Benign Prostatic Hyperplasia – Pipeline Review, H2 2016

Global Markets Direct’s, ‘Benign Prostatic Hyperplasia – Pipeline Review, H2 2016’, provides an overview of the Benign Prostatic Hyperplasia pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Benign Prostatic Hyperplasia, complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The report also covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. Additionally, the report provides an overview of key players involved in therapeutic development for Benign Prostatic Hyperplasia and features dormant and discontinued projects.

Global Markets Direct’s report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from Global Markets Direct’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Drug profiles featured in the report undergoes periodic review following a stringent set of processes to ensure that all the profiles are updated with the latest set of information. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis.

The report helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage.

Note: Certain sections in the report may be removed or altered based on the availability and relevance of data.

Scope

The report provides a snapshot of the global therapeutic landscape of Benign Prostatic Hyperplasia

The report reviews pipeline therapeutics for Benign Prostatic Hyperplasia by companies and universities/research institutes based on information derived from company and industry-specific sources

The report covers pipeline products based on various stages of development ranging from pre-registration till discovery and undisclosed stages

The report features descriptive drug profiles for the pipeline products which includes, product description, descriptive MoA, R&D brief, licensing and collaboration details & other developmental activities

The report reviews key players involved Benign Prostatic Hyperplasia therapeutics and enlists all their major and minor projects

The report assesses Benign Prostatic Hyperplasia therapeutics based on drug target, mechanism of action (MoA), route of administration (RoA) and molecule type

The report summarizes all the dormant and discontinued pipeline projects

The report reviews latest news related to pipeline therapeutics for Benign Prostatic Hyperplasia

Reasons to buy

Gain strategically significant competitor information, analysis, and insights to formulate effective R&D strategies

Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage

Identify and understand important and diverse types of therapeutics under development for Benign Prostatic Hyperplasia

Identify potential new clients or partners in the target demographic

Develop strategic initiatives by understanding the focus areas of leading companies

Plan mergers and acquisitions effectively by identifying key players and it’s most promising pipeline therapeutics

Devise corrective measures for pipeline projects by understanding Benign Prostatic Hyperplasia pipeline depth and focus of Indication therapeutics

Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope

Modify the therapeutic portfolio by identifying discontinued projects and understanding the factors that drove them from pipeline

Companies mentioned

Addex Therapeutics Ltd

AndroScience Corporation

Aphios Corporation

BCWorld Pharm Co. Ltd.

Biolab Farmaceutica Ltda

Chong Kun Dang Pharmaceutical Corp.

Dongkook Pharmaceutical Co., Ltd.

Hanmi Pharmaceuticals, Co. Ltd.

Health Ever Bio-Tech Co., Ltd.

Jeil Pharmaceutical Co., Ltd.

Kaken Pharmaceutical Co., Ltd.

MEI Pharma, Inc.

Meiji Seika Pharma Co., Ltd.

Mezzion Pharma Co. Ltd.

Monosol Rx LLC

Nymox Pharmaceutical Corporation

Ogeda SA

Ono Pharmaceutical Co., Ltd.

SK Chemicals Co., Ltd.

SOM Biotech SL

Sophiris Bio, Inc.

Vantia Therapeutics

XuanZhu Pharma Co Ltd

Yungjin Pharm. Co., Ltd.

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 7

List of Figures 8

Introduction 9

Global Markets Direct Report Coverage 9

Benign Prostatic Hyperplasia Overview 10

Therapeutics Development 11

Pipeline Products for Benign Prostatic Hyperplasia - Overview 11

Pipeline Products for Benign Prostatic Hyperplasia - Comparative Analysis 12

Benign Prostatic Hyperplasia - Therapeutics under Development by Companies 13

Benign Prostatic Hyperplasia - Therapeutics under Investigation by Universities/Institutes 15

Benign Prostatic Hyperplasia - Pipeline Products Glance 16

Late Stage Products 16

Clinical Stage Products 17

Early Stage Products 18

Unknown Stage Products 19

Benign Prostatic Hyperplasia - Products under Development by Companies 20

Benign Prostatic Hyperplasia - Products under Investigation by Universities/Institutes 22

