Celiac Disease – Pipeline Review, H2 2016

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

The report provides comprehensive information on the therapeutics under development for Celiac 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 Celiac 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 Celiac Disease

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

The report assesses Celiac 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 Celiac 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 Celiac 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 Celiac 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

Amgen Inc.

Amyra Biotech AG

Avaxia Biologics, Inc.

Calypso Biotech SA

enGene, Inc

F. Hoffmann-La Roche Ltd.

Glenmark Pharmaceuticals Ltd.

ImmusanT, Inc.

Innovate Biopharmaceuticals, Inc.

Intrexon Corporation

Sanofi

Zedira GmbH

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

Celiac Disease Overview 9

Therapeutics Development 10

Pipeline Products for Celiac Disease - Overview 10

Pipeline Products for Celiac Disease - Comparative Analysis 11

Celiac Disease - Therapeutics under Development by Companies 12

Celiac Disease - Therapeutics under Investigation by Universities/Institutes 14

Celiac Disease - Pipeline Products Glance 15

Clinical Stage Products 15

Early Stage Products 16

Celiac Disease - Products under Development by Companies 17

Celiac Disease - Products under Investigation by Universities/Institutes 18

Celiac Disease - Companies Involved in Therapeutics Development 19

Amgen Inc. 19

Amyra Biotech AG 20

Avaxia Biologics, Inc. 21

Calypso Biotech SA 22

enGene, Inc 23

F. Hoffmann-La Roche Ltd. 24

Glenmark Pharmaceuticals Ltd. 25

ImmusanT, Inc. 26

Innovate Biopharmaceuticals, Inc. 27

Intrexon Corporation 28

Sanofi 29

Zedira GmbH 30

Celiac Disease - Therapeutics Assessment 31

Assessment by Monotherapy 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

AMG-714 - Drug Profile 40

Product Description 40

Mechanism Of Action 40

R&D Progress 40

AVX-176 - Drug Profile 42

Product Description 42

Mechanism Of Action 42

R&D Progress 42

Biologic for Celiac Disease - Drug Profile 43

Product Description 43

Mechanism Of Action 43

R&D Progress 43

BNZ-2 - Drug Profile 44

Product Description 44

Mechanism Of Action 44

R&D Progress 44

CALY-002 - Drug Profile 45

Product Description 45

Mechanism Of Action 45

R&D Progress 45

ERW-1041E - Drug Profile 46

Product Description 46

Mechanism Of Action 46

R&D Progress 46

GBR-830 - Drug Profile 47

Product Description 47

Mechanism Of Action 47

R&D Progress 47

larazotide acetate - Drug Profile 48

Product Description 48

Mechanism Of Action 48

R&D Progress 48

latiglutenase - Drug Profile 50

Product Description 50

Mechanism Of Action 50

R&D Progress 50

Monoclonal Antibody to Antagonize IL-2R Beta for Celiac Disease, Central Nervous System and Oncology - Drug Profile 53

Product Description 53

Mechanism Of Action 53

R&D Progress 53

Nexvax-2 - Drug Profile 54

Product Description 54

Mechanism Of Action 54

R&D Progress 54

Nexvax-3 - Drug Profile 57

Product Description 57

Mechanism Of Action 57

R&D Progress 57

Oligonucleotides for Celiac Disease - Drug Profile 58

Product Description 58

Mechanism Of Action 58

R&D Progress 58

Protein for Celiac Disease - Drug Profile 59

Product Description 59

Mechanism Of Action 59

R&D Progress 59

Recombinant Enzymes for Celiac Disease - Drug Profile 60

Product Description 60

Mechanism Of Action 60

R&D Progress 60

Recombinant Protein for Celiac Disease and Type-1 Diabetes - Drug Profile 61

Product Description 61

Mechanism Of Action 61

R&D Progress 61

RG-7625 - Drug Profile 62

Product Description 62

Mechanism Of Action 62

R&D Progress 62

Synthetic Peptides to Inhibit DQ2/DQ8 for Celiac Disease and Type 1 Diabetes - Drug Profile 63

Product Description 63

Mechanism Of Action 63

R&D Progress 63

Vaccine for Celiac Disease - Drug Profile 64

Product Description 64

Mechanism Of Action 64

R&D Progress 64

Vaccine for Celiac Disease - Drug Profile 65

Product Description 65

Mechanism Of Action 65

R&D Progress 65

ZED-1227 - Drug Profile 66

Product Description 66

Mechanism Of Action 66

R&D Progress 66

ZED-754 - Drug Profile 67

Product Description 67

Mechanism Of Action 67

R&D Progress 67

Celiac Disease - Dormant Projects 68

Celiac Disease - Product Development Milestones 69

Featured News & Press Releases 69

May 24, 2016: ImmusanT Reports Nexvax2 Phase 1 Data in Patients with Celiac Disease 69

