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Growth Hormone Deficiency-Pipeline Review, H1 2015

Growth Hormone Deficiency-Pipeline Review, H1 2015


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Executive Summary

Growth Hormone Deficiency-Pipeline Review, H1 2015

Summary

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

This report provides comprehensive information on the therapeutic development for Growth Hormone 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 Growth Hormone 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 Growth Hormone 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 Growth Hormone Deficiency and enlists all their major and minor projects

The report summarizes all the dormant and discontinued pipeline projects

A review of the Growth Hormone 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 Growth Hormone 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 Growth Hormone Deficiency

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

Devise corrective measures for pipeline projects by understanding Growth Hormone 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 6

List of Figures 7

Introduction 8

Global Markets Direct Report Coverage 8

Growth Hormone Deficiency Overview 9

Therapeutics Development 10

Pipeline Products for Growth Hormone Deficiency-Overview 10

Pipeline Products for Growth Hormone Deficiency-Comparative Analysis 11

Growth Hormone Deficiency-Therapeutics under Development by Companies 12

Growth Hormone Deficiency-Pipeline Products Glance 15

Late Stage Products 15

Clinical Stage Products 16

Early Stage Products 17

Unknown Stage Products 18

Growth Hormone Deficiency-Products under Development by Companies 19

Growth Hormone Deficiency-Companies Involved in Therapeutics Development 21

Aeterna Zentaris Inc. 21

Aileron Therapeutics, Inc. 22

Ascendis Pharma A/S 23

Biogenomics Limited 24

Bolder Biotechnology, Inc. 25

Braasch Biotech LLC 26

CJ CheilJedang Corp. 27

Critical Pharmaceuticals Limited 28

Delpor, Inc. 29

Emisphere Technologies, Inc. 30

Flamel Technologies S.A. 31

Genexine, Inc. 32

HanAll Biopharma Co., Ltd. 33

Hanmi Pharmaceuticals, Co. Ltd. 34

Inbiopro Solutions Pvt. Ltd. 35

LG Life Sciences, Ltd. 36

OPKO Health, Inc. 37

Pfenex Inc. 38

Prometheon Pharma, LLC 39

Teva Pharmaceutical Industries Limited 40

Versartis, Inc. 41

XL-protein GmbH 42

Growth Hormone Deficiency-Therapeutics Assessment 43

Assessment by Monotherapy Products 43

Assessment by Target 44

Assessment by Mechanism of Action 46

Assessment by Route of Administration 48

Assessment by Molecule Type 50

Drug Profiles 52

ACP-001-Drug Profile 52

Product Description 52

Mechanism of Action 52

R&D Progress 52

albutropin-Drug Profile 54

Product Description 54

Mechanism of Action 54

R&D Progress 54

ALRN-5281-Drug Profile 55

Product Description 55

Mechanism of Action 55

R&D Progress 55

BBT-031-Drug Profile 57

Product Description 57

Mechanism of Action 57

R&D Progress 57

CJ-40002-Drug Profile 58

Product Description 58

Mechanism of Action 58

R&D Progress 58

CP-016-Drug Profile 59

Product Description 59

Mechanism of Action 59

R&D Progress 59

GXH-9-Drug Profile 60

Product Description 60

Mechanism of Action 60

R&D Progress 60

HL-032-Drug Profile 61

Product Description 61

Mechanism of Action 61

R&D Progress 61

HM-10560A-Drug Profile 63

Product Description 63

Mechanism of Action 63

R&D Progress 63

IBPB-003HH-Drug Profile 64

Product Description 64

Mechanism of Action 64

R&D Progress 64

macimorelin acetate-Drug Profile 65

Product Description 65

Mechanism of Action 65

R&D Progress 65

MOD-4023-Drug Profile 67

Product Description 67

Mechanism of Action 67

R&D Progress 67

Pegylated Somatropin-Drug Profile 69

Product Description 69

Mechanism of Action 69

R&D Progress 69

somatropin-Drug Profile 70

Product Description 70

Mechanism of Action 70

R&D Progress 70

somatropin-Drug Profile 71

Product Description 71

Mechanism of Action 71

R&D Progress 71

somatropin-Drug Profile 73

Product Description 73

