................................................................................................................ 122 8.7 GLYCATION ALTERING AGENTS.................................................................................................... 124 8.8 ALDOSE REDUCTASE INHIBITORS (ARI)....................................................................................... 125 8.9 ADVANCED GLYCATION END PRODUCT (AGE) INHIBITORS .................................................. 125 8.10 HORMONES ......................................................................................................................................... 126 8.11 IMMUNOTHERAPY ............................................................................................................................. 127 8.12 ADHESION MOLECULES ................................................................................................................... 128 8.13 VACCINES............................................................................................................................................ 129 8.14 INSULIN AND INSULIN ANALOGS .................................................................................................. 129 8.15 INSULIN ANALOGUES AND AGONISTS ......................................................................................... 130 8.16 INSULIN DELIVERY SYSTEMS......................................................................................................... 130 8.17 SULFONYLUREAS.............................................................................................................................. 133 8.18 INSULINOTROPIC AGENTS............................................................................................................... 133 8.19 GLP-1..................................................................................................................................................... 134 8.20 INSULIN SENSITIZERS ....................................................................................................................... 135 8.21 MOLECULAR....................................................................................................................................... 137 8.22 NEUROTRANSMITTER MODULATORS ..........................................................................................140 8.23 SIGNAL TRANSDUCTION MODULATORS......................................................................................141 8.24 THIAZOLIDINES, PPAR AGONISTS AND RXR AGONISTS .......................................................... 143 8.25 OTHER TECHNOLOGIES................................................................................................................... 145 SECTION 9 COMPANY PROFILES OF INNOVATIVE FIRMS REPRESENTING ACQUISITIONS, LICENSING, AND COMARKETING OPPORTUNITIES IN DIABETES THERAPY.... 147 9.1 ALLERGAN.......................................................................................................................................... 147 9.2 ALIZYME.............................................................................................................................................. 147 9.3 ALTEON................................................................................................................................................ 148 9.4 AMYLIN................................................................................................................................................ 148 9.5 ASTA MEDICA .................................................................................................................................... 149 9.6 BECTON DICKINSON......................................................................................................................... 149 9.7 BIOMEDICA FOSCAMA...................................................................................................................... 150 9.8 BIOSTRATUM...................................................................................................................................... 150 9.9 BIOTECH HOLDINGS......................................................................................................................... 150 9.10 CALYX THERAPEUTICS .................................................................................................................... 151 9.11 COELACANTH..................................................................................................................................... 151 9.12 COLLAGENEX PHARMACEUTICALS.............................................................................................. 152 9.13 DAINIPPON.......................................................................................................................................... 152 9.14 DESMOS ............................................................................................................................................... 152 9.15 DEVELOGEN ....................................................................................................................................... 153 9.16 DR REDDY’S RESEARCH FOUNDATION........................................................................................ 153 9.17 EXOCELL ............................................................................................................................................. 153 iii 9.18 FUJISAWA............................................................................................................................................ 154 9.19 GILEAD SCIENCES............................................................................................................................. 154 9.20 INSMED ................................................................................................................................................ 155 9.21 ISIS ..................................................................................................................................................... 156 9.22 JAPAN TOBACCO ............................................................................................................................... 156 9.23 KERYX BIOPHARMACEUTICALS .................................................................................................... 157 9.24 KYOWA HAKKO................................................................................................................................. 157 9.25 MAXIA PHARMACEUTICALS ........................................................................................................... 158 9.26 MEDIGENE........................................................................................................................................... 158 9.27 MERCK KGAA..................................................................................................................................... 159 9.28 METABOLEX....................................................................................................................................... 159 9.29 NEUROCHEM ...................................................................................................................................... 160 9.30 NEUROGEN.......................................................................................................................................... 160 9.31 NEXELL (FORMERLY VIMRX PHARMACEUTICALS).................................................................. 160 9.32 NIH ..................................................................................................................................................... 161 9.33 NIPPON CHEMIPHAR......................................................................................................................... 