Table of Contents
Table of Contents 2
List of Tables 5
List of Figures 6
Introduction 7
Global Markets Direct Report Coverage 7
Renal Anemia Overview 8
Therapeutics Development 9
An Overview of Pipeline Products for Renal Anemia 9
Renal Anemia Therapeutics under Development by Companies 11
Late Stage Products 13
Comparative Analysis 13
Mid Clinical Stage Products 14
Comparative Analysis 14
Early Clinical Stage Products 15
Comparative Analysis 15
Pre-Clinical Stage Products 16
Comparative Analysis 16
Renal Anemia Therapeutics – Products under Development by Companies 17
Companies Involved in Renal Anemia Therapeutics Development 18
Hospira, Inc. 18
Kyowa Hakko Kirin Co., Ltd. 19
Medgenics Inc. 20
FibroGen, Inc. 21
Dong-A Pharmaceutical Co., Ltd. 22
Zydus Cadila Healthcare Limited 23
Bayer AG 24
3SBio Inc. 25
Panacea Biotec Limited 26
Affymax, Inc. 27
Acceleron Pharma, Inc. 28
Akebia Therapeutics, Inc. 29
Renal Anemia – Therapeutics Assessment 30
Assessment by Monotherapy Products 30
Assessment by Route of Administration 31
Assessment by Molecule Type 33
Drug Profiles 35
FG-2216 - Drug Profile 35
Product Description 35
Mechanism of Action 35
R&D Progress 35
FG-4592 - Drug Profile 36
Product Description 36
Mechanism of Action 36
R&D Progress 36
Peginesatide - Drug Profile 38
Product Description 38
Mechanism of Action 38
R&D Progress 38
Sotatercept - Drug Profile 40
Product Description 40
Mechanism of Action 40
R&D Progress 40
NuPIAO - Drug Profile 42
Product Description 42
Mechanism of Action 42
R&D Progress 42
EPODURE - Drug Profile 43
Product Description 43
Mechanism of Action 43
R&D Progress 43
AKB-6548 - Drug Profile 45
Product Description 45
Mechanism of Action 45
R&D Progress 45
Feraheme - Drug Profile 47
Product Description 47
Mechanism of Action 47
R&D Progress 47
KRN321 - Drug Profile 48
Product Description 48
Mechanism of Action 48
R&D Progress 48
KRN321 - Drug Profile 49
Product Description 49
Mechanism of Action 49
R&D Progress 49
PEG-EPO - Drug Profile 50
Product Description 50
Mechanism of Action 50
R&D Progress 50
Biosimilar Erythropoietin - Drug Profile 51
Product Description 51
Mechanism of Action 51
R&D Progress 51
BAY85-3934 - Drug Profile 53
Product Description 53
Mechanism of Action 53
R&D Progress 53
DA-3880 - Drug Profile 54
Product Description 54
Mechanism of Action 54
R&D Progress 54
AP032 - Drug Profile 55
Product Description 55
Mechanism of Action 55
R&D Progress 55
Renal Anemia Therapeutics – Drug Profile Updates 56
Renal Anemia Therapeutics – Discontinued Products 68
Renal Anemia Therapeutics - Dormant Products 69
Renal Anemia – Product Development Milestones 70
Featured News & Press Releases 70
Feb 13, 2012: Xenetic Commences Phase I/IIa IV Trial For ErepoXen 70
Jan 09, 2012: Hospira Initiates US Phase III Biosimilar Erythropoietin Clinical Program 71
Nov 15, 2011: Akebia Therapeutics Announces Presentation Of Clinical Data At Kidney Week 2011 71
Nov 15, 2011: Medgenics Presents Expanded Results Of Phase I/II Study Of EPODURE Biopump For Treatment Of Anemia At ASN Kidney Week 2011 72
Nov 15, 2011: FibroGen Reports Dose-finding Data From Phase IIb Study Of FG-4592 For Anemia Correction And Maintenance In Chronic Kidney Disease Patients 73
Nov 11, 2011: Affymax And Takeda Report Additional Analyses Of Peginesatide Phase III Studies In Dialysis Patients At ASN Kidney Week 2011 74
Oct 24, 2011: Affymax Announces FDA Advisory Committee To Review Peginesatide 77
Oct 10, 2011: Affymax And Takeda To Present Peginesatide Data At American Society of Nephrology Kidney Week 2011 77
Sep 06, 2011: Hospira Announces Positive Results From Phase I US Clinical Trial Of Biosimilar Erythropoietin In Renal Patients 78
Aug 11, 2011: Affymax Announces Assignment Of PDUFA Date For Peginesatide New Drug Application 79
Appendix 80
Methodology 80
Coverage 80
Secondary Research 80
Primary Research 80
Expert Panel Validation 80
Contact Us 81
Disclaimer 81
List of Tables
Number of Products Under Development for Renal Anemia, H1 2012 9
Products under Development for Renal Anemia – Comparative Analysis, H1 2012 10
Number of Products under Development by Companies, H1 2012 12
Comparative Analysis by Late Stage Development, H1 2012 13
Comparative Analysis by Mid Clinical Stage Development, H1 2012 14
Comparative Analysis by Early Clinical Stage Development, H1 2012 15
Comparative Analysis by Pre-Clinical Stage Development, H1 2012 16
Products under Development by Companies, H1 2012 17
Hospira, Inc., H1 2012 18
Kyowa Hakko Kirin Co., Ltd., H1 2012 19
Medgenics Inc., H1 2012 20
FibroGen, Inc., H1 2012 21
Dong-A Pharmaceutical Co., Ltd., H1 2012 22
Zydus Cadila Healthcare Limited, H1 2012 23
Bayer AG, H1 2012 24
3SBio Inc., H1 2012 25
Panacea Biotec Limited, H1 2012 26
Affymax, Inc., H1 2012 27
Acceleron Pharma, Inc., H1 2012 28
Akebia Therapeutics, Inc., H1 2012 29
Assessment by Monotherapy Products, H1 2012 30
Assessment by Stage and Route of Administration, H1 2012 32
Assessment by Stage and Molecule Type, H1 2012 34
Renal Anemia Therapeutics – Drug Profile Updates 56
Renal Anemia Therapeutics – Discontinued Products 68
Renal Anemia Therapeutics – Dormant Products 69
List of Figures
Number of Products under Development for Renal Anemia, H1 2012 9
Products under Development for Renal Anemia – Comparative Analysis, H1 2012 10
Products under Development by Companies, H1 2012 11
Late Stage Products, H1 2012 13
Mid Clinical Stage Products, H1 2012 14
Early Clinical Stage Products, H1 2012 15
Pre-Clinical Stage Products, H1 2012 16
Assessment by Monotherapy Products, H1 2012 30
Assessment by Route of Administration, H1 2012 31
Assessment by Stage and Route of Administration, H1 2012 32
Assessment by Molecule Type, H1 2012 33
Assessment by Stage and Molecule Type, H1 2012 34