Benign Prostatic Hyperplasia - Companies Involved in Therapeutics Development 23

Addex Therapeutics Ltd 23

AndroScience Corporation 24

Aphios Corporation 25

BCWorld Pharm Co. Ltd. 26

Biolab Farmaceutica Ltda 27

Chong Kun Dang Pharmaceutical Corp. 28

Dongkook Pharmaceutical Co., Ltd. 29

Hanmi Pharmaceuticals, Co. Ltd. 30

Health Ever Bio-Tech Co., Ltd. 31

Jeil Pharmaceutical Co., Ltd. 32

Kaken Pharmaceutical Co., Ltd. 33

MEI Pharma, Inc. 34

Meiji Seika Pharma Co., Ltd. 35

Mezzion Pharma Co. Ltd. 36

Monosol Rx LLC 37

Nymox Pharmaceutical Corporation 38

Ogeda SA 39

Ono Pharmaceutical Co., Ltd. 40

SK Chemicals Co., Ltd. 41

SOM Biotech SL 42

Sophiris Bio, Inc. 43

Vantia Therapeutics 44

XuanZhu Pharma Co Ltd 45

Yungjin Pharm. Co., Ltd. 46

Benign Prostatic Hyperplasia - Therapeutics Assessment 47

Assessment by Monotherapy Products 47

Assessment by Combination Products 48

Assessment by Target 49

Assessment by Mechanism of Action 51

Assessment by Route of Administration 53

Assessment by Molecule Type 55

Drug Profiles 57

(dutasteride + tadalafil) - Drug Profile 57

Product Description 57

Mechanism Of Action 57

R&D Progress 57

(solifenacin succinate + tamsulosin hydrochloride) - Drug Profile 58

Product Description 58

Mechanism Of Action 58

R&D Progress 58

(tadalafil + tamsulosin hydrochloride) - Drug Profile 59

Product Description 59

Mechanism Of Action 59

R&D Progress 59

ADX-68692 - Drug Profile 60

Product Description 60

Mechanism Of Action 60

R&D Progress 60

ASC-JM.X2 - Drug Profile 61

Product Description 61

Mechanism Of Action 61

R&D Progress 61

AUS-131 - Drug Profile 62

Product Description 62

Mechanism Of Action 62

R&D Progress 62

BCWPE-004 - Drug Profile 64

Product Description 64

Mechanism Of Action 64

R&D Progress 64

BL-214 - Drug Profile 65

Product Description 65

Mechanism Of Action 65

R&D Progress 65

ESN-364 - Drug Profile 66

Product Description 66

Mechanism Of Action 66

R&D Progress 66

fadanafil - Drug Profile 68

Product Description 68

Mechanism Of Action 68

R&D Progress 68

fedovapagon - Drug Profile 69

Product Description 69

Mechanism Of Action 69

R&D Progress 69

fexapotide triflutate - Drug Profile 70

Product Description 70

Mechanism Of Action 70

R&D Progress 70

HCP-1303 - Drug Profile 83

Product Description 83

Mechanism Of Action 83

R&D Progress 83

HIP-1402 - Drug Profile 84

Product Description 84

Mechanism Of Action 84

R&D Progress 84

KKM-1202 - Drug Profile 85

Product Description 85

Mechanism Of Action 85

R&D Progress 85

L-1AD3 - Drug Profile 86

Product Description 86

Mechanism Of Action 86

R&D Progress 86

MCS-2 - Drug Profile 87

Product Description 87

Mechanism Of Action 87

R&D Progress 87

NCE-403 - Drug Profile 88

Product Description 88

Mechanism Of Action 88

R&D Progress 88

ONO-8430506 - Drug Profile 89

Product Description 89

Mechanism Of Action 89

R&D Progress 89

S-40542 - Drug Profile 90

Product Description 90

Mechanism Of Action 90

R&D Progress 90

Small Molecules to Inhibit Steroidal 5-Alpha Reductase for Benign Prostatic Hyperplasia - Drug Profile 91

Product Description 91

Mechanism Of Action 91

R&D Progress 91

SOM-2391 - Drug Profile 92

Product Description 92

Mechanism Of Action 92

R&D Progress 92

SOM-2393 - Drug Profile 93

Product Description 93

Mechanism Of Action 93

R&D Progress 93

Sperol - Drug Profile 94

Product Description 94

Mechanism Of Action 94

R&D Progress 94

Synthetic Peptide to Antagonize GPR54 for Womens Health, Male Health and Oncology - Drug Profile 95

