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Alpha- Antitrypsin Deficiency-Pipeline Review, H1 2015

Alpha- Antitrypsin Deficiency-Pipeline Review, H1 2015


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Executive Summary

Alpha- Antitrypsin Deficiency-Pipeline Review, H1 2015

Summary

Global Markets Direct's, 'Alpha- Antitrypsin Deficiency-Pipeline Review, H1 2015', provides an overview of the Alpha- Antitrypsin Deficiency's therapeutic pipeline.

This report provides comprehensive information on the therapeutic development for Alpha- Antitrypsin Deficiency, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Alpha- Antitrypsin Deficiency and special features on late-stage 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, 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. Drug profiles/records featured in the report undergoes periodic updation following a stringent set of processes that ensures that all the profiles are updated with the latest set of information. Additionally, processes including live news & deals tracking, browser based alert-box and clinical trials registries tracking ensure that the most recent developments are captured on a real time basis.

The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products.

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

Scope

The report provides a snapshot of the global therapeutic landscape of AlphaAntitrypsin Deficiency

The report reviews key pipeline products under drug profile section which includes, product description, MoA and R&D brief, licensing and collaboration details & other developmental activities

The report reviews key players involved in the therapeutics development for AlphaAntitrypsin Deficiency and enlists all their major and minor projects

The report summarizes all the dormant and discontinued pipeline projects

A review of the AlphaAntitrypsin Deficiency products under development by companies and universities/research institutes based on information derived from company and industry-specific sources

Pipeline products coverage based on various stages of development ranging from pre-registration till discovery and undisclosed stages

A detailed assessment of monotherapy and combination therapy pipeline projects

Coverage of the AlphaAntitrypsin Deficiency pipeline on the basis of target, MoA, route of administration and molecule type

Latest news and deals relating related to pipeline products

Reasons To Buy

Provides strategically significant competitor information, analysis, and insights to formulate effective R&D development strategies

Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage

Develop strategic initiatives by understanding the focus areas of leading companies

Identify and understand important and diverse types of therapeutics under development for AlphaAntitrypsin Deficiency

Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline

Devise corrective measures for pipeline projects by understanding AlphaAntitrypsin Deficiency 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

Table of Contents

Table of Contents 2

List of Tables 5

List of Figures 6

Introduction 7

Global Markets Direct Report Coverage 7

Alpha- Antitrypsin Deficiency Overview 8

Therapeutics Development 9

Pipeline Products for Alpha- Antitrypsin Deficiency-Overview 9

Pipeline Products for Alpha- Antitrypsin Deficiency-Comparative Analysis 10

Alpha- Antitrypsin Deficiency-Therapeutics under Development by Companies 11

Alpha- Antitrypsin Deficiency-Therapeutics under Investigation by Universities/Institutes 13

Alpha- Antitrypsin Deficiency-Pipeline Products Glance 14

Late Stage Products 14

Clinical Stage Products 15

Early Stage Products 16

Alpha- Antitrypsin Deficiency-Products under Development by Companies 17

Alpha- Antitrypsin Deficiency-Products under Investigation by Universities/Institutes 19

