Skeletal Disease Drug Development Pipeline Review, 2017

This report provides an overview of the skeletal disease pipeline landscape. The report provides comprehensive information on the therapeutics under development and key players involved in therapeutic development for osteoporosis, post-menopausal osteoporosis and osteoarthritis (OA).

OA is one of the most common forms of arthritis. It is a chronic condition in which the cartilage breaks down. Symptoms of osteoarthritis include sore or stiff joints, pain that is worse after activity, bone spurs and grating sensation. Risk factors include older age, joint injuries and obesity. Treatment includes surgery, medications like non-steroidal anti-inflammatory drugs (NSAIDs) and exercise.

Osteoporosis, or thinning bones, makes bones weak and more likely to break. Risk factors for osteoporosis include aging, being female, low body weight, low sex hormones or menopause, smoking, and some medications. Postmenopausal osteoporosis is the most common subtype of osteoporosis, and affects many women after menopause. Signs and symptoms of osteoporosis include back pain, caused by a fractured or collapsed vertebra, loss of height over time, a stooped posture, a bone fracture that occurs much more easily than expected. Prevention and treatment include calcium and vitamin D, exercise, and other osteoporosis medications.

The size of these pipelines ranges from 13 products in postmenopausal osteoporosis to 116 in OA. The predominant targets within OA are prostaglandin G/H synthases 1 and 2, although a wide range of targets, including extracellular matrix-organizing proteins and interleukins, are being studied. Likewise, within both osteoporosis and the post-menopausal subtype, a broad range of molecular targets are being studied. The targets being most frequently studied are the parathyroid hormone receptor, tumor necrosis factor ligand superfamily member 11 and sclerostin.

Scope

– Which companies are the most active within the pipeline for osteoporosis and OA therapeutics?

– 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 the field of osteoporosis and OA therapeutics?

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

Table of Contents

Table of Contents

GBI Research Report Guidance 2

Executive Summary 3

Table of Contents 4

List of Tables 5

List of Figures 9

Introduction 10

Skeletal Disease Report Coverage 10

Osteoarthritis - Overview 10

Osteoporosis - Overview 10

Post Menopausal Osteoporosis - Overview 10

Therapeutics Development 11

Osteoarthritis 11

Osteoporosis 21

Post Menopausal Osteoporosis 31

Therapeutics Assessment 34

Osteoarthritis 34

Osteoporosis 44

Post Menopausal Osteoporosis 54

Companies Involved in Therapeutics Development 62

Osteoarthritis 62

Osteoporosis 96

Post Menopausal Osteoporosis 124

Dormant Projects 129

Osteoarthritis 129

Osteoporosis 133

Post Menopausal Osteoporosis 138

Discontinued Products 139

Osteoarthritis 139

Osteoporosis 140

Post Menopausal Osteoporosis 141

Product Development Milestones 142

Osteoarthritis 142

Osteoporosis 154

Post Menopausal Osteoporosis 164

Appendix 175

Methodology 175

Coverage 175

Secondary Research 175

Primary Research 175

Expert Panel Validation 175

Contact Us 175

Disclaimer 176

List of Tables

List of Tables

Number of Products under Development for Osteoarthritis 11

Number of Products under Development by Companies, Osteoarthritis 13

Number of Products under Development by Universities/Institutes, Osteoarthritis 15

Products under Development by Companies, Osteoarthritis 16

Products under Development by Universities/Institutes, Osteoarthritis 20

Number of Products under Development for Osteoporosis 21

Number of Products under Development by Companies, Osteoporosis 23

Number of Products under Development by Universities/Institutes, Osteoporosis 25

Products under Development by Companies, Osteoporosis 26

Products under Development by Universities/Institutes, Osteoporosis 30

Number of Products under Development for Post Menopausal Osteoporosis 31

Number of Products under Development by Companies, Post Menopausal Osteoporosis 32

Products under Development by Companies, Post Menopausal Osteoporosis 33

Number of Products by Stage and Target, Osteoarthritis 35

Number of Products by Stage and Mechanism of Action, Osteoarthritis 38

Number of Products by Stage and Route of Administration, Osteoarthritis 41

Number of Products by Stage and Molecule Type, Osteoarthritis 43

Number of Products by Stage and Target, Osteoporosis 45

Number of Products by Stage and Mechanism of Action, Osteoporosis 48

Number of Products by Stage and Route of Administration, Osteoporosis 51

Number of Products by Stage and Molecule Type, Osteoporosis 53

Number of Products by Stage and Target, Post Menopausal Osteoporosis 55

Number of Products by Stage and Mechanism of Action, Post Menopausal Osteoporosis 57

