Lipodystrophy – Pipeline Review, H2 2016

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

The report provides comprehensive information on the therapeutics under development for Lipodystrophy, 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 Lipodystrophy 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 Lipodystrophy

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

The report assesses Lipodystrophy 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 Lipodystrophy

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 Lipodystrophy

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 Lipodystrophy 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

Aegerion Pharmaceuticals, Inc.

Akcea Therapeutics Inc

Ambrx, Inc.

Amunix Operating Inc.

Bolder Biotechnology, Inc.

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 4

List of Figures 4

Introduction 5

Global Markets Direct Report Coverage 5

Lipodystrophy Overview 6

Therapeutics Development 7

Pipeline Products for Lipodystrophy - Overview 7

Lipodystrophy - Therapeutics under Development by Companies 8

Lipodystrophy - Pipeline Products Glance 9

Late Stage Products 9

Early Stage Products 10

Lipodystrophy - Products under Development by Companies 11

Lipodystrophy - Companies Involved in Therapeutics Development 12

Aegerion Pharmaceuticals, Inc. 12

Akcea Therapeutics Inc 13

Ambrx, Inc. 14

Amunix Operating Inc. 15

Bolder Biotechnology, Inc. 16

Lipodystrophy - Therapeutics Assessment 17

Assessment by Monotherapy Products 17

Assessment by Target 18

Assessment by Mechanism of Action 20

Assessment by Route of Administration 22

Assessment by Molecule Type 23

Drug Profiles 25

AMX-342 - Drug Profile 25

Product Description 25

Mechanism Of Action 25

R&D Progress 25

ARX-328 - Drug Profile 26

Product Description 26

Mechanism Of Action 26

R&D Progress 26

BBT-031 - Drug Profile 27

Product Description 27

Mechanism Of Action 27

R&D Progress 27

metreleptin - Drug Profile 28

Product Description 28

Mechanism Of Action 28

R&D Progress 28

volanesorsen sodium - Drug Profile 33

Product Description 33

Mechanism Of Action 33

R&D Progress 33

Lipodystrophy - Product Development Milestones 39

Featured News & Press Releases 39

Jul 28, 2016: Akcea Therapeutics Receives Orphan Designation in Europe for Volanesorsen for the Treatment of Familial Partial Lipodystrophy 39

Jun 27, 2016: Akcea Announces Publication of Positive Volanesorsen Clinical Data Showing Reduced Triglycerides and Improved Insulin Sensitivity in Patients with High Triglycerides and Type 2 Diabetes 39

May 29, 2014: Zydus Explores Newer Treatment Options With its Breakthrough Drug, Lipaglyn 40

Feb 25, 2014: FDA approves Myalept to treat rare metabolic disease 41

Dec 12, 2013: FDA Advisory Committee votes on investigational medicine metreleptin 42

Jun 04, 2013: Bristol-Myers Squibb And AstraZeneca Receive FDA Priority Review Designation For Metreleptin 42

May 06, 2013: Bristol-Myers Squibb And AstraZeneca Announce Positive Results From Sub-Group Analysis Of Metreleptin In Pediatric Patients With Lipodystrophy 43

Aug 01, 2012: Shionogi Files New Drug Application For Recombinant Human Leptin For Lipodystrophy 43

Jun 25, 2012: New Clinical Data Analyses Show Amylin Pharma's Metreleptin Reduced Blood Glucose And Triglyceride Levels In Patients With Rare Forms Of Lipodystrophy 44

Apr 03, 2012: Amylin Completes Biologics License Application For Metreleptin To Treat Diabetes And/Or Hypertriglyceridemia In Patients With Rare Forms Of Lipodystrophy 45

Jun 04, 2011: Amylin's Study Results Show Treatment With Metreleptin Improves Diabetes And Lipid Control In Patients With Partial Lipodystrophy 46

Apr 15, 2011: Amylin To Present Data Showing Investigational Metreleptin Treatment Led To Long-Term Improvements In Diabetes And Lipid Control In Patients With Lipodystrophy 47

Dec 20, 2010: Amylin Submits Clinical And Nonclinical Sections Of Rolling Biologics License Application For Metreleptin To Treat Rare Forms Of Lipodystrophy 48

Nov 03, 2010: Bolder BioTechnology Announces $1.2 Million in Qualifying Therapeutic Discovery Project Grants 48

Dec 16, 2008: Bolder BioTechnology Receives $1.9 million NIH Grant To Continue Development of Long-Acting Growth Hormone Product BBT-031 49

Appendix 50

Methodology 50

Coverage 50

Secondary Research 50

Primary Research 50

Expert Panel Validation 50

Contact Us 50

Disclaimer 51

List of Tables

List of Tables

Number of Products under Development for Lipodystrophy, H2 2016 7

Number of Products under Development by Companies, H2 2016 8

Comparative Analysis by Late Stage Development, H2 2016 9

Comparative Analysis by Early Stage Development, H2 2016 10

Products under Development by Companies, H2 2016 11

Lipodystrophy – Pipeline by Aegerion Pharmaceuticals, Inc., H2 2016 12

Lipodystrophy – Pipeline by Akcea Therapeutics Inc, H2 2016 13

Lipodystrophy – Pipeline by Ambrx, Inc., H2 2016 14

Lipodystrophy – Pipeline by Amunix Operating Inc. , H2 2016 15

Lipodystrophy – Pipeline by Bolder Biotechnology, Inc., H2 2016 16

Assessment by Monotherapy Products, H2 2016 17

Number of Products by Stage and Target, H2 2016 19

Number of Products by Stage and Mechanism of Action, H2 2016 21

Number of Products by Stage and Route of Administration, H2 2016 22

Number of Products by Stage and Molecule Type, H2 2016 24

List of Figures

List of Figures

Number of Products under Development for Lipodystrophy, H2 2016 7

Number of Products under Development by Companies, H2 2016 8

Comparative Analysis by Early Stage Products, H2 2016 10

Assessment by Monotherapy Products, H2 2016 17

Number of Products by Targets, H2 2016 18

Number of Products by Stage and Targets, H2 2016 18

Number of Products by Mechanism of Actions, H2 2016 20

Number of Products by Stage and Mechanism of Actions, H2 2016 20

Number of Products by Molecule Types, H2 2016 23

Number of Products by Stage and Molecule Types, H2 2016 23

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