Alpha- Antitrypsin Deficiency-Companies Involved in Therapeutics Development 20

Applied Genetic Technologies Corporation 20

Arrowhead Research Corporation 21

Carolus Therapeutics, Inc. 22

Cevec Pharmaceuticals GmbH 23

Dicerna Pharmaceuticals, Inc. 24

Grifols, S.A. 25

iBio, Inc. 26

Inhibrx 27

International Stem Cell Corporation 28

Intrexon Corporation 29

Kamada Ltd. 30

Polyphor Ltd. 31

Promethera Biosciences S.A. 32

Sangamo BioSciences, Inc. 33

Alpha- Antitrypsin Deficiency-Therapeutics Assessment 34

Assessment by Monotherapy Products 34

Assessment by Target 35

Assessment by Mechanism of Action 37

Assessment by Route of Administration 39

Assessment by Molecule Type 41

Drug Profiles 43

Alpha-1 Antitrypsin With rHuPH20-Drug Profile 43

Product Description 43

Mechanism of Action 43

R&D Progress 43

alpha-1 proteinase inhibitor (human) second generation-Drug Profile 44

Product Description 44

Mechanism of Action 44

R&D Progress 44

ARC-AAT-Drug Profile 47

Product Description 47

Mechanism of Action 47

R&D Progress 47

CT-2009-Drug Profile 48

Product Description 48

Mechanism of Action 48

R&D Progress 48

DC-AIM-Drug Profile 49

Product Description 49

Mechanism of Action 49

R&D Progress 49

Gene Therapy to Activate A1AT for Alpha 1-Antitrypsin Deficiency-Drug Profile 50

Product Description 50

Mechanism of Action 50

R&D Progress 50

Gene Therapy to Activate Alpha-1 Antitrypsin-Drug Profile 51

Product Description 51

Mechanism of Action 51

R&D Progress 51

HepaStem-Drug Profile 52

Product Description 52

Mechanism of Action 52

R&D Progress 52

POL-6014-Drug Profile 54

Product Description 54

Mechanism of Action 54

R&D Progress 54

rAAV1-CB-hAAT-Drug Profile 56

Product Description 56

Mechanism of Action 56

R&D Progress 56

rAAV2-CB-hAAT-Drug Profile 57

Product Description 57

Mechanism of Action 57

R&D Progress 57

Recombinant A1PI-Drug Profile 58

Product Description 58

Mechanism of Action 58

R&D Progress 58

Recombinant Human Alpha-1 Antitrypsin-Drug Profile 60

Product Description 60

Mechanism of Action 60

R&D Progress 60

Recombinant Protein to Replace Alpha-1 Antitrypsin for Alpha Antitrypsin Deficiency-Drug Profile 61

Product Description 61

Mechanism of Action 61

R&D Progress 61

Recombinant Protein to Replace Alpha-1 Antitrypsin for Alpha-Antitrypsin Deficiency-Drug Profile 62

Product Description 62

Mechanism of Action 62

R&D Progress 62

RNAi Oligonucleotide for Alpha- Antitrypsin Deficiency-Drug Profile 63

Product Description 63

Mechanism of Action 63

R&D Progress 63

Stem Cell Therapy for Alpha-Antitrypsin Deficiency and Crigler-Najjar Syndrome-Drug Profile 65

Product Description 65

Mechanism of Action 65

R&D Progress 65

Alpha- Antitrypsin Deficiency-Recent Pipeline Updates 66

Alpha- Antitrypsin Deficiency-Dormant Projects 70

Alpha- Antitrypsin Deficiency-Discontinued Products 71

Alpha- Antitrypsin Deficiency-Product Development Milestones 72

Featured News & Press Releases 72

Jan 07, 2015: Kamada Reports Encouraging Discussions with European Co-Rapporteurs Regarding European Filing for Inhaled Alpha-1 Antitrypsin to Treat AATD 72

Nov 18, 2014: Arrowhead Files For Regulatory Permission To Begin Phase 1 Trial Of RNAi Therapeutic ARC-AAT 72

Nov 10, 2014: Arrowhead Presents Data on ARC-AAT at AASLD The Liver Meeting 2014 73

Sep 04, 2014: Kamada Reports Final Results from Phase 2/3 Clinical Trial of Inhaled Alpha-1 Antitrypsin to Treat Alpha-1 Antitrypsin Deficiency 74

Sep 03, 2014: Kamada to Announce Final Results from Phase 2/3 Clinical Trial of Inhaled AAT to Treat Alpha-1 Antitrypsin Deficiency on September 4, 2014 74

Jun 19, 2014: Arrowhead Announces New Clinical Candidate ARC-AAT for Treatment of Alpha-1 Antitrypsin Deficiency-Associated Liver Disease 75

May 16, 2014: Kamada Announces Preliminary Results from Phase II/III Pivotal Trial in Europe and Canada of Inhaled AAT to Treat Alpha-1 Antitrypsin Deficiency 76

May 15, 2014: Kamada to Announce Results from Phase 2/3 Clinical Trial of Inhaled AAT to Treat Alpha-1 Antitrypsin Deficiency on May 16 77

Mar 24, 2014: Kamada Announces Initiation of a Phase 2 U.S. Clinical Trial of Inhaled AAT to Treat Alpha-1 Antitrypsin Deficiency 78

Mar 21, 2014: Kamada to Report Top-Line Data from Phase 2/3 Clinical Trial of Inhaled AAT to Treat Alpha-1 Antitrypsin Deficiency by Late April or Early May 78

Appendix 80

Methodology 80

Coverage 80

Secondary Research 80

Primary Research 80

Expert Panel Validation 80

Contact Us 80

Disclaimer 81

List of Tables

Number of Products under Development for Alpha- Antitrypsin Deficiency, H1 2015 9

Number of Products under Development for Alpha- Antitrypsin Deficiency-Comparative Analysis, H1 2015 10

