Growth Hormone Deficiency ' Pipeline Review, H2 2012

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Growth Hormone Deficiency ' Pipeline Review, H2 2012
Published on September 2012

Report Summary


Summary

Global Markets Direct's, 'Growth Hormone Deficiency - Pipeline Review, H2 2012', provides an overview of the indication's
therapeutic pipeline. This report provides information on the therapeutic development for Growth Hormone Deficiency, complete with
latest updates, and special features on late-stage and discontinued projects. It also reviews key players involved in the therapeutic
development for Growth Hormone Deficiency. Growth Hormone Deficiency - Pipeline Review, Half Year 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.

Note*: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated
disease.

Scope

- A snapshot of the global therapeutic scenario for Growth Hormone Deficiency.
- 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.
- Coverage of products based on various stages of development ranging from discovery till registration stages.
- A feature on pipeline projects on the basis of monotherapy and combined therapeutics.
- Coverage of the Growth Hormone Deficiency pipeline on the basis of route of administration and molecule type.
- Key discontinued pipeline projects.
- Latest news and deals relating to the products.

Reasons to buy

- Identify and understand important and diverse types of therapeutics under development for Growth Hormone Deficiency.
- Identify emerging players with potentially strong product portfolio and design effective counter-strategies to gain competitive
advantage.
- Plan mergers and acquisitions effectively by identifying 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.

Growth Hormone Deficiency ' Pipeline Review, H2 2012 (From Slideshare) Page 1/8


Table of Content

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
An Overview of Pipeline Products for Growth Hormone Deficiency 10
Growth Hormone Deficiency Therapeutics under Development by Companies 12
Growth Hormone Deficiency Therapeutics under Investigation by Universities/Institutes 15
Late Stage Products 16
Comparative Analysis 16
Mid Clinical Stage Products 17
Early Clinical Stage Products 18
Discovery and Pre-Clinical Stage Products 19
Growth Hormone Deficiency Therapeutics ' Products under Development by Companies 20
Growth Hormone Deficiency Therapeutics ' Products under Investigation by Universities/Institutes 21
Companies Involved in Growth Hormone Deficiency Therapeutics Development 22
Ipsen S.A. 22
TransPharma Medical Ltd. 23
Zosano Pharma, Inc. 24
PROLOR Biotech, Inc. 25
Flamel Technologies S.A. 26
Emisphere Technologies, Inc. 27
Theratechnologies Inc. 28
Hanall Pharmaceutical Co., Ltd. 29
LG Life Sciences, Ltd 30
Critical Pharmaceuticals Limited 31
Ambrx, Inc. 32
Phage Biotechnology Corporation 33
Versartis, Inc. 34
Bolder Biotechnology, Inc. 35
PharmaEssentia Corporation 36
Ascendis Pharma A/S 37
Pfenex Inc. 38
Growth Hormone Deficiency ' Therapeutics Assessment 39
Assessment by Monotherapy Products 39
Assessment by Combination Products 40
Assessment by Route of Administration 41
Assessment by Molecule Type 43



Drug Profiles 45
somatropin - Drug Profile 45
Product Description 45
Mechanism of Action 45
R&D Progress 45
LB-03002 - Drug Profile 46
R&D Progress 46
LB-03002 - Drug Profile 48
R&D Progress 48
tesamorelin acetate - Drug Profile 50
R&D Progress 50
Oral Recombinant Human Growth Hormone Program - Drug Profile 53
R&D Progress 53
MOD-4023 - Drug Profile 54
R&D Progress 54
PEGylated somatotropin - Drug Profile 56
R&D Progress 56
ARX-201 - Drug Profile 57
R&D Progress 57
VRS-317 - Drug Profile 59
R&D Progress 59
VRS-317 - Drug Profile 60
R&D Progress 60
syntropin - Drug Profile 62
R&D Progress 62
ACP-001 - Drug Profile 64



R&D Progress 64
Vitatropin - Drug Profile 65
R&D Progress 65
Genotropin - Drug Profile 67
R&D Progress 67
Growth Hormone Replacement - Drug Profile 68
R&D Progress 68
R&D Progress 69
Increlex + Nutropin AQ - Drug Profile 71
R&D Progress 71
R&D Progress 72
somatotropin - Drug Profile 74
R&D Progress 74
R&D Progress 75
BBT-031 - Drug Profile 76
R&D Progress 76
Human Growth Hormone - Drug Profile 78
R&D Progress 78
GRF Analog - Drug Profile 79
R&D Progress 79
Growth Hormone Deficiency Therapeutics ' Drug Profile Updates 80
Growth Hormone Deficiency Therapeutics ' Discontinued Products 89
Growth Hormone Deficiency Therapeutics - Dormant Products 90



