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Amyloidosis-Pipeline Review, H1 2015

Amyloidosis-Pipeline Review, H1 2015


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Executive Summary

Amyloidosis-Pipeline Review, H1 2015

Summary

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

This report provides comprehensive information on the therapeutic development for Amyloidosis, 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 Amyloidosis 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 Amyloidosis

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 Amyloidosis and enlists all their major and minor projects

The report summarizes all the dormant and discontinued pipeline projects

A review of the Amyloidosis 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 Amyloidosis 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 Amyloidosis

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

Devise corrective measures for pipeline projects by understanding Amyloidosis 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 6

List of Figures 7

Introduction 8

Global Markets Direct Report Coverage 8

Amyloidosis Overview 9

Therapeutics Development 10

Pipeline Products for Amyloidosis-Overview 10

Pipeline Products for Amyloidosis-Comparative Analysis 11

Amyloidosis-Therapeutics under Development by Companies 12

Amyloidosis-Therapeutics under Investigation by Universities/Institutes 14

Amyloidosis-Pipeline Products Glance 15

Late Stage Products 15

Clinical Stage Products 16

Early Stage Products 17

Amyloidosis-Products under Development by Companies 18

Amyloidosis-Products under Investigation by Universities/Institutes 20

Amyloidosis-Companies Involved in Therapeutics Development 21

Alnylam Pharmaceuticals, Inc. 21

Arcturus Therapeutics, Inc 23

Auven Therapeutics Management L.L.L.P 24

Bellus Health Inc. 25

Bsim2 26

Celgene Corporation 27

GlaxoSmithKline plc 28

Immune System Therapeutics Ltd. 29

Isis Pharmaceuticals, Inc. 30

NeuroPhage Pharmaceuticals, Inc. 31

Onyx Pharmaceuticals, Inc. 32

Pfizer Inc. 33

ProteoTech, Inc. 34

Prothena Corporation plc 35

SOM Innovation Biotech SL 36

Takeda Oncology 37

Amyloidosis-Therapeutics Assessment 38

Assessment by Monotherapy Products 38

Assessment by Combination Products 39

Assessment by Target 40

Assessment by Mechanism of Action 42

Assessment by Route of Administration 44

Assessment by Molecule Type 46

Drug Profiles 48

ALN-TTRsc-Drug Profile 48

Product Description 48

Mechanism of Action 48

R&D Progress 48

ALNTTR-01-Drug Profile 50

Product Description 50

Mechanism of Action 50

R&D Progress 50

Antisense Oligonucleotide for Transthyretin Amyloidosis-Drug Profile 52

Product Description 52

Mechanism of Action 52

R&D Progress 52

carfilzomib-Drug Profile 53

Product Description 53

Mechanism of Action 53

R&D Progress 53

eprodisate disodium-Drug Profile 57

Product Description 57

Mechanism of Action 57

R&D Progress 57

GSK-2315698-Drug Profile 59

Product Description 59

Mechanism of Action 59

R&D Progress 59

GSK-2315698 + GSK-2398852-Drug Profile 60

Product Description 60

Mechanism of Action 60

R&D Progress 60

GSK-2398852-Drug Profile 61

Product Description 61

Mechanism of Action 61

R&D Progress 61

ISIS-TTRRx-Drug Profile 62

Product Description 62

Mechanism of Action 62

R&D Progress 62

IST-1097-Drug Profile 63

Product Description 63

Mechanism of Action 63

R&D Progress 63

ixazomib citrate-Drug Profile 64

Product Description 64

Mechanism of Action 64

R&D Progress 64

LUNAR-102-Drug Profile 67

Product Description 67

Mechanism of Action 67

R&D Progress 67

Monoclonal Antibody for Amyloidosis-Drug Profile 68

Product Description 68

Mechanism of Action 68

R&D Progress 68

Monoclonal Antibody to Inhibit ATTR for Familial Amyloid Polyneuropathy-Drug Profile 69

