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Overactive Bladder-Pipeline Review, H1 2015

Overactive Bladder-Pipeline Review, H1 2015


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Executive Summary

Overactive Bladder-Pipeline Review, H1 2015

Summary

Global Markets Direct's, 'Overactive Bladder-Pipeline Review, H1 2015', provides an overview of the Overactive Bladder's therapeutic pipeline.

This report provides comprehensive information on the therapeutic development for Overactive Bladder, 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 Overactive Bladder 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 Overactive Bladder

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 Overactive Bladder and enlists all their major and minor projects

The report summarizes all the dormant and discontinued pipeline projects

A review of the Overactive Bladder 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 Overactive Bladder 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 Overactive Bladder

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

Devise corrective measures for pipeline projects by understanding Overactive Bladder 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

Table of Contents

Table of Contents 2

List of Tables 7

List of Figures 8

Introduction 9

Global Markets Direct Report Coverage 9

Overactive Bladder Overview 10

Therapeutics Development 11

Pipeline Products for Overactive Bladder-Overview 11

Pipeline Products for Overactive Bladder-Comparative Analysis 12

Overactive Bladder-Therapeutics under Development by Companies 13

Overactive Bladder-Therapeutics under Investigation by Universities/Institutes 15

Overactive Bladder-Pipeline Products Glance 16

Late Stage Products 16

Clinical Stage Products 17

Early Stage Products 18

Overactive Bladder-Products under Development by Companies 19

Overactive Bladder-Products under Investigation by Universities/Institutes 22

Overactive Bladder-Companies Involved in Therapeutics Development 23

Addex Therapeutics Ltd 23

Allergan, Inc. 24

Asahi Kasei Pharma Corp. 25

Astellas Pharma Inc. 26

Dong-A Socio Group 27

FemmePharma Global Healthcare, Inc. 28

Ferring International Center S.A. 29

Hydra Biosciences, Inc. 30

Ion Channel Innovations, LLC 31

Ipsen S.A. 32

Jeil Pharmaceutical Co., Ltd. 33

Laboratorios SALVAT S.A. 34

Lipella Pharmaceuticals, Inc. 35

Merck & Co., Inc. 36

Mezzion Pharma Co. Ltd. 37

MI.TO. Technology S.r.L. 38

NeuroSearch A/S 39

Recordati S.p.A. 40

Sanofi 41

Takeda Pharmaceutical Company Limited 42

TARIS BioMedical, Inc. 43

TheraVida, Inc. 44

Toray Industries, Inc. 45

Overactive Bladder-Therapeutics Assessment 46

Assessment by Monotherapy Products 46

Assessment by Combination Products 47

Assessment by Target 48

Assessment by Mechanism of Action 50

Assessment by Route of Administration 52

Assessment by Molecule Type 54

Drug Profiles 56

(mirabegron + solifenacin succinate)-Drug Profile 56

Product Description 56

Mechanism of Action 56

R&D Progress 56

abobotulinumtoxin A-Drug Profile 58

Product Description 58

Mechanism of Action 58

R&D Progress 58

ADX-71441-Drug Profile 60

Product Description 60

Mechanism of Action 60

R&D Progress 60

DA-8010-Drug Profile 61

Product Description 61

Mechanism of Action 61

R&D Progress 61

FE-999309-Drug Profile 62

Product Description 62

Mechanism of Action 62

R&D Progress 62

HC-067047-Drug Profile 63

Product Description 63

Mechanism of Action 63

R&D Progress 63

JLP-1207-Drug Profile 64

Product Description 64

Mechanism of Action 64

R&D Progress 64

mirabegron ER-Drug Profile 65

Product Description 65

Mechanism of Action 65

R&D Progress 65

NS-19504-Drug Profile 67

Product Description 67

Mechanism of Action 67

R&D Progress 67

onabotulinumtoxin A liposomal-Drug Profile 68

Product Description 68

Mechanism of Action 68

R&D Progress 68

oxybutynin chloride-Drug Profile 70

Product Description 70

Mechanism of Action 70

R&D Progress 70

oxybutynin hydrochloride-Drug Profile 71

Product Description 71

Mechanism of Action 71

R&D Progress 71

Peptide to Antagonize PACAP Receptor for CNS and Overactive Bladder-Drug Profile 72

Product Description 72

Mechanism of Action 72

R&D Progress 72

pVAX-hSlo-Drug Profile 73

Product Description 73

Mechanism of Action 73

R&D Progress 73

REC-0438-Drug Profile 75

Product Description 75

Mechanism of Action 75

R&D Progress 75

SAR-244181-Drug Profile 76

Product Description 76

Mechanism of Action 76

R&D Progress 76

senrebotase-Drug Profile 77

Product Description 77

Mechanism of Action 77

R&D Progress 77

Small Molecule to Agonize GABAB Receptor for Overactive Bladder and Pain-Drug Profile 79

