Diabetes and Associated Metabolic Conditions Drug Development Pipeline Review, 2018

This report provides an overview of the pipeline landscape for diabetes and associated metabolic conditions. It provides comprehensive information on the therapeutics under development and key players involved in therapeutic development for type I diabetes, type II diabetes, hyperinsulinemia and hyperglycemia, and features dormant and discontinued products.

Diabetes refers to a group of metabolic diseases that result from defects in insulin secretion, insulin action or both of these. Type I diabetes is an autoimmune disease in which the pancreas stops producing insulin, a hormone that enables people to get energy from food. It occurs when the body’s immune system attacks and destroys the insulin-producing cells in the pancreas, called beta cells. There are 263 products in development for this indication.

Type 2 diabetes, however, results from a combination of resistance to insulin action and an inadequate compensatory insulin secretory response. Type 2 diabetes is more closely related to lifestyle choices such as diet and exercise habits than type I diabetes, with the majority of patients being overweight or obese. There are 574 products in development for this indication.

Hyperinsulinemia is a condition in which there are excess levels of insulin circulating in the blood relative to the level of glucose. Insulin resistance is the primary cause of hyperinsulinemia. There are 10 products in development for this indication.

Hyperglycemia is a condition that occurs when blood glucose levels get too high. Several factors can contribute to hyperglycemia, including food and physical activity choices, illness, non-diabetes medications, or not taking enough glucose-lowering medication. There are seven products in development for this indication.

Molecular targets acted on by products in development for diabetes and associated metabolic conditions include the insulin receptor, glucagon-like peptide 1 (GLP-1) receptor, glucagon receptor and glucokinase. Companies operating in this pipeline space include Novo Nordisk, Eli Lilly and Zealand Pharma

Scope

– Which companies are the most active within each pipeline?

– Which pharmaceutical approaches are the most prominent at each stage of the pipeline and within each indication?

– To what extent do universities and institutions play a role within this pipeline, compared to pharmaceutical companies?

– What are the most important R&D milestones and data publications to have happened in this disease area?

Reasons to buy

- Understand the overall pipeline, with an at-a-glance overview of all products in therapeutic development for each indication

- Assess the products in development in granular detail, with an up-to-date overview of each individual pipeline program in each indication and a comprehensive picture of recent updates and milestones for each

- Analyze the companies, institutions and universities currently operating in the pipeline and the products being fielded by each of these

- Understand the composition of the pipeline in terms of molecule type, molecular target, mechanism of action and route of administration

