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Inclusion Body Myositis (IBM)-Pipeline Review, H1 2015

Inclusion Body Myositis (IBM)-Pipeline Review, H1 2015


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Executive Summary

Inclusion Body Myositis (IBM)-Pipeline Review, H1 2015

Summary

Global Markets Direct's, 'Inclusion Body Myositis (IBM)-Pipeline Review, H1 2015', provides an overview of the Inclusion Body Myositis (IBM)'s therapeutic pipeline.

This report provides comprehensive information on the therapeutic development for Inclusion Body Myositis (IBM), 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 Inclusion Body Myositis (IBM) 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 Inclusion Body Myositis (IBM)

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 Inclusion Body Myositis (IBM) and enlists all their major and minor projects

The report summarizes all the dormant and discontinued pipeline projects

A review of the Inclusion Body Myositis (IBM) 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 Inclusion Body Myositis (IBM) 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 Inclusion Body Myositis (IBM)

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

Devise corrective measures for pipeline projects by understanding Inclusion Body Myositis (IBM) 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 4

Introduction 5

Global Markets Direct Report Coverage 5

Inclusion Body Myositis (IBM) Overview 6

Therapeutics Development 7

Pipeline Products for Inclusion Body Myositis (IBM)-Overview 7

Pipeline Products for Inclusion Body Myositis (IBM)-Comparative Analysis 8

Inclusion Body Myositis (IBM)-Therapeutics under Development by Companies 9

Inclusion Body Myositis (IBM)-Pipeline Products Glance 10

Late Stage Products 10

Clinical Stage Products 11

Inclusion Body Myositis (IBM)-Products under Development by Companies 12

Inclusion Body Myositis (IBM)-Companies Involved in Therapeutics Development 13

Acceleron Pharma, Inc. 13

New Zealand Pharmaceuticals Limited 14

Nobelpharma Co., Ltd. 15

Novartis AG 16

Ultragenyx Pharmaceutical Inc. 17

Inclusion Body Myositis (IBM)-Therapeutics Assessment 18

Assessment by Monotherapy Products 18

Assessment by Target 19

Assessment by Mechanism of Action 21

Assessment by Route of Administration 23

Assessment by Molecule Type 25

Drug Profiles 27

AAV1-Foliistatin-Drug Profile 27

Product Description 27

Mechanism of Action 27

R&D Progress 27

ACE-083-Drug Profile 28

Product Description 28

Mechanism of Action 28

R&D Progress 28

aceneuramic acid-Drug Profile 29

Product Description 29

Mechanism of Action 29

R&D Progress 29

bimagrumab-Drug Profile 31

Product Description 31

Mechanism of Action 31

R&D Progress 31

DEXM-74-Drug Profile 33

Product Description 33

Mechanism of Action 33

R&D Progress 33

UX-007-Drug Profile 35

Product Description 35

Mechanism of Action 35

R&D Progress 35

Inclusion Body Myositis (IBM)-Recent Pipeline Updates 36

Inclusion Body Myositis (IBM)-Dormant Projects 43

Inclusion Body Myositis (IBM)-Product Development Milestones 44

Featured News & Press Releases 44

Jan 12, 2015: Ultragenyx Announces Intent to File for Conditional Approval in Europe for Sialic Acid Extended-Release Tablets in Hereditary Inclusion Body Myopathy 44

Oct 13, 2014: Ultragenyx Announces Interim Data From Phase 2 Extension Study of Sialic Acid Extended-Release at International Congress of the World Muscle Society 45

Apr 30, 2014: Ultragenyx Announces Positive Data From Phase 2 Study of Sialic Acid Extended-Release at Emerging Sciences Session of American Academy of Neurology Annual Meeting 45

Dec 20, 2013: Ultragenyx Announces Results from Phase 2 Study of Sialic Acid Extended-Release Treatment in Hereditary Inclusion Body Myopathy 47

