Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline Review, H2 2016

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1 Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline Review, H2 2016

2 Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline Review, H Sector Publishing Intelligence Limited (SPi) has been marketing business and market research reports from selected publishers for over five years. SPi offers a personal service to our customers with dedicated research managers who will work with you to source the best report for your needs. Based in the UK, SPi is well positioned to coordinate our customers' orders sourced from over 30 global report publishers. We are pleased to present details of this report to assist your buying decision and administrative process. You will find easy-to-use How To Buy information on the last page of this document. We look forward to being of service to you. If you have bulk and/or recurring requirements, please get in touch - we can liaise with publishers to obtain sample pages and negotiate discounts on your behalf. Phone: +44 (0) or office@sectorpublishing.com 2

3 Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline Review, H Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline Review, H Summary Global Markets Direct's latest Pharmaceutical and Healthcare disease pipeline guide Anemia in Chronic Kidney Disease Pipeline Review, H2 2016, provides an overview of the Anemia in Chronic Kidney Disease (Hematological Disorders) pipeline landscape. Renal anemia is a disease in which the patient has an unusually low count of red blood cells. Renal is a term that means of the kidneys, so anemia is often associated with kidney disease. This type of anemia is caused by a lack of erythropoietin, a protein produced in the kidneys that helps to create red blood cells. Symptoms caused by renal anemia include pale skin and gums, become short of breath, dizziness and inability to think clearly. Report Highlights Global Markets Direct's Pharmaceutical and Healthcare latest pipeline guide Anemia in Chronic Kidney Disease Pipeline Review, H2 2016, provides comprehensive information on the therapeutics under development for Anemia in Chronic Kidney Disease (Hematological Disorders), complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The guide covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. The Anemia in Chronic Kidney Disease (Hematological Disorders) pipeline guide also reviews of key players involved in therapeutic development for Anemia in Chronic Kidney Disease (Renal Anemia) and features dormant and discontinued projects. The guide covers therapeutics under Development by Companies /Universities /Institutes, the molecules developed by Companies in Pre-Registration, Filing rejected/withdrawn, Phase III, Phase II, Phase I, IND/CTA Filed, Preclinical, Discovery and Unknown stages are 1, 1, 11, 9, 4, 1, 6, 2 and 1 respectively. Anemia in Chronic Kidney Disease (Hematological Disorders) pipeline guide 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. The guide 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. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis. Note: Certain content / sections in the pipeline guide may be removed or altered based on the availability and relevance of data. Scope - The pipeline guide provides a snapshot of the global therapeutic landscape of Anemia in Chronic Kidney Disease (Hematological Disorders). 3

4 - The pipeline guide reviews pipeline therapeutics for Anemia in Chronic Kidney Disease (Hematological Disorders) by companies and universities/research institutes based on information derived from company and industry-specific sources. - The pipeline guide covers pipeline products based on several stages of development ranging from pre-registration till discovery and undisclosed stages. - The pipeline guide features descriptive drug profiles for the pipeline products which comprise, product description, descriptive licensing and collaboration details, R&D brief, MoA & other developmental activities. - The pipeline guide reviews key companies involved in Anemia in Chronic Kidney Disease (Hematological Disorders) therapeutics and enlists all their major and minor projects. - The pipeline guide evaluates Anemia in Chronic Kidney Disease (Hematological Disorders) therapeutics based on mechanism of action (MoA), drug target, route of administration (RoA) and molecule type. - The pipeline guide encapsulates all the dormant and discontinued pipeline projects. - The pipeline guide reviews latest news related to pipeline therapeutics for Anemia in Chronic Kidney Disease (Hematological Disorders) Reasons to buy - Procure strategically important competitor information, analysis, and insights to formulate effective R&D strategies. - Recognize emerging players with potentially strong product portfolio and create effective counterstrategies to gain competitive advantage. - Find and recognize significant and varied types of therapeutics under development for Anemia in Chronic Kidney Disease (Hematological Disorders). - Classify potential new clients or partners in the target demographic. - Develop tactical initiatives by understanding the focus areas of leading companies. - Plan mergers and acquisitions meritoriously by identifying key players and it s most promising pipeline therapeutics. - Formulate corrective measures for pipeline projects by understanding Anemia in Chronic Kidney Disease (Hematological Disorders) 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. - Adjust the therapeutic portfolio by recognizing discontinued projects and understand from the knowhow what drove them from pipeline. Additional Details Publisher : Global Markets Direct Reference : GMDHC8849IDB Number of Pages : 136 Report Format : PDF Publisher Information : Welcome to Global Markets Direct The home of leading edge research and analysis. The Global Markets Direct brand features thousands of high quality company and market research reports across a broad range of industries. Browse or search our collection of reports today to access the latest in business intelligence from some of the world s leading publishers. 4