Companies mentioned

Adocia SAS

Aegis Therapeutics LLC

AFFiRiS AG

AiCuris GmbH & Co KG

Akcea Therapeutics Inc

Allist Shanghai Pharmaceutical Technology Co Ltd

Amarantus Bioscience Holdings Inc

Amarna Therapeutics BV

Amgen Inc

apceth Biopharma GmbH

Aphios Corp

Apodemus AB

Arecor Ltd

Arena Pharmaceuticals Inc

Astellas Pharma Inc

AstraZeneca Plc

Atlantic Bio Sci LLC

AusBio Ltd

Avadel Pharmaceuticals Plc

Axxam SpA

Bayer AG

Beta-Cell NV

Betagenon AB

Betta Pharmaceuticals Co Ltd

Biocon Ltd

BioLineRx Ltd

BioLingus AG

BioRestorative Therapies Inc

Biozeus

BirchBioMed Inc

Biscayne Pharmaceuticals Inc

Boehringer Ingelheim GmbH

Boston Therapeutics Inc

Braasch Biotech LLC

Bristol-Myers Squibb Co

BTB Pharma AB

C4X Discovery Holdings PLC

Cadila Healthcare Ltd

Cadila Pharmaceuticals Ltd

Caelus Health

Caladrius Biosciences Inc

Cancer Prevention Pharmaceuticals Inc

Cardax Inc

Carmot Therapeutics Inc

Cellix Bio Pvt Ltd

Celon Pharma SA

Center Laboratories Inc

Chipscreen Biosciences Ltd

Chong Kun Dang Pharmaceutical Corp

Cinnagen Co

CJ HealthCare Corp

CohBar Inc

Compugen Ltd

Concenter BioPharma Silkim Ltd

CymaBay Therapeutics Inc

Daewoong Pharmaceutical Co Ltd

Daiichi Sankyo Co Ltd

Dance Biopharm Inc

DanDrit Biotech A/S

Delpor Inc

Denceptor Therapeutics Ltd

Diabetology (Products) Ltd

Diamyd Medical AB

Diasome Pharmaceuticals Inc

DiaVacs Inc

DiscoveryBiomed Inc

DNJ Pharma Inc

Dompe Farmaceutici SpA

Dong-A Socio Holdings Co Ltd

Elcelyx Therapeutics Inc

Eli Lilly and Co

Eloxx Pharmaceuticals Inc

Energenesis Biomedical Co Ltd

Ensol Biosciences Inc

Enteris BioPharma Inc

Enzene Biosciences Ltd

Enzo Biochem Inc

Epichem Pty Ltd

EpiVax Inc

Eternygen GmbH

Evotec AG

F. Hoffmann-La Roche Ltd

Fate Therapeutics Inc

Generex Biotechnology Corp

GeNeuro SA

Genexine Inc

Genfit SA

Genmedica Therapeutics SL

Genovate Biotechnology Co LTD

Geropharm LLC

Gilead Sciences Inc

GlaxoSmithKline Plc

Glucox Biotech AB

Hanmi Pharmaceuticals Co Ltd

Heptares Therapeutics Ltd

HitGen LTD

Hyundai Pharmaceutical Co Ltd

ImCyse SA

Immupharma Plc

Immuron Ltd

Inflazome Ltd

Innovative Targeting Solutions Inc

Inspyr Therapeutics Inc

InStar Technologies AS

Intarcia Therapeutics Inc

Intas Pharmaceuticals Ltd

Integral Molecular Inc

Intercept Pharmaceuticals Inc

Intrexon Corp

Ionis Pharmaceuticals Inc

Japan Tobacco Inc

Jeil Pharmaceutical Co Ltd

JHL Biotech Inc

Jiangsu Hansoh Pharmaceutical Group Co Ltd

Jiangsu Hengrui Medicine Co Ltd

Johnson & Johnson

Just Biotherapeutics Inc

Kadimastem Ltd

Kadmon Corp LLC

Kamada Ltd

Kasiak Research Pvt Ltd

Kissei Pharmaceutical Co Ltd

Kowa Co Ltd

Laboratorios Silanes SA de CV

Lead Discovery Center GmbH

Leading BioSciences Inc

Lexicon Pharmaceuticals Inc

LG Chem Ltd

LipimetiX Development Inc

Longevity Biotech Inc

Luye Pharma Group Ltd

Magnus Life Ltd

MannKind Corp

Maruho Co Ltd

Medesis Pharma SA

MedImmune LLC

Medlab Clinical Ltd

Medtronic Plc

Medy-Tox Inc

Merck & Co Inc

Meridigen Biotech Co Ltd

Mesoblast Ltd

Metabolic Solutions Development Company LLC

Metabolys SAS

Metacrine Inc

Mitsubishi Chemical Holdings Corp

Mitsubishi Tanabe Pharma Corp

Naia Ltd

Neovacs SA

Neurimmune Holding AG

NGM Biopharmaceuticals Inc

Novapeutics LLC

Novartis AG

NovaTarg Therapeutics Inc

Novo Nordisk AS

Omeros Corp

OPKO Biologics Ltd

OPKO Health Inc

Oramed Pharmaceuticals Inc

Orgenesis Inc

Original BioMedicals Co Ltd

OSE Immunotherapeutics

Palatin Technologies Inc

Panacea Biotec Ltd

Paras Biopharmaceuticals Finland Oy

Parvus Therapeutics Inc

Pathfinder Cell Therapy Inc

Peptron Inc

Pfizer Inc

PharmaCyte Biotech Inc

PharmaIN Corp

Pharmasum Therapeutics AS