Oct 02, 2013: MorphoSys Collaborator to Start Pivotal Study with Bimagrumab 47

Sep 26, 2013: Ultragenyx Announces Three Abstracts Accepted for Poster Presentation at 18th Annual World Muscle Society Congress 48

Aug 20, 2013: Novartis receives FDA breakthrough therapy designation for BYM338 (bimagrumab) for sporadic inclusion body myositis (sIBM) 48

Jul 03, 2013: Ultragenyx Announces a Positive Signal in Interim Data from Phase 2 Study of UX001 in Hereditary Inclusion Body Myopathy 49

Dec 15, 2011: New Zealand Pharma Obtains FDA Orphan Drug Designation For DEX-M74 To Treat Hereditary Inclusion Body Myopathy 50

Appendix 51

Methodology 51

Coverage 51

Secondary Research 51

Primary Research 51

Expert Panel Validation 51

Contact Us 51

Disclaimer 52

List of Tables

Number of Products under Development for Inclusion Body Myositis (IBM), H1 2015 7

Number of Products under Development for Inclusion Body Myositis (IBM)-Comparative Analysis, H1 2015 8

Number of Products under Development by Companies, H1 2015 9

Comparative Analysis by Late Stage Development, H1 2015 10

Comparative Analysis by Clinical Stage Development, H1 2015 11

Products under Development by Companies, H1 2015 12

Inclusion Body Myositis (IBM)-Pipeline by Acceleron Pharma, Inc., H1 2015 13

Inclusion Body Myositis (IBM)-Pipeline by New Zealand Pharmaceuticals Limited, H1 2015 14

Inclusion Body Myositis (IBM)-Pipeline by Nobelpharma Co., Ltd., H1 2015 15

Inclusion Body Myositis (IBM)-Pipeline by Novartis AG, H1 2015 16

Inclusion Body Myositis (IBM)-Pipeline by Ultragenyx Pharmaceutical Inc., H1 2015 17

Assessment by Monotherapy Products, H1 2015 18

Number of Products by Stage and Target, H1 2015 20

Number of Products by Stage and Mechanism of Action, H1 2015 22

Number of Products by Stage and Route of Administration, H1 2015 24

Number of Products by Stage and Molecule Type, H1 2015 26

Inclusion Body Myositis (IBM) Therapeutics-Recent Pipeline Updates, H1 2015 36

Inclusion Body Myositis (IBM)-Dormant Projects, H1 2015 43

List of Figures

Number of Products under Development for Inclusion Body Myositis (IBM), H1 2015 7

Number of Products under Development for Inclusion Body Myositis (IBM)-Comparative Analysis, H1 2015 8

Number of Products under Development by Companies, H1 2015 9

Comparative Analysis by Clinical Stage Development, H1 2015 11

Assessment by Monotherapy Products, H1 2015 18

Number of Products by Top 10 Targets, H1 2015 19

Number of Products by Stage and Top 10 Targets, H1 2015 20

Number of Products by Top 10 Mechanism of Actions, H1 2015 21

Number of Products by Stage and Top 10 Mechanism of Actions, H1 2015 22

Number of Products by Top 10 Routes of Administration, H1 2015 23

Number of Products by Stage and Top 10 Routes of Administration, H1 2015 24

Number of Products by Top 10 Molecule Types, H1 2015 25

Number of Products by Stage and Top 10 Molecule Types, H1 2015 26

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Acceleron Pharma, Inc.

New Zealand Pharmaceuticals Limited

Nobelpharma Co., Ltd.

Novartis AG

Ultragenyx Pharmaceutical Inc.

Inclusion Body Myositis (IBM) Therapeutic Products under Development, Key Players in Inclusion Body Myositis (IBM) Therapeutics, Inclusion Body Myositis (IBM) Pipeline Overview, Inclusion Body Myositis (IBM) Pipeline, Inclusion Body Myositis (IBM) Pipeline Assessment


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