Lupus Nephritis - Pipeline Review, H2 2016

Global Markets Direct’s, ‘Lupus Nephritis - Pipeline Review, H2 2016’, provides an overview of the Lupus Nephritis pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Lupus Nephritis, 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 Lupus Nephritis 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 Lupus Nephritis

The report reviews pipeline therapeutics for Lupus Nephritis 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 Lupus Nephritis therapeutics and enlists all their major and minor projects

The report assesses Lupus Nephritis 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 Lupus Nephritis

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 Lupus Nephritis

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 Lupus Nephritis 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

AbbVie Inc

Asahi Kasei Pharma Corp.

Astellas Pharma Inc.

Aurinia Pharmaceuticals Inc

Azano Pharmaceuticals Inc.

Boehringer Ingelheim GmbH

Bristol-Myers Squibb Company

Deltanoid Pharmaceuticals Inc.

F. ...

AbbVie Inc

Asahi Kasei Pharma Corp.

Astellas Pharma Inc.

Aurinia Pharmaceuticals Inc

Azano Pharmaceuticals Inc.

Boehringer Ingelheim GmbH

Bristol-Myers Squibb Company

Deltanoid Pharmaceuticals Inc.

F. Hoffmann-La Roche Ltd.

GlaxoSmithKline Plc

HanAll Biopharma Co., Ltd.

Invion Limited

KPI Therapeutics, Inc.

MedImmune, LLC

Omeros Corporation

Ra Pharmaceuticals, Inc.

Resolve Therapeutics, LLC

Takeda Pharmaceutical Company Limited

TxCell SA

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 6

List of Figures 7

Introduction 8

Global Markets Direct Report Coverage 8

Lupus Nephritis ...