161 9.34 NISSAN CHEMICAL ............................................................................................................................ 162 9.35 PEPTECH .............................................................................................................................................. 162 9.36 PHARMACEUTICAL DISCOVERY .................................................................................................... 162 9.37 PHOTOVISION..................................................................................................................................... 163 9.38 PHYLOMED ......................................................................................................................................... 163 9.39 PROBIODRUG...................................................................................................................................... 163 9.40 PROTEIN DELIVERY (NOW NOBEX CORPORATION).................................................................. 164 9.41 PROVALIS ............................................................................................................................................ 164 9.42 QUADRANT HEALTHCARE............................................................................................................... 165 9.43 SANWA KAGAKU KENKYUSHO...................................................................................................... 166 9.44 SERTOLI TECHNOLOGIES................................................................................................................. 166 9.45 SERVIER............................................................................................................................................... 167 9.46 STEMCELLS......................................................................................................................................... 167 9.47 SUNTORY............................................................................................................................................. 168 9.48 SUPERGEN........................................................................................................................................... 168 9.49 TAKEDA............................................................................................................................................... 168 9.50 TANABE SEIYAKU............................................................................................................................. 169 9.51 TELIK (FORMERLY TERRAPIN TECHNOLOGIES) ........................................................................ 169 9.52 VICAL ................................................................................................................................................... 169 9.53 VIVORX................................................................................................................................................ 170 9.54 YISSUM ................................................................................................................................................ 170 9.55 WATSON LABS (FORMERLY THERATECH)................................................................................... 170 9.56 ZYCOS .................................................................................................................................................. 170 iv DETAILED TABLE OF CONTENTS EXECUTIVE SUMMARY...............................................................................................................................................i Current Therapeutic Regimens.......................................................................................................................................vii Future Treatments...........................................................................................................................................................vii SECTION 1 INTRODUCTION................................................................................................................................ 1 1.1 SCOPE AND OBJECTIVES OF RESEARCH INVESTIGATION........................................................... 1 1.2 METHODOLOGY OF INVESTIGATION................................................................................................ 2 1.3 LIMITATIONS OF INVESTIGATION ..................................................................................................... 3 SECTION 2 DELPHI PANEL AND THOUGHT LEADER INTERVIEW: DISCUSSION AND SUMMARY OF DIABETES INNOVATION.................................................................................................... 5 2.1 INTRODUCTION ..................................................................................................................................... 5 2.2 RESULTS OF DELPHI PANEL INTERVIEWS....................................................................................... 6 2.2.1 Diabetic complications.................................................................................................................... 6 2.2.2 A.G.E.s and Diabetic Complications................................................................................................ 7 2.2.3 Impact of ACE Inhibitors on Diabetes ............................................................................................. 8 2.2.4 Combination Therapy in Type II Diabetes ....................................................................................... 9 2.2.5 New Approaches for Insulin Therapy............................................................................................. 11 2.2.6 Islet Cell Transplantation............................................................................................................... 12 2.2.7 Thiazolidines and PPARs ............................................................................................................... 13 2.2.8 GLP-1............................................................................................................................................ 15 2.2.9 Genomics....................................................................................................................................... 16 2.2.10 Future Trends and Issues in Diabetes ............................................................................................ 16 2.3 DELPHI SUMMARY.............................................................................................................................. 18 Current Therapeutic Regimens.......................................................................................................................................18 Future Treatments...........................................................................................................................................................19 SECTION 3 TYPE I DIABETES BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITIES . 21 3.1 INTRODUCTION TO THE DISEASE STATE AND ITS EPIDEMIOLOGY ....................................... 21 3.1.1 Epidemiology................................................................................................................................. 21 3.1.2 Etiology ......................................................................................................................................... 22 3.1.3 Pathophysiology ............................................................................................................................. 22 3.2 EVALUATION OF INNOVATION ACTIVITIES UNDER WAY......................................................... 24 3.3 PRODUCT TECHNOLOGY ANALYSIS ............................................................................................... 26 3.3.1 Current Therapeutics ..................................................................................................................... 