Pila Pharma AB

Poxel SA

Prometheon Pharma LLC

ProMetic Life Sciences Inc

Prothena Corp Plc

Purzer Pharmaceutical Co Ltd

Reata Pharmaceuticals Inc

RedHill Biopharma Ltd

REGiMMUNE Corp

Reliance Life Sciences Pvt Ltd

reMYND NV

Renova Therapeutics Inc

Reset Therapeutics Inc

Rezolute Inc

Rubius Therapeutics Inc

Saniona AB

Sanofi

Sanwa Kagaku Kenkyusho Co Ltd

SATT Conectus Alsace SAS

SBI Pharmaceuticals Co Ltd

ScandiCure AB

Semma Therapeutics Inc

Seres Therapeutics Inc

Serodus ASA

Serometrix LLC

Shenzhen HighTide Biopharmaceutical Ltd

Shionogi & Co Ltd

Sirona Biochem Corp

SJT Molecular Research SL

SK Chemicals Co Ltd

Sotio AS

Sprint Bioscience AB

Sumitomo Dainippon Pharma Co Ltd

Suzuken Co Ltd

Taisho Pharmaceutical Holdings Co Ltd

Takeda Pharmaceutical Co Ltd

Teijin Pharma Ltd

Tetragenetics Inc

The Medicines Company

Theracos Inc

Thermalin Diabetes LLC

Tiziana Life Sciences Plc

Toleranzia AB

Tolerion Inc

Topas Therapeutics GmbH

Toray Industries Inc

Torrent Pharmaceuticals Ltd

Transgene Biotek Ltd

TTY Biopharm Company Ltd

Twoxar Inc

UCB SA

Uni-Bio Science Group Ltd

Unicyte AG

Ventria Bioscience

ViaCyte Inc

Vichem Chemie Research Ltd

Vicore Pharma AB

Viking Therapeutics Inc

Vivus Inc

vTv Therapeutics Inc

Vybion Inc

XBiotech Inc

XERIS Pharmaceuticals Inc

XL-protein GmbH

XOMA Corp

XuanZhu Pharma Co Ltd

Yabao Pharmaceutical Group Co Ltd

Yuhan Corp

Zafgen Inc

Zealand Pharma AS

Table of Contents

1 Table of Contents

1 Table of Contents 4

1.1 List of Tables 5

1.2 List of Figures 11

2 Introduction 12

2.1 Diabetes and Associated Metabolic Conditions Report Coverage 12

2.2 Type1 diabetes (Juvenile Diabetes) - Overview 12

2.3 Hyperinsulinemia - Overview 12

2.4 Hyperglycemia - Overview 12

3 Therapeutics Development 13

3.1 Type1 diabetes (Juvenile Diabetes) 13

3.2 Type2 diabetes 34

3.3 Hyperinsulinemia 71

3.4 Hyperglycemia 75

4 Therapeutics Assessment 78

4.1 Type1 diabetes (Juvenile Diabetes) 78

4.2 Type2 diabetes 89

4.3 Hyperinsulinemia 107

4.4 Hyperglycemia 114

5 Companies Involved in Therapeutics Development 119

5.1 Type1 diabetes (Juvenile Diabetes) 119

5.2 Type2 diabetes 168

5.3 Hyperinsulinemia 264

5.4 Hyperglycemia 266

6 Dormant Projects 267

6.1 Type1 diabetes (Juvenile Diabetes) 267

6.2 Type2 diabetes 277

6.3 Hyperinsulinemia 302

6.4 Hyperglycemia 302

7 Discontinued Products 303

7.1 Type1 diabetes (Juvenile Diabetes) 303

7.2 Type2 diabetes 305

7.3 Hyperglycemia 312

8 Product Development Milestones 313

8.1 Type1 diabetes (Juvenile Diabetes) 313

8.2 Type2 diabetes 324

8.3 Hyperinsulinemia 336

9 Appendix 343

9.1 Methodology 343

9.2 Coverage 343

9.3 Secondary Research 343

9.4 Primary Research 343

9.5 Expert Panel Validation 343

9.6 Contact Us 344

9.7 Disclaimer 344

List of Tables

1.1 List of Tables

Table 1: Number of Products under Development for Type1 diabetes (Juvenile Diabetes) 13

Table 2: Number of Products under Development by Companies, Type1 diabetes (Juvenile Diabetes) 15

Table 3: Number of Products under Development by Universities/Institutes, Type1 diabetes (Juvenile Diabetes) 20

Table 4: Products under Development by Companies, Type1 diabetes (Juvenile Diabetes) 21

Table 5: Products under Development by Universities/Institutes, Type1 diabetes (Juvenile Diabetes) 32

Table 6: Number of Products under Development for Type2 diabetes 34

Table 7: Number of Products under Development by Companies, Type2 diabetes 36

Table 8: Number of Products under Development by Universities/Institutes, Type2 diabetes 45

Table 9: Products under Development by Companies, Type2 diabetes 47

Table 10: Products under Development by Universities/Institutes, Type2 diabetes 67

