Male Health Drug Development Pipeline Review, 2017

This report provides an overview of the pipeline landscape for male health. The report provides comprehensive information on the therapeutics under development and key players involved in therapeutic development for Male Hypogonadism, Erectile Dysfunction and Benign Prostatic Hyperplasia, and features dormant and discontinued projects.

Male hypogonadism is a condition in which the body doesn’t produce enough testosterone, resulting in signs and symptoms of testosterone deficiency and/or infertility. Symptoms include fatigue, hot flashes, infertility, decrease in muscle mass and loss of bone mass (osteoporosis).

Erectile dysfunction is the inability of a man to achieve and sustain an erection sufficient to have sexual intercourse. It can also be known as impotence. The predisposing factors include tobacco usage, overweight, injuries, drug and alcohol use and medications, including antidepressants, antihistamines and medications to treat high blood pressure, pain or prostate cancer.

Benign prostatic hyperplasia is the enlargement of the prostate gland and occurs when cells of the prostate gland begin to multiply. Symptoms include painful urination, leakage of urine, nocturia and blood in the urine.

The size of these pipelines ranges from 23 products in male hypogonadism to 36 in erectile dysfunction. Across all three of these indications, however, androgen receptors and phosphodiesterase 5 are the most common targets, closely reflecting the current treatment landscape of these diseases.

Scope

– Which companies are the most active within the pipeline for male health 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 male health?

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

1 Table of Contents

1 Table of Contents 4

1.1 List of Tables 5

1.2 List of Figures 7

2 Introduction 8

2.1 Male Health Report Coverage 8

2.2 Male Hypogonadism - Overview 8

2.3 Erectile Dysfunction - Overview 8

2.4 Benign Prostatic Hyperplasia - Overview 8

3 Therapeutics Development 9

3.1 Male Hypogonadism 9

3.2 Erectile Dysfunction 15

3.3 Benign Prostatic Hyperplasia 22

4 Therapeutics Assessment 29

4.1 Male Hypogonadism 29

4.2 Erectile Dysfunction 36

4.3 Benign Prostatic Hyperplasia 43

5 Companies Involved in Therapeutics Development 52

5.1 Male Hypogonadism 52

5.2 Erectile Dysfunction 58

5.3 Benign Prostatic Hyperplasia 71

6 Dormant Projects 84

6.1 Male Hypogonadism 84

6.2 Erectile Dysfunction 85

6.3 Benign Prostatic Hyperplasia 88

7 Discontinued Products 90

7.1 Male Hypogonadism 90

7.2 Erectile Dysfunction 90

7.3 Benign Prostatic Hyperplasia 91

8 Product Development Milestones 92

8.1 Male Hypogonadism 92

8.2 Erectile Dysfunction 103

8.3 Benign Prostatic Hyperplasia 111

9 Appendix 124

9.1 Methodology 124

9.2 Coverage 124

9.3 Secondary Research 124

9.4 Primary Research 124

9.5 Expert Panel Validation 124

9.6 Contact Us 125

9.7 Disclaimer 125

List of Tables

1.1 List of Tables

Table 1: Number of Products under Development for Male Hypogonadism, H2 2017 9

Table 2: Number of Products under Development by Companies, H2 2017 11

Table 3: Number of Products under Development by Universities/Institutes, H2 2017 12

Table 4: Products under Development by Companies, H2 2017 13

Table 5: Products under Development by Universities/Institutes, H2 2017 14

Table 6: Number of Products under Development for Erectile Dysfunction, H2 2017 15

Table 7: Number of Products under Development by Companies, H2 2017 17

Table 8: Number of Products under Development by Universities/Institutes, H2 2017 18

Table 9: Products under Development by Companies, H2 2017 19

Table 10: Products under Development by Universities/Institutes, H2 2017 21

Table 11: Number of Products under Development for Benign Prostatic Hyperplasia, H2 2017 22

Table 12: Number of Products under Development by Companies, H2 2017 24

Table 13: Number of Products under Development by Universities/Institutes, H2 2017 25

Table 14: Products under Development by Companies, H2 2017 26

Table 15: Products under Development by Universities/Institutes, H2 2017 28

Table 16: Number of Products by Stage and Target, H2 2017 30

Table 17: Number of Products by Stage and Mechanism of Action, H2 2017 32

Table 18: Number of Products by Stage and Route of Administration, H2 2017 34

Table 19: Number of Products by Stage and Molecule Type, H2 2017 36

Table 20: Number of Products by Stage and Target, H2 2017 37

Table 21: Number of Products by Stage and Mechanism of Action, H2 2017 39

Table 22: Number of Products by Stage and Route of Administration, H2 2017 41

Table 23: Number of Products by Stage and Molecule Type, H2 2017 43

Table 24: Number of Products by Stage and Target, H2 2017 45

Table 25: Number of Products by Stage and Mechanism of Action, H2 2017 47

Table 26: Number of Products by Stage and Route of Administration, H2 2017 49

Table 27: Number of Products by Stage and Molecule Type, H2 2017 51

Table 28: Male Hypogonadism – Pipeline by Antares Pharma Inc, H2 2017 52

Table 29: Male Hypogonadism – Pipeline by Clarus Therapeutics Inc, H2 2017 52

Table 30: Male Hypogonadism – Pipeline by EndoCeutics Inc, H2 2017 53

Table 31: Male Hypogonadism – Pipeline by Ferring International Center SA, H2 2017 53