31 3.3.2 Near-term Therapeutics.................................................................................................................. 31 3.3.3 Longer-term Therapeutics .............................................................................................................. 32 3.4 MARKET ANALYSIS AND FORECAST .............................................................................................. 33 3.5 BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITY IDENTIFICATION ................ 35 SECTION 4 TYPE II DIABETES BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITIES 39 4.1 INTRODUCTION TO THE DISEASE STATE AND ITS EPIDEMIOLOGY ....................................... 39 4.1.1 Epidemiology................................................................................................................................. 39 4.1.2 Risk Factors for NIDDM................................................................................................................ 39 4.1.3 Prevalence..................................................................................................................................... 40 v 4.1.4 Etiology ......................................................................................................................................... 40 4.1.5 Diagnosis of Type II Diabetes ........................................................................................................ 41 4.1.6 Mortality........................................................................................................................................ 41 4.1.7 Current Therapy: Value And Limitations ....................................................................................... 41 4.2 EVALUATION OF INNOVATION ACTIVITIES UNDER WAY......................................................... 44 4.2.1 Recent events in diabetes Type II ................................................................................................... 44 4.3 PRODUCT TECHNOLOGY ANALYSIS ............................................................................................... 48 4.3.1 Assumption Structure ..................................................................................................................... 52 4.3.2 Current Therapeutics ..................................................................................................................... 53 4.3.3 Near-term Therapeutics.................................................................................................................. 55 4.3.4 Longer-term Therapeutics .............................................................................................................. 56 4.4 MARKET ANALYSIS AND FORECAST .............................................................................................. 60 4.5 BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITY IDENTIFICATION ................ 64 SECTION 5 DIABETIC NEPHROPATHY BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITIES...................................................................................................................... 71 5.1 INTRODUCTION TO THE DISEASE STATE AND ITS EPIDEMIOLOGY ....................................... 71 5.1.1 Epidemiology................................................................................................................................. 71 5.1.2 Definition....................................................................................................................................... 72 5.1.3 Etiology ......................................................................................................................................... 73 5.1.4 Pathophysiology ............................................................................................................................. 73 5.1.5 Diagnosis....................................................................................................................................... 75 5.1.6 Treatment ...................................................................................................................................... 75 5.2 EVALUATION OF INNOVATION ACTIVITIES UNDER WAY......................................................... 75 5.3 PRODUCT TECHNOLOGY ANALYSIS ............................................................................................... 76 5.3.1 Assumption Structure ..................................................................................................................... 79 5.3.2 Current Therapeutics ..................................................................................................................... 79 5.3.3 Near-term Therapeutics.................................................................................................................. 80 5.3.4 Longer-term Therapeutics .............................................................................................................. 81 5.4 MARKET ANALYSIS AND FORECAST .............................................................................................. 82 5.5 BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITY IDENTIFICATION ................ 83 SECTION 6 DIABETIC NEUROPATHY BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITIES...................................................................................................................... 87 6.1 INTRODUCTION TO THE DISEASE STATE AND ITS EPIDEMIOLOGY ....................................... 87 6.1.1 Epidemiology................................................................................................................................. 87 6.1.2 Definition....................................................................................................................................... 87 6.1.3 Types of Neuropathy...................................................................................................................... 88 6.1.4 Etiology ......................................................................................................................................... 88 6.1.5 Pathophysiology ............................................................................................................................. 89 6.1.6 Diagnosis....................................................................................................................................... 90 6.1.7 Treatment ...................................................................................................................................... 90 6.2 EVALUATION OF INNOVATION ACTIVITIES UNDER WAY......................................................... 91 6.3 PRODUCT TECHNOLOGY ANALYSIS ............................................................................................... 91 6.3.1 Assumption Structure ..................................................................................................................... 94 6.3.2 Current Therapeutics ..................................................................................................................... 94 6.3.3 Near-term Therapeutics.................................................................................................................. 94 6.3.4 Longer-term Therapeutics .............................................................................................................. 94 6.4 MARKET ANALYSIS AND FORECAST .............................................................................................. 96 6.5 BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITY IDENTIFICATION ................ 97 SECTION 7 DIABETIC RETINOPATHY BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITIES.................................................................................................................... 