Table 11: Number of Products under Development for Hyperinsulinemia 71

Table 12: Number of Products under Development by Companies, Hyperinsulinemia 73

Table 13: Number of Products under Development by Universities/Institutes, Hyperinsulinemia 74

Table 14: Products under Development by Companies, Hyperinsulinemia 74

Table 15: Products under Development by Universities/Institutes, Hyperinsulinemia 74

Table 16: Number of Products under Development for Hyperglycemia 75

Table 17: Number of Products under Development by Companies, Hyperglycemia 75

Table 18: Number of Products under Development by Universities/Institutes, Hyperglycemia 76

Table 19: Products under Development by Companies, Hyperglycemia 76

Table 20: Products under Development by Universities/Institutes, Hyperglycemia 77

Table 21: Number of Products by Stage and Target, Type1 diabetes (Juvenile Diabetes) 79

Table 22: Number of Products by Stage and Mechanism of Action, Type1 diabetes (Juvenile Diabetes) 82

Table 23: Number of Products by Stage and Route of Administration, Type1 diabetes (Juvenile Diabetes) 86

Table 24: Number of Products by Stage and Molecule Type, Type1 diabetes (Juvenile Diabetes) 88

Table 25: Number of Products by Stage and Target, Type2 diabetes 90

Table 26: Number of Products by Stage and Mechanism of Action, Type2 diabetes 96

Table 27: Number of Products by Stage and Route of Administration, Type2 diabetes 104

Table 28: Number of Products by Stage and Molecule Type, Type2 diabetes 106

Table 29: Number of Products by Stage and Target, Hyperinsulinemia 108

Table 30: Number of Products by Stage and Mechanism of Action, Hyperinsulinemia 110

Table 31: Number of Products by Stage and Route of Administration, Hyperinsulinemia 112

Table 32: Number of Products by Stage and Molecule Type, Hyperinsulinemia 113

Table 33: Number of Products by Stage and Target, Hyperglycemia 115

Table 34: Number of Products by Stage and Mechanism of Action, Hyperglycemia 116

Table 35: Number of Products by Stage and Route of Administration, Hyperglycemia 116

Table 36: Number of Products by Stage and Molecule Type, Hyperglycemia 118

Table 37: Type1 diabetes (Juvenile Diabetes) – Pipeline by Adocia SAS, 119

Table 38: Type1 diabetes (Juvenile Diabetes) – Pipeline by AiCuris GmbH & Co KG, 120

Table 39: Type1 diabetes (Juvenile Diabetes) – Pipeline by Allist Shanghai Pharmaceutical Technology Co Ltd, 120

Table 40: Type1 diabetes (Juvenile Diabetes) – Pipeline by Amarantus Bioscience Holdings Inc, 120

Table 41: Type1 diabetes (Juvenile Diabetes) – Pipeline by Amarna Therapeutics BV, 121

Table 42: Type1 diabetes (Juvenile Diabetes) – Pipeline by apceth Biopharma GmbH, 121

Table 43: Type1 diabetes (Juvenile Diabetes) – Pipeline by Aphios Corp, 122

Table 44: Type1 diabetes (Juvenile Diabetes) – Pipeline by Apodemus AB, 122

Table 45: Type1 diabetes (Juvenile Diabetes) – Pipeline by Arecor Ltd, 123

Table 46: Type1 diabetes (Juvenile Diabetes) – Pipeline by Astellas Pharma Inc, 123

Table 47: Type1 diabetes (Juvenile Diabetes) – Pipeline by AstraZeneca Plc, 124

Table 48: Type1 diabetes (Juvenile Diabetes) – Pipeline by Atlantic Bio Sci LLC, 125

Table 49: Type1 diabetes (Juvenile Diabetes) – Pipeline by Axxam SpA, 125

Table 50: Type1 diabetes (Juvenile Diabetes) – Pipeline by Beta-Cell NV, 125

Table 51: Type1 diabetes (Juvenile Diabetes) – Pipeline by Biocon Ltd, 126

Table 52: Type1 diabetes (Juvenile Diabetes) – Pipeline by BioLineRx Ltd, 127

Table 53: Type1 diabetes (Juvenile Diabetes) – Pipeline by BioLingus AG, 127

Table 54: Type1 diabetes (Juvenile Diabetes) – Pipeline by Biozeus, 127

Table 55: Type1 diabetes (Juvenile Diabetes) – Pipeline by BirchBioMed Inc, 128

Table 56: Type1 diabetes (Juvenile Diabetes) – Pipeline by Boehringer Ingelheim GmbH, 128