Table 32: Male Hypogonadism – Pipeline by Lipocine Inc, H2 2017 54

Table 33: Male Hypogonadism – Pipeline by M et P Pharma AG, H2 2017 54

Table 34: Male Hypogonadism – Pipeline by Medlab Clinical Ltd, H2 2017 55

Table 35: Male Hypogonadism – Pipeline by Merck & Co Inc, H2 2017 55

Table 36: Male Hypogonadism – Pipeline by Mereo Biopharma Group Plc, H2 2017 56

Table 37: Male Hypogonadism – Pipeline by Repros Therapeutics Inc, H2 2017 56

Table 38: Male Hypogonadism – Pipeline by TesoRx Pharma LLC, H2 2017 57

Table 39: Male Hypogonadism – Pipeline by The Female Health Company, H2 2017 58

Table 40: Male Hypogonadism – Pipeline by Viramal Ltd, H2 2017 58

Table 41: Erectile Dysfunction – Pipeline by Apricus Biosciences Inc, H2 2017 58

Table 42: Erectile Dysfunction – Pipeline by Astellas Pharma Inc, H2 2017 59

Table 43: Erectile Dysfunction – Pipeline by Biolab Farmaceutica Ltda, H2 2017 59

Table 44: Erectile Dysfunction – Pipeline by Biopharm GmbH, H2 2017 60

Table 45: Erectile Dysfunction – Pipeline by Can-Fite BioPharma Ltd, H2 2017 60

Table 46: Erectile Dysfunction – Pipeline by Fabre-Kramer Pharmaceuticals Inc, H2 2017 61

Table 47: Erectile Dysfunction – Pipeline by Futura Medical Plc, H2 2017 61

Table 48: Erectile Dysfunction – Pipeline by Hanmi Pharmaceuticals Co Ltd, H2 2017 62

Table 49: Erectile Dysfunction – Pipeline by Humanetics Corp, H2 2017 62

Table 50: Erectile Dysfunction – Pipeline by IntelGenx Corp, H2 2017 63

Table 51: Erectile Dysfunction – Pipeline by Ion Channel Innovations LLC, H2 2017 63

Table 52: Erectile Dysfunction – Pipeline by iX Biopharma Ltd, H2 2017 64

Table 53: Erectile Dysfunction – Pipeline by Mezzion Pharma Co Ltd, H2 2017 64

Table 54: Erectile Dysfunction – Pipeline by Mitsubishi Tanabe Pharma Corp, H2 2017 65

Table 55: Erectile Dysfunction – Pipeline by Monosol Rx LLC, H2 2017 65

Table 56: Erectile Dysfunction – Pipeline by N4 Pharma Plc, H2 2017 66

Table 57: Erectile Dysfunction – Pipeline by NAL Pharmaceuticals Ltd, H2 2017 66

Table 58: Erectile Dysfunction – Pipeline by Nanoform Cardiovascular Therapeutics Ltd, H2 2017 67

Table 59: Erectile Dysfunction – Pipeline by Palatin Technologies Inc, H2 2017 67

Table 60: Erectile Dysfunction – Pipeline by Pharmicell Co Ltd, H2 2017 68

Table 61: Erectile Dysfunction – Pipeline by SK Chemicals Co Ltd, H2 2017 68

Table 62: Erectile Dysfunction – Pipeline by Suda Ltd, H2 2017 69

Table 63: Erectile Dysfunction – Pipeline by XuanZhu Pharma Co Ltd, H2 2017 69

Table 64: Erectile Dysfunction – Pipeline by Yangtze River Pharmaceutical Group, H2 2017 70

Table 65: Erectile Dysfunction – Pipeline by Yungjin Pharm Co Ltd, H2 2017 70

Table 66: Benign Prostatic Hyperplasia – Pipeline by Addex Therapeutics Ltd, H2 2017 71

Table 67: Benign Prostatic Hyperplasia – Pipeline by AndroScience Corp, H2 2017 71

Table 68: Benign Prostatic Hyperplasia – Pipeline by Aphios Corp, H2 2017 72

Table 69: Benign Prostatic Hyperplasia – Pipeline by BCWorld Pharm Co Ltd, H2 2017 72

Table 70: Benign Prostatic Hyperplasia – Pipeline by Biolab Farmaceutica Ltda, H2 2017 73

Table 71: Benign Prostatic Hyperplasia – Pipeline by Chong Kun Dang Pharmaceutical Corp, H2 2017 73

Table 72: Benign Prostatic Hyperplasia – Pipeline by Curadis GmbH, H2 2017 74

Table 73: Benign Prostatic Hyperplasia – Pipeline by Dongkook Pharmaceutical Co Ltd, H2 2017 74

