Benign Prostatic Hyperplasia-Pipeline Review, H2 2015

Benign Prostatic Hyperplasia-Pipeline Review, H2 2015


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Executive Summary

Benign Prostatic Hyperplasia-Pipeline Review, H2 2015

Summary

Global Markets Direct's, 'Benign Prostatic Hyperplasia-Pipeline Review, H2 2015', provides an overview of the Benign Prostatic Hyperplasia's therapeutic pipeline.

This report provides comprehensive information on the therapeutic development for Benign Prostatic Hyperplasia, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Benign Prostatic Hyperplasia and special features on late-stage 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, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources, put together by Global Markets Direct's team. Drug profiles/records featured in the report undergoes periodic updation following a stringent set of processes that ensures that all the profiles are updated with the latest set of information. Additionally, processes including live news & deals tracking, browser based alert-box and clinical trials registries tracking ensure that the most recent developments are captured on a real time basis.

The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products.

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

Scope

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

The report reviews key pipeline products under drug profile section which includes, product description, MoA and R&D brief, licensing and collaboration details & other developmental activities

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

The report summarizes all the dormant and discontinued pipeline projects

A review of the Benign Prostatic Hyperplasia products under development by companies and universities/research institutes based on information derived from company and industry-specific sources

Pipeline products coverage based on various stages of development ranging from pre-registration till discovery and undisclosed stages

A detailed assessment of monotherapy and combination therapy pipeline projects

Coverage of the Benign Prostatic Hyperplasia pipeline on the basis of target, MoA, route of administration and molecule type

Latest news and deals relating related to pipeline products

Reasons To Buy

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

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

Develop strategic initiatives by understanding the focus areas of leading companies

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

Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline

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



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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