Product Description 95

Mechanism Of Action 95

R&D Progress 95

tadalafil - Drug Profile 96

Product Description 96

Mechanism Of Action 96

R&D Progress 96

talaporfin sodium - Drug Profile 97

Product Description 97

Mechanism Of Action 97

R&D Progress 97

tamsulosin hydrochloride CR - Drug Profile 99

Product Description 99

Mechanism Of Action 99

R&D Progress 99

tamsulosin hydrochloride DR - Drug Profile 100

Product Description 100

Mechanism Of Action 100

R&D Progress 100

tamsulosin hydrochloride SR - Drug Profile 101

Product Description 101

Mechanism Of Action 101

R&D Progress 101

tertomotide - Drug Profile 102

Product Description 102

Mechanism Of Action 102

R&D Progress 102

topsalysin - Drug Profile 104

Product Description 104

Mechanism Of Action 104

R&D Progress 104

udenafil - Drug Profile 108

Product Description 108

Mechanism Of Action 108

R&D Progress 108

YBH-1603 - Drug Profile 111

Product Description 111

Mechanism Of Action 111

R&D Progress 111

YOB-1604 - Drug Profile 112

Product Description 112

Mechanism Of Action 112

R&D Progress 112

Benign Prostatic Hyperplasia - Dormant Projects 113

Benign Prostatic Hyperplasia - Discontinued Products 116

Benign Prostatic Hyperplasia - Product Development Milestones 117

Featured News & Press Releases 117

Sep 20, 2016: Addex collaborators publish new data on negative allosteric modulator ADX68692 117

May 05, 2016: Sophiris Bio To Present Topsalysin Phase 3 Data from Positive PLUS-1 Study as a Late Breaking Poster During the 111th American Urological Association Annual Meeting 118

Apr 01, 2015: Nymox Announces Phase 3 BPH Studies 118

Dec 15, 2014: Sophiris Bio Reports Administrative Interim Analysis for the "PLUS-1" Phase 3 Trial of PRX302 for Benign Prostatic Hyperplasia 118

Nov 02, 2014: Nymox NX-1207 BPH Pivotal Phase 3 U.S. Studies NX02-0017 and NX02-0018 Fail to Meet Primary Efficacy Endpoints 119

Sep 02, 2014: Sophiris Bio Reports Completion of Enrollment in the "PLUS-1" Phase 3 Trial of PRX302 for Benign Prostatic Hyperplasia 119

Jul 22, 2014: Nymox Announces Positive Efficacy Results in Phase 3 Repeat Injection Trial of NX-1207 for BPH 120

Jul 15, 2014: Nymox Announces Completion of Enrollment for Second BPH Re-Injection Study 121

Jun 17, 2014: Nymox Reports Positive Update on Nerve Sparing and Sexual Function Preservation in Men Treated With NX-1207 121

Jun 11, 2014: Nymox Reports Positive New Safety Study Data for Phase 3 BPH Drug 122

May 08, 2014: Nymox Announces Completion of Second Pivotal Phase 3 NX-1207 Trial for BPH 123

Nov 11, 2013: Nymox Reports Update and Positive Safety Data for Phase 3 NX02-0022 Reinjection Study of NX-1207 for BPH 124

Oct 28, 2013: Sophiris Announces First Patients Dosed in the PLUS-1 Phase 3 Trial of PRX302 for Benign Prostatic Hyperplasia 125

Aug 22, 2013: Nymox Reports Positive Results of Safety Monitoring Committee Review of NX02-0018 Phase 3 Trial 125

Jul 11, 2013: Nymox Reports Positive Safety Monitoring Committee Results for Pivotal NX02-0017 Phase 3 Trial 126

Appendix 127

Methodology 127

Coverage 127

Secondary Research 127

Primary Research 127

Expert Panel Validation 127

Contact Us 127

Disclaimer 128

List of Tables

List of Tables

Number of Products under Development for Benign Prostatic Hyperplasia, H2 2016 11

Number of Products under Development for Benign Prostatic Hyperplasia – Comparative Analysis, H2 2016 12

Number of Products under Development by Companies, H2 2016 14

Number of Products under Investigation by Universities/Institutes, H2 2016 15

Comparative Analysis by Late Stage Development, H2 2016 16

Comparative Analysis by Clinical Stage Development, H2 2016 17

Comparative Analysis by Early Stage Development, H2 2016 18

Comparative Analysis by Unknown Stage Development, H2 2016 19

Products under Development by Companies, H2 2016 20

Products under Development by Companies, H2 2016 (Contd..1) 21

Products under Investigation by Universities/Institutes, H2 2016 22

Benign Prostatic Hyperplasia – Pipeline by Addex Therapeutics Ltd, H2 2016 23

Benign Prostatic Hyperplasia – Pipeline by AndroScience Corporation, H2 2016 24

Benign Prostatic Hyperplasia – Pipeline by Aphios Corporation, H2 2016 25

Benign Prostatic Hyperplasia – Pipeline by BCWorld Pharm Co. Ltd., H2 2016 26

Benign Prostatic Hyperplasia – Pipeline by Biolab Farmaceutica Ltda, H2 2016 27

Benign Prostatic Hyperplasia – Pipeline by Chong Kun Dang Pharmaceutical Corp., H2 2016 28