Table 57: Type1 diabetes (Juvenile Diabetes) – Pipeline by Boston Therapeutics Inc, 128

Table 58: Type1 diabetes (Juvenile Diabetes) – Pipeline by BTB Pharma AB, 129

Table 59: Type1 diabetes (Juvenile Diabetes) – Pipeline by Caladrius Biosciences Inc, 129

Table 60: Type1 diabetes (Juvenile Diabetes) – Pipeline by Cancer Prevention Pharmaceuticals Inc, 130

List of Figures

1.2 List of Figures

Figure 1: Number of Products under Development for Type1 diabetes (Juvenile Diabetes) 13

Figure 2: Number of Products under Development by Companies, Type1 diabetes (Juvenile Diabetes) 14

Figure 3: Number of Products under Development by Universities/Institutes, Type1 diabetes (Juvenile Diabetes) 19

Figure 4: Number of Products under Development for Type2 diabetes 34

Figure 5: Number of Products under Development by Companies, Type2 diabetes 35

Figure 6: Number of Products under Development by Universities/Institutes, Type2 diabetes 44

Figure 7: Number of Products under Development for Hyperinsulinemia 71

Figure 8: Number of Products under Development by Companies, Hyperinsulinemia 72

Figure 9: Number of Products under Development for Hyperglycemia 75

Figure 10: Number of Products under Development by Universities/Institutes, Hyperglycemia 76

Figure 11: Number of Products by Top 10 Targets, Type1 diabetes (Juvenile Diabetes) 78

Figure 12: Number of Products by Stage and Top 10 Targets, Type1 diabetes (Juvenile Diabetes) 78

Figure 13: Number of Products by Top 10 Mechanism of Actions, Type1 diabetes (Juvenile Diabetes) 81

Figure 14: Number of Products by Stage and Top 10 Mechanism of Actions, Type1 diabetes (Juvenile Diabetes) 81

Figure 15: Number of Products by Top 10 Routes of Administration, Type1 diabetes (Juvenile Diabetes) 85

Figure 16: Number of Products by Stage and Top 10 Routes of Administration, Type1 diabetes (Juvenile Diabetes) 85

Figure 17: Number of Products by Top 10 Molecule Types, Type1 diabetes (Juvenile Diabetes) 87

Figure 18: Number of Products by Stage and Top 10 Molecule Types, Type1 diabetes (Juvenile Diabetes) 87

Figure 19: Number of Products by Top 10 Targets, Type2 diabetes 89

Figure 20: Number of Products by Stage and Top 10 Targets, Type2 diabetes 89

Figure 21: Number of Products by Top 10 Mechanism of Actions, Type2 diabetes 95

Figure 22: Number of Products by Stage and Top 10 Mechanism of Actions, Type2 diabetes 95

Figure 23: Number of Products by Top 10 Routes of Administration, Type2 diabetes 103

Figure 24: Number of Products by Stage and Top 10 Routes of Administration, Type2 diabetes 103

Figure 25: Number of Products by Top 10 Molecule Types, Type2 diabetes 105

Figure 26: Number of Products by Stage and Top 10 Molecule Types, Type2 diabetes 105

Figure 27: Number of Products by Targets, Hyperinsulinemia 107

Figure 28: Number of Products by Stage and Targets, Hyperinsulinemia 107

Figure 29: Number of Products by Mechanism of Actions, Hyperinsulinemia 109

Figure 30: Number of Products by Stage and Mechanism of Actions, Hyperinsulinemia 109

Figure 31: Number of Products by Routes of Administration, Hyperinsulinemia 111

Figure 32: Number of Products by Stage and Routes of Administration, Hyperinsulinemia 111

Figure 33: Number of Products by Molecule Types, Hyperinsulinemia 112

Figure 34: Number of Products by Stage and Molecule Types, Hyperinsulinemia 113

Figure 35: Number of Products by Targets, Hyperglycemia 114

Figure 36: Number of Products by Stage and Targets, Hyperglycemia 114

Figure 37: Number of Products by Mechanism of Actions, Hyperglycemia 115

Figure 38: Number of Products by Stage and Mechanism of Actions, Hyperglycemia 116

Figure 39: Number of Products by Molecule Types, Hyperglycemia 117

Figure 40: Number of Products by Stage and Molecule Types, Hyperglycemia 117

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