AmVac AG 24

AndroScience Corporation 25

Aphios Corporation 26

Ausio Pharmaceuticals, LLC 27

BCWorld Pharm Co. Ltd. 28

Biolab Sanus Farmaceutica Ltda. 29

Chong Kun Dang Pharmaceutical Corp. 30

Dongkook Pharmaceutical Co., Ltd. 31

Euroscreen S.A. 32

Hanmi Pharmaceuticals, Co. Ltd. 33

IntelGenx Corp. 34

Jeil Pharmaceutical Co., Ltd. 35

KAEL-GemVax Co., Ltd. 36

Kaken Pharmaceutical Co., Ltd. 37

Meiji Seika Pharma Co., Ltd. 38

Mezzion Pharma Co. Ltd. 39

Monosol Rx, LLC 40

Nymox Pharmaceutical Corporation 41

Ono Pharmaceutical Co., Ltd. 42

Quest PharmaTech Inc. 43

SK Chemicals Co., Ltd. 44

SOM Innovation Biotech SL 45

Sophiris Bio, Inc. 46

Yungjin Pharm. Co., Ltd. 47

Benign Prostatic Hyperplasia-Therapeutics Assessment 48

Assessment by Monotherapy Products 48

Assessment by Combination Products 49

Assessment by Target 50

Assessment by Mechanism of Action 52

Assessment by Route of Administration 54

Assessment by Molecule Type 56

Drug Profiles 58

(dutasteride + tadalafil)-Drug Profile 58

Product Description 58

Mechanism of Action 58

R&D Progress 58

(solifenacin succinate + tamsulosin hydrochloride)-Drug Profile 59

Product Description 59

Mechanism of Action 59

R&D Progress 59

(tamsulosin hydrochloride + dutasteride)-Drug Profile 60

Product Description 60

Mechanism of Action 60

R&D Progress 60

ADX-68692-Drug Profile 61

Product Description 61

Mechanism of Action 61

R&D Progress 61

AMV-110-Drug Profile 62

Product Description 62

Mechanism of Action 62

R&D Progress 62

ASC-JM.X2-Drug Profile 63

Product Description 63

Mechanism of Action 63

R&D Progress 63

AUS-131-Drug Profile 64

Product Description 64

Mechanism of Action 64

R&D Progress 64

BCWPE-004-Drug Profile 66

Product Description 66

Mechanism of Action 66

R&D Progress 66

BL-214-Drug Profile 67

Product Description 67

Mechanism of Action 67

R&D Progress 67

CKD-902-Drug Profile 68

Product Description 68

Mechanism of Action 68

R&D Progress 68

ESN-364-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 72

Product Description 72

Mechanism of Action 72

R&D Progress 72

HIP-1402-Drug Profile 73

Product Description 73

Mechanism of Action 73

R&D Progress 73

INT-0031-Drug Profile 74

Product Description 74

Mechanism of Action 74

R&D Progress 74

L-1AD3-Drug Profile 75

Product Description 75

Mechanism of Action 75

R&D Progress 75

MCS-2-Drug Profile 76

Product Description 76

Mechanism of Action 76

R&D Progress 76

Micselon-Drug Profile 77

Product Description 77

Mechanism of Action 77

R&D Progress 77

NCE-403-Drug Profile 78

Product Description 78

Mechanism of Action 78

R&D Progress 78

ONO-8430506-Drug Profile 79

Product Description 79

Mechanism of Action 79

R&D Progress 79

S-40542-Drug Profile 80

Product Description 80

Mechanism of Action 80

R&D Progress 80

SL-052-Drug Profile 81

Product Description 81

Mechanism of Action 81

R&D Progress 81

Small Molecules to Inhibit Steroidal 5-Alpha Reductase for Benign Prostatic Hyperplasia-Drug Profile 83

Product Description 83

Mechanism of Action 83

R&D Progress 83

SOM-2391-Drug Profile 84

Product Description 84

Mechanism of Action 84

R&D Progress 84

SOM-2393-Drug Profile 85

Product Description 85

Mechanism of Action 85

R&D Progress 85

Sperol-Drug Profile 86

Product Description 86

Mechanism of Action 86

R&D Progress 86

Synthetic Peptide to Antagonize GPR54 for Womens Health, Male Health and Oncology-Drug Profile 87

Product Description 87

Mechanism of Action 87

R&D Progress 87

tadalafil-Drug Profile 88

Product Description 88

Mechanism of Action 88

R&D Progress 88

talaporfin sodium-Drug Profile 89

Product Description 89

Mechanism of Action 89

R&D Progress 89

tamsulosin hydrochloride CR-Drug Profile 92

Product Description 92

Mechanism of Action 92

R&D Progress 92

tamsulosin hydrochloride DR-Drug Profile 93

Product Description 93

Mechanism of Action 93

R&D Progress 93

tertomotide-Drug Profile 94

Product Description 94

Mechanism of Action 94

R&D Progress 94

topsalysin-Drug Profile 96

Product Description 96

Mechanism of Action 96

R&D Progress 96

udenafil-Drug Profile 98

Product Description 98

Mechanism of Action 98

R&D Progress 98

YBH-1603-Drug Profile 100

Product Description 100

Mechanism of Action 100

R&D Progress 100

YOB-1604-Drug Profile 101

Product Description 101

Mechanism of Action 101

R&D Progress 101

Benign Prostatic Hyperplasia-Recent Pipeline Updates 102

Benign Prostatic Hyperplasia-Dormant Projects 119

Benign Prostatic Hyperplasia-Discontinued Products 122

Benign Prostatic Hyperplasia-Product Development Milestones 123

Featured News & Press Releases 123

Apr 01, 2015: Nymox Announces Phase 3 BPH Studies 123

Dec 15, 2014: Sophiris Bio Reports Administrative Interim Analysis for the "PLUS-1" Phase 3 Trial of PRX302 for Benign Prostatic Hyperplasia 123

Nov 02, 2014: Nymox NX-1207 BPH Pivotal Phase 3 U.S. Studies NX02-0017 and NX02-0018 Fail to Meet Primary Efficacy Endpoints 124