Number of Products under Development by Companies, H1 2015 12

Number of Products under Investigation by Universities/Institutes, H1 2015 13

Comparative Analysis by Late Stage Development, H1 2015 14

Comparative Analysis by Clinical Stage Development, H1 2015 15

Comparative Analysis by Early Stage Development, H1 2015 16

Products under Development by Companies, H1 2015 17

Products under Development by Companies, H1 2015 (Contd..1) 18

Products under Investigation by Universities/Institutes, H1 2015 19

Alpha- Antitrypsin Deficiency-Pipeline by Applied Genetic Technologies Corporation, H1 2015 20

Alpha- Antitrypsin Deficiency-Pipeline by Arrowhead Research Corporation, H1 2015 21

Alpha- Antitrypsin Deficiency-Pipeline by Carolus Therapeutics, Inc., H1 2015 22

Alpha- Antitrypsin Deficiency-Pipeline by Cevec Pharmaceuticals GmbH, H1 2015 23

Alpha- Antitrypsin Deficiency-Pipeline by Dicerna Pharmaceuticals, Inc., H1 2015 24

Alpha- Antitrypsin Deficiency-Pipeline by Grifols, S.A., H1 2015 25

Alpha- Antitrypsin Deficiency-Pipeline by iBio, Inc., H1 2015 26

Alpha- Antitrypsin Deficiency-Pipeline by Inhibrx, H1 2015 27

Alpha- Antitrypsin Deficiency-Pipeline by International Stem Cell Corporation, H1 2015 28

Alpha- Antitrypsin Deficiency-Pipeline by Intrexon Corporation, H1 2015 29

Alpha- Antitrypsin Deficiency-Pipeline by Kamada Ltd., H1 2015 30

Alpha- Antitrypsin Deficiency-Pipeline by Polyphor Ltd., H1 2015 31

Alpha- Antitrypsin Deficiency-Pipeline by Promethera Biosciences S.A., H1 2015 32

Alpha- Antitrypsin Deficiency-Pipeline by Sangamo BioSciences, Inc., H1 2015 33

Assessment by Monotherapy Products, H1 2015 34

Number of Products by Stage and Target, H1 2015 36

Number of Products by Stage and Mechanism of Action, H1 2015 38

Number of Products by Stage and Route of Administration, H1 2015 40

Number of Products by Stage and Molecule Type, H1 2015 42

Alpha- Antitrypsin Deficiency Therapeutics-Recent Pipeline Updates, H1 2015 66

Alpha- Antitrypsin Deficiency-Dormant Projects, H1 2015 70

Alpha- Antitrypsin Deficiency-Discontinued Products, H1 2015 71

List of Figures

Number of Products under Development for Alpha- Antitrypsin Deficiency, H1 2015 9

Number of Products under Development for Alpha- Antitrypsin Deficiency-Comparative Analysis, H1 2015 10

Number of Products under Development by Companies, H1 2015 11

Comparative Analysis by Clinical Stage Development, H1 2015 15

Comparative Analysis by Early Stage Products, H1 2015 16

Assessment by Monotherapy Products, H1 2015 34

Number of Products by Top 10 Targets, H1 2015 35

Number of Products by Stage and Top 10 Targets, H1 2015 36

Number of Products by Top 10 Mechanism of Actions, H1 2015 37

Number of Products by Stage and Top 10 Mechanism of Actions, H1 2015 38

Number of Products by Top 10 Routes of Administration, H1 2015 39

Number of Products by Stage and Top 10 Routes of Administration, H1 2015 40

Number of Products by Top 10 Molecule Types, H1 2015 41

Number of Products by Stage and Top 10 Molecule Types, H1 2015 42

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Applied Genetic Technologies Corporation

Arrowhead Research Corporation

Carolus Therapeutics, Inc.

Cevec Pharmaceuticals GmbH

Dicerna Pharmaceuticals, Inc.

Grifols, S.A.

iBio, Inc.

Inhibrx

International Stem Cell Corporation

Intrexon Corporation

Kamada Ltd.

Polyphor Ltd.

Promethera Biosciences S.A.

Sangamo BioSciences, Inc.

Alpha- Antitrypsin Deficiency Therapeutic Products under Development, Key Players in Alpha- Antitrypsin Deficiency Therapeutics, Alpha- Antitrypsin Deficiency Pipeline Overview, Alpha- Antitrypsin Deficiency Pipeline, Alpha- Antitrypsin Deficiency Pipeline Assessment


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