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  4. > Growth Hormone Deficiency - Pipeline Review, H2 2015

Growth Hormone Deficiency - Pipeline Review, H2 2015

  • October 2015
  • -
  • Global Markets Direct
  • -
  • 111 pages

Growth Hormone Deficiency - Pipeline Review, H2 2015

Summary

Global Markets Direct’s, ‘Growth Hormone Deficiency - Pipeline Review, H2 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

Growth Hormone Deficiency - Pipeline Review, H2 2015
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 20
Aeterna Zentaris Inc. 20
Aileron Therapeutics, Inc. 21
Ascendis Pharma A/S 22
Biogenomics Limited 23
Bolder Biotechnology, Inc. 24
Braasch Biotech LLC 25
Carlina Technologies SAS 26
Critical Pharmaceuticals Limited 27
Delpor, Inc. 28
Flamel Technologies S.A. 29
Genexine, Inc. 30
HanAll Biopharma Co., Ltd. 31
Hanmi Pharmaceuticals, Co. Ltd. 32
Inbiopro Solutions Pvt. Ltd. 33
JCR Pharmaceuticals Co., Ltd. 34
LG Life Sciences Limited 35
OPKO Health, Inc. 36
Pfenex Inc. 37
Prometheon Pharma, LLC 38
Teva Pharmaceutical Industries Limited 39
Versartis, Inc. 40
XL-protein GmbH 41
Growth Hormone Deficiency - Therapeutics Assessment 42
Assessment by Monotherapy Products 42
Assessment by Target 43
Assessment by Mechanism of Action 45
Assessment by Route of Administration 47
Assessment by Molecule Type 49
Drug Profiles 51
ACP-001 - Drug Profile 51
Product Description 51
Mechanism of Action 51
RandD Progress 51
albutropin - Drug Profile 53
Product Description 53
Mechanism of Action 53
RandD Progress 53
ALRN-5281 - Drug Profile 54
Product Description 54
Mechanism of Action 54
RandD Progress 54
BBT-031 - Drug Profile 56
Product Description 56
Mechanism of Action 56
RandD Progress 56
CP-016 SR - Drug Profile 57
Product Description 57
Mechanism of Action 57
RandD Progress 57
CP-024 - Drug Profile 58
Product Description 58
Mechanism of Action 58
RandD Progress 58
GXH-9 - Drug Profile 59
Product Description 59
Mechanism of Action 59
RandD Progress 59
HL-032 - Drug Profile 60
Product Description 60
Mechanism of Action 60
RandD Progress 60
HM-10560A - Drug Profile 62
Product Description 62
Mechanism of Action 62
RandD Progress 62
IBPB-003HH - Drug Profile 63
Product Description 63
Mechanism of Action 63
RandD Progress 63
macimorelin acetate - Drug Profile 64
Product Description 64
Mechanism of Action 64
RandD Progress 64
MOD-4023 - Drug Profile 66
Product Description 66
Mechanism of Action 66
RandD Progress 66
Pegylated Somatropin - Drug Profile 68
Product Description 68
Mechanism of Action 68
RandD Progress 68
somatotropin SR - Drug Profile 69
Product Description 69
Mechanism of Action 69
RandD Progress 69
somatotropin SR - Drug Profile 70
Product Description 70
Mechanism of Action 70
RandD Progress 70
somatropin - Drug Profile 71
Product Description 71
Mechanism of Action 71
RandD Progress 71
somatropin - Drug Profile 73
Product Description 73
Mechanism of Action 73
RandD Progress 73
somatropin - Drug Profile 74
Product Description 74
Mechanism of Action 74
RandD Progress 74
somatropin - Drug Profile 75
Product Description 75
Mechanism of Action 75
RandD Progress 75
somatropin biobetter - Drug Profile 76
Product Description 76
Mechanism of Action 76
RandD Progress 76
somatropin biobetter - Drug Profile 77
Product Description 77
Mechanism of Action 77
RandD Progress 77
somatropin pegol - Drug Profile 78
Product Description 78
Mechanism of Action 78
RandD Progress 78
somatropin SR - Drug Profile 79
Product Description 79
Mechanism of Action 79
RandD Progress 79
somavaratan - Drug Profile 81
Product Description 81
Mechanism of Action 81
RandD Progress 81
Vaccine for Growth Hormone Deficiencies - Drug Profile 83
Product Description 83
Mechanism of Action 83
RandD Progress 83
XL-020 - Drug Profile 84
Product Description 84
Mechanism of Action 84
RandD Progress 84
Growth Hormone Deficiency - Recent Pipeline Updates 85
Growth Hormone Deficiency - Dormant Projects 101
Growth Hormone Deficiency - Discontinued Products 102
Growth Hormone Deficiency - Product Development Milestones 103
Featured News and Press Releases 103
Oct 01, 2015: Versartis Presents Confirmatory 18-Month Data From Ongoing Somavaratan Extension Study at Late-Breaker Session at ESPE Annual Meeting 103
Sep 18, 2015: Versartis Announces Confirmatory 18-Month Data From Ongoing Extension Study of Somavaratan in GHD Children 104
Sep 10, 2015: Versartis Initiates Phase 2 Trial of Monthly Somavaratan in Adults With Growth Hormone Deficiency 105
Sep 08, 2015: Versartis Announces Agenda and Event Details for Investor Symposium Featuring Global Opinion Leaders in Pediatric Human Growth Hormone Deficiency 105
Aug 05, 2015: Two Reports on hGH-CTP Pediatric Phase 2 Clinical Data Accepted for Oral Presentation at the 54th Annual Meeting of the European Society for Paediatric Endocrinology 106
Aug 04, 2015: Versartis Abstract Accepted for Late-Breaker Presentation at the 54th Annual Meeting of the European Society for Paediatric Endocrinology 106
Jul 30, 2015: Ascendis Pharma Announces Positive Top-line Results from a Phase 2 Pediatric Study of Once-Weekly TransCon Growth Hormone for the Treatment of Growth Hormone Deficiency 107
Jul 10, 2015: Opko Announces Completion Of Enrollment In Phase 3 Trial Of Hgh-Ctp In Growth Hormone Deficient Adults 108
Jul 06, 2015: Versartis Announces Removal of FDA Partial Clinical Hold and Continuation of VRS-317 Phase 3 Clinical Trial 108
Jun 25, 2015: Aeterna Zentaris Announces Selection of Ergomed to Conduct Confirmatory Phase 3 Clinical Trial of Macrilen in AGHD 109
Appendix 110
Methodology 110
Coverage 110
Secondary Research 110
Primary Research 110
Expert Panel Validation 110
Contact Us 110
Disclaimer 111