Mechanism of Action 73

R&D Progress 73

somatropin-Drug Profile 74

Product Description 74

Mechanism of Action 74

R&D Progress 74

somatropin biobetter-Drug Profile 75

Product Description 75

Mechanism of Action 75

R&D Progress 75

somatropin biobetter-Drug Profile 76

Product Description 76

Mechanism of Action 76

R&D Progress 76

somatropin biosimilar-Drug Profile 77

Product Description 77

Mechanism of Action 77

R&D Progress 77

somatropin biosimilar-Drug Profile 79

Product Description 79

Mechanism of Action 79

R&D Progress 79

somatropin pegol-Drug Profile 80

Product Description 80

Mechanism of Action 80

R&D Progress 80

somatropin SR-Drug Profile 81

Product Description 81

Mechanism of Action 81

R&D Progress 81

somatropin true patch-Drug Profile 83

Product Description 83

Mechanism of Action 83

R&D Progress 83

SYN-20100504RU-Drug Profile 84

Product Description 84

Mechanism of Action 84

R&D Progress 84

Vaccine for Growth Hormone Deficiencies-Drug Profile 85

Product Description 85

Mechanism of Action 85

R&D Progress 85

XL-020-Drug Profile 86

Product Description 86

Mechanism of Action 86

R&D Progress 86

Growth Hormone Deficiency-Recent Pipeline Updates 87

Growth Hormone Deficiency -Dormant Projects 100

Growth Hormone Deficiency-Discontinued Products 101

Growth Hormone Deficiency-Product Development Milestones 102

Featured News & Press Releases 102

Dec 29, 2014: Versartis to Hold Conference Call to Discuss VRS-317 Clinical Update From Ongoing Extension Study 102

Dec 15, 2014: Ascendis Pharma Announces Positive Six-Month Interim Results from a Phase 2 Pediatric Study of Once-Weekly TransCon Growth Hormone for the Treatment of Growth Hormone Deficiency 102

Oct 30, 2014: Versartis Schedules Conference Call to Discuss Plans for Phase 3 Trial for VRS-317 in Pediatric Growth Hormone Deficiency Patients 103

Sep 18, 2014: Prometheon's CEO/CSO Invited to Deliver Oral Presentation at the European Society for Paediatric Endocrinology Meeting 104

Sep 16, 2014: Ascendis Pharma A/S Announces Positive Interim Results from a Phase 2 Pediatric Study of Once-Weekly TransCon Growth Hormone for the Treatment of Growth Hormone Deficiency 104

Sep 11, 2014: Data Supporting Once-Weekly Dosing of hGH-CTP in Growth Hormone Deficient Pediatric Population to be Presented as a Late Breaking Presentation at the European Society of Paediatric Endocrinology Conference 105

Jun 30, 2014: Amunix Congratulates Versartis on Its Positive Phase 2a Results With VRS-317 105

Jun 27, 2014: OPKO Granted Patent from European Patent Office for Lagova 106

Jun 25, 2014: Strong Data from Lagova Phase II Clinical Study Presented during Webcast 106

Jun 23, 2014: OPKO Announces Positive Interim Six-Month Lagova (hGH-CTP) Phase 2 Data in Pediatric Growth Hormone Deficiency Disorder 107

Appendix 109

Methodology 109

Coverage 109

Secondary Research 109

Primary Research 109

Expert Panel Validation 109

Contact Us 110

Disclaimer 110

List of Tables

Number of Products under Development for Growth Hormone Deficiency, H1 2015 10

Number of Products under Development for Growth Hormone Deficiency-Comparative Analysis, H1 2015 11

Number of Products under Development by Companies, H1 2015 13

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

Comparative Analysis by Unknown Stage Development, H1 2015 18

Products under Development by Companies, H1 2015 19

Products under Development by Companies, H1 2015 (Contd..1) 20

Growth Hormone Deficiency-Pipeline by Aeterna Zentaris Inc., H1 2015 21

Growth Hormone Deficiency-Pipeline by Aileron Therapeutics, Inc., H1 2015 22

Growth Hormone Deficiency-Pipeline by Ascendis Pharma A/S, H1 2015 23

Growth Hormone Deficiency-Pipeline by Biogenomics Limited, H1 2015 24

Growth Hormone Deficiency-Pipeline by Bolder Biotechnology, Inc., H1 2015 25

Growth Hormone Deficiency-Pipeline by Braasch Biotech LLC, H1 2015 26

Growth Hormone Deficiency-Pipeline by CJ CheilJedang Corp., H1 2015 27

Growth Hormone Deficiency-Pipeline by Critical Pharmaceuticals Limited, H1 2015 28

