Muscle Wasting Disorders ' Pipeline Review, H1 2013

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Muscle Wasting Disorders ' Pipeline Review, H1 2013
Published on February 2013

Report Summary


Summary

Global Markets Direct's, 'Muscle Wasting Disorders - Pipeline Review, H1 2013', provides an overview of the indication's therapeutic
pipeline. This report provides information on the therapeutic development for Muscle Wasting Disorders, complete with latest updates,
and special features on late-stage and discontinued projects. It also reviews key players involved in the therapeutic development for
Muscle Wasting Disorders. Muscle Wasting Disorders - 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 Muscle Wasting Disorders.
- A review of the Muscle Wasting Disorders 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 Muscle Wasting Disorders 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 Muscle Wasting Disorders.
- 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 Muscle Wasting Disorders 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.

Muscle Wasting Disorders ' Pipeline Review, H1 2013 (From Slideshare) Page 1/10


Table of Content

Table of Contents

Table of Contents 2
List of Tables 8
List of Figures 9
Introduction 10
Global Markets Direct Report Coverage 10
Muscle Wasting Disorders Overview 11
Therapeutics Development 12
An Overview of Pipeline Products for Muscle Wasting Disorders 12
Muscle Wasting Disorders Therapeutics under Development by Companies 14
Muscle Wasting Disorders Therapeutics under Investigation by Universities/Institutes 17
Late Stage Products 18
Comparative Analysis 18
Mid Clinical Stage Products 19
Early Clinical Stage Products 20
Discovery and Pre-Clinical Stage Products 21
Muscle Wasting Disorders Therapeutics ' Products under Development by Companies 22
Muscle Wasting Disorders Therapeutics ' Products under Investigation by Universities/Institutes 25
Companies Involved in Muscle Wasting Disorders Therapeutics Development 26
Amgen Inc. 26
Eli Lilly and Company 27
GlaxoSmithKline plc 28
BioLineRx, Ltd. 29
Novartis AG 30
Aphios Corporation 31
GTx, Inc. 32
Rigel Pharmaceuticals, Inc. 33
AEterna Zentaris Inc. 34
Ligand Pharmaceuticals Incorporated 35
Calzada Limited 36
Palatin Technologies, Inc. 37
Cytokinetics, Inc 38
Santhera Pharmaceuticals Holding AG 39
Asubio Pharmaceuticals, Inc. 40
Helsinn Healthcare S.A. 41
AnaptysBio, Inc. 42
Alder Biopharmaceuticals Inc. 43
KangLaiTe USA 44
Fate Therapeutics, Inc. 45
Elixir Pharmaceuticals, Inc. 46



Vicus Therapeutics, LLC 47
OHR Pharmaceutical Inc. 48
Progenra, Inc. 49
XBiotech USA, Inc. 50
Acacia Pharma Ltd. 51
Rhythm Pharmaceuticals 52
Muscle Wasting Disorders ' Therapeutics Assessment 53
Assessment by Monotherapy Products 53
Assessment by Combination Products 54
Assessment by Route of Administration 55
Assessment by Molecule Type 57
Drug Profiles 59
SUN-11031 - Drug Profile 59
Product Description 59
Mechanism of Action 59
R&D Progress 59
macimorelin - Drug Profile 61
R&D Progress 61
AMG-745 - Drug Profile 63
R&D Progress 63
enobosarm - Drug Profile 64
R&D Progress 64
RM-131 - Drug Profile 66
R&D Progress 66
BL-5040 - Drug Profile 68
R&D Progress 68
dronabinol - Drug Profile 69
R&D Progress 69
clazakizumab - Drug Profile 70
R&D Progress 70
EX-1314 - Drug Profile 72
R&D Progress 72



LGD-4033 - Drug Profile 74
R&D Progress 74
AOD-9604 - Drug Profile 76
R&D Progress 76
Kanglaite - Drug Profile 78
R&D Progress 78
anamorelin hydrochloride - Drug Profile 80
R&D Progress 80
anamorelin hydrochloride - Drug Profile 82
R&D Progress 82
(megestrol + formoterol) - Drug Profile 84
R&D Progress 84
(etodolac + propranolol) - Drug Profile 85
R&D Progress 85
GDF8 inhibitor - Drug Profile 87
R&D Progress 87
OHR/AVR-118 - Drug Profile 88
R&D Progress 88
(etodolac + propranolol hydrochloride) + [sorafenib] - Drug Profile 90
R&D Progress 90
MT-102 - Drug Profile 91
R&D Progress 91
LY-2495655 - Drug Profile 93
R&D Progress 93



