Polycystic Kidney Disease – Pipeline Review, H2 2016

Global Markets Direct’s, ‘Polycystic Kidney Disease – Pipeline Review, H2 2016’, provides an overview of the Polycystic Kidney Disease pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Polycystic Kidney Disease, 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 Polycystic Kidney Disease 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 Polycystic Kidney Disease

The report reviews pipeline therapeutics for Polycystic Kidney Disease 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 Polycystic Kidney Disease therapeutics and enlists all their major and minor projects

The report assesses Polycystic Kidney Disease 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 Polycystic Kidney Disease

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 Polycystic Kidney Disease

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 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

Companies mentioned

Angion Biomedica Corp.

Aptevo Therapeutics Inc

DiscoveryBiomed, Inc.

Endocyte, Inc.

IC-MedTech, Inc.

Ipsen S.A.

Kadmon Corporation, LLC

ManRos Therapeutics

Metabolic Solutions Development Company, LLC

NovaTarg Therapeutics, Inc

Otsuka Holdings Co., Ltd.

XORTX Pharma Corp.

Table of Contents

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

Angion Biomedica Corp. 18

Aptevo Therapeutics Inc 19

DiscoveryBiomed, Inc. 20

Endocyte, Inc. 21

IC-MedTech, Inc. 22

Ipsen S.A. 23

Kadmon Corporation, LLC 24

ManRos Therapeutics 25

Metabolic Solutions Development Company, LLC 26

NovaTarg Therapeutics, Inc 27

Otsuka Holdings Co., Ltd. 28

XORTX Pharma Corp. 29

Polycystic Kidney Disease - Therapeutics Assessment 30

Assessment by Monotherapy Products 30

Assessment by Combination Products 31

Assessment by Target 32

Assessment by Mechanism of Action 34

Assessment by Route of Administration 36

Assessment by Molecule Type 38

Drug Profiles 40

(ascorbic acid + menadione) - Drug Profile 40

Product Description 40

Mechanism Of Action 40

R&D Progress 40

ANG-3070 - Drug Profile 42

Product Description 42

Mechanism Of Action 42

R&D Progress 42

CIM-2 - Drug Profile 43

Product Description 43

Mechanism Of Action 43

R&D Progress 43

CR-8 - Drug Profile 44

Product Description 44

Mechanism Of Action 44

R&D Progress 44

DBM-43H11 - Drug Profile 45

Product Description 45

Mechanism Of Action 45

R&D Progress 45

Drugs for Polycystic Kidney Disease - Drug Profile 46

Product Description 46

Mechanism Of Action 46

R&D Progress 46

EC-0371 - Drug Profile 47

Product Description 47

Mechanism Of Action 47

R&D Progress 47

JP-153 - Drug Profile 48

Product Description 48

Mechanism Of Action 48

R&D Progress 48

lanreotide acetate - Drug Profile 49

Product Description 49

Mechanism Of Action 49

R&D Progress 49

menadione sodium bisulfite - Drug Profile 53

Product Description 53

Mechanism Of Action 53

R&D Progress 53

MSDC-0160 - Drug Profile 54

Product Description 54

Mechanism Of Action 54

R&D Progress 54

MSDC-0602 - Drug Profile 57

Product Description 57

Mechanism Of Action 57

R&D Progress 57

oxypurinol - Drug Profile 59

Product Description 59

Mechanism Of Action 59

R&D Progress 59

pyrimethamine - Drug Profile 60

Product Description 60

Mechanism Of Action 60

R&D Progress 60

Small Molecule to Inhibit EnaC and CFTR for Cystic Fibrosis, Diarrhea and Autosomal Dominant Polycystic Kidney Disease - Drug Profile 61

Product Description 61

Mechanism Of Action 61

R&D Progress 61

Small Molecules to Activate AMPK for Polycystic Kidney Disease - Drug Profile 62

Product Description 62

Mechanism Of Action 62

R&D Progress 62

Small Molecules to Activate Somatostatin Receptor Type 4 for Polycystic Kidney Disease, Acromegaly and Neuroendocrine Tumors - Drug Profile 63

Product Description 63

Mechanism Of Action 63

R&D Progress 63

Small Molecules to Inhibit Hsp90 for Polycystic Kidney Disease - Drug Profile 64

Product Description 64

Mechanism Of Action 64

R&D Progress 64

STA-2842 - Drug Profile 65

Product Description 65

Mechanism Of Action 65

R&D Progress 65

tesevatinib tosylate - Drug Profile 66

Product Description 66

Mechanism Of Action 66

R&D Progress 66

TNFR x TWEAKR - Drug Profile 69

Product Description 69

Mechanism Of Action 69

R&D Progress 69

tolvaptan - Drug Profile 70

Product Description 70

Mechanism Of Action 70

R&D Progress 70

Polycystic Kidney Disease - Dormant Projects 73

Polycystic Kidney Disease - Discontinued Products 74

Polycystic Kidney Disease - Product Development Milestones 75

Featured News & Press Releases 75

Jan 11, 2016: Scottish Medicines Consortium Issues Positive Advice For First Ever Treatment For Autosomal dominant polycystic kidney disease 75

