Interstitial Cystitis (Painful Bladder Syndrome) - Pipeline Review, H2 2016

Interstitial Cystitis (Painful Bladder Syndrome) - Pipeline Review, H2 2016


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Executive Summary

Interstitial Cystitis (Painful Bladder Syndrome) - Pipeline Review, H2 2016

Summary

Global Markets Direct's, 'Interstitial Cystitis (Painful Bladder Syndrome) - Pipeline Review, H2 2016', provides an overview of the Interstitial Cystitis (Painful Bladder Syndrome) pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Interstitial Cystitis (Painful Bladder Syndrome), 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 Interstitial Cystitis (Painful Bladder Syndrome) 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 Interstitial Cystitis (Painful Bladder Syndrome)

- The report reviews pipeline therapeutics for Interstitial Cystitis (Painful Bladder Syndrome) 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 Interstitial Cystitis (Painful Bladder Syndrome) therapeutics and enlists all their major and minor projects

- The report assesses Interstitial Cystitis (Painful Bladder Syndrome) 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 Interstitial Cystitis (Painful Bladder Syndrome)

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 Interstitial Cystitis (Painful Bladder Syndrome)

- 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 Interstitial Cystitis (Painful Bladder Syndrome) 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 5

List of Figures 6

Introduction 7

Global Markets Direct Report Coverage 7

Interstitial Cystitis (Painful Bladder Syndrome) Overview 8

Therapeutics Development 9

Pipeline Products for Interstitial Cystitis (Painful Bladder Syndrome) - Overview 9

Pipeline Products for Interstitial Cystitis (Painful Bladder Syndrome) - Comparative Analysis 10

Interstitial Cystitis (Painful Bladder Syndrome) - Therapeutics under Development by Companies 11

Interstitial Cystitis (Painful Bladder Syndrome) - Therapeutics under Investigation by Universities/Institutes 12

Interstitial Cystitis (Painful Bladder Syndrome) - Pipeline Products Glance 13

Late Stage Products 13

Clinical Stage Products 14

Early Stage Products 15

Interstitial Cystitis (Painful Bladder Syndrome) - Products under Development by Companies 16

Interstitial Cystitis (Painful Bladder Syndrome) - Products under Investigation by Universities/Institutes 17

Interstitial Cystitis (Painful Bladder Syndrome) - Companies Involved in Therapeutics Development 18