Benign Prostatic Hyperplasia – Pipeline by Dongkook Pharmaceutical Co., Ltd., H2 2016 29

Benign Prostatic Hyperplasia – Pipeline by Hanmi Pharmaceuticals, Co. Ltd., H2 2016 30

Benign Prostatic Hyperplasia – Pipeline by Health Ever Bio-Tech Co., Ltd., H2 2016 31

Benign Prostatic Hyperplasia – Pipeline by Jeil Pharmaceutical Co., Ltd., H2 2016 32

Benign Prostatic Hyperplasia – Pipeline by Kaken Pharmaceutical Co., Ltd., H2 2016 33

Benign Prostatic Hyperplasia – Pipeline by MEI Pharma, Inc., H2 2016 34

Benign Prostatic Hyperplasia – Pipeline by Meiji Seika Pharma Co., Ltd., H2 2016 35

Benign Prostatic Hyperplasia – Pipeline by Mezzion Pharma Co. Ltd., H2 2016 36

Benign Prostatic Hyperplasia – Pipeline by Monosol Rx LLC, H2 2016 37

Benign Prostatic Hyperplasia – Pipeline by Nymox Pharmaceutical Corporation, H2 2016 38

Benign Prostatic Hyperplasia – Pipeline by Ogeda SA, H2 2016 39

Benign Prostatic Hyperplasia – Pipeline by Ono Pharmaceutical Co., Ltd., H2 2016 40

Benign Prostatic Hyperplasia – Pipeline by SK Chemicals Co., Ltd., H2 2016 41

Benign Prostatic Hyperplasia – Pipeline by SOM Biotech SL, H2 2016 42

Benign Prostatic Hyperplasia – Pipeline by Sophiris Bio, Inc., H2 2016 43

Benign Prostatic Hyperplasia – Pipeline by Vantia Therapeutics, H2 2016 44

Benign Prostatic Hyperplasia – Pipeline by XuanZhu Pharma Co Ltd, H2 2016 45

Benign Prostatic Hyperplasia – Pipeline by Yungjin Pharm. Co., Ltd., H2 2016 46

Assessment by Monotherapy Products, H2 2016 47

Assessment by Combination Products, H2 2016 48

Number of Products by Stage and Target, H2 2016 50

Number of Products by Stage and Mechanism of Action, H2 2016 52

Number of Products by Stage and Route of Administration, H2 2016 54

Number of Products by Stage and Molecule Type, H2 2016 56

Benign Prostatic Hyperplasia – Dormant Projects, H2 2016 113

Benign Prostatic Hyperplasia – Dormant Projects (Contd..1), H2 2016 114

Benign Prostatic Hyperplasia – Dormant Projects (Contd..2), H2 2016 115

Benign Prostatic Hyperplasia – Discontinued Products, H2 2016 116

List of Figures

List of Figures

Number of Products under Development for Benign Prostatic Hyperplasia, H2 2016 11

Number of Products under Development for Benign Prostatic Hyperplasia – Comparative Analysis, H2 2016 12

Number of Products under Development by Companies, H2 2016 13

Number of Products under Investigation by Universities/Institutes, H2 2016 15

Comparative Analysis by Clinical Stage Development, H2 2016 17

Comparative Analysis by Early Stage Products, H2 2016 18

Assessment by Monotherapy Products, H2 2016 47

Assessment by Combination Products, H2 2016 48

Number of Products by Top 10 Targets, H2 2016 49

Number of Products by Stage and Top 10 Targets, H2 2016 49

Number of Products by Top 10 Mechanism of Actions, H2 2016 51

Number of Products by Stage and Top 10 Mechanism of Actions, H2 2016 51

Number of Products by Routes of Administration, H2 2016 53

Number of Products by Stage and Routes of Administration, H2 2016 53

Number of Products by Molecule Types, H2 2016 55

Number of Products by Stage and Molecule Types, H2 2016 55

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