Product Description 79

Mechanism of Action 79

R&D Progress 79

Small Molecule to Antagonize Neurokinin-1 Receptor for Overactive Bladder-Drug Profile 80

Product Description 80

Mechanism of Action 80

R&D Progress 80

Small Molecules to Agonize Beta3-Adrenoceptor for Anxiety, Depression and Overactive Bladder-Drug Profile 81

Product Description 81

Mechanism of Action 81

R&D Progress 81

Small Molecules to Antagonize EP1 Receptor for Overactive Bladder-Drug Profile 82

Product Description 82

Mechanism of Action 82

R&D Progress 82

Small Molecules to Antagonize TRPM8 for Overactive Bladder and Pain-Drug Profile 83

Product Description 83

Mechanism of Action 83

R&D Progress 83

Small Molecules to Antagonize TRPV1 for Overactive Bladder-Drug Profile 84

Product Description 84

Mechanism of Action 84

R&D Progress 84

solifenacin succinate-Drug Profile 85

Product Description 85

Mechanism of Action 85

R&D Progress 85

solifenacin succinate-Drug Profile 87

Product Description 87

Mechanism of Action 87

R&D Progress 87

tacrolimus liposomal-Drug Profile 88

Product Description 88

Mechanism of Action 88

R&D Progress 88

tarafenacin-Drug Profile 89

Product Description 89

Mechanism of Action 89

R&D Progress 89

TD-302-Drug Profile 91

Product Description 91

Mechanism of Action 91

R&D Progress 91

THVD-201-Drug Profile 92

Product Description 92

Mechanism of Action 92

R&D Progress 92

THVD-202-Drug Profile 93

Product Description 93

Mechanism of Action 93

R&D Progress 93

udenafil-Drug Profile 94

Product Description 94

Mechanism of Action 94

R&D Progress 94

vibegron-Drug Profile 96

Product Description 96

Mechanism of Action 96

R&D Progress 96

Overactive Bladder-Recent Pipeline Updates 97

Overactive Bladder-Dormant Projects 108

Overactive Bladder-Discontinued Products 114

Overactive Bladder-Product Development Milestones 116

Featured News & Press Releases 116

May 17, 2015: Mirabegron As Add-On Treatment To Solifenacin Therapy Demonstrated Superior Results To Solifenacin Monotherapy In BESIDE Trial 116

May 05, 2015: Astellas Announces New Data To Be Presented During Late Breaking Plenary Session At AUA Annual Meeting 117

Dec 08, 2014: Lipella's Liposome Formulation of Botulinum Toxin (LP-09) Superior to Placebo for Overactive Bladder Symptoms in Double-Blind Trial 117

Apr 08, 2014: Positive Clinical Trial Results of Topical Botulinum Toxin for Overactive Bladder 118

Jul 03, 2013: Impax Laboratories Confirms Patent Challenge Relating to Generic TOVIAZ 4 mg and 8 mg 118

May 21, 2013: Addex Validates Potential Efficacy Biomarker For Phase I Trial Of ADX71441 119

May 17, 2013: Astellas's Betmiga Obtains NICE Recommendation For Restricted Use In Treatment Of Overactive Bladder 119

May 07, 2013: Astellas Pharma Presents Clinical Data On Myrbetriq At American Urological Association Annual Meeting 120

Apr 10, 2013: Astellas Introduces Myrbetriq For Canadian Patients With Overactive Bladder 120

Apr 09, 2013: Laboratorios Salvat And Kwang Dong Pharma Announce Positive Phase IIb Results Of Tarafenacin For Overactive Bladder Treatment 121

Appendix 122

Methodology 122

Coverage 122

Secondary Research 122

Primary Research 122

Expert Panel Validation 122

Contact Us 122

Disclaimer 123

List of Tables

Number of Products under Development for Overactive Bladder, H1 2015 11

Number of Products under Development for Overactive Bladder-Comparative Analysis, H1 2015 12

