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Polycystic Kidney Disease-Pipeline Review, H1 2015

Polycystic Kidney Disease-Pipeline Review, H1 2015


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Executive Summary

Polycystic Kidney Disease-Pipeline Review, H1 2015

Summary

Global Markets Direct's, 'Polycystic Kidney Disease-Pipeline Review, H1 2015', provides an overview of the Polycystic Kidney Disease's therapeutic pipeline.

This report provides comprehensive information on the therapeutic development for Polycystic Kidney Disease, 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 Polycystic Kidney Disease 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 Polycystic Kidney Disease

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 Polycystic Kidney Disease and enlists all their major and minor projects

The report summarizes all the dormant and discontinued pipeline projects

A review of the Polycystic Kidney Disease 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 Polycystic Kidney Disease 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 Polycystic Kidney Disease

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

Devise corrective measures for pipeline projects by understanding Polycystic Kidney Disease 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 5

List of Figures 6

Introduction 7

Global Markets Direct Report Coverage 7

Polycystic Kidney Disease Overview 8

Therapeutics Development 9

Pipeline Products for Polycystic Kidney Disease-Overview 9

Pipeline Products for Polycystic Kidney Disease-Comparative Analysis 10

Polycystic Kidney Disease-Therapeutics under Development by Companies 11

Polycystic Kidney Disease-Therapeutics under Investigation by Universities/Institutes 12

Polycystic Kidney Disease-Pipeline Products Glance 13

Late Stage Products 13

Clinical Stage Products 14

Early Stage Products 15

Polycystic Kidney Disease-Products under Development by Companies 16

Polycystic Kidney Disease-Products under Investigation by Universities/Institutes 17

Polycystic Kidney Disease-Companies Involved in Therapeutics Development 18

DiscoveryBiomed, Inc. 18

Endocyte, Inc. 19

IC-MedTech, Inc. 20

Ipsen S.A. 21

Kadmon Corporation, LLC 22

Metabolic Solutions Development Company, LLC 23

Otsuka Holdings Co., Ltd. 24

Synta Pharmaceuticals Corp. 25

Polycystic Kidney Disease-Therapeutics Assessment 26

Assessment by Monotherapy Products 26

Assessment by Combination Products 27

Assessment by Target 28

Assessment by Mechanism of Action 30

Assessment by Route of Administration 32

Assessment by Molecule Type 34

Drug Profiles 36

(ascorbic acid + menadione)-Drug Profile 36

Product Description 36

Mechanism of Action 36

R&D Progress 36

DBM-43H11-Drug Profile 38

Product Description 38

Mechanism of Action 38

R&D Progress 38

Drugs for Polycystic Kidney Disease-Drug Profile 39

Product Description 39

Mechanism of Action 39

R&D Progress 39

EC-0371-Drug Profile 40

Product Description 40

Mechanism of Action 40

R&D Progress 40

JP-153-Drug Profile 41

Product Description 41

Mechanism of Action 41

R&D Progress 41

lanreotide acetate-Drug Profile 42

Product Description 42

Mechanism of Action 42

R&D Progress 42

MSDC-0160-Drug Profile 44

Product Description 44

Mechanism of Action 44

R&D Progress 44

MSDC-0602-Drug Profile 46

Product Description 46

Mechanism of Action 46

R&D Progress 46

Small Molecule to Inhibit EnaC and CFTR for Cystic Fibrosis, Diarrhea and Autosomal Dominant Polycystic Kidney Disease-Drug Profile 48

Product Description 48

Mechanism of Action 48

R&D Progress 48

Small Molecule to Inhibit Xanthine Oxidase for Polycystic Kidney Disease-Drug Profile 49

Product Description 49

Mechanism of Action 49

R&D Progress 49

Small Molecules to Activate AMPK for Polycystic Kidney Disease-Drug Profile 50

Product Description 50

Mechanism of Action 50

R&D Progress 50

Small Molecules to Activate Somatostatin Receptor Type 4 for Oncology, Genito Urinary System And Sex Hormones and Metabolic Disorders-Drug Profile 51

Product Description 51

Mechanism of Action 51

R&D Progress 51

Small Molecules to Inhibit Hsp90 for Polycystic Kidney Disease-Drug Profile 52

Product Description 52

Mechanism of Action 52

R&D Progress 52

Small Molecules to Target CIL-1 for Genetic Disorders and Polycystic Kidney Disease-Drug Profile 53

Product Description 53

Mechanism of Action 53

R&D Progress 53

STA-2842-Drug Profile 54

Product Description 54

Mechanism of Action 54

R&D Progress 54

tesevatinib tosylate-Drug Profile 55

Product Description 55

Mechanism of Action 55

R&D Progress 55

tolvaptan-Drug Profile 57

Product Description 57

Mechanism of Action 57

R&D Progress 57

Polycystic Kidney Disease-Recent Pipeline Updates 59

Polycystic Kidney Disease-Dormant Projects 68

Polycystic Kidney Disease-Discontinued Products 69

Polycystic Kidney Disease-Product Development Milestones 70

Featured News & Press Releases 70

May 28, 2015: Otsuka's JINARC the First-Ever Treatment Approved in Europe for Adults Living with ADPKD, a Chronic Genetic Kidney Disease 70

Mar 18, 2015: Metabolic Solutions Development Company Highlights Plans for MSDC-0602 in NASH and Polycystic Kidney Disease 71

