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Mucopolysaccharidosis II (MPS II) (Hunter Syndrome)-Pipeline Review, H1 2015

Mucopolysaccharidosis II (MPS II) (Hunter Syndrome)-Pipeline Review, H1 2015


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Executive Summary

Mucopolysaccharidosis II (MPS II) (Hunter Syndrome)-Pipeline Review, H1 2015

Summary

Global Markets Direct's, 'Mucopolysaccharidosis II (MPS II) (Hunter Syndrome)-Pipeline Review, H1 2015', provides an overview of the Mucopolysaccharidosis II (MPS II) (Hunter Syndrome)'s therapeutic pipeline.

This report provides comprehensive information on the therapeutic development for Mucopolysaccharidosis II (MPS II) (Hunter Syndrome), 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 Mucopolysaccharidosis II (MPS II) (Hunter Syndrome) 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 Mucopolysaccharidosis II (MPS II) (Hunter Syndrome)

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 Mucopolysaccharidosis II (MPS II) (Hunter Syndrome) and enlists all their major and minor projects

The report summarizes all the dormant and discontinued pipeline projects

A review of the Mucopolysaccharidosis II (MPS II) (Hunter Syndrome) 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 Mucopolysaccharidosis II (MPS II) (Hunter Syndrome) 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 Mucopolysaccharidosis II (MPS II) (Hunter Syndrome)

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

Devise corrective measures for pipeline projects by understanding Mucopolysaccharidosis II (MPS II) (Hunter Syndrome) 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 4

List of Figures 5

Introduction 6

Global Markets Direct Report Coverage 6

Mucopolysaccharidosis II (MPS II) (Hunter Syndrome) Overview 7

Therapeutics Development 8

Pipeline Products for Mucopolysaccharidosis II (MPS II) (Hunter Syndrome)-Overview 8

Pipeline Products for Mucopolysaccharidosis II (MPS II) (Hunter Syndrome)-Comparative Analysis 9

Mucopolysaccharidosis II (MPS II) (Hunter Syndrome)-Therapeutics under Development by Companies 10

Mucopolysaccharidosis II (MPS II) (Hunter Syndrome)-Pipeline Products Glance 11

Clinical Stage Products 11

Early Stage Products 12

Mucopolysaccharidosis II (MPS II) (Hunter Syndrome)-Products under Development by Companies 13

Mucopolysaccharidosis II (MPS II) (Hunter Syndrome)-Companies Involved in Therapeutics Development 14

ArmaGen Technologies, Inc. 14

biOasis Technologies Inc. 15

Fate Therapeutics, Inc. 16

Green Cross Corporation 17

JCR Pharmaceuticals Co., Ltd. 18

Sangamo BioSciences, Inc. 19

Shire Plc 20

Synageva BioPharma Corp. 21

Mucopolysaccharidosis II (MPS II) (Hunter Syndrome)-Therapeutics Assessment 22

Assessment by Monotherapy Products 22

Assessment by Target 23

Assessment by Mechanism of Action 24

Assessment by Route of Administration 25

Assessment by Molecule Type 27

Drug Profiles 29

AGT-182-Drug Profile 29

Product Description 29

Mechanism of Action 29

R&D Progress 29

FT-1050-Drug Profile 30

Product Description 30

Mechanism of Action 30

R&D Progress 30

Gene Therapy to Target Iduronate 2-Sulfatase for Hunter Syndrome-Drug Profile 33

Product Description 33

Mechanism of Action 33

R&D Progress 33

idursulfase-Drug Profile 34

Product Description 34

Mechanism of Action 34

R&D Progress 34

idursulfase-Drug Profile 35

Product Description 35

Mechanism of Action 35

R&D Progress 35

JR-032-Drug Profile 36

Product Description 36

Mechanism of Action 36

R&D Progress 36

MTf-I2S-Drug Profile 37

Product Description 37

Mechanism of Action 37

R&D Progress 37

MTfp-I2S-Drug Profile 39

Product Description 39

Mechanism of Action 39

R&D Progress 39

Next Generation biologics for Pompe, Fabry and Hunter-Drug Profile 40

Product Description 40

Mechanism of Action 40

R&D Progress 40

SHP-631-Drug Profile 41

Product Description 41

Mechanism of Action 41

R&D Progress 41

Mucopolysaccharidosis II (MPS II) (Hunter Syndrome)-Recent Pipeline Updates 42

Mucopolysaccharidosis II (MPS II) (Hunter Syndrome)-Dormant Projects 46

Mucopolysaccharidosis II (MPS II) (Hunter Syndrome)-Product Development Milestones 47

Featured News & Press Releases 47

Mar 10, 2015: PacificGMP and ArmaGen Announce Successful Manufacture of ArmaGen's investigational enzyme replacement therapy, AGT-182, for Phase 1 Clinical Trial 47

Dec 11, 2014: ArmaGen Announces FDA Acceptance of IND Application for AGT-182 for the Treatment of Hunter Syndrome 47

