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End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) '
Pipeline Review, H2 2012
Published on December 2012

                                                                                                                           Report Summary

End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) ' Pipeline Review, H2 2012


Summary


Global Markets Direct's, 'End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) - Pipeline Review, H2 2012', provides an
overview of the indication's therapeutic pipeline. This report provides information on the therapeutic development for End-Stage
Kidney Disease (End-Stage Renal Disease or ESRD), complete with latest updates, and special features on late-stage and
discontinued projects. It also reviews key players involved in the therapeutic development for End-Stage Kidney Disease (End-Stage
Renal Disease or ESRD). End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) - Pipeline Review, Half Year 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.


Note*: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated
disease.


Scope


- A snapshot of the global therapeutic scenario for End-Stage Kidney Disease (End-Stage Renal Disease or ESRD).
- A review of the End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) products under development by companies and
universities/research institutes based on information derived from company and industry-specific sources.
- Coverage of products based on various stages of development ranging from discovery till registration stages.
- A feature on pipeline projects on the basis of monotherapy and combined therapeutics.
- Coverage of the End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) pipeline on the basis of route of administration
and molecule type.
- Key discontinued pipeline projects.
- Latest news and deals relating to the products.


Reasons to buy


- Identify and understand important and diverse types of therapeutics under development for End-Stage Kidney Disease (End-Stage
Renal Disease or ESRD).
- Identify emerging players with potentially strong product portfolio and design effective counter-strategies to gain competitive
advantage.
- Plan mergers and acquisitions effectively by identifying players of the most promising pipeline.
- Devise corrective measures for pipeline projects by understanding End-Stage Kidney Disease (End-Stage Renal Disease or ESRD)
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.


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- Modify the therapeutic portfolio by identifying discontinued projects and understanding the factors that drove them from pipeline.




                                                                                                                            Table of Content

Table of Contents
Table of Contents 2
List of Tables 5
List of Figures 5
Introduction 6
Global Markets Direct Report Coverage 6
End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) Overview 7
Therapeutics Development 8
An Overview of Pipeline Products for End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) 8
End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) Therapeutics under Development by Companies 10
End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) Therapeutics under Investigation by Universities/Institutes 11
Late Stage Products 12
Comparative Analysis 12
Mid Clinical Stage Products 13
Comparative Analysis 13
Early Clinical Stage Products 14
Comparative Analysis 14
Pre-Clinical Stage Products 15
Comparative Analysis 15
End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) Therapeutics ' Products under Development by Companies 16
End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) Therapeutics ' Products under Investigation by Universities/Institutes
17
Companies Involved in End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) Therapeutics Development 18
Eli Lilly and Company 18
Isis Pharmaceuticals, Inc. 19
La Jolla Pharmaceutical Company 20
Hawthorn Pharmaceuticals, Inc. 21
Ardelyx, Inc. 22
End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) ' Therapeutics Assessment 23
Assessment by Monotherapy Products 23
Assessment by Combination Products 24
Assessment by Route of Administration 25
Assessment by Molecule Type 27
Drug Profiles 29
tabalumab - Drug Profile 29
Product Description 29
Mechanism of Action 29
R&D Progress 29
benazepril hydrochloride - Drug Profile 31
Product Description 31
Mechanism of Action 31
R&D Progress 31



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valsartan - Drug Profile 33
Product Description 33
Mechanism of Action 33
R&D Progress 33
Benazepril + Valsartan - Drug Profile 35
Product Description 35
Mechanism of Action 35
R&D Progress 35
Folate + Pyridoxine + Cyanocobalamin - Drug Profile 37
Product Description 37
Mechanism of Action 37
R&D Progress 37
Neo-Kidney Augment - Drug Profile 39
Product Description 39
Mechanism of Action 39
R&D Progress 39
haw Nuv-15 - Drug Profile 40
Product Description 40
Mechanism of Action 40
R&D Progress 40
haw Nuv16 - Drug Profile 41
Product Description 41
Mechanism of Action 41
R&D Progress 41
acetylcysteine - Drug Profile 42
Product Description 42
Mechanism of Action 42
R&D Progress 42
ISIS-CRPRx - Drug Profile 43
Product Description 43
Mechanism of Action 43
R&D Progress 43
LJPC-101 - Drug Profile 44
Product Description 44
Mechanism of Action 44
R&D Progress 44
spironolactone - Drug Profile 45
Product Description 45
Mechanism of Action 45
R&D Progress 45
RDX-013 - Drug Profile 46
Product Description 46
Mechanism of Action 46
R&D Progress 46
End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) Therapeutics ' Drug Profile Updates 47
End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) Therapeutics ' Discontinued Products 50
End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) Therapeutics - Dormant Products 51
End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) ' Product Development Milestones 52