101 7.1 INTRODUCTION TO THE DISEASE STATE AND ITS EPIDEMIOLOGY ..................................... 101 7.1.1 Epidemiology............................................................................................................................... 101 7.1.2 Definition..................................................................................................................................... 101 7.1.3 Epidemiology............................................................................................................................... 102 7.1.4 Etiology and Pathophysiology...................................................................................................... 103 7.1.5 Diagnosis..................................................................................................................................... 104 7.2 EVALUATION OF INNOVATION ACTIVITIES UNDER WAY....................................................... 105 7.3 PRODUCT TECHNOLOGY ANALYSIS ............................................................................................. 105 7.3.1 Assumption Structure ................................................................................................................... 108 7.3.2 Current Therapeutics ................................................................................................................... 108 7.3.3 Near-term Therapeutics................................................................................................................ 109 7.3.4 Longer-term Therapeutics ............................................................................................................ 110 7.4 MARKET ANALYSIS AND FORECAST ............................................................................................ 111 7.5 BUSINESS DEVELOPMENT AND INNOVATION OPPORTUNITY IDENTIFICATION .............. 112 SECTION 8 TECHNOLOGY PLATFORMS PRODUCT TECHNOLOGIES IMPACTING DIABETES THERAPEUTICS ...................................................................................................................... 115 8.1 INTRODUCTION TO PRODUCT TECHNOLOGIES IMPACTING DIABETES THERAPEUTICS 115 8.2 ANGIOGENISIS INHIBITORS............................................................................................................. 116 8.3 ANTIHYPERTENSIVE AGENTS......................................................................................................... 117 8.3.1 ACE inhibitors............................................................................................................................. 117 8.3.2 Angiotensin II Antagonists ........................................................................................................... 118 8.4 CELL THERAPY .................................................................................................................................. 118 8.5 ENZYME INHIBITORS ........................................................................................................................ 120 8.5.1 Pancreatic Lipase......................................................................................................................... 120 8.5.2 Hormone-Sensitive Lipase............................................................................................................ 120 8.5.3 Alpha Glucosidase Inhibitors ....................................................................................................... 121 8.5.4 Glycogen Phosphorylase.............................................................................................................. 121 8.5.5 CPT-1 (carnitine palmytoyl transferase I) ................................................................................... 121 8.6 GROWTH FACTORS ............................................................................................................................ 122 8.6.1 Insulin-like Growth Factor (IGF-1) ............................................................................................. 122 8.6.2 Neurotrophic Growth Factors...................................................................................................... 123 8.7 GLYCATION ALTERING AGENTS.................................................................................................... 124 8.8 ALDOSE REDUCTASE INHIBITORS (ARI)....................................................................................... 125 8.9 ADVANCED GLYCATION END PRODUCT (AGE) INHIBITORS .................................................. 125 8.10 HORMONES ......................................................................................................................................... 126 8.10.1 Leptin........................................................................................................................................... 126 8.10.2 Amylin.......................................................................................................................................... 126 8.10.3 Steroid Hormones........................................................................................................................ 126 8.10.4 Glucagon ..................................................................................................................................... 126 8.10.5 Glucagon Antagonists .................................................................................................................. 127 8.11 IMMUNOTHERAPY ............................................................................................................................. 127 8.11.1 Immunomodulators...................................................................................................................... 127 8.12 ADHESION MOLECULES ................................................................................................................... 128 8.13 VACCINES............................................................................................................................................ 129 8.14 INSULIN AND INSULIN ANALOGS .................................................................................................. 129 8.15 INSULIN ANALOGUES AND AGONISTS ......................................................................................... 130 8.16 INSULIN DELIVERY SYSTEMS......................................................................................................... 130 8.16.1 Inhaled Insulin............................................................................................................................. 131 8.16.2 Oral Insulin ................................................................................................................................. 132 8.16.3 insulin secretagogues ................................................................................................................... 132 8.17 SULFONYLUREAS.............................................................................................................................. 133 8.18 INSULINOTROPIC AGENTS............................................................................................................... 133 8.19 GLP-1..................................................................................................................................................... 134 8.20 INSULIN SENSITIZERS ....................................................................................................................... 135 8.20.1 Biguanides................................................................................................................................... 135 8.20.2 Glucose Uptake Mediators ........................................................................................................... 