Table of Contents

Table of Contents 2

List of Tables 6

List of Figures 7

Introduction 8

Global Markets Direct Report Coverage 8

Lupus Nephritis Overview 9

Therapeutics Development 10

Pipeline Products for Lupus Nephritis - Overview 10

Pipeline Products for Lupus Nephritis - Comparative Analysis 11

Lupus Nephritis - Therapeutics under Development by Companies 12

Lupus Nephritis - Therapeutics under Investigation by Universities/Institutes 14

Lupus Nephritis - Pipeline Products Glance 15

Late Stage Products 15

Clinical Stage Products 16

Early Stage Products 17

Lupus Nephritis - Products under Development by Companies 18

Lupus Nephritis - Products under Investigation by Universities/Institutes 20

Lupus Nephritis - Companies Involved in Therapeutics Development 21

AbbVie Inc 21

Asahi Kasei Pharma Corp. 22

Astellas Pharma Inc. 23

Aurinia Pharmaceuticals Inc 24

Azano Pharmaceuticals Inc. 25

Boehringer Ingelheim GmbH 26

Bristol-Myers Squibb Company 27

Deltanoid Pharmaceuticals Inc. 28

F. Hoffmann-La Roche Ltd. 29

GlaxoSmithKline Plc 30

HanAll Biopharma Co., Ltd. 31

Invion Limited 32

KPI Therapeutics, Inc. 33

MedImmune, LLC 34

Omeros Corporation 35

Ra Pharmaceuticals, Inc. 36

Resolve Therapeutics, LLC 37

Takeda Pharmaceutical Company Limited 38

TxCell SA 39

Lupus Nephritis - Therapeutics Assessment 40

Assessment by Monotherapy Products 40

Assessment by Target 41

Assessment by Mechanism of Action 43

Assessment by Route of Administration 45

Assessment by Molecule Type 47

Drug Profiles 49

abatacept - Drug Profile 49

Product Description 49

Mechanism Of Action 49

R&D Progress 49

anifrolumab - Drug Profile 54

Product Description 54

Mechanism Of Action 54

R&D Progress 54

belimumab - Drug Profile 56

Product Description 56

Mechanism Of Action 56

R&D Progress 56

BI-655064 - Drug Profile 62

Product Description 62

Mechanism Of Action 62

R&D Progress 62

BMS-986147 - Drug Profile 64

Product Description 64

Mechanism Of Action 64

R&D Progress 64

dalazatide - Drug Profile 65

Product Description 65

Mechanism Of Action 65

R&D Progress 65

DP-001 - Drug Profile 69

Product Description 69

Mechanism Of Action 69

R&D Progress 69

Drug to Antagonize Bradykinin Receptor B1 for Lupus Nephritis - Drug Profile 70

Product Description 70

Mechanism Of Action 70

R&D Progress 70

ENTX-DN - Drug Profile 71

Product Description 71

Mechanism Of Action 71

R&D Progress 71

HL-161 - Drug Profile 72

Product Description 72

Mechanism Of Action 72

R&D Progress 72

INV-103 - Drug Profile 73

Product Description 73

Mechanism Of Action 73

R&D Progress 73

ixazomib citrate - Drug Profile 76

Product Description 76

Mechanism Of Action 76

R&D Progress 76

mizoribine - Drug Profile 85

Product Description 85

Mechanism Of Action 85

R&D Progress 85

Monoclonal Antibody for Lupus Nephritis - Drug Profile 86

Product Description 86

Mechanism Of Action 86

R&D Progress 86

obinutuzumab - Drug Profile 87

Product Description 87

Mechanism Of Action 87

R&D Progress 87

OMS-721 - Drug Profile 94

Product Description 94

Mechanism Of Action 94

R&D Progress 94

P-Dex - Drug Profile 99

Product Description 99

Mechanism Of Action 99

R&D Progress 99

RA-101495 - Drug Profile 100

Product Description 100

Mechanism Of Action 100

R&D Progress 100

RO-5461111 - Drug Profile 102

Product Description 102

Mechanism Of Action 102

R&D Progress 102

RSLV-145 - Drug Profile 103

Product Description 103

Mechanism Of Action 103

R&D Progress 103

Stem Cell Therapy for Autoimmune Diseases - Drug Profile 104

Product Description 104

Mechanism Of Action 104

R&D Progress 104

Synthetic Peptide to Inhibit Complement C5 for Paroxysmal Nocturnal Hemoglobinuria, Atypical Hemolytic Uremic Syndrome and Autoimmune Disorders - Drug Profile 106

Product Description 106

Mechanism Of Action 106

R&D Progress 106

venetoclax - Drug Profile 107

Product Description 107

Mechanism Of Action 107

R&D Progress 107

voclosporin - Drug Profile 116

Product Description 116

Mechanism Of Action 116

R&D Progress 116

Y-175L - Drug Profile 123

Product Description 123

Mechanism Of Action 123

R&D Progress 123

Lupus Nephritis - Dormant Projects 124

Lupus Nephritis - Discontinued Products 126

Lupus Nephritis - Product Development Milestones 127

Featured News & Press Releases 127

Aug 15, 2016: Aurinia Pharmaceuticals Announces Voclosporin Meets Primary Endpoint in Phase IIB AURA-LV Study in Lupus Nephritis 127

Jun 28, 2016: Aurinia Announces 24 Week Remission Rates from the First Seven Patients in its Open Label AURION Study in Lupus Nephritis (LN) 129

Jun 10, 2016: Alliance for Children Therapeutics Presents Dalazatide Data Demonstrating Positive Response in Lupus 130

May 23, 2016: KPI Therapeutics to Present Updated Dalazatide Study Data in Lupus 131

May 12, 2016: Aurinia Announces Presentations at the European Renal Association - European Dialysis and Transplant Association Meeting 131

May 09, 2016: Aurinia Initiates First Clinical Study of Voclosporin for Japan 132

Apr 20, 2016: Patient Dosing Initiated for OMS721 Phase 2 Program in Renal Diseases 133

Mar 29, 2016: Aurinia Announces Result from Data and Safety Monitoring Board for Its Phase 2b Study in Lupus Nephritis - Study to Continue as Planned 134

Mar 02, 2016: Aurina Receives FDA Fast Track Designation for Voclosporin for the Treatment of Lupus Nephritis 135

Feb 08, 2016: Aurinia Announces Preliminary Topline Data From its Open Label Aurion Study in Lupus Nephritis 135

Feb 02, 2016: Deltanoid Pharmaceuticals Announces Appointment of Douglas Jermasek as Chief Executive Officer 136

Jan 19, 2016: Aurinia Announces Completion of Patient Enrollment in Its Phase 2B AURA-LV Study in Lupus Nephritis 137

Dec 03, 2015: Ocata’s Hemangio-derived Mesenchymal Cells Preserve Kidney Function and Extend Lifespan in Preclinical Model of Lupus Nephritis 138

Nov 24, 2015: Aurinia Pharmaceuticals Announces Outcome from Data and Safety Monitoring Board for Its Phase 2b Study in Lupus Nephritis - Study to Continue as Planned 139

Nov 10, 2015: Kineta, Seattle Children’s Research Institute Present New Data Demonstrating Positive, Predictive Responses to Dalazatide In Lupus 139

Appendix 141

Methodology 141

Coverage 141

Secondary Research 141

Primary Research 141

Expert Panel Validation 141

Contact Us 141

Disclaimer 142

List of Tables

List of Tables

Number of Products under Development for Lupus Nephritis, H2 2016 10

Number of Products under Development for Lupus Nephritis - Comparative Analysis, ...