Number of Products by Stage and Route of Administration, Post Menopausal Osteoporosis 59

Number of Products by Stage and Molecule Type, Post Menopausal Osteoporosis 61

Osteoarthritis – Pipeline by A. Menarini Industrie Farmaceutiche Riunite Srl 62

Osteoarthritis – Pipeline by AbbVie Inc 62

Osteoarthritis – Pipeline by Abiogen Pharma SpA 63

Osteoarthritis – Pipeline by Ablynx NV 63

Osteoarthritis – Pipeline by Achelios Therapeutics Inc 64

Osteoarthritis – Pipeline by Addex Therapeutics Ltd 64

Osteoarthritis – Pipeline by Amgen Inc 65

Osteoarthritis – Pipeline by Amura Holdings Ltd 65

Osteoarthritis – Pipeline by Arcarios BV 66

Osteoarthritis – Pipeline by Asahi Kasei Pharma Corp 66

Osteoarthritis – Pipeline by Asklepios BioPharmaceutical Inc 67

Osteoarthritis – Pipeline by Astellas Pharma Inc 67

Osteoarthritis – Pipeline by Biopharm GmbH 68

Osteoarthritis – Pipeline by Bone Therapeutics SA 68

Osteoarthritis – Pipeline by Can-Fite BioPharma Ltd 69

Osteoarthritis – Pipeline by Cardax Inc 69

Osteoarthritis – Pipeline by Cellular Biomedicine Group Inc 70

Osteoarthritis – Pipeline by Cipla Ltd 70

Osteoarthritis – Pipeline by Corestem Inc 71

Osteoarthritis – Pipeline by Dong-A Socio Holdings Co Ltd 71

Osteoarthritis – Pipeline by Evgen Pharma Plc 72

Osteoarthritis – Pipeline by F. Hoffmann-La Roche Ltd 72

Osteoarthritis – Pipeline by Galapagos NV 73

Osteoarthritis – Pipeline by Gemphire Therapeutics Inc 73

Osteoarthritis – Pipeline by GeneFrontier Corp 74

Osteoarthritis – Pipeline by Genequine Biotherapeutics GmbH 74

Osteoarthritis – Pipeline by GlaxoSmithKline Plc 75

Osteoarthritis – Pipeline by HSRx Group 75

Osteoarthritis – Pipeline by InKemia IUCT Group SA 76

Osteoarthritis – Pipeline by International Stem Cell Corp 76

Osteoarthritis – Pipeline by Jeil Pharmaceutical Co Ltd 77

Osteoarthritis – Pipeline by Jenrin Discovery Inc 77

Osteoarthritis – Pipeline by K-Stemcell Co Ltd 78

Osteoarthritis – Pipeline by Kang Stem Biotech Co Ltd 78

Osteoarthritis – Pipeline by Levolta Pharmaceuticals Inc 79

Osteoarthritis – Pipeline by LG Chem, Ltd. 79

Osteoarthritis – Pipeline by Marina Biotech Inc 80

Osteoarthritis – Pipeline by Medivir AB 80

Osteoarthritis – Pipeline by Merck KGaA 81

Osteoarthritis – Pipeline by Mesoblast Ltd 81

Osteoarthritis – Pipeline by Mor Research Application Ltd 82

Osteoarthritis – Pipeline by NicOx SA 82

Osteoarthritis – Pipeline by Nordic Bioscience A/S 83

Osteoarthritis – Pipeline by Novartis AG 83

Osteoarthritis – Pipeline by NovelMed Therapeutics Inc 84

Osteoarthritis – Pipeline by Omeros Corp 84

Osteoarthritis – Pipeline by Ono Pharmaceutical Co Ltd 85

Osteoarthritis – Pipeline by OrthoCyte Corp 85

Osteoarthritis – Pipeline by Osteologix Holdings Plc 86

Osteoarthritis – Pipeline by Pfizer Inc 86

Osteoarthritis – Pipeline by Pharmalink AB 87

Osteoarthritis – Pipeline by Philogen SpA 87

Osteoarthritis – Pipeline by PhytoHealth Corp 88

Osteoarthritis – Pipeline by PLx Pharma Inc 88

Osteoarthritis – Pipeline by ProteoThera Inc 89