Feb 27, 2015: CHMP Recommends JINARC (Tolvaptan) for Approval in EU: The First Pharmaceutical Treatment for Autosomal Dominant Polycystic Kidney Disease 71

Feb 26, 2015: First-Ever Treatment Approved in Canada for Adults Living with ADPKD, a Life-Threatening Kidney Disease 72

Sep 15, 2014: DiscoveryBioMed Awarded A Dual SBIR Awards For Drug Discovery, Validation, Optimization And Development For Autosomal Dominant Polycystic Kidney Disease, The Leading Genetic Cause Of Dialysis And Transplantation Worldwide 73

Jun 19, 2014: Kadmon Corporation Initiates Phase 2a Portion of KD020 Study in Autosomal Dominant Polycystic Kidney Disease 74

Jun 11, 2014: Otsuka Pharmaceutical Initiates Phase 3 Clinical Trial Of Tolvaptan In Patients With Autosomal Dominant Polycystic Kidney Disease 75

May 23, 2014: Launch in Japan of Samsca 30 mg Tablet Formulation for Patients With Autosomal Dominant Polycystic Kidney Disease, an Orphan Disease 75

Mar 24, 2014: Otsuka Pharmaceutical's Samsca Approved in Japan as the World's First Drug Therapy for ADPKD, a Rare Kidney Disease 75

Dec 27, 2013: European Medicines Agency Accepts Otsuka's Marketing Authorisation Application for Tolvaptan, an Investigational Compound for Autosomal Dominant Polycystic Kidney Disease 76

Appendix 78

Methodology 78

Coverage 78

Secondary Research 78

Primary Research 78

Expert Panel Validation 78

Contact Us 78

Disclaimer 79

List of Tables

Number of Products under Development for Polycystic Kidney Disease, H1 2015 9

Number of Products under Development for Polycystic Kidney Disease-Comparative Analysis, H1 2015 10

Number of Products under Development by Companies, H1 2015 11

Number of Products under Investigation by Universities/Institutes, H1 2015 12

Comparative Analysis by Late Stage Development, H1 2015 13

Comparative Analysis by Clinical Stage Development, H1 2015 14

Comparative Analysis by Early Stage Development, H1 2015 15

Products under Development by Companies, H1 2015 16

Products under Investigation by Universities/Institutes, H1 2015 17

Polycystic Kidney Disease-Pipeline by DiscoveryBiomed, Inc., H1 2015 18

Polycystic Kidney Disease-Pipeline by Endocyte, Inc., H1 2015 19

Polycystic Kidney Disease-Pipeline by IC-MedTech, Inc., H1 2015 20

Polycystic Kidney Disease-Pipeline by Ipsen S.A., H1 2015 21

Polycystic Kidney Disease-Pipeline by Kadmon Corporation, LLC, H1 2015 22

Polycystic Kidney Disease-Pipeline by Metabolic Solutions Development Company, LLC, H1 2015 23

Polycystic Kidney Disease-Pipeline by Otsuka Holdings Co., Ltd., H1 2015 24

Polycystic Kidney Disease-Pipeline by Synta Pharmaceuticals Corp., H1 2015 25

Assessment by Monotherapy Products, H1 2015 26

Assessment by Combination Products, H1 2015 27

Number of Products by Stage and Target, H1 2015 29

Number of Products by Stage and Mechanism of Action, H1 2015 31

Number of Products by Stage and Route of Administration, H1 2015 33

Number of Products by Stage and Molecule Type, H1 2015 35

Polycystic Kidney Disease Therapeutics-Recent Pipeline Updates, H1 2015 59

Polycystic Kidney Disease-Dormant Projects, H1 2015 68

Polycystic Kidney Disease-Discontinued Products, H1 2015 69

List of Figures

Number of Products under Development for Polycystic Kidney Disease, H1 2015 9

Number of Products under Development for Polycystic Kidney Disease-Comparative Analysis, H1 2015 10

Number of Products under Development by Companies, H1 2015 11

Number of Products under Investigation by Universities/Institutes, H1 2015 12

Comparative Analysis by Early Stage Products, H1 2015 15

Assessment by Monotherapy Products, H1 2015 26

Number of Products by Top 10 Targets, H1 2015 28

Number of Products by Stage and Top 10 Targets, H1 2015 28

Number of Products by Top 10 Mechanism of Actions, H1 2015 30

Number of Products by Stage and Top 10 Mechanism of Actions, H1 2015 30

Number of Products by Top 10 Routes of Administration, H1 2015 32

Number of Products by Stage and Top 10 Routes of Administration, H1 2015 33

Number of Products by Top 10 Molecule Types, H1 2015 34

Number of Products by Stage and Top 10 Molecule Types, H1 2015 35

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DiscoveryBiomed, Inc.

Endocyte, Inc.

IC-MedTech, Inc.

Ipsen S.A.

Kadmon Corporation, LLC

Metabolic Solutions Development Company, LLC

Otsuka Holdings Co., Ltd.

Synta Pharmaceuticals Corp.

Polycystic Kidney Disease Therapeutic Products under Development, Key Players in Polycystic Kidney Disease Therapeutics, Polycystic Kidney Disease Pipeline Overview, Polycystic Kidney Disease Pipeline, Polycystic Kidney Disease Pipeline Assessment


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