Sep 02, 2014: Sophiris Bio Reports Completion of Enrollment in the "PLUS-1" Phase 3 Trial of PRX302 for Benign Prostatic Hyperplasia 124

Jul 22, 2014: Nymox Announces Positive Efficacy Results in Phase 3 Repeat Injection Trial of NX-1207 for BPH 125

Jul 15, 2014: Nymox Announces Completion of Enrollment for Second BPH Re-Injection Study 125

Jun 17, 2014: Nymox Reports Positive Update on Nerve Sparing and Sexual Function Preservation in Men Treated With NX-1207 126

Jun 11, 2014: Nymox Reports Positive New Safety Study Data for Phase 3 BPH Drug 127

May 08, 2014: Nymox Announces Completion of Second Pivotal Phase 3 NX-1207 Trial for BPH 127

Nov 11, 2013: Nymox Reports Update and Positive Safety Data for Phase 3 NX02-0022 Reinjection Study of NX-1207 for BPH 128

Appendix 130

Methodology 130

Coverage 130

Secondary Research 130

Primary Research 130

Expert Panel Validation 130

Contact Us 130

Disclaimer 131

List of Tables

Number of Products under Development for Benign Prostatic Hyperplasia, H2 2015 11

Number of Products under Development for Benign Prostatic Hyperplasia-Comparative Analysis, H2 2015 12

Number of Products under Development by Companies, H2 2015 14

Number of Products under Investigation by Universities/Institutes, H2 2015 15

Comparative Analysis by Late Stage Development, H2 2015 16

Comparative Analysis by Clinical Stage Development, H2 2015 17

Comparative Analysis by Early Stage Development, H2 2015 18

Comparative Analysis by Unknown Stage Development, H2 2015 19

Products under Development by Companies, H2 2015 20

Products under Development by Companies, H2 2015 (Contd...1) 21

Products under Investigation by Universities/Institutes, H2 2015 22

Benign Prostatic Hyperplasia-Pipeline by Addex Therapeutics Ltd, H2 2015 23

Benign Prostatic Hyperplasia-Pipeline by AmVac AG, H2 2015 24

Benign Prostatic Hyperplasia-Pipeline by AndroScience Corporation, H2 2015 25

Benign Prostatic Hyperplasia-Pipeline by Aphios Corporation, H2 2015 26

Benign Prostatic Hyperplasia-Pipeline by Ausio Pharmaceuticals, LLC, H2 2015 27

Benign Prostatic Hyperplasia-Pipeline by BCWorld Pharm Co. Ltd., H2 2015 28

Benign Prostatic Hyperplasia-Pipeline by Biolab Sanus Farmaceutica Ltda., H2 2015 29

Benign Prostatic Hyperplasia-Pipeline by Chong Kun Dang Pharmaceutical Corp., H2 2015 30

Benign Prostatic Hyperplasia-Pipeline by Dongkook Pharmaceutical Co., Ltd., H2 2015 31

Benign Prostatic Hyperplasia-Pipeline by Euroscreen S.A., H2 2015 32

Benign Prostatic Hyperplasia-Pipeline by Hanmi Pharmaceuticals, Co. Ltd., H2 2015 33

Benign Prostatic Hyperplasia-Pipeline by IntelGenx Corp., H2 2015 34

Benign Prostatic Hyperplasia-Pipeline by Jeil Pharmaceutical Co., Ltd., H2 2015 35

Benign Prostatic Hyperplasia-Pipeline by KAEL-GemVax Co., Ltd., H2 2015 36

Benign Prostatic Hyperplasia-Pipeline by Kaken Pharmaceutical Co., Ltd., H2 2015 37

Benign Prostatic Hyperplasia-Pipeline by Meiji Seika Pharma Co., Ltd., H2 2015 38

Benign Prostatic Hyperplasia-Pipeline by Mezzion Pharma Co. Ltd., H2 2015 39

Benign Prostatic Hyperplasia-Pipeline by Monosol Rx, LLC, H2 2015 40

Benign Prostatic Hyperplasia-Pipeline by Nymox Pharmaceutical Corporation, H2 2015 41