Allergan Plc 19

Aquinox Pharmaceuticals Inc. 20

Astellas Pharma Inc. 21

Kytogenics Pharmaceuticals, Inc. 22

Lipella Pharmaceuticals, Inc. 23

MediPost Co., Ltd. 24

UCB S.A. 25

Urigen Pharmaceuticals, Inc. 26

UroGen Pharmaceuticals, Ltd. 27

Interstitial Cystitis (Painful Bladder Syndrome) - Therapeutics Assessment 28

Assessment by Monotherapy Products 28

Assessment by Combination Products 29

Assessment by Target 30

Assessment by Mechanism of Action 32

Assessment by Route of Administration 34

Assessment by Molecule Type 36

Drug Profiles 38

(heparin + lidocaine) - Drug Profile 38

Product Description 38

Mechanism Of Action 38

R&D Progress 38

AQX-1125 - Drug Profile 41

Product Description 41

Mechanism Of Action 41

R&D Progress 41

ASP-6294 - Drug Profile 46

Product Description 46

Mechanism Of Action 46

R&D Progress 46

Cartistem - Drug Profile 47

Product Description 47

Mechanism Of Action 47

R&D Progress 47

certolizumab pegol - Drug Profile 49

Product Description 49

Mechanism Of Action 49

R&D Progress 49

GM-0111 - Drug Profile 60

Product Description 60

Mechanism Of Action 60

R&D Progress 60

lidocaine hydrochloride - Drug Profile 62

Product Description 62

Mechanism Of Action 62

R&D Progress 62

LP-08 - Drug Profile 64

Product Description 64

Mechanism Of Action 64

R&D Progress 64

mesalamine - Drug Profile 66

Product Description 66

Mechanism Of Action 66

R&D Progress 66

MK-7264 - Drug Profile 67

Product Description 67

Mechanism Of Action 67

R&D Progress 67

NEO-5937 - Drug Profile 71

Product Description 71

Mechanism Of Action 71

R&D Progress 71

onabotulinumtoxinA - Drug Profile 72

Product Description 72

Mechanism Of Action 72

R&D Progress 72

onabotulinumtoxinA SR - Drug Profile 74

Product Description 74

Mechanism Of Action 74

R&D Progress 74

pentosan polysulfate sodium - Drug Profile 75

Product Description 75

Mechanism Of Action 75

R&D Progress 75

URG-801 - Drug Profile 76

Product Description 76

Mechanism Of Action 76

R&D Progress 76

Interstitial Cystitis (Painful Bladder Syndrome) - Dormant Projects 77

Interstitial Cystitis (Painful Bladder Syndrome) - Discontinued Products 78

Interstitial Cystitis (Painful Bladder Syndrome) - Product Development Milestones 79

Featured News & Press Releases 79

May 25, 2016: Aquinox Announces Executive Appointments 79

May 10, 2016: Aquinox Pharmaceuticals Announces First Quarter 2016 Financial Results 79

May 03, 2016: Allergan Presents New Data on LiRIS 400 mg at the American Urological Association Meeting in San Diego 81

Jan 11, 2016: Aquinox Announces Update on Development Program for AQX-1125 Following Meeting With FDA 81

Dec 22, 2015: Aquinox Pharmaceuticals Announces Appointment of Ms. Shelley McCloskey as Vice President, Human Resources & Administration 82

Sep 18, 2015: Aquinox Presents at 2015 International Society for the Study of BPS Conference 82

Aug 27, 2015: Lipella Pharmaceuticals Announces Enrollment of First Patient in Phase-2 Trial in Interstitial Cystitis 83

Aug 25, 2015: LEADERSHIP Results Accepted for Podium Presentation at the 2015 Annual Meeting of the International Society for the Study of BPS 84

Aug 06, 2015: Aquinox Pharmaceuticals Announces Positive Results From Secondary Endpoints From Phase 2 LEADERSHIP Trial in BPS/IC 84

Jul 28, 2015: Aquinox Pharmaceuticals to Provide Update on Secondary Endpoints From Phase 2 LEADERSHIP Trial in BPS/IC 84

Jun 25, 2015: Aquinox Pharmaceuticals Announces Results From LEADERSHIP Trial With AQX-1125 in Patients With Bladder Pain Syndrome/Interstitial Cystitis 85

May 18, 2015: Canadian Journal of Urology Study Highlights the Benefits of Heparin and Alkalinized Lidocaine Combination Formulation for the Relief of Interstitial Cystitis Symptoms 85

Mar 02, 2015: Aquinox Pharmaceuticals Completes Enrollment in the Phase 2 LEADERSHIP Trial of AQX-1125 in Bladder Pain Syndrome/Interstitial Cystitis 86

Feb 26, 2015: Afferent Clinical Data for Lead Candidate, AF-219, Demonstrate Improvements in Pain and Urinary Urgency in Interstitial Cystitis / Bladder Pain Syndrome 87

Jun 02, 2014: Aquinox Pharmaceuticals Announces Expansion of Ongoing Phase 2 Trials of AQX-1125, Including Acceptance of U.S. IND 88

Appendix 89

Methodology 89

Coverage 89

Secondary Research 89

Primary Research 89

Expert Panel Validation 89

Contact Us 89

Disclaimer 90

List of Figures

Number of Products under Development for Interstitial Cystitis (Painful Bladder Syndrome), H2 2016 9

Number of Products under Development for Interstitial Cystitis (Painful Bladder Syndrome) - Comparative Analysis, H2 2016 10