Product Description 69

Mechanism of Action 69

R&D Progress 69

NEOD-001-Drug Profile 70

Product Description 70

Mechanism of Action 70

R&D Progress 70

NPT-005-Drug Profile 72

Product Description 72

Mechanism of Action 72

R&D Progress 72

patisiran-Drug Profile 73

Product Description 73

Mechanism of Action 73

R&D Progress 73

pomalidomide-Drug Profile 74

Product Description 74

Mechanism of Action 74

R&D Progress 74

PTI-110-Drug Profile 78

Product Description 78

Mechanism of Action 78

R&D Progress 78

RNAi Oligonucleotides to Inhibit Amyloid Precursor Protein for Amyloidosis-Drug Profile 79

Product Description 79

Mechanism of Action 79

R&D Progress 79

Small Molecule for AL Amyloidosis-Drug Profile 80

Product Description 80

Mechanism of Action 80

R&D Progress 80

Small Molecules to Inhibit Transthyretin for Familial Amyloid Polyneuropathy-Drug Profile 81

Product Description 81

Mechanism of Action 81

R&D Progress 81

Small Molecules to Inhibit Transthyretin Related Amyloid Protein for Familial Amyloidotic Cardiomyopathy-Drug Profile 82

Product Description 82

Mechanism of Action 82

R&D Progress 82

Small Molecules to Inhibit Transthyretin Related Amyloid Protein for Familial Amyloidotic Polyneuropathy-Drug Profile 83

Product Description 83

Mechanism of Action 83

R&D Progress 83

tafamidis meglumine-Drug Profile 84

Product Description 84

Mechanism of Action 84

R&D Progress 84

tolcapone-Drug Profile 86

Product Description 86

Mechanism of Action 86

R&D Progress 86

Amyloidosis-Recent Pipeline Updates 87

Amyloidosis-Dormant Projects 116

Amyloidosis-Product Development Milestones 117

Featured News & Press Releases 117

Dec 15, 2014: Prothena Receives FDA Fast Track Designation for NEOD001, a Monoclonal Antibody for the Treatment of Patients With AL Amyloidosis 117

Dec 11, 2014: Alnylam Initiates ENDEAVOUR Phase 3 Clinical Trial with Revusiran (ALN-TTRsc), an Investigational RNAi Therapeutic Targeting Transthyretin (TTR) for the Treatment of TTR Cardiac Amyloidosis 118

Dec 11, 2014: Alnylam Initiates ENDEAVOUR Phase 3 Clinical Trial with Revusiran (ALN-TTRsc), an Investigational RNAi Therapeutic Targeting Transthyretin (TTR) for the Treatment of TTR Cardiac Amyloidosis 119

Dec 02, 2014: Prothena Initiates NEOD001 Global Phase 3 Registrational Trial Based on Positive Results in Ongoing Phase 1/2 Study of NEOD001 in Patients With AL Amyloidosis 121

Dec 01, 2014: Takeda's Investigational, Oral Proteasome Inhibitor Ixazomib Granted Breakthrough Therapy Designation by U.S. FDA for Relapsed or Refractory Systemic Light-chain Amyloidosis 123

Nov 14, 2014: Alnylam Announces Positive Initial Phase 2 Data with Revusiran 124

Nov 05, 2014: Alnylam Completes Phase 2 Enrollment and Initiates Open-Label Extension Study with Revusiran (ALN-TTRsc), an Investigational RNAi Therapeutic Targeting Transthyretin for the Treatment of TTR Cardiac Amyloidosis 126

Oct 14, 2014: Alnylam Presents Additional Data From Phase 1 Trial With ALN-TTRsc At 10th Annual Meeting of the Oligonucleotide Therapeutics Society 128

Oct 13, 2014: Arcturus Therapeutics to Present Gene Knockdown Data in Non-Human Primates, Showing up to 94% Reduction in Gene Expression with a Single Low Dose 129

Oct 13, 2014: Alnylam Reports Six-Month Clinical Data from Patisiran Phase 2 Open-Label Extension (OLE) Study in Patients with Familial Amyloidotic Polyneuropathy (FAP) 129

Appendix 132

Methodology 132

Coverage 132

Secondary Research 132

Primary Research 132

Expert Panel Validation 132

Contact Us 133

Disclaimer 133

List of Tables

Number of Products under Development for Amyloidosis, H1 2015 10

Number of Products under Development for Amyloidosis-Comparative Analysis, H1 2015 11