136 8.20.3 Oxadiazole................................................................................................................................... 136 8.21 MOLECULAR....................................................................................................................................... 137 vii 8.21.1 Gene therapy ............................................................................................................................... 137 8.21.2 Antisense Technology ................................................................................................................... 138 8.21.3 Genomics..................................................................................................................................... 139 8.22 NEUROTRANSMITTER MODULATORS ..........................................................................................140 8.22.1 Adrenergic Agents ........................................................................................................................ 140 8.22.2 Dopamine .................................................................................................................................... 140 8.23 SIGNAL TRANSDUCTION MODULATORS......................................................................................141 8.23.1 Protein Kinase C (PKC) Inhibitors .............................................................................................. 141 8.23.2 Phosphodiesterase (PDE) Inhibitors............................................................................................ 142 8.23.3 Insulin Signaling, Tyrosine kinase/phosphatase........................................................................... 142 8.24 THIAZOLIDINES, PPAR AGONISTS AND RXR AGONISTS .......................................................... 143 8.24.1 Thiazolidines ............................................................................................................................... 144 8.24.2 PPAR Agonists ............................................................................................................................. 144 8.24.3 RXR Agonists............................................................................................................................... 144 8.25 OTHER TECHNOLOGIES................................................................................................................... 145 SECTION 9 COMPANY PROFILES OF INNOVATIVE FIRMS REPRESENTING ACQUISITIONS, LICENSING, AND COMARKETING OPPORTUNITIES IN DIABETES THERAPY.... 147 9.1 ALLERGAN.......................................................................................................................................... 147 9.2 ALIZYME.............................................................................................................................................. 147 9.3 ALTEON................................................................................................................................................ 148 9.4 AMYLIN................................................................................................................................................ 148 9.5 ASTA MEDICA .................................................................................................................................... 149 9.6 BECTON DICKINSON......................................................................................................................... 149 9.7 BIOMEDICA FOSCAMA...................................................................................................................... 150 9.8 BIOSTRATUM...................................................................................................................................... 150 9.9 BIOTECH HOLDINGS......................................................................................................................... 150 9.10 CALYX THERAPEUTICS .................................................................................................................... 151 9.11 COELACANTH..................................................................................................................................... 151 9.12 COLLAGENEX PHARMACEUTICALS.............................................................................................. 152 9.13 DAINIPPON.......................................................................................................................................... 152 9.14 DESMOS ............................................................................................................................................... 152 9.15 DEVELOGEN ....................................................................................................................................... 153 9.16 DR REDDY’S RESEARCH FOUNDATION........................................................................................ 153 9.17 EXOCELL ............................................................................................................................................. 153 9.18 FUJISAWA............................................................................................................................................ 154 9.19 GILEAD SCIENCES............................................................................................................................. 154 9.20 INSMED ................................................................................................................................................ 155 9.21 ISIS ..................................................................................................................................................... 156 9.22 JAPAN TOBACCO ............................................................................................................................... 156 9.23 KERYX BIOPHARMACEUTICALS .................................................................................................... 157 9.24 KYOWA HAKKO................................................................................................................................. 157 9.25 MAXIA PHARMACEUTICALS ........................................................................................................... 158 9.26 MEDIGENE........................................................................................................................................... 158 9.27 MERCK KGAA..................................................................................................................................... 159 9.28 METABOLEX....................................................................................................................................... 159 9.29 NEUROCHEM ...................................................................................................................................... 160 9.30 NEUROGEN.......................................................................................................................................... 160 9.31 NEXELL (FORMERLY VIMRX PHARMACEUTICALS).................................................................. 160 9.32 NIH ..................................................................................................................................................... 161 9.33 NIPPON CHEMIPHAR......................................................................................................................... 161 9.34 NISSAN CHEMICAL ............................................................................................................................ 162 9.35 PEPTECH .............................................................................................................................................. 