5 Table Of Contents for Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline Review, H [Updated: ] Table of Contents Table of Contents 2 List of Tables 7 List of Figures 8 Introduction 9 Global Markets Direct Report Coverage 9 Anemia in Chronic Kidney Disease (Renal Anemia) Overview 10 Therapeutics Development 11 Pipeline Products for Anemia in Chronic Kidney Disease (Renal Anemia) - Overview 11 Anemia in Chronic Kidney Disease (Renal Anemia) - Therapeutics under Development by Companies 12 Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline Products Glance 15 Late Stage Products 15 Clinical Stage Products 16 Early Stage Products 17 Unknown Stage Products 18 Anemia in Chronic Kidney Disease (Renal Anemia) - Products under Development by Companies 19 Anemia in Chronic Kidney Disease (Renal Anemia) - Companies Involved in Therapeutics Development 22 3SBio Inc 22 Acceleron Pharma Inc 23 Aevi Genomic Medicine Inc 24 Akebia Therapeutics Inc 25 Amgen Inc 26 Bayer AG 27 Biocad 28 CCM Duopharma Biotech Bhd 29 Chong Kun Dang Pharmaceutical Corp 30 CJ HealthCare Corp 31 Daiichi Sankyo Company Ltd 32 Dong-A Socio Holdings Co Ltd 33 Dr. Reddy's Laboratories Ltd 34 FibroGen Inc 35 GlaxoSmithKline Plc 36 Intas Pharmaceuticals Ltd 37 Japan Tobacco Inc 38 JCR Pharmaceuticals Co Ltd 39 Jiangsu Hansoh Pharmaceutical Co Ltd 40 LG Life Science LTD 41 Myungmoon pharmaceutical Co Ltd 42 Panacea Biotec Ltd 43 Pfizer Inc 44 PharmaEssentia Corp 45 PhytoHealth Corp 46 5

6 Pieris Pharmaceuticals Inc 47 Reliance Life Sciences Pvt Ltd 48 Sandoz International GmbH 49 Zydus Cadila Healthcare Ltd 50 Anemia in Chronic Kidney Disease (Renal Anemia) - Therapeutics Assessment 51 Assessment by Monotherapy Products 51 Assessment by Target 52 Assessment by Mechanism of Action 54 Assessment by Route of Administration 56 Assessment by Molecule Type 58 Drug Profiles 60 daprodustat - Drug Profile 60 Product Description 60 Mechanism Of Action 60 R&D Progress 60 darbepoetin alfa - Drug Profile 63 Product Description 63 Mechanism Of Action 63 R&D Progress 63 darbepoetin alfa - Drug Profile 66 Product Description 66 Mechanism Of Action 66 R&D Progress 66 darbepoetin alfa - Drug Profile 67 Product Description 67 Mechanism Of Action 67 R&D Progress 67 darbepoetin alfa - Drug Profile 68 Product Description 68 Mechanism Of Action 68 R&D Progress 68 darbepoetin alfa - Drug Profile 69 Product Description 69 Mechanism Of Action 69 R&D Progress 69 darbepoetin alfa - Drug Profile 70 Product Description 70 Mechanism Of Action 70 R&D Progress 70 darbepoetin alfa - Drug Profile 71 Product Description 71 Mechanism Of Action 71 R&D Progress 71 darbepoetin alfa - Drug Profile 72 Product Description 72 Mechanism Of Action 72 R&D Progress 72 darbepoetin alfa - Drug Profile 73 Product Description 73 Mechanism Of Action 73 R&D Progress 73 6