Number of Products under Development by Companies, H2 2016 11

Comparative Analysis by Clinical Stage Development, H2 2016 14

Comparative Analysis by Early Stage Products, H2 2016 15

Assessment by Monotherapy Products, H2 2016 28

Number of Products by Targets, H2 2016 30

Number of Products by Stage and Targets, H2 2016 30

Number of Products by Mechanism of Actions, H2 2016 32

Number of Products by Stage and Mechanism of Actions, H2 2016 32

Number of Products by Routes of Administration, H2 2016 34

Number of Products by Stage and Routes of Administration, H2 2016 34

Number of Products by Molecule Types, H2 2016 36

Number of Products by Stage and Molecule Types, H2 2016 36

List of Tables

Number of Products under Development for Interstitial Cystitis (Painful Bladder Syndrome), H2 2016 9

Number of Products under Development for Interstitial Cystitis (Painful Bladder Syndrome) - Comparative Analysis, H2 2016 10

Number of Products under Development by Companies, H2 2016 11

Number of Products under Investigation by Universities/Institutes, H2 2016 12

Comparative Analysis by Late Stage Development, H2 2016 13

Comparative Analysis by Clinical Stage Development, H2 2016 14

Comparative Analysis by Early Stage Development, H2 2016 15

Products under Development by Companies, H2 2016 16

Products under Investigation by Universities/Institutes, H2 2016 17

Interstitial Cystitis (Painful Bladder Syndrome) - Pipeline by Afferent Pharmaceuticals, Inc., H2 2016 18

Interstitial Cystitis (Painful Bladder Syndrome) - Pipeline by Allergan Plc, H2 2016 19

Interstitial Cystitis (Painful Bladder Syndrome) - Pipeline by Aquinox Pharmaceuticals Inc., H2 2016 20

Interstitial Cystitis (Painful Bladder Syndrome) - Pipeline by Astellas Pharma Inc., H2 2016 21

Interstitial Cystitis (Painful Bladder Syndrome) - Pipeline by Kytogenics Pharmaceuticals, Inc., H2 2016 22

Interstitial Cystitis (Painful Bladder Syndrome) - Pipeline by Lipella Pharmaceuticals, Inc., H2 2016 23

Interstitial Cystitis (Painful Bladder Syndrome) - Pipeline by MediPost Co., Ltd., H2 2016 24

Interstitial Cystitis (Painful Bladder Syndrome) - Pipeline by UCB S.A., H2 2016 25

Interstitial Cystitis (Painful Bladder Syndrome) - Pipeline by Urigen Pharmaceuticals, Inc., H2 2016 26

Interstitial Cystitis (Painful Bladder Syndrome) - Pipeline by UroGen Pharmaceuticals, Ltd., H2 2016 27

Assessment by Monotherapy Products, H2 2016 28

Assessment by Combination Products, H2 2016 29

Number of Products by Stage and Target, H2 2016 31

Number of Products by Stage and Mechanism of Action, H2 2016 33

Number of Products by Stage and Route of Administration, H2 2016 35

Number of Products by Stage and Molecule Type, H2 2016 37

Interstitial Cystitis (Painful Bladder Syndrome) - Dormant Projects, H2 2016 77

Interstitial Cystitis (Painful Bladder Syndrome) - Discontinued Products, H2 2016 78

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Allergan Plc

Aquinox Pharmaceuticals Inc.

Astellas Pharma Inc.

Kytogenics Pharmaceuticals, Inc.

Lipella Pharmaceuticals, Inc.

MediPost Co., Ltd.

UCB S.A.

Urigen Pharmaceuticals, Inc.

UroGen Pharmaceuticals, Ltd.

Interstitial Cystitis (Painful Bladder Syndrome) Therapeutic Products under Development, Key Players in Interstitial Cystitis (Painful Bladder Syndrome) Therapeutics, Interstitial Cystitis (Painful Bladder Syndrome) Pipeline Overview, Interstitial Cystitis (Painful Bladder Syndrome) Pipeline, Interstitial Cystitis (Painful Bladder Syndrome) Pipeline Assessment

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