Number of Products under Development by Companies, H1 2015 13

Number of Products under Development by Companies, H1 2015 (Contd..1) 14

Number of Products under Investigation by Universities/Institutes, H1 2015 15

Comparative Analysis by Late Stage Development, H1 2015 16

Comparative Analysis by Clinical Stage Development, H1 2015 17

Comparative Analysis by Early Stage Development, H1 2015 18

Products under Development by Companies, H1 2015 19

Products under Development by Companies, H1 2015 (Contd..1) 20

Products under Development by Companies, H1 2015 (Contd..2) 21

Products under Investigation by Universities/Institutes, H1 2015 22

Overactive Bladder-Pipeline by Addex Therapeutics Ltd, H1 2015 23

Overactive Bladder-Pipeline by Allergan, Inc., H1 2015 24

Overactive Bladder-Pipeline by Asahi Kasei Pharma Corp., H1 2015 25

Overactive Bladder-Pipeline by Astellas Pharma Inc., H1 2015 26

Overactive Bladder-Pipeline by Dong-A Socio Group, H1 2015 27

Overactive Bladder-Pipeline by FemmePharma Global Healthcare, Inc., H1 2015 28

Overactive Bladder-Pipeline by Ferring International Center S.A., H1 2015 29

Overactive Bladder-Pipeline by Hydra Biosciences, Inc., H1 2015 30

Overactive Bladder-Pipeline by Ion Channel Innovations, LLC, H1 2015 31

Overactive Bladder-Pipeline by Ipsen S.A., H1 2015 32

Overactive Bladder-Pipeline by Jeil Pharmaceutical Co., Ltd., H1 2015 33

Overactive Bladder-Pipeline by Laboratorios SALVAT S.A., H1 2015 34

Overactive Bladder-Pipeline by Lipella Pharmaceuticals, Inc., H1 2015 35

Overactive Bladder-Pipeline by Merck & Co., Inc., H1 2015 36

Overactive Bladder-Pipeline by Mezzion Pharma Co. Ltd., H1 2015 37

Overactive Bladder-Pipeline by MI.TO. Technology S.r.L., H1 2015 38

Overactive Bladder-Pipeline by NeuroSearch A/S, H1 2015 39

Overactive Bladder-Pipeline by Recordati S.p.A., H1 2015 40

Overactive Bladder-Pipeline by Sanofi, H1 2015 41

Overactive Bladder-Pipeline by Takeda Pharmaceutical Company Limited, H1 2015 42

Overactive Bladder-Pipeline by TARIS BioMedical, Inc., H1 2015 43

Overactive Bladder-Pipeline by TheraVida, Inc., H1 2015 44

Overactive Bladder-Pipeline by Toray Industries, Inc., H1 2015 45

Assessment by Monotherapy Products, H1 2015 46

Assessment by Combination Products, H1 2015 47

Number of Products by Stage and Target, H1 2015 49

Number of Products by Stage and Mechanism of Action, H1 2015 51

Number of Products by Stage and Route of Administration, H1 2015 53

Number of Products by Stage and Molecule Type, H1 2015 55

Overactive Bladder Therapeutics-Recent Pipeline Updates, H1 2015 97

Overactive Bladder-Dormant Projects, H1 2015 108

Overactive Bladder-Dormant Projects (Contd..1), H1 2015 109

Overactive Bladder-Dormant Projects (Contd..2), H1 2015 110

Overactive Bladder-Dormant Projects (Contd..3), H1 2015 111

Overactive Bladder-Dormant Projects (Contd..4), H1 2015 112

Overactive Bladder-Dormant Projects (Contd..5), H1 2015 113

Overactive Bladder-Discontinued Products, H1 2015 114

Overactive Bladder-Discontinued Products (Contd..1), H1 2015 115

List of Figures

Number of Products under Development for Overactive Bladder, H1 2015 11

Number of Products under Development for Overactive Bladder-Comparative Analysis, H1 2015 12

Number of Products under Development by Companies, H1 2015 13

Comparative Analysis by Clinical Stage Development, H1 2015 17

Comparative Analysis by Early Stage Products, H1 2015 18

Assessment by Monotherapy Products, H1 2015 46

Number of Products by Top 10 Targets, H1 2015 48

Number of Products by Stage and Top 10 Targets, H1 2015 49

Number of Products by Top 10 Mechanism of Actions, H1 2015 50

Number of Products by Stage and Top 10 Mechanism of Actions, H1 2015 51

Number of Products by Top 10 Routes of Administration, H1 2015 52

Number of Products by Stage and Top 10 Routes of Administration, H1 2015 53

Number of Products by Top 10 Molecule Types, H1 2015 54

Number of Products by Stage and Top 10 Molecule Types, H1 2015 55

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Addex Therapeutics Ltd

Allergan, Inc.

Asahi Kasei Pharma Corp.

Astellas Pharma Inc.

Dong-A Socio Group

FemmePharma Global Healthcare, Inc.

Ferring International Center S.A.

Hydra Biosciences, Inc.

Ion Channel Innovations, LLC

Ipsen S.A.

Jeil Pharmaceutical Co., Ltd.

Laboratorios SALVAT S.A.

Lipella Pharmaceuticals, Inc.

Merck & Co., Inc.

Mezzion Pharma Co. Ltd.

MI.TO. Technology S.r.L.

NeuroSearch A/S

Recordati S.p.A.

Sanofi

Takeda Pharmaceutical Company Limited

TARIS BioMedical, Inc.

TheraVida, Inc.

Toray Industries, Inc.

Overactive Bladder Therapeutic Products under Development, Key Players in Overactive Bladder Therapeutics, Overactive Bladder Pipeline Overview, Overactive Bladder Pipeline, Overactive Bladder Pipeline Assessment


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