7 darbepoetin alfa - Drug Profile 74 Product Description 74 Mechanism Of Action 74 R&D Progress 74 DS Drug Profile 75 Product Description 75 Mechanism Of Action 75 R&D Progress 75 EPO-018B - Drug Profile 76 Product Description 76 Mechanism Of Action 76 R&D Progress 76 epoetin alfa - Drug Profile 77 Product Description 77 Mechanism Of Action 77 R&D Progress 77 epoetin alfa - Drug Profile 79 Product Description 79 Mechanism Of Action 79 R&D Progress 79 epoetin zeta - Drug Profile 80 Product Description 80 Mechanism Of Action 80 R&D Progress 80 erythropoietin - Drug Profile 83 Product Description 83 Mechanism Of Action 83 R&D Progress 83 FG Drug Profile 84 Product Description 84 Mechanism Of Action 84 R&D Progress 84 HSA-EPO - Drug Profile 85 Product Description 85 Mechanism Of Action 85 R&D Progress 85 JTZ Drug Profile 86 Product Description 86 Mechanism Of Action 86 R&D Progress 86 LBDE - Drug Profile 87 Product Description 87 Mechanism Of Action 87 R&D Progress 87 MDGN Drug Profile 88 Product Description 88 Mechanism Of Action 88 R&D Progress 88 MMP Drug Profile 90 Product Description 90 Mechanism Of Action 90 7

8 R&D Progress 90 molidustat - Drug Profile 91 Product Description 91 Mechanism Of Action 91 R&D Progress 91 PEG-EPO - Drug Profile 93 Product Description 93 Mechanism Of Action 93 R&D Progress 93 Peg-EPO - Drug Profile 94 Product Description 94 Mechanism Of Action 94 R&D Progress 94 PEG-EPO - Drug Profile 95 Product Description 95 Mechanism Of Action 95 R&D Progress 95 pegylated erythropoietin - Drug Profile 96 Product Description 96 Mechanism Of Action 96 R&D Progress 96 PHEP-01 - Drug Profile 97 Product Description 97 Mechanism Of Action 97 R&D Progress 97 PRS Drug Profile 98 Product Description 98 Mechanism Of Action 98 R&D Progress 98 Recombinant Protein for Renal Anemia - Drug Profile 100 Product Description 100 Mechanism Of Action 100 R&D Progress 100 roxadustat - Drug Profile 101 Product Description 101 Mechanism Of Action 101 R&D Progress 101 sotatercept - Drug Profile 107 Product Description 107 Mechanism Of Action 107 R&D Progress 107 SSS-06 - Drug Profile 112 Product Description 112 Mechanism Of Action 112 R&D Progress 112 SSS-17 - Drug Profile 113 Product Description 113 Mechanism Of Action 113 R&D Progress 113 vadadustat - Drug Profile 114 Product Description 114 8

9 Mechanism Of Action 114 R&D Progress 114 Anemia in Chronic Kidney Disease (Renal Anemia) - Dormant Projects 121 Anemia in Chronic Kidney Disease (Renal Anemia) - Discontinued Products 122 Anemia in Chronic Kidney Disease (Renal Anemia) - Product Development Milestones 123 Featured News & Press Releases 123 Nov 24, 2016: GSK starts phase III programme with daprodustat for anemia associated with chronic kidney disease 123 Sep 26, 2016: Akebia Announces Publication Highlighting Potential Benefits of HIF Treatments for Patients with Renal Anemia 123 Sep 19, 2016: Akebia Announces Publication of Phase 2b Data for Vadadustat in Non-Dialysis Patients with Anemia Related to Chronic Kidney Disease 124 Aug 22, 2016: Akebia Announces Publication Highlighting Need for New Solutions in Treating Dialysis Patients 125 Aug 09, 2016: Kissei and JCR to Initiate a Phase III Clinical Trial of a Long-Acting Erythropoiesis- Stimulating Agent (Development Code: JR-131) 126 Aug 08, 2016: Akebia Initiates INNO2VATE Phase 3 Program for Vadadustat in Dialysis Patients With Anemia Related to Chronic Kidney Disease 126 Jul 25, 2016: Astellas And Fibrogen Announce First Patient Treated In Phase 3 Studies And Positive Phase 2 Results Of Roxadustat In Patients With Chronic Kidney Disease In Japan 126 Jun 09, 2016: Fibrogen Announces Initiation By Astellas Of Phase 3 Clinical Study In Japan Of Roxadustat/ASP1517 For The Treatment Of Anemia Of Chronic Kidney Disease Triggering $10.0 Million Milestone Payment 128 May 23, 2016: Akebia Announces Positive Vadadustat Data Demonstrating No Clinically Significant Drug-Drug Interaction 128 May 05, 2016: Akebia Provides Update On Phase 3 INNO2VATE Program For Vadadustat 129 Apr 26, 2016: Akebia Therapeutics Announces Presentation of Vadadustat Phase 2 Dialysis Data at Upcoming National Kidney Foundation 2016 Spring Clinical Meetings 130 Apr 08, 2016: Sandoz receives EC approval for subcutaneous route of administration in biosimilar Binocrit's nephrology indication 130 Mar 09, 2016: Akebia Prevails in European Patent Dispute and Preserves Access to Key Market for Vadadustat 131 Feb 16, 2016: FibroGen Publishes Encouraging Phase 2 Anemia Data Demonstrating Roxadustat s Ability to Maintain Hemoglobin Levels in Patients With Chronic Kidney Disease 131 Jan 04, 2016: Akebia Initiates Phase 3 PRO2TECT Program 133 Appendix 135 Methodology 135 Coverage 135 Secondary Research 135 Primary Research 135 Expert Panel Validation 135 Contact Us 135 Disclaimer 136 9