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Featured News & Press Releases 52
Nov 05, 2012: Tengion Receives Notice Of Allowance For US Patent Application Covering Renal Regeneration For Neo-Kidney
Augment Product Candidate 52
Jul 31, 2012: La Jolla Pharma Announces FDA Agreement With Proposed Phase I Clinical Trial Of GCS-100 In Chronic Kidney
Disease 53
Jul 31, 2012: Rockwell Medical Completes Patient Enrollment In Phase III Clinical Trials For SFP Iron-Delivery In Hemodialysis
Patients 53
Jun 27, 2012: Rockwell Medical Receives Canadian Patent For SFP-Iron Delivery 53
Apr 30, 2012: Rockwell Medical Completes Patient Enrollment In PRIME Clinical Study 54
Mar 19, 2012: Rockwell Medical Data Safety Monitoring Board Recommends SFP Phase III Efficacy Studies To Continue as Planned
54
Dec 12, 2011: Rockwell Medical Data Safety Monitoring Board Recommends Phase III CRUISE Studies Continue As Planned 55
Nov 14, 2011: KAI Announces Results From Phase II study Of ONO-5163/KAI-4169, Calcium Sensing Receptor Agonist 55
Appendix 57
Methodology 57
Coverage 57
Secondary Research 57
Primary Research 57
Expert Panel Validation 57
Contact Us 58
Disclaimer 58




List of Tables


Number of Products Under Development for End-Stage Kidney Disease (End-Stage Renal Disease or ESRD), H2 2012 8
Products under Development for End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) ' Comparative Analysis, H2 2012 9
Number of Products under Development by Companies, H2 2012 10
Number of Products under Investigation by Universities/Institutes, H2 2012 11
Comparative Analysis by Late Stage Development, H2 2012 12
Comparative Analysis by Mid Clinical Stage Development, H2 2012 13
Comparative Analysis by Early Clinical Stage Development, H2 2012 14
Comparative Analysis by Pre-Clinical Stage Development, H2 2012 15
Products under Development by Companies, H2 2012 16
Products under Investigation by Universities/Institutes, H2 2012 17
Eli Lilly and Company, H2 2012 18
Isis Pharmaceuticals, Inc., H2 2012 19
La Jolla Pharmaceutical Company, H2 2012 20
Hawthorn Pharmaceuticals, Inc., H2 2012 21
Ardelyx, Inc., H2 2012 22
Assessment by Monotherapy Products, H2 2012 23
Assessment by Combination Products, H2 2012 24
Assessment by Stage and Route of Administration, H2 2012 26
Assessment by Stage and Molecule Type, H2 2012 28
End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) Therapeutics ' Drug Profile Updates 47
End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) Therapeutics ' Discontinued Products 50
End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) Therapeutics ' Dormant Products 51



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List of Figures


Number of Products under Development for End-Stage Kidney Disease (End-Stage Renal Disease or ESRD), H2 2012 8
Products under Development for End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) ' Comparative Analysis, H2 2012 9
Products under Development by Companies, H2 2012 10
Products under Investigation by Universities/Institutes, H2 2012 11
Late Stage Products, H2 2012 12
Mid Clinical Stage Products, H2 2012 13
Early Clinical Stage Products, H2 2012 14
Pre-Clinical Stage Products, H2 2012 15
Assessment by Monotherapy Products, H2 2012 23
Assessment by Combination Products, H2 2012 24
Assessment by Route of Administration, H2 2012 25
Assessment by Stage and Route of Administration, H2 2012 26
Assessment by Molecule Type, H2 2012 27
Assessment by Stage and Molecule Type, H2 2012 28




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End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) ' Pipeline Review, H2 2012