Osteoarthritis – Pipeline by Regeneus Ltd 89

Osteoarthritis – Pipeline by Regulaxis SAS 90

Osteoarthritis – Pipeline by Rottapharm Biotech Srl 90

Osteoarthritis – Pipeline by Samumed LLC 91

Osteoarthritis – Pipeline by Seikagaku Corp 91

Osteoarthritis – Pipeline by Stelis Biopharma Pvt Ltd 92

Osteoarthritis – Pipeline by Takeda Pharmaceutical Company Ltd 92

Osteoarthritis – Pipeline by TissueGene Inc 93

Osteoarthritis – Pipeline by Yooyoung Pharmaceutical Co Ltd 93

Osteoarthritis – Pipeline by Yuhan Corp 94

Osteoarthritis – Pipeline by Yungjin Pharm Co Ltd 94

Osteoarthritis – Pipeline by Zimmer Biomet Holdings Inc 95

Osteoporosis – Pipeline by Addex Therapeutics Ltd 96

Osteoporosis – Pipeline by Alize Pharma SAS 96

Osteoporosis – Pipeline by Alvogen Korea Co Ltd 97

Osteoporosis – Pipeline by Amgen Inc 97

Osteoporosis – Pipeline by Amura Holdings Ltd 98

Osteoporosis – Pipeline by BiologicsMD Inc 98

Osteoporosis – Pipeline by Bone Biologics Corp 99

Osteoporosis – Pipeline by Bristol-Myers Squibb Company 99

Osteoporosis – Pipeline by Cellmid Ltd 100

Osteoporosis – Pipeline by ChoDang Pharm Co Ltd 100

Osteoporosis – Pipeline by Chugai Pharmaceutical Co Ltd 101

Osteoporosis – Pipeline by Corium International Inc 101

Osteoporosis – Pipeline by Critical Pharmaceuticals Ltd 102

Osteoporosis – Pipeline by Daiichi Sankyo Company Ltd 102

Osteoporosis – Pipeline by ElexoPharm GmbH 103

Osteoporosis – Pipeline by EndoCeutics Inc 103

Osteoporosis – Pipeline by Entera Bio Ltd 104

Osteoporosis – Pipeline by Enteris BioPharma Inc 104

Osteoporosis – Pipeline by Enzo Biochem Inc 105

Osteoporosis – Pipeline by F. Hoffmann-La Roche Ltd 105

Osteoporosis – Pipeline by Gador SA 106

Osteoporosis – Pipeline by GL Pharm Tech Corp 106

Osteoporosis – Pipeline by Glide Pharmaceutical Technologies Ltd 107

Osteoporosis – Pipeline by Hanmi Pharmaceuticals Co Ltd 107

Osteoporosis – Pipeline by Haoma Medica Ltd 108

Osteoporosis – Pipeline by Immunovo BV 108

Osteoporosis – Pipeline by Immunwork Inc 109

Osteoporosis – Pipeline by Intas Pharmaceuticals Ltd 109

Osteoporosis – Pipeline by Ipsen SA 110

Osteoporosis – Pipeline by Kaken Pharmaceutical Co Ltd 110

Osteoporosis – Pipeline by Lead Discovery Center GmbH 111

Osteoporosis – Pipeline by Ligand Pharmaceuticals Inc 111

Osteoporosis – Pipeline by Lotus Pharmaceutical Co Ltd 112

Osteoporosis – Pipeline by Lupin Ltd 112

Osteoporosis – Pipeline by Merck & Co Inc 113

Osteoporosis – Pipeline by Mereo Biopharma Group Plc 113

Osteoporosis – Pipeline by NIBEC 114

Osteoporosis – Pipeline by Omeros Corp 114

Osteoporosis – Pipeline by Oncobiologics Inc 115

Osteoporosis – Pipeline by Osteologix Holdings Plc 115

Osteoporosis – Pipeline by Paras Biopharmaceuticals Finland Oy 116

Osteoporosis – Pipeline by Pfenex Inc 116

Osteoporosis – Pipeline by PhytoHealth Corp 117

Osteoporosis – Pipeline by R Pharm 117

Osteoporosis – Pipeline by Ribomic Inc 118

Osteoporosis – Pipeline by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co Ltd 118