May 19, 2016: ImmusanT Announces Presentations at Digestive Disease Week 2016 70

May 05, 2016: Celimmune Commences First-Ever Dosing with AMG 714 in Celiac Disease 71

Mar 31, 2016: Celimmune Commences Screening in Phase 2 Clinical Study in Refractory Celiac Disease Type II 72

Sep 23, 2015: Celimmune to Present Overview of Non-Dietary Celiac Disease Therapies in Development at Annual Celiac Support Association Meeting 73

Sep 03, 2015: Glenmark's Novel Monoclonal Antibody GBR 830 to Enter Phase 2 Clinical Studies in Atopic Dermatitis and Celiac Disease in US and Europe 73

Jun 22, 2015: Celimmune to Present Experimental Anti3IL315 Antibody AMG!714 at 16th International Coeliac Disease Symposium 74

Jun 22, 2015: Cour Pharmaceuticals Releases Data on Potential Breakthrough Treatment for Celiac Disease 74

Nov 19, 2014: ImmusanT’s Immunotherapy for Celiac Disease, Nexvax2, Selected as One of Informa’s Top 10 Autoimmune/Anti-Inflammatory Projects to Watch 75

Jun 12, 2014: Potential New Treatment May Protect Celiac Patients from Gluten-Induced Injury 76

Feb 11, 2014: Alba Therapeutics Announces Positive Results of Phase IIb Trial in Celiac Disease 76

Oct 29, 2013: Alvine Pharmaceuticals Doses First Patient in Phase 2b Trial for ALV003 in Celiac Disease 77

Aug 06, 2013: ImmusanT Initiates Study at Joslin Diabetes Center to Investigate Relationship Between Celiac Disease and Type 1 Diabetes 78

Apr 19, 2013: ImmusanT’s Epitope-specific Immunotherapy For Celiac Disease Informs Potential Of Vaccines Against Other Autoimmune Diseases 78

Sep 05, 2012: Alvine Pharma's ALV003 Receives Fast Track Designation From FDA For Treatment Of Celiac Disease 79

Appendix 81

Methodology 81

Coverage 81

Secondary Research 81

Primary Research 81

Expert Panel Validation 81

Contact Us 81

Disclaimer 82

List of Tables

List of Tables

Number of Products under Development for Celiac Disease, H2 2016 10

Number of Products under Development for Celiac Disease – 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 Clinical Stage Development, H2 2016 15

Comparative Analysis by Early Stage Development, H2 2016 16

Products under Development by Companies, H2 2016 17

Products under Investigation by Universities/Institutes, H2 2016 18

Celiac Disease – Pipeline by Amgen Inc., H2 2016 19

Celiac Disease – Pipeline by Amyra Biotech AG, H2 2016 20

Celiac Disease – Pipeline by Avaxia Biologics, Inc., H2 2016 21

Celiac Disease – Pipeline by Calypso Biotech SA, H2 2016 22

Celiac Disease – Pipeline by enGene, Inc, H2 2016 23

Celiac Disease – Pipeline by F. Hoffmann-La Roche Ltd., H2 2016 24

Celiac Disease – Pipeline by Glenmark Pharmaceuticals Ltd., H2 2016 25

Celiac Disease – Pipeline by ImmusanT, Inc., H2 2016 26

Celiac Disease – Pipeline by Innovate Biopharmaceuticals, Inc., H2 2016 27

Celiac Disease – Pipeline by Intrexon Corporation, H2 2016 28

Celiac Disease – Pipeline by Sanofi, H2 2016 29

Celiac Disease – Pipeline by Zedira GmbH, H2 2016 30

Assessment by Monotherapy 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

Celiac Disease – Dormant Projects, H2 2016 68

List of Figures

List of Figures

Number of Products under Development for Celiac Disease, H2 2016 10

Number of Products under Development for Celiac Disease – Comparative Analysis, H2 2016 11

Number of Products under Development by Companies, H2 2016 12

Comparative Analysis by Clinical Stage Development, H2 2016 15

Comparative Analysis by Early Stage Products, H2 2016 16

Assessment by Monotherapy Products, H2 2016 31

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 Top 10 Molecule Types, H2 2016 38

Number of Products by Stage and Top 10 Molecule Types, H2 2016 38

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