Growth Hormone Deficiency ' Product Development Milestones 91
Featured News & Press Releases 91
Jun 26, 2012: Aeterna Zentaris Presents Final Phase III Results For AEZS-130 In Adult Growth Hormone Deficiency At ENDO
Meeting 91
Jun 26, 2012: Prolor Biotech Reports Presention Of Phase II Trial Data Of Human Growth Hormone At Endo 2012 91
Jun 25, 2012: Versartis Presents Positive Results From Phase I Study Of VRS-317 At ENDO 2012 92
Jun 14, 2012: Aeterna Zentaris Presents Phase III Results Of AEZS-130 At Upcoming ENDO Meeting 93
Jun 07, 2012: Versartis Announces Publication Of Preclinical Data Of VRS-317 In Journal Of Pharmaceutical Sciences 94
May 07, 2012: Prolor Biotech Announces Top-Line Results From Four-Month Treatment Extension Of Long-Acting Human Growth
Hormone Phase II Trial 94
Mar 20, 2012: PROLOR Initiates Phase II Trial Of Its Long-Acting Human Growth Hormone In Children With Growth Hormone
Deficiency 95
Jan 18, 2012: PROLOR Announces Positive Results From Post-Phase II Pilot Study Of Long-Acting Human Growth Hormone 96
Oct 03, 2011: PROLOR Receives Notice Of Allowance For Patent Application Covering CTP-Enhanced Fuman Growth Hormone 96
Sep 27, 2011: Biopartners And LG Life Sciences Present Positive Phase III, 24 Months Efficacy And Safety Data For LB03002 Given
To Children With Growth Hormone Deficiency 97
Appendix 98
Methodology 98
Coverage 98
Secondary Research 98
Primary Research 98
Expert Panel Validation 98
Contact Us 99
Disclaimer 99

List of Tables

Number of Products Under Development for Growth Hormone Deficiency, H2 2012 10
Products under Development for Growth Hormone Deficiency ' Comparative Analysis, H2 2012 11
Number of Products under Development by Companies, H2 2012 13
Number of Products under Development by Companies, H2 2012 (Contd..1) 14
Number of Products under Investigation by Universities/Institutes, H2 2012 15
Comparative Analysis by Late Stage Development, H2 2012 16
Comparative Analysis by Mid Clinical Stage Development, H2 2012 17
Comparative Analysis by Early Clinical Stage Development, H2 2012 18
Comparative Analysis by Discovery and Pre-Clinical Stage Development, H2 2012 19
Products under Development by Companies, H2 2012 20
Products under Investigation by Universities/Institutes, H2 2012 21
Ipsen S.A., H2 2012 22
TransPharma Medical Ltd., H2 2012 23
Zosano Pharma, Inc., H2 2012 24
PROLOR Biotech, Inc., H2 2012 25
Flamel Technologies S.A., H2 2012 26
Emisphere Technologies, Inc., H2 2012 27
Theratechnologies Inc., H2 2012 28
Hanall Pharmaceutical Co., Ltd., H2 2012 29
LG Life Sciences, Ltd, H2 2012 30
Critical Pharmaceuticals Limited, H2 2012 31



Ambrx, Inc., H2 2012 32
Phage Biotechnology Corporation, H2 2012 33
Versartis, Inc., H2 2012 34
Bolder Biotechnology, Inc., H2 2012 35
PharmaEssentia Corporation, H2 2012 36
Ascendis Pharma A/S, H2 2012 37
Pfenex Inc., H2 2012 38
Assessment by Monotherapy Products, H2 2012 39
Assessment by Combination Products, H2 2012 40
Assessment by Stage and Route of Administration, H2 2012 42
Assessment by Stage and Molecule Type, H2 2012 44
Growth Hormone Deficiency Therapeutics ' Drug Profile Updates 80
Growth Hormone Deficiency Therapeutics ' Discontinued Products 89
Growth Hormone Deficiency Therapeutics ' Dormant Products 90

List of Figures

Number of Products under Development for Growth Hormone Deficiency, H2 2012 10
Products under Development for Growth Hormone Deficiency ' Comparative Analysis, H2 2012 11
Products under Development by Companies, H2 2012 12
Products under Investigation by Universities/Institutes, H2 2012 15
Late Stage Products, H2 2012 16
Mid Clinical Stage Products, H2 2012 17
Early Clinical Stage Products, H2 2012 18
Discovery and Pre-Clinical Stage Products, H2 2012 19
Assessment by Monotherapy Products, H2 2012 39
Assessment by Combination Products, H2 2012 40
Assessment by Route of Administration, H2 2012 41
Assessment by Stage and Route of Administration, H2 2012 42
Assessment by Molecule Type, H2 2012 43
Assessment by Stage and Molecule Type, H2 2012 44


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