  • 1. Find Industry reports, Company profiles ReportLinker and Market Statistics >> Get this Report Now by email! End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) ' Pipeline Review, H2 2012 Published on December 2012 Report Summary End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) ' Pipeline Review, H2 2012 Summary Global Markets Direct's, 'End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) - Pipeline Review, H2 2012', provides an overview of the indication's therapeutic pipeline. This report provides information on the therapeutic development for End-Stage Kidney Disease (End-Stage Renal Disease or ESRD), complete with latest updates, and special features on late-stage and discontinued projects. It also reviews key players involved in the therapeutic development for End-Stage Kidney Disease (End-Stage Renal Disease or ESRD). End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) - Pipeline Review, Half Year 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. Note*: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease. Scope - A snapshot of the global therapeutic scenario for End-Stage Kidney Disease (End-Stage Renal Disease or ESRD). - A review of the End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) products under development by companies and universities/research institutes based on information derived from company and industry-specific sources. - Coverage of products based on various stages of development ranging from discovery till registration stages. - A feature on pipeline projects on the basis of monotherapy and combined therapeutics. - Coverage of the End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) pipeline on the basis of route of administration and molecule type. - Key discontinued pipeline projects. - Latest news and deals relating to the products. Reasons to buy - Identify and understand important and diverse types of therapeutics under development for End-Stage Kidney Disease (End-Stage Renal Disease or ESRD). - Identify emerging players with potentially strong product portfolio and design effective counter-strategies to gain competitive advantage. - Plan mergers and acquisitions effectively by identifying players of the most promising pipeline. - Devise corrective measures for pipeline projects by understanding End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) 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. End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) ' Pipeline Review, H2 2012 (From Slideshare) Page 1/7
  • 2. Find Industry reports, Company profiles ReportLinker and Market Statistics >> Get this Report Now by email! - Modify the therapeutic portfolio by identifying discontinued projects and understanding the factors that drove them from pipeline. Table of Content Table of Contents Table of Contents 2 List of Tables 5 List of Figures 5 Introduction 6 Global Markets Direct Report Coverage 6 End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) Overview 7 Therapeutics Development 8 An Overview of Pipeline Products for End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) 8 End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) Therapeutics under Development by Companies 10 End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) Therapeutics under Investigation by Universities/Institutes 11 Late Stage Products 12 Comparative Analysis 12 Mid Clinical Stage Products 13 Comparative Analysis 13 Early Clinical Stage Products 14 Comparative Analysis 14 Pre-Clinical Stage Products 15 Comparative Analysis 15 End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) Therapeutics ' Products under Development by Companies 16 End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) Therapeutics ' Products under Investigation by Universities/Institutes 17 Companies Involved in End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) Therapeutics Development 18 Eli Lilly and Company 18 Isis Pharmaceuticals, Inc. 19 La Jolla Pharmaceutical Company 20 Hawthorn Pharmaceuticals, Inc. 21 Ardelyx, Inc. 22 End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) ' Therapeutics Assessment 23 Assessment by Monotherapy Products 23 Assessment by Combination Products 24 Assessment by Route of Administration 25 Assessment by Molecule Type 27 Drug Profiles 29 tabalumab - Drug Profile 29 Product Description 29 Mechanism of Action 29 R&D Progress 29 benazepril hydrochloride - Drug Profile 31 Product Description 31 Mechanism of Action 31 R&D Progress 31 End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) ' Pipeline Review, H2 2012 (From Slideshare) Page 2/7