Table 74: Benign Prostatic Hyperplasia – Pipeline by GL Pharm Tech Corp, H2 2017 75

Table 75: Benign Prostatic Hyperplasia – Pipeline by Health Ever Bio-Tech Co Ltd, H2 2017 75

Table 76: Benign Prostatic Hyperplasia – Pipeline by Jeil Pharmaceutical Co Ltd, H2 2017 76

Table 77: Benign Prostatic Hyperplasia – Pipeline by MEI Pharma Inc, H2 2017 76

Table 78: Benign Prostatic Hyperplasia – Pipeline by Meiji Seika Pharma Co Ltd, H2 2017 77

Table 79: Benign Prostatic Hyperplasia – Pipeline by Mezzion Pharma Co Ltd, H2 2017 77

Table 80: Benign Prostatic Hyperplasia – Pipeline by Nymox Pharmaceutical Corp, H2 2017 78

Table 81: Benign Prostatic Hyperplasia – Pipeline by Ono Pharmaceutical Co Ltd, H2 2017 78

Table 82: Benign Prostatic Hyperplasia – Pipeline by OPKO Health Inc, H2 2017 79

Table 83: Benign Prostatic Hyperplasia – Pipeline by SK Chemicals Co Ltd, H2 2017 79

Table 84: Benign Prostatic Hyperplasia – Pipeline by Sophiris Bio Inc, H2 2017 80

Table 85: Benign Prostatic Hyperplasia – Pipeline by Sun Pharma Advanced Research Company Ltd, H2 2017 80

Table 86: Benign Prostatic Hyperplasia – Pipeline by The Female Health Company, H2 2017 81

Table 87: Benign Prostatic Hyperplasia – Pipeline by XuanZhu Pharma Co Ltd, H2 2017 81

Table 88: Benign Prostatic Hyperplasia – Pipeline by Yungjin Pharm Co Ltd, H2 2017 82

Table 89: Benign Prostatic Hyperplasia – Pipeline by Yuyu Pharma Inc, H2 2017 83

Table 90: Male Hypogonadism – Dormant Projects, H2 2017 84

Table 91: Erectile Dysfunction – Dormant Projects, H2 2017 85

Table 92: Benign Prostatic Hyperplasia – Dormant Projects, H2 2017 88

Table 93: Male Hypogonadism – Discontinued Products, H2 2017 90

Table 94: Erectile Dysfunction – Discontinued Products, H2 2017 90

Table 95: Benign Prostatic Hyperplasia – Discontinued Products, H2 2017 91

List of Figures

1.2 List of Figures

Figure 1: Number of Products under Development for Male Hypogonadism, H2 2017 9

Figure 2: Number of Products under Development by Companies, H2 2017 10

Figure 3: Number of Products under Development for Erectile Dysfunction, H2 2017 15

Figure 4: Number of Products under Development by Companies, H2 2017 16

Figure 5: Number of Products under Development by Universities/Institutes, H2 2017 18

Figure 6: Number of Products under Development for Benign Prostatic Hyperplasia, H2 2017 22

Figure 7: Number of Products under Development by Companies, H2 2017 23

Figure 8: Number of Products under Development by Universities/Institutes, H2 2017 25

Figure 9: Number of Products by Targets, H2 2017 29

Figure 10: Number of Products by Stage and Targets, H2 2017 29

Figure 11: Number of Products by Mechanism of Actions, H2 2017 31

Figure 12: Number of Products by Stage and Mechanism of Actions, H2 2017 31

Figure 13: Number of Products by Routes of Administration, H2 2017 33

Figure 14: Number of Products by Stage and Routes of Administration, H2 2017 33

Figure 15: Number of Products by Molecule Types, H2 2017 35

Figure 16: Number of Products by Stage and Molecule Types, H2 2017 35

Figure 17: Number of Products by Top 10 Targets, H2 2017 36

Figure 18: Number of Products by Stage and Top 10 Targets, H2 2017 37

Figure 19: Number of Products by Top 10 Mechanism of Actions, H2 2017 38

Figure 20: Number of Products by Stage and Top 10 Mechanism of Actions, H2 2017 38

Figure 21: Number of Products by Routes of Administration, H2 2017 40

Figure 22: Number of Products by Stage and Routes of Administration, H2 2017 40

Figure 23: Number of Products by Molecule Types, H2 2017 42

Figure 24: Number of Products by Stage and Molecule Types, H2 2017 42

Figure 25: Number of Products by Top 10 Targets, H2 2017 43

Figure 26: Number of Products by Stage and Top 10 Targets, H2 2017 44

Figure 27: Number of Products by Top 10 Mechanism of Actions, H2 2017 46

Figure 28: Number of Products by Stage and Top 10 Mechanism of Actions, H2 2017 46

Figure 29: Number of Products by Routes of Administration, H2 2017 48

Figure 30: Number of Products by Stage and Routes of Administration, H2 2017 48

Figure 31: Number of Products by Molecule Types, H2 2017 50

Figure 32: Number of Products by Stage and Molecule Types, H2 2017 50

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