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Growth Hormone Deficiency - Pipeline Review, H1 2014

Published By :

Global Markets Direct

Published Date : Mar 2014

Category :

Metabolic Disorders

No. of Pages : 115 Pages

Growth Hormone Deficiency Pipeline Review, H1 2014, provides an overview of the Growth Hormone Deficiencys 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 Directs 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 Directs 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 Directs 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.

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 Content

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
Growth Hormone Deficiency - Products under Development by Companies 18
Growth Hormone Deficiency - Companies Involved in Therapeutics Development 19
Teva Pharmaceutical Industries Limited 19
OPKO Health, Inc. 20
Access Pharmaceuticals, Inc. 21
Flamel Technologies S.A. 22
Emisphere Technologies, Inc. 23
Theratechnologies Inc. 24
HanAll Biopharma Co., Ltd. 25
LG Life Sciences, Ltd. 26
CJ CheilJedang Corp. 27
Critical Pharmaceuticals Limited 28
Aileron Therapeutics, Inc. 29
Ambrx, Inc. 30
Braasch Biotech LLC 31
Phage Pharmaceuticals, Inc. 32
Versartis, Inc. 33
Bolder Biotechnology, Inc. 34
PharmaEssentia Corporation 35
Ascendis Pharma A/S 36
Pfenex Inc. 37
Delpor, Inc. 38
Inbiopro Solutions Pvt. Ltd. 39
SynBio LLC 40
Biogenomics 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 49
Assessment by Molecule Type 51
Drug Profiles 53
somatropin SR - Drug Profile 53
Product Description 53
Mechanism of Action 53
R&D Progress 53
somatropin SR - Drug Profile 55
Product Description 55
Mechanism of Action 55
R&D Progress 55
MOD-4023 - Drug Profile 57
Product Description 57
Mechanism of Action 57
R&D Progress 57
somatropin - Drug Profile 59
Product Description 59
Mechanism of Action 59
R&D Progress 59
tesamorelin acetate - Drug Profile 61
Product Description 61
Mechanism of Action 61
R&D Progress 61
MOD-4023 - Drug Profile 64
Product Description 64
Mechanism of Action 64
R&D Progress 64
ARX-201 - Drug Profile 66
Product Description 66
Mechanism of Action 66
R&D Progress 66
ACP-001 - Drug Profile 67
Product Description 67
Mechanism of Action 67
R&D Progress 67
TV-1106 - Drug Profile 68
Product Description 68
Mechanism of Action 68
R&D Progress 68
SYN-20100504RU - 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
HL-032 - Drug Profile 75
Product Description 75
Mechanism of Action 75
R&D Progress 75
somatropin - Drug Profile 77
Product Description 77
Mechanism of Action 77
R&D Progress 77
ALRN-5281 - Drug Profile 78
Product Description 78
Mechanism of Action 78
R&D Progress 78
somatropin biobetter - Drug Profile 79
Product Description 79
Mechanism of Action 79
R&D Progress 79
CP-016 - Drug Profile 80
Product Description 80
Mechanism of Action 80
R&D Progress 80
CobOral hGH - Drug Profile 81
Product Description 81
Mechanism of Action 81
R&D Progress 81
BBT-031 - Drug Profile 82
Product Description 82
Mechanism of Action 82
R&D Progress 82
somatropin biosimilar - Drug Profile 83
Product Description 83
Mechanism of Action 83
R&D Progress 83
IBPB-003-HH - Drug Profile 84
Product Description 84
Mechanism of Action 84
R&D Progress 84
somatropin biosimilar - Drug Profile 85
Product Description 85
Mechanism of Action 85
R&D Progress 85
Vaccine For Growth Hormone Deficiencies - Drug Profile 86
Product Description 86
Mechanism of Action 86
R&D Progress 86
xl-020 - Drug Profile 87
Product Description 87
Mechanism of Action 87
R&D Progress 87
CJ-40002 - Drug Profile 88
Product Description 88
Mechanism of Action 88
R&D Progress 88
Pegylated Growth Hormone - Drug Profile 89
Product Description 89
Mechanism of Action 89
R&D Progress 89
somatropin - Drug Profile 90
Product Description 90
Mechanism of Action 90
R&D Progress 90
Growth Hormone Deficiency - Recent Pipeline Updates 91
Growth Hormone Deficiency - Dormant Projects 105
Growth Hormone Deficiency - Discontinued Products 106
Growth Hormone Deficiency - Product Development Milestones 107
Featured News & Press Releases 107
Jan 06, 2014: Aeterna Zentaris NDA for Macimorelin Acetate in AGHD Accepted for Filing by the FDA 107
Dec 18, 2013: US FDA Grants Orphan Drug Designation to Versartis\' Treatment for Growth Hormone Deficiency 107
Nov 05, 2013: Aeterna Zentaris Submits New Drug Application to FDA for Macimorelin Acetate for Evaluation of AGHD 108
Sep 22, 2013: Versartis Presents Latest Positive Results From Its Pediatric Study of Long-Acting Growth Hormone Treatment at International Endocrinology Conference 108
Sep 19, 2013: Ascendis Pharma initiates dosing of its once-weekly human growth hormone product in a Phase 2 pediatric clinical study 109
Sep 13, 2013: Versartis Receives Orphan Drug Status for Its Novel Long-Acting Growth Hormone Treatment From European Commission 110
Jun 16, 2013: Versartis Presents Positive Results From First Pediatric Clinical Study Of VRS-317 At ENDO 2013 Annual Meeting 111
Jun 13, 2013: Prolor Biotech To Present New Data On Its Long-acting Human Growth Hormone At ENDO 2013 112
Jun 04, 2013: Prolor Biotech Initiates Pivotal Phase III Trial Of Its Longer-acting Version Of Human Growth Hormone 112
May 31, 2013: Biopartners Announces Positive CHMP Opinion For Once-Weekly Somatropin Biopartners 113