Nov 02, 2015: Kadmon to Present Clinical Data on Tesevatinib for the Treatment of Polycystic Kidney Disease at ASN's Kidney Week 2015 76

May 28, 2015: Otsuka’s JINARC the First-Ever Treatment Approved in Europe for Adults Living with ADPKD, a Chronic Genetic Kidney Disease 76

Apr 14, 2015: DiscoveryBioMed is developing a novel and unprecedented “dual action” small molecule monotherapy for all cystic fibrosis (CF) patients and for other chronic larger market or rare lung and vascular diseases 77

Mar 18, 2015: Metabolic Solutions Development Company Highlights Plans for MSDC-0602 in NASH and Polycystic Kidney Disease 78

Feb 27, 2015: CHMP Recommends JINARC (Tolvaptan) for Approval in EU: The First Pharmaceutical Treatment for Autosomal Dominant Polycystic Kidney Disease 79

Feb 26, 2015: First-Ever Treatment Approved in Canada for Adults Living with ADPKD, a Life-Threatening Kidney Disease 79

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 81

Jun 19, 2014: Kadmon Corporation Initiates Phase 2a Portion of KD020 Study in Autosomal Dominant Polycystic Kidney Disease 82

Jun 11, 2014: Otsuka Pharmaceutical Initiates Phase 3 Clinical Trial Of Tolvaptan In Patients With Autosomal Dominant Polycystic Kidney Disease 82

May 23, 2014: Launch in Japan of Samsca 30 mg Tablet Formulation for Patients With Autosomal Dominant Polycystic Kidney Disease, an Orphan Disease 83

Mar 24, 2014: Otsuka Pharmaceutical's Samsca Approved in Japan as the World's First Drug Therapy for ADPKD, a Rare Kidney Disease 83

Dec 27, 2013: European Medicines Agency Accepts Otsuka's Marketing Authorisation Application for Tolvaptan, an Investigational Compound for Autosomal Dominant Polycystic Kidney Disease 84

Aug 29, 2013: Otsuka Receives Complete Response Letter from U.S. Food and Drug Administration for Tolvaptan for Use in Patients with Autosomal Dominant Polycystic Kidney Disease 84

Aug 05, 2013: U.S. Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee Recommends Not to Approve Otsuka Pharmaceutical’s Tolvaptan for Use in Autosomal Dominant Polycystic Kidney Disease 85

Appendix 86

Methodology 86

Coverage 86

Secondary Research 86

Primary Research 86

Expert Panel Validation 86

Contact Us 86

Disclaimer 87

List of Tables

List of Tables

Number of Products under Development for Polycystic Kidney Disease, H2 2016 9

Number of Products under Development for Polycystic Kidney Disease – 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

Polycystic Kidney Disease – Pipeline by Angion Biomedica Corp., H2 2016 18

Polycystic Kidney Disease – Pipeline by Aptevo Therapeutics Inc, H2 2016 19

Polycystic Kidney Disease – Pipeline by DiscoveryBiomed, Inc., H2 2016 20

Polycystic Kidney Disease – Pipeline by Endocyte, Inc., H2 2016 21

Polycystic Kidney Disease – Pipeline by IC-MedTech, Inc., H2 2016 22

Polycystic Kidney Disease – Pipeline by Ipsen S.A., H2 2016 23

Polycystic Kidney Disease – Pipeline by Kadmon Corporation, LLC, H2 2016 24

Polycystic Kidney Disease – Pipeline by ManRos Therapeutics, H2 2016 25

Polycystic Kidney Disease – Pipeline by Metabolic Solutions Development Company, LLC, H2 2016 26

Polycystic Kidney Disease – Pipeline by NovaTarg Therapeutics, Inc, H2 2016 27

Polycystic Kidney Disease – Pipeline by Otsuka Holdings Co., Ltd., H2 2016 28

Polycystic Kidney Disease – Pipeline by XORTX Pharma Corp., H2 2016 29

Assessment by Monotherapy Products, H2 2016 30

Assessment by Combination Products, H2 2016 31

Number of Products by Stage and Target, H2 2016 33

Number of Products by Stage and Mechanism of Action, H2 2016 35

Number of Products by Stage and Route of Administration, H2 2016 37

Number of Products by Stage and Molecule Type, H2 2016 39

Polycystic Kidney Disease – Dormant Projects, H2 2016 73

Polycystic Kidney Disease – Discontinued Products, H2 2016 74

List of Figures

List of Figures

Number of Products under Development for Polycystic Kidney Disease, H2 2016 9

Number of Products under Development for Polycystic Kidney Disease – 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 Products, H2 2016 15

Assessment by Monotherapy Products, H2 2016 30

Number of Products by Top 10 Targets, H2 2016 32

Number of Products by Stage and Top 10 Targets, H2 2016 32

Number of Products by Top 10 Mechanism of Actions, H2 2016 34

Number of Products by Stage and Top 10 Mechanism of Actions, H2 2016 34

Number of Products by Routes of Administration, H2 2016 36

Number of Products by Stage and Routes of Administration, H2 2016 36

Number of Products by Molecule Types, H2 2016 38

Number of Products by Stage and Molecule Types, H2 2016 38

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