Sep 18, 2014: biOasis Initiates MPS II Study with Renowned Lysosomal Storage Disease Expert Dr. Maurizio Scarpa and The Brains for Brain Foundation 48

Jun 17, 2014: ArmaGen Receives Notice of Allowance for U.S. Patent Covering Novel Investigational Therapy for Hunter Syndrome 49

Oct 02, 2013: Green Cross Exports Orphan Disease Drug Hunterase to Algeria 50

Jul 18, 2013: ARMAGEN Receives US Orphan Designation For Lead Product AGT-182 50

Apr 08, 2013: Green Cross Announces Publication Of Clinical Trial Paper On Hunter Syndrome Drug Hunterase In International Scientific Press 51

Feb 18, 2013: Green Cross Receives FDA Orphan Drug Designation For Hunterase For Treatment Of Hunter Syndrome 51

Jan 10, 2012: Green Cross Receives Korean Approval For Hunterase 52

Oct 12, 2011: Green Cross Files Application For Korean Approval Of Hunterase For Treatment Of Hunter Syndrome 52

Appendix 54

Methodology 54

Coverage 54

Secondary Research 54

Primary Research 54

Expert Panel Validation 54

Contact Us 54

Disclaimer 55

List of Tables

Number of Products under Development for Mucopolysaccharidosis II (MPS II) (Hunter Syndrome), H1 2015 8

Number of Products under Development for Mucopolysaccharidosis II (MPS II) (Hunter Syndrome)-Comparative Analysis, H1 2015 9

Number of Products under Development by Companies, H1 2015 10

Comparative Analysis by Clinical Stage Development, H1 2015 11

Comparative Analysis by Early Stage Development, H1 2015 12

Products under Development by Companies, H1 2015 13

Mucopolysaccharidosis II (MPS II) (Hunter Syndrome)-Pipeline by ArmaGen Technologies, Inc., H1 2015 14

Mucopolysaccharidosis II (MPS II) (Hunter Syndrome)-Pipeline by biOasis Technologies Inc., H1 2015 15

Mucopolysaccharidosis II (MPS II) (Hunter Syndrome)-Pipeline by Fate Therapeutics, Inc., H1 2015 16

Mucopolysaccharidosis II (MPS II) (Hunter Syndrome)-Pipeline by Green Cross Corporation, H1 2015 17

Mucopolysaccharidosis II (MPS II) (Hunter Syndrome)-Pipeline by JCR Pharmaceuticals Co., Ltd., H1 2015 18

Mucopolysaccharidosis II (MPS II) (Hunter Syndrome)-Pipeline by Sangamo BioSciences, Inc., H1 2015 19

Mucopolysaccharidosis II (MPS II) (Hunter Syndrome)-Pipeline by Shire Plc, H1 2015 20

Mucopolysaccharidosis II (MPS II) (Hunter Syndrome)-Pipeline by Synageva BioPharma Corp., H1 2015 21

Assessment by Monotherapy Products, H1 2015 22

Number of Products by Stage and Target, H1 2015 23

Number of Products by Stage and Mechanism of Action, H1 2015 24

Number of Products by Stage and Route of Administration, H1 2015 26

Number of Products by Stage and Molecule Type, H1 2015 28

Mucopolysaccharidosis II (MPS II) (Hunter Syndrome) Therapeutics-Recent Pipeline Updates, H1 2015 42

Mucopolysaccharidosis II (MPS II) (Hunter Syndrome)-Dormant Projects, H1 2015 46

List of Figures

Number of Products under Development for Mucopolysaccharidosis II (MPS II) (Hunter Syndrome), H1 2015 8

Number of Products under Development for Mucopolysaccharidosis II (MPS II) (Hunter Syndrome)-Comparative Analysis, H1 2015 9

Number of Products under Development by Companies, H1 2015 10

Comparative Analysis by Clinical Stage Development, H1 2015 11

Assessment by Monotherapy Products, H1 2015 22

Number of Products by Stage and Top 10 Targets, H1 2015 23

Number of Products by Stage and Top 10 Mechanism of Actions, H1 2015 24

Number of Products by Top 10 Routes of Administration, H1 2015 25

Number of Products by Stage and Top 10 Routes of Administration, H1 2015 26

Number of Products by Top 10 Molecule Types, H1 2015 27

Number of Products by Stage and Top 10 Molecule Types, H1 2015 28

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ArmaGen Technologies, Inc.

biOasis Technologies Inc.

Fate Therapeutics, Inc.

Green Cross Corporation

JCR Pharmaceuticals Co., Ltd.

Sangamo BioSciences, Inc.

Shire Plc

Synageva BioPharma Corp.

Mucopolysaccharidosis II (MPS II) (Hunter Syndrome) Therapeutic Products under Development, Key Players in Mucopolysaccharidosis II (MPS II) (Hunter Syndrome) Therapeutics, Mucopolysaccharidosis II (MPS II) (Hunter Syndrome) Pipeline Overview, Mucopolysaccharidosis II (MPS II) (Hunter Syndrome) Pipeline, Mucopolysaccharidosis II (MPS II) (Hunter Syndrome) Pipeline Assessment


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