Benign Prostatic Hyperplasia-Pipeline by Ono Pharmaceutical Co., Ltd., H2 2015 42

Benign Prostatic Hyperplasia-Pipeline by Quest PharmaTech Inc., H2 2015 43

Benign Prostatic Hyperplasia-Pipeline by SK Chemicals Co., Ltd., H2 2015 44

Benign Prostatic Hyperplasia-Pipeline by SOM Innovation Biotech SL, H2 2015 45

Benign Prostatic Hyperplasia-Pipeline by Sophiris Bio, Inc., H2 2015 46

Benign Prostatic Hyperplasia-Pipeline by Yungjin Pharm. Co., Ltd., H2 2015 47

Assessment by Monotherapy Products, H2 2015 48

Assessment by Combination Products, H2 2015 49

Number of Products by Stage and Target, H2 2015 51

Number of Products by Stage and Mechanism of Action, H2 2015 53

Number of Products by Stage and Route of Administration, H2 2015 55

Number of Products by Stage and Molecule Type, H2 2015 57

Benign Prostatic Hyperplasia Therapeutics-Recent Pipeline Updates, H2 2015 102

Benign Prostatic Hyperplasia-Dormant Projects, H2 2015 119

Benign Prostatic Hyperplasia-Dormant Projects (Contd...1), H2 2015 120

Benign Prostatic Hyperplasia-Dormant Projects (Contd...2), H2 2015 121

Benign Prostatic Hyperplasia-Discontinued Products, H2 2015 122

List of Figures

Number of Products under Development for Benign Prostatic Hyperplasia, H2 2015 11

Number of Products under Development for Benign Prostatic Hyperplasia-Comparative Analysis, H2 2015 12

Number of Products under Development by Companies, H2 2015 13

Number of Products under Investigation by Universities/Institutes, H2 2015 15

Comparative Analysis by Clinical Stage Development, H2 2015 17

Comparative Analysis by Early Stage Products, H2 2015 18

Assessment by Monotherapy Products, H2 2015 48

Assessment by Combination Products, H2 2015 49

Number of Products by Top 10 Targets, H2 2015 50

Number of Products by Stage and Top 10 Targets, H2 2015 50

Number of Products by Top 10 Mechanism of Actions, H2 2015 52

Number of Products by Stage and Top 10 Mechanism of Actions, H2 2015 52

Number of Products by Routes of Administration, H2 2015 54

Number of Products by Stage and Routes of Administration, H2 2015 54

Number of Products by Molecule Types, H2 2015 56

Number of Products by Stage and Molecule Types, H2 2015 56

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Addex Therapeutics Ltd

AmVac AG

AndroScience Corporation

Aphios Corporation

Ausio Pharmaceuticals, LLC

BCWorld Pharm Co. Ltd.

Biolab Sanus Farmaceutica Ltda.

Chong Kun Dang Pharmaceutical Corp.

Dongkook Pharmaceutical Co., Ltd.

Euroscreen S.A.

Hanmi Pharmaceuticals, Co. Ltd.

IntelGenx Corp.

Jeil Pharmaceutical Co., Ltd.

KAEL-GemVax Co., Ltd.

Kaken Pharmaceutical Co., Ltd.

Meiji Seika Pharma Co., Ltd.

Mezzion Pharma Co. Ltd.

Monosol Rx, LLC

Nymox Pharmaceutical Corporation

Ono Pharmaceutical Co., Ltd.

Quest PharmaTech Inc.

SK Chemicals Co., Ltd.

SOM Innovation Biotech SL

Sophiris Bio, Inc.

Yungjin Pharm. Co., Ltd.

Benign Prostatic Hyperplasia Therapeutic Products under Development, Key Players in Benign Prostatic Hyperplasia Therapeutics, Benign Prostatic Hyperplasia Pipeline Overview, Benign Prostatic Hyperplasia Pipeline, Benign Prostatic Hyperplasia Pipeline Assessment

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