List of Tables

Number of Products under Development for Lupus Nephritis, H2 2016 10

Number of Products under Development for Lupus Nephritis - Comparative Analysis, H2 2016 11

Number of Products under Development by Companies, H2 2016 13

Number of Products under Investigation by Universities/Institutes, H2 2016 14

Comparative Analysis by Late Stage Development, H2 2016 15

Comparative Analysis by Clinical Stage Development, H2 2016 16

Comparative Analysis by Early Stage Development, H2 2016 17

Products under Development by Companies, H2 2016 18

Products under Development by Companies, H2 2016 (Contd..1) 19

Products under Investigation by Universities/Institutes, H2 2016 20

Lupus Nephritis - Pipeline by AbbVie Inc, H2 2016 21

Lupus Nephritis - Pipeline by Asahi Kasei Pharma Corp., H2 2016 22

Lupus Nephritis - Pipeline by Astellas Pharma Inc., H2 2016 23

Lupus Nephritis - Pipeline by Aurinia Pharmaceuticals Inc, H2 2016 24

Lupus Nephritis - Pipeline by Azano Pharmaceuticals Inc., H2 2016 25

Lupus Nephritis - Pipeline by Boehringer Ingelheim GmbH, H2 2016 26

Lupus Nephritis - Pipeline by Bristol-Myers Squibb Company, H2 2016 27

Lupus Nephritis - Pipeline by Deltanoid Pharmaceuticals Inc., H2 2016 28

Lupus Nephritis - Pipeline by F. Hoffmann-La Roche Ltd., H2 2016 29

Lupus Nephritis - Pipeline by GlaxoSmithKline Plc, H2 2016 30

Lupus Nephritis - Pipeline by HanAll Biopharma Co., Ltd., H2 2016 31

Lupus Nephritis - Pipeline by Invion Limited, H2 2016 32

Lupus Nephritis - Pipeline by KPI Therapeutics, Inc., H2 2016 33

Lupus Nephritis - Pipeline by MedImmune, LLC, H2 2016 34

Lupus Nephritis - Pipeline by Omeros Corporation, H2 2016 35

Lupus Nephritis - Pipeline by Ra Pharmaceuticals, Inc., H2 2016 36

Lupus Nephritis - Pipeline by Resolve Therapeutics, LLC, H2 2016 37

Lupus Nephritis - Pipeline by Takeda Pharmaceutical Company Limited, H2 2016 38

Lupus Nephritis - Pipeline by TxCell SA, H2 2016 39

Assessment by Monotherapy Products, H2 2016 40

Number of Products by Stage and Target, H2 2016 42

Number of Products by Stage and Mechanism of Action, H2 2016 44

Number of Products by Stage and Route of Administration, H2 2016 46

Number of Products by Stage and Molecule Type, H2 2016 48

Lupus Nephritis - Dormant Projects, H2 2016 124

Lupus Nephritis - Dormant Projects (Contd..1), H2 2016 125

Lupus Nephritis - Discontinued Products, H2 2016 126

List of Figures

List of Figures

Number of Products under Development for Lupus Nephritis, H2 2016 10

Number of Products under Development for Lupus Nephritis - Comparative Analysis, ...

List of Figures

Number of Products under Development for Lupus Nephritis, H2 2016 10

Number of Products under Development for Lupus Nephritis - Comparative Analysis, H2 2016 11

Number of Products under Development by Companies, H2 2016 12

Number of Products under Investigation by Universities/Institutes, H2 2016 14

Comparative Analysis by Clinical Stage Development, H2 2016 16

Comparative Analysis by Early Stage Products, H2 2016 17

Assessment by Monotherapy Products, H2 2016 40

Number of Products by Top 10 Targets, H2 2016 41

Number of Products by Stage and Top 10 Targets, H2 2016 41

Number of Products by Top 10 Mechanism of Actions, H2 2016 43

Number of Products by Stage and Top 10 Mechanism of Actions, H2 2016 43

Number of Products by Routes of Administration, H2 2016 45

Number of Products by Stage and Routes of Administration, H2 2016 45

Number of Products by Molecule Types, H2 2016 47

Number of Products by Stage and Molecule Types, H2 2016 47

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