Appendix 114
Methodology 114
Coverage 114
Secondary Research 114
Primary Research 114
Expert Panel Validation 114
Contact Us 115
Disclaimer 115

List of Table


Number of Products under Development for Growth Hormone Deficiency, H1 2014 10
Number of Products under Development for Growth Hormone Deficiency - Comparative Analysis, H1 2014 11
Number of Products under Development by Companies, H1 2014 13
Number of Products under Development by Companies, H1 2014 (Contd..1) 14
Comparative Analysis by Late Stage Development, H1 2014 15
Comparative Analysis by Clinical Stage Development, H1 2014 16
Comparative Analysis by Early Stage Development, H1 2014 17
Products under Development by Companies, H1 2014 18
Growth Hormone Deficiency - Pipeline by Teva Pharmaceutical Industries Limited, H1 2014 19
Growth Hormone Deficiency - Pipeline by OPKO Health, Inc., H1 2014 20
Growth Hormone Deficiency - Pipeline by Access Pharmaceuticals, Inc., H1 2014 21
Growth Hormone Deficiency - Pipeline by Flamel Technologies S.A., H1 2014 22
Growth Hormone Deficiency - Pipeline by Emisphere Technologies, Inc., H1 2014 23
Growth Hormone Deficiency - Pipeline by Theratechnologies Inc., H1 2014 24
Growth Hormone Deficiency - Pipeline by HanAll Biopharma Co., Ltd., H1 2014 25
Growth Hormone Deficiency - Pipeline by LG Life Sciences, Ltd., H1 2014 26
Growth Hormone Deficiency - Pipeline by CJ CheilJedang Corp., H1 2014 27
Growth Hormone Deficiency - Pipeline by Critical Pharmaceuticals Limited, H1 2014 28
Growth Hormone Deficiency - Pipeline by Aileron Therapeutics, Inc., H1 2014 29
Growth Hormone Deficiency - Pipeline by Ambrx, Inc., H1 2014 30
Growth Hormone Deficiency - Pipeline by Braasch Biotech LLC, H1 2014 31
Growth Hormone Deficiency - Pipeline by Phage Pharmaceuticals, Inc., H1 2014 32
Growth Hormone Deficiency - Pipeline by Versartis, Inc., H1 2014 33
Growth Hormone Deficiency - Pipeline by Bolder Biotechnology, Inc., H1 2014 34
Growth Hormone Deficiency - Pipeline by PharmaEssentia Corporation, H1 2014 35
Growth Hormone Deficiency - Pipeline by Ascendis Pharma A/S, H1 2014 36
Growth Hormone Deficiency - Pipeline by Pfenex Inc., H1 2014 37
Growth Hormone Deficiency - Pipeline by Delpor, Inc., H1 2014 38
Growth Hormone Deficiency - Pipeline by Inbiopro Solutions Pvt. Ltd., H1 2014 39
Growth Hormone Deficiency - Pipeline by SynBio LLC, H1 2014 40
Growth Hormone Deficiency - Pipeline by Biogenomics, H1 2014 41
Growth Hormone Deficiency - Pipeline by XL-protein GmbH, H1 2014 42
Assessment by Monotherapy Products, H1 2014 43
Number of Products by Stage and Target, H1 2014 45
Number of Products by Stage and Mechanism of Action, H1 2014 48
Number of Products by Stage and Route of Administration, H1 2014 50
Number of Products by Stage and Molecule Type, H1 2014 52
Growth Hormone Deficiency Therapeutics - Recent Pipeline Updates, H1 2014 91
Growth Hormone Deficiency - Dormant Projects, H1 2014 105
Growth Hormone Deficiency - Discontinued Products, H1 2014 106

List of Chart


Number of Products under Development for Growth Hormone Deficiency, H1 2014 10
Number of Products under Development for Growth Hormone Deficiency - Comparative Analysis, H1 2014 11
Number of Products under Development by Companies, H1 2014 12
Comparative Analysis by Late Stage Development, H1 2014 15
Comparative Analysis by Clinical Stage Development, H1 2014 16
Comparative Analysis by Early Stage Products, H1 2014 17
Assessment by Monotherapy Products, H1 2014 43
Number of Products by Top 10 Target, H1 2014 44
Number of Products by Stage and Top 10 Target, H1 2014 45
Number of Products by Top 10 Mechanism of Action, H1 2014 46
Number of Products by Stage and Top 10 Mechanism of Action, H1 2014 47
Number of Products by Top 10 Route of Administration, H1 2014 49
Number of Products by Stage and Top 10 Route of Administration, H1 2014 50
Number of Products by Top 10 Molecule Type, H1 2014 51
Number of Products by Stage and Top 10 Molecule Type, H1 2014 52

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