CK-2066260 - Drug Profile 94
R&D Progress 94
FT-301 - Drug Profile 95
R&D Progress 95
UX-001 SA-ER - Drug Profile 96
R&D Progress 96
BYM-338 - Drug Profile 97
R&D Progress 97
Drug For Cachexia - Drug Profile 99
R&D Progress 99
Drug For Cancer Cachexia - Drug Profile 100
R&D Progress 100
ANA-012 - Drug Profile 101
R&D Progress 101
mirtazapine + megestrol acetate - Drug Profile 102
R&D Progress 102
Ghrelin Receptor Agonists - Drug Profile 103
R&D Progress 103
Drug Targeting PIFR - Drug Profile 104
R&D Progress 104
CK-2127107 - Drug Profile 105
R&D Progress 105
PLX-4720 - Drug Profile 106
R&D Progress 106



GSK-2849466 - Drug Profile 107
R&D Progress 107
Xilonix - Drug Profile 108
R&D Progress 108
SNT-207707 - Drug Profile 109
R&D Progress 109
SNT-209858 - Drug Profile 110
R&D Progress 110
Drugs For Cancer Cachexia - Drug Profile 111
R&D Progress 111
Drug Targeting USP19 - Drug Profile 112
R&D Progress 112
P-013222 - Drug Profile 113
R&D Progress 113
DLN-101 - Drug Profile 114
R&D Progress 114
Muscle Wasting Disorders Therapeutics ' Drug Profile Updates 115
Muscle Wasting Disorders Therapeutics ' Discontinued Products 130
Muscle Wasting Disorders Therapeutics - Dormant Products 131
Muscle Wasting Disorders ' Product Development Milestones 133
Featured News & Press Releases 133
Oct 29, 2012: GTx To Continue Phase III Clinical Development Of Enobosarm For Muscle Wasting In Lung Cancer Patients Following
Planned Safety Review 133
Oct 10, 2012: Ultragenyx Pharma Presents Three Abstracts Related To UX001 Sialic Acid Extended Release Tablets At 17th Annual
World Muscle Society Congress 133
Oct 08, 2012: GTx To Present Scientific Poster Presentations On Enobosarm At International Society Of Geriatric Oncology 134
Oct 03, 2012: XBiotech Receives Fast Track Designation From FDA For Anti-Cachexia Drug Xilonix 135
Oct 03, 2012: XBiotech Receives Fast Track Designation From FDA For Anti-Cachexia Drug Xilonix 135
Sep 17, 2012: GTx Announces Symposium And Presentation Of Data On Muscle Wasting In Non-Small Cell Lung Cancer Patients
136
Aug 28, 2012: Aeterna Zentaris Recruits First Patient For Phase IIA Trial In Cancer Cachexia With AEZS-130 136
Jul 05, 2012: Ultragenyx Pharma Initiates Phase II Study Of UX001 In Hereditary Inclusion Body Myopathy 137



Jun 26, 2012: GTx Announces Presentations On Effect Of Enobosarm On Improving Physical Function In Cancer Patients 138
Jun 25, 2012: GTx Announces Presentation On Enobosarm's Improvement In Physical Function In Cancer Patients With Both Low
And Normal Testosterone Levels 138
Appendix 140
Methodology 140
Coverage 140
Secondary Research 140
Primary Research 140
Expert Panel Validation 140
Contact Us 141
Disclaimer 141

List of Tables

Number of Products Under Development for Muscle Wasting Disorders, H1 2013 12
Products under Development for Muscle Wasting Disorders ' Comparative Analysis, H1 2013 13
Number of Products under Development by Companies, H1 2013 15
Number of Products under Development by Companies, H1 2013 (Contd..1) 16
Number of Products under Investigation by Universities/Institutes, H1 2013 17
Comparative Analysis by Late Stage Development, H1 2013 18
Comparative Analysis by Mid Clinical Stage Development, H1 2013 19
Comparative Analysis by Early Clinical Stage Development, H1 2013 20
Comparative Analysis by Discovery and Pre-Clinical Stage Development, H1 2013 21
Products under Development by Companies, H1 2013 22
Products under Development by Companies, H1 2013 (Contd..1) 23
Products under Development by Companies, H1 2013 (Contd..2) 24
Products under Investigation by Universities/Institutes, H1 2013 25
Amgen Inc., H1 2013 26
Eli Lilly and Company, H1 2013 27
GlaxoSmithKline plc, H1 2013 28
BioLineRx, Ltd., H1 2013 29
Novartis AG, H1 2013 30
Aphios Corporation, H1 