Osteoporosis – Pipeline by Shin Poong PharmCo Ltd 119

Osteoporosis – Pipeline by Sinil Pharmaceutical Co Ltd 119

Osteoporosis – Pipeline by Stelis Biopharma Pvt Ltd 120

Osteoporosis – Pipeline by Sumitomo Dainippon Pharma Co Ltd 120

Osteoporosis – Pipeline by Terpenoid Therapeutics Inc 121

Osteoporosis – Pipeline by TSH Biopharm Corporation Ltd 121

Osteoporosis – Pipeline by Uni-Bio Science Group Ltd 122

Osteoporosis – Pipeline by Viking Therapeutics Inc 122

Osteoporosis – Pipeline by Wroclawskie Centrum Badan EIT+ Sp z oo 123

Osteoporosis – Pipeline by Yooyoung Pharm Co Ltd 123

Osteoporosis – Pipeline by Zydus Cadila Healthcare Ltd 124

Post Menopausal Osteoporosis – Pipeline by Amgen Inc 124

Post Menopausal Osteoporosis – Pipeline by Enteris BioPharma Inc 125

Post Menopausal Osteoporosis – Pipeline by Intas Pharmaceuticals Ltd 125

Post Menopausal Osteoporosis – Pipeline by Ipsen SA 126

Post Menopausal Osteoporosis – Pipeline by Ligand Pharmaceuticals Inc 126

Post Menopausal Osteoporosis – Pipeline by Lupin Ltd 127

Post Menopausal Osteoporosis – Pipeline by NIBEC 127

Post Menopausal Osteoporosis – Pipeline by Oncobiologics Inc 128

Post Menopausal Osteoporosis – Pipeline by Paras Biopharmaceuticals Finland Oy 128

Osteoarthritis – Dormant Projects 129

Osteoporosis – Dormant Projects 133

Post Menopausal Osteoporosis – Dormant Projects 138

Osteoarthritis – Discontinued Products 139

Osteoporosis – Discontinued Products 140

Post Menopausal Osteoporosis – Discontinued Products 141

List of Figures

List of Figures

Number of Products under Development for Osteoarthritis 11

Number of Products under Development by Companies, Osteoarthritis 12

Number of Products under Development by Universities/Institutes, Osteoarthritis 15

Number of Products under Development for Osteoporosis 21

Number of Products under Development by Companies, Osteoporosis 22

Number of Products under Development by Universities/Institutes, Osteoporosis 25

Number of Products under Development for Post Menopausal Osteoporosis 31

Number of Products under Development by Companies, Post Menopausal Osteoporosis 32

Number of Products by Top 10 Targets, Osteoarthritis 34

Number of Products by Stage and Top 10 Targets, Osteoarthritis 34

Number of Products by Top 10 Mechanism of Actions, Osteoarthritis 37

Number of Products by Stage and Top 10 Mechanism of Actions, Osteoarthritis 37

Number of Products by Routes of Administration, Osteoarthritis 40

Number of Products by Stage and Routes of Administration, Osteoarthritis 40

Number of Products by Top 10 Molecule Types, Osteoarthritis 42

Number of Products by Stage and Top 10 Molecule Types, Osteoarthritis 42

Number of Products by Top 10 Targets, Osteoporosis 44

Number of Products by Stage and Top 10 Targets, Osteoporosis 44

Number of Products by Top 10 Mechanism of Actions, Osteoporosis 47

Number of Products by Stage and Top 10 Mechanism of Actions, Osteoporosis 47

Number of Products by Top 10 Routes of Administration, Osteoporosis 50

Number of Products by Stage and Top 10 Routes of Administration, Osteoporosis 50

Number of Products by Top 10 Molecule Types, Osteoporosis 52

Number of Products by Stage and Top 10 Molecule Types, Osteoporosis 52

Number of Products by Targets, Post Menopausal Osteoporosis 54

Number of Products by Stage and Targets, Post Menopausal Osteoporosis 54

Number of Products by Mechanism of Actions, Post Menopausal Osteoporosis 56

Number of Products by Stage and Mechanism of Actions, Post Menopausal Osteoporosis 56

Number of Products by Routes of Administration, Post Menopausal Osteoporosis 58

Number of Products by Stage and Routes of Administration, Post Menopausal Osteoporosis 58

Number of Products by Molecule Types, Post Menopausal Osteoporosis 60

Number of Products by Stage and Molecule Types, Post Menopausal Osteoporosis 60

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