10 List Of Tables in Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline Review, H [Updated: ] List of Tables Number of Products under Development for Anemia in Chronic Kidney Disease (Renal Anemia), H Number of Products under Development by Companies, H Number of Products under Development by Companies, H (Contd..1) 14 Comparative Analysis by Late Stage Development, H Comparative Analysis by Clinical Stage Development, H Comparative Analysis by Early Stage Development, H Comparative Analysis by Unknown Stage Development, H Products under Development by Companies, H Products under Development by Companies, H (Contd..1) 20 Products under Development by Companies, H (Contd..2) 21 Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline by 3SBio Inc, H Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline by Acceleron Pharma Inc, H Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline by Aevi Genomic Medicine Inc, H Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline by Akebia Therapeutics Inc, H Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline by Amgen Inc, H Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline by Bayer AG, H Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline by Biocad, H Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline by CCM Duopharma Biotech Bhd, H Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline by Chong Kun Dang Pharmaceutical Corp, H Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline by CJ HealthCare Corp, H Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline by Daiichi Sankyo Company Ltd, H Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline by Dong-A Socio Holdings Co Ltd, H Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline by Dr. Reddy's Laboratories Ltd, H Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline by FibroGen Inc, H Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline by GlaxoSmithKline Plc, H Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline by Intas Pharmaceuticals Ltd, H Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline by Japan Tobacco Inc, H Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline by JCR Pharmaceuticals Co Ltd, H Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline by Jiangsu Hansoh Pharmaceutical Co Ltd, H Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline by LG Life Science LTD, H Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline by Myungmoon pharmaceutical Co Ltd, H Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline by Panacea Biotec Ltd, H Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline by Pfizer Inc, H

11 Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline by PharmaEssentia Corp, H Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline by PhytoHealth Corp, H Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline by Pieris Pharmaceuticals Inc, H Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline by Reliance Life Sciences Pvt Ltd, H Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline by Sandoz International GmbH, H Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline by Zydus Cadila Healthcare Ltd, H Assessment by Monotherapy Products, H Number of Products by Stage and Target, H Number of Products by Stage and Mechanism of Action, H Number of Products by Stage and Route of Administration, H Number of Products by Stage and Molecule Type, H Anemia in Chronic Kidney Disease (Renal Anemia) - Dormant Projects, H Anemia in Chronic Kidney Disease (Renal Anemia) - Discontinued Products, H

12 List Of Figures, Charts and Diagrams in Anemia in Chronic Kidney Disease (Renal Anemia) - Pipeline Review, H [Updated: ] List of Figures Number of Products under Development for Anemia in Chronic Kidney Disease (Renal Anemia), H Number of Products under Development by Companies, H Comparative Analysis by Late Stage Development, H Comparative Analysis by Clinical Stage Development, H Comparative Analysis by Early Stage Products, H Assessment by Monotherapy Products, H Number of Products by Targets, H Number of Products by Stage and Targets, H Number of Products by Mechanism of Actions, H Number of Products by Stage and Mechanism of Actions, H Number of Products by Routes of Administration, H Number of Products by Stage and Routes of Administration, H Number of Products by Molecule Types, H Number of Products by Stage and Molecule Types, H

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