  • 3. Find Industry reports, Company profiles ReportLinker and Market Statistics >> Get this Report Now by email! valsartan - Drug Profile 33 Product Description 33 Mechanism of Action 33 R&D Progress 33 Benazepril + Valsartan - Drug Profile 35 Product Description 35 Mechanism of Action 35 R&D Progress 35 Folate + Pyridoxine + Cyanocobalamin - Drug Profile 37 Product Description 37 Mechanism of Action 37 R&D Progress 37 Neo-Kidney Augment - Drug Profile 39 Product Description 39 Mechanism of Action 39 R&D Progress 39 haw Nuv-15 - Drug Profile 40 Product Description 40 Mechanism of Action 40 R&D Progress 40 haw Nuv16 - Drug Profile 41 Product Description 41 Mechanism of Action 41 R&D Progress 41 acetylcysteine - Drug Profile 42 Product Description 42 Mechanism of Action 42 R&D Progress 42 ISIS-CRPRx - Drug Profile 43 Product Description 43 Mechanism of Action 43 R&D Progress 43 LJPC-101 - Drug Profile 44 Product Description 44 Mechanism of Action 44 R&D Progress 44 spironolactone - Drug Profile 45 Product Description 45 Mechanism of Action 45 R&D Progress 45 RDX-013 - Drug Profile 46 Product Description 46 Mechanism of Action 46 R&D Progress 46 End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) Therapeutics ' Drug Profile Updates 47 End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) Therapeutics ' Discontinued Products 50 End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) Therapeutics - Dormant Products 51 End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) ' Product Development Milestones 52 End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) ' Pipeline Review, H2 2012 (From Slideshare) Page 3/7
  • 4. Find Industry reports, Company profiles ReportLinker and Market Statistics >> Get this Report Now by email! Featured News & Press Releases 52 Nov 05, 2012: Tengion Receives Notice Of Allowance For US Patent Application Covering Renal Regeneration For Neo-Kidney Augment Product Candidate 52 Jul 31, 2012: La Jolla Pharma Announces FDA Agreement With Proposed Phase I Clinical Trial Of GCS-100 In Chronic Kidney Disease 53 Jul 31, 2012: Rockwell Medical Completes Patient Enrollment In Phase III Clinical Trials For SFP Iron-Delivery In Hemodialysis Patients 53 Jun 27, 2012: Rockwell Medical Receives Canadian Patent For SFP-Iron Delivery 53 Apr 30, 2012: Rockwell Medical Completes Patient Enrollment In PRIME Clinical Study 54 Mar 19, 2012: Rockwell Medical Data Safety Monitoring Board Recommends SFP Phase III Efficacy Studies To Continue as Planned 54 Dec 12, 2011: Rockwell Medical Data Safety Monitoring Board Recommends Phase III CRUISE Studies Continue As Planned 55 Nov 14, 2011: KAI Announces Results From Phase II study Of ONO-5163/KAI-4169, Calcium Sensing Receptor Agonist 55 Appendix 57 Methodology 57 Coverage 57 Secondary Research 57 Primary Research 57 Expert Panel Validation 57 Contact Us 58 Disclaimer 58 List of Tables Number of Products Under Development for End-Stage Kidney Disease (End-Stage Renal Disease or ESRD), H2 2012 8 Products under Development for End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) ' Comparative Analysis, H2 2012 9 Number of Products under Development by Companies, H2 2012 10 Number of Products under Investigation by Universities/Institutes, H2 2012 11 Comparative Analysis by Late Stage Development, H2 2012 12 Comparative Analysis by Mid Clinical Stage Development, H2 2012 13 Comparative Analysis by Early Clinical Stage Development, H2 2012 14 Comparative Analysis by Pre-Clinical Stage Development, H2 2012 15 Products under Development by Companies, H2 2012 16 Products under Investigation by Universities/Institutes, H2 2012 17 Eli Lilly and Company, H2 2012 18 Isis Pharmaceuticals, Inc., H2 2012 19 La Jolla Pharmaceutical Company, H2 2012 20 Hawthorn Pharmaceuticals, Inc., H2 2012 21 Ardelyx, Inc., H2 2012 22 Assessment by Monotherapy Products, H2 2012 23 Assessment by Combination Products, H2 2012 24 Assessment by Stage and Route of Administration, H2 2012 26 Assessment by Stage and Molecule Type, H2 2012 28 End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) Therapeutics ' Drug Profile Updates 47 End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) Therapeutics ' Discontinued Products 50 End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) Therapeutics ' Dormant Products 51 End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) ' Pipeline Review, H2 2012 (From Slideshare) Page 4/7
  • 5. Find Industry reports, Company profiles ReportLinker and Market Statistics >> Get this Report Now by email! List of Figures Number of Products under Development for End-Stage Kidney Disease (End-Stage Renal Disease or ESRD), H2 2012 8 Products under Development for End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) ' Comparative Analysis, H2 2012 9 Products under Development by Companies, H2 2012 10 Products under Investigation by Universities/Institutes, H2 2012 11 Late Stage Products, H2 2012 12 Mid Clinical Stage Products, H2 2012 13 Early Clinical Stage Products, H2 2012 14 Pre-Clinical Stage Products, H2 2012 15 Assessment by Monotherapy Products, H2 2012 23 Assessment by Combination Products, H2 2012 24 Assessment by Route of Administration, H2 2012 25 Assessment by Stage and Route of Administration, H2 2012 26 Assessment by Molecule Type, H2 2012 27 Assessment by Stage and Molecule Type, H2 2012 28 End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) ' Pipeline Review, H2 2012 (From Slideshare) Page 5/7
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