Number of Products under Development by Companies, H1 2015 13

Number of Products under Investigation by Universities/Institutes, H1 2015 14

Comparative Analysis by Late Stage Development, H1 2015 15

Comparative Analysis by Clinical Stage Development, H1 2015 16

Comparative Analysis by Early Stage Development, H1 2015 17

Products under Development by Companies, H1 2015 18

Products under Development by Companies, H1 2015 (Contd..1) 19

Products under Investigation by Universities/Institutes, H1 2015 20

Amyloidosis-Pipeline by Alnylam Pharmaceuticals, Inc., H1 2015 22

Amyloidosis-Pipeline by Arcturus Therapeutics, Inc, H1 2015 23

Amyloidosis-Pipeline by Auven Therapeutics Management L.L.L.P, H1 2015 24

Amyloidosis-Pipeline by Bellus Health Inc., H1 2015 25

Amyloidosis-Pipeline by Bsim2, H1 2015 26

Amyloidosis-Pipeline by Celgene Corporation, H1 2015 27

Amyloidosis-Pipeline by GlaxoSmithKline plc, H1 2015 28

Amyloidosis-Pipeline by Immune System Therapeutics Ltd., H1 2015 29

Amyloidosis-Pipeline by Isis Pharmaceuticals, Inc., H1 2015 30

Amyloidosis-Pipeline by NeuroPhage Pharmaceuticals, Inc., H1 2015 31

Amyloidosis-Pipeline by Onyx Pharmaceuticals, Inc., H1 2015 32

Amyloidosis-Pipeline by Pfizer Inc., H1 2015 33

Amyloidosis-Pipeline by ProteoTech, Inc., H1 2015 34

Amyloidosis-Pipeline by Prothena Corporation plc, H1 2015 35

Amyloidosis-Pipeline by SOM Innovation Biotech SL, H1 2015 36

Amyloidosis-Pipeline by Takeda Oncology, H1 2015 37

Assessment by Monotherapy Products, H1 2015 38

Assessment by Combination Products, H1 2015 39

Number of Products by Stage and Target, H1 2015 41

Number of Products by Stage and Mechanism of Action, H1 2015 43

Number of Products by Stage and Route of Administration, H1 2015 45

Number of Products by Stage and Molecule Type, H1 2015 47

Amyloidosis Therapeutics-Recent Pipeline Updates, H1 2015 87

Amyloidosis-Dormant Projects, H1 2015 116

List of Figures

Number of Products under Development for Amyloidosis, H1 2015 10

Number of Products under Development for Amyloidosis-Comparative Analysis, H1 2015 11

Number of Products under Development by Companies, H1 2015 12

Number of Products under Investigation by Universities/Institutes, H1 2015 14

Comparative Analysis by Late Stage Development, H1 2015 15

Comparative Analysis by Clinical Stage Development, H1 2015 16

Comparative Analysis by Early Stage Products, H1 2015 17

Assessment by Monotherapy Products, H1 2015 38

Number of Products by Top 10 Targets, H1 2015 40

Number of Products by Stage and Top 10 Targets, H1 2015 41

Number of Products by Top 10 Mechanism of Actions, H1 2015 42

Number of Products by Stage and Top 10 Mechanism of Actions, H1 2015 43

Number of Products by Top 10 Routes of Administration, H1 2015 44

Number of Products by Stage and Top 10 Routes of Administration, H1 2015 45

Number of Products by Top 10 Molecule Types, H1 2015 46

Number of Products by Stage and Top 10 Molecule Types, H1 2015 47

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Alnylam Pharmaceuticals, Inc.

Arcturus Therapeutics, Inc

Auven Therapeutics Management L.L.L.P

Bellus Health Inc.

Bsim2

Celgene Corporation

GlaxoSmithKline plc

Immune System Therapeutics Ltd.

Isis Pharmaceuticals, Inc.

NeuroPhage Pharmaceuticals, Inc.

Onyx Pharmaceuticals, Inc.

Pfizer Inc.

ProteoTech, Inc.

Prothena Corporation plc

SOM Innovation Biotech SL

Takeda Oncology

Amyloidosis Therapeutic Products under Development, Key Players in Amyloidosis Therapeutics, Amyloidosis Pipeline Overview, Amyloidosis Pipeline, Amyloidosis Pipeline Assessment


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