Growth Hormone Deficiency-Pipeline by Delpor, Inc., H1 2015 29

Growth Hormone Deficiency-Pipeline by Emisphere Technologies, Inc., H1 2015 30

Growth Hormone Deficiency-Pipeline by Flamel Technologies S.A., H1 2015 31

Growth Hormone Deficiency-Pipeline by Genexine, Inc., H1 2015 32

Growth Hormone Deficiency-Pipeline by HanAll Biopharma Co., Ltd., H1 2015 33

Growth Hormone Deficiency-Pipeline by Hanmi Pharmaceuticals, Co. Ltd., H1 2015 34

Growth Hormone Deficiency-Pipeline by Inbiopro Solutions Pvt. Ltd., H1 2015 35

Growth Hormone Deficiency-Pipeline by LG Life Sciences, Ltd., H1 2015 36

Growth Hormone Deficiency-Pipeline by OPKO Health, Inc., H1 2015 37

Growth Hormone Deficiency-Pipeline by Pfenex Inc., H1 2015 38

Growth Hormone Deficiency-Pipeline by Prometheon Pharma, LLC, H1 2015 39

Growth Hormone Deficiency-Pipeline by Teva Pharmaceutical Industries Limited, H1 2015 40

Growth Hormone Deficiency-Pipeline by Versartis, Inc., H1 2015 41

Growth Hormone Deficiency-Pipeline by XL-protein GmbH, H1 2015 42

Assessment by Monotherapy Products, H1 2015 43

Number of Products by Stage and Target, H1 2015 45

Number of Products by Stage and Mechanism of Action, H1 2015 47

Number of Products by Stage and Route of Administration, H1 2015 49

Number of Products by Stage and Molecule Type, H1 2015 51

Growth Hormone Deficiency Therapeutics-Recent Pipeline Updates, H1 2015 87

Growth Hormone Deficiency-Dormant Projects, H1 2015 100

Growth Hormone Deficiency-Discontinued Products, H1 2015 101

List of Figures

Number of Products under Development for Growth Hormone Deficiency, H1 2015 10

Number of Products under Development for Growth Hormone Deficiency-Comparative Analysis, H1 2015 11

Number of Products under Development by Companies, H1 2015 12

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 43

Number of Products by Top 10 Targets, H1 2015 44

Number of Products by Stage and Top 10 Targets, H1 2015 44

Number of Products by Top 10 Mechanism of Actions, H1 2015 46

Number of Products by Stage and Top 10 Mechanism of Actions, H1 2015 47

Number of Products by Top 10 Routes of Administration, H1 2015 48

Number of Products by Stage and Top 10 Routes of Administration, H1 2015 49

Number of Products by Top 10 Molecule Types, H1 2015 50

Number of Products by Stage and Top 10 Molecule Types, H1 2015 51

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Aeterna Zentaris Inc.

Aileron Therapeutics, Inc.

Ascendis Pharma A/S

Biogenomics Limited

Bolder Biotechnology, Inc.

Braasch Biotech LLC

CJ CheilJedang Corp.

Critical Pharmaceuticals Limited

Delpor, Inc.

Emisphere Technologies, Inc.

Flamel Technologies S.A.

Genexine, Inc.

HanAll Biopharma Co., Ltd.

Hanmi Pharmaceuticals, Co. Ltd.

Inbiopro Solutions Pvt. Ltd.

LG Life Sciences, Ltd.

OPKO Health, Inc.

Pfenex Inc.

Prometheon Pharma, LLC

Teva Pharmaceutical Industries Limited

Versartis, Inc.

XL-protein GmbH

Growth Hormone Deficiency Therapeutic Products under Development, Key Players in Growth Hormone Deficiency Therapeutics, Growth Hormone Deficiency Pipeline Overview, Growth Hormone Deficiency Pipeline, Growth Hormone Deficiency Pipeline Assessment


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