List of Tables
Number of Products under Development for Growth Hormone Deficiency, H2 2015 10
Number of Products under Development for Growth Hormone Deficiency - Comparative Analysis, H2 2015 11
Number of Products under Development by Companies, H2 2015 13
Number of Products under Development by Companies, H2 2015 (Contd..1) 14
Comparative Analysis by Late Stage Development, H2 2015 15
Comparative Analysis by Clinical Stage Development, H2 2015 16
Comparative Analysis by Early Stage Development, H2 2015 17
Comparative Analysis by Unknown Stage Development, H2 2015 18
Products under Development by Companies, H2 2015 19
Growth Hormone Deficiency - Pipeline by Aeterna Zentaris Inc., H2 2015 20
Growth Hormone Deficiency - Pipeline by Aileron Therapeutics, Inc., H2 2015 21
Growth Hormone Deficiency - Pipeline by Ascendis Pharma A/S, H2 2015 22
Growth Hormone Deficiency - Pipeline by Biogenomics Limited, H2 2015 23
Growth Hormone Deficiency - Pipeline by Bolder Biotechnology, Inc., H2 2015 24
Growth Hormone Deficiency - Pipeline by Braasch Biotech LLC, H2 2015 25
Growth Hormone Deficiency - Pipeline by Carlina Technologies SAS, H2 2015 26
Growth Hormone Deficiency - Pipeline by Critical Pharmaceuticals Limited, H2 2015 27
Growth Hormone Deficiency - Pipeline by Delpor, Inc., H2 2015 28
Growth Hormone Deficiency - Pipeline by Flamel Technologies S.A., H2 2015 29
Growth Hormone Deficiency - Pipeline by Genexine, Inc., H2 2015 30
Growth Hormone Deficiency - Pipeline by HanAll Biopharma Co., Ltd., H2 2015 31
Growth Hormone Deficiency - Pipeline by Hanmi Pharmaceuticals, Co. Ltd., H2 2015 32
Growth Hormone Deficiency - Pipeline by Inbiopro Solutions Pvt. Ltd., H2 2015 33
Growth Hormone Deficiency - Pipeline by JCR Pharmaceuticals Co., Ltd., H2 2015 34
Growth Hormone Deficiency - Pipeline by LG Life Sciences Limited, H2 2015 35
Growth Hormone Deficiency - Pipeline by OPKO Health, Inc., H2 2015 36
Growth Hormone Deficiency - Pipeline by Pfenex Inc., H2 2015 37
Growth Hormone Deficiency - Pipeline by Prometheon Pharma, LLC, H2 2015 38
Growth Hormone Deficiency - Pipeline by Teva Pharmaceutical Industries Limited, H2 2015 39
Growth Hormone Deficiency - Pipeline by Versartis, Inc., H2 2015 40
Growth Hormone Deficiency - Pipeline by XL-protein GmbH, H2 2015 41
Assessment by Monotherapy Products, H2 2015 42
Number of Products by Stage and Target, H2 2015 44
Number of Products by Stage and Mechanism of Action, H2 2015 46
Number of Products by Stage and Route of Administration, H2 2015 48
Number of Products by Stage and Molecule Type, H2 2015 50
Growth Hormone Deficiency Therapeutics - Recent Pipeline Updates, H2 2015 85
Growth Hormone Deficiency - Dormant Projects, H2 2015 101
Growth Hormone Deficiency - Discontinued Products, H2 2015 102

List of Figures
Number of Products under Development for Growth Hormone Deficiency, H2 2015 10
Number of Products under Development for Growth Hormone Deficiency - Comparative Analysis, H2 2015 11
Number of Products under Development by Companies, H2 2015 12
Comparative Analysis by Late Stage Development, H2 2015 15
Comparative Analysis by Clinical Stage Development, H2 2015 16
Comparative Analysis by Early Stage Products, H2 2015 17
Assessment by Monotherapy Products, H2 2015 42
Number of Products by Top 10 Targets, H2 2015 43
Number of Products by Stage and Top 10 Targets, H2 2015 43
Number of Products by Top 10 Mechanism of Actions, H2 2015 45
Number of Products by Stage and Top 10 Mechanism of Actions, H2 2015 45
Number of Products by Top 10 Routes of Administration, H2 2015 47
Number of Products by Stage and Top 10 Routes of Administration, H2 2015 47
Number of Products by Top 10 Molecule Types, H2 2015 49
Number of Products by Stage and Top 10 Molecule Types, H2 2015 49

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