162 9.36 PHARMACEUTICAL DISCOVERY .................................................................................................... 162 9.37 PHOTOVISION..................................................................................................................................... 163 9.38 PHYLOMED ......................................................................................................................................... 163 viii 9.39 PROBIODRUG...................................................................................................................................... 163 9.40 PROTEIN DELIVERY (NOW NOBEX CORPORATION).................................................................. 164 9.41 PROVALIS ............................................................................................................................................ 164 9.42 QUADRANT HEALTHCARE............................................................................................................... 165 9.43 SANWA KAGAKU KENKYUSHO...................................................................................................... 166 9.44 SERTOLI TECHNOLOGIES................................................................................................................. 166 9.45 SERVIER............................................................................................................................................... 167 9.46 STEMCELLS......................................................................................................................................... 167 9.47 SUNTORY............................................................................................................................................. 168 9.48 SUPERGEN........................................................................................................................................... 168 9.49 TAKEDA............................................................................................................................................... 168 9.50 TANABE SEIYAKU............................................................................................................................. 169 9.51 TELIK (FORMERLY TERRAPIN TECHNOLOGIES) ........................................................................ 169 9.52 VICAL ................................................................................................................................................... 169 9.53 VIVORX................................................................................................................................................ 170 9.54 YISSUM ................................................................................................................................................ 170 9.55 WATSON LABS (FORMERLY THERATECH)................................................................................... 170 9.56 ZYCOS .................................................................................................................................................. 170 ix LIST OF FIGURES Figure ES-1 Product Development Activity in Diabetes by Disease State ................................ iv Figure ES-2 Product Development Activity in Diabetes Therapy by Phase of Development .... v Figure ES-3 Unpartnered vs. Partnered Programs by Phase of Development ........................... vi Figure 3.1 Market Impact Matrix for Technology Platforms in Type I Diabetes Therapy.... 28 Figure 3.2 WW Forecast for Type I Diabetes Therapy by Technology Platform .................. 29 Figure 3.3 US Forecast for Insulin Delivery Platforms.......................................................... 30 Figure 4.1 Market Impact Matrix for Technology Platforms in Type II Diabetes Therapy... 51 Figure 4.2 WW Forecast for Type II Diabetes Therapy by Technology Platform................. 52 Figure 5.1 Market Impact Matrix for Technology Platforms in Diabetic Nephropathy Therapy.................................................................................................................. 78 Figure 5.2 WW Forecast for Diabetic Nephropathy Therapy by Technology Platform ........ 79 Figure 6.1 Market Impact Matrix for Technology Platforms in Diabetic Neuropathy Therapy.................................................................................................................. 93 Figure 6.2 WW Forecast for Diabetic Neuropathy Therapy by Technology Platform .......... 93 Figure 7.1 Market Impact Matrix for Technology Platforms in Diabetic Retinopathy Therapy................................................................................................................ 107 Figure 7.2 WW Forecast for Diabetic Retinopathy Therapy by Technology Platform........ 108 x LIST OF TABLES Table ES-1 US Sales Forecast for Major Diabetes Categories ...............................................viii Table ES-2 Opportunity Sorting Matrix for All Diabetes Therapies ........................................ xi Table 3.1 Product Development Activity for Type I Diabetes Therapy by Phase of Development ......................................................................................................... 27 Table 3.2 US Market Forecast for Type I Diabetes Therapy by Technology....................... 34 Table 3.3 Opportunity Sorting Matrix for Type I Diabetes Therapy .................................... 36 Table 3.4 Product Development Activity for Type I Diabetes Therapy ............................... 37 Table 4.1 Product Development Activity for Type II Diabetes Therapy by Phase of Development ......................................................................................................... 49 Table 4.2 US Market Forecast for Type II Diabetes Therapy by Technology...................... 63 Table 4.3 Opportunity Sorting Matrix for Type II Diabetes Therapy................................... 65 Table 4.4 Product Development Activity for Type II Diabetes Therapy.............................. 67 Table 5.1 Product Development Activity for Diabetic Nephropathy Therapy by Phase of Development ......................................................................................................... 76 Table 5.2 US Market Forecast for Diabetic Nephropathy Therapy by Technology ............. 83 Table 5.3 Opportunity Sorting Matrix for Diabetic Nephropathy Therapy .......................... 84 Table 5.4 Product Development Activity for Diabetic Nephropathy Therapy ..................... 86 Table 6.1 Product Development Activity for Diabetic Neuropathy Therapy by Phase of Development ......................................................................................................... 92 Table 6.2 US Market Forecast for Diabetic Neuropathy Therapy by Technology ............... 97 Table 6.3 Opportunity Sorting Matrix for Diabetic Neuropathy Therapy ............................ 98 Table 6.4 Product Development Activity for Diabetic Neuropathy Therapy ....................... 99 Table 7.1 Product Development Activity for Diabetic Retinopathy Therapy by Phase of Development ....................................................................................................... 106 Table 7.2 US Market Forecast for Diabetic Retinopathy Therapy by Technology ............ 112 Table 7.3 Opportunity Sorting Matrix for Diabetic Retinopathy Therapy ......................... 113 Table 7.4 Product Development Activity for Diabetic Retinopathy Therapy..................... 114

Summary:

This report is designed to provide a useful tool to professionals in research and development (R&D), marketing, business development, licensing, and strategic planning who are, or are anticipating, involvement in the discovery, development, licensing, and/or marketing of therapeutics for the treatment of Type I diabetes, Type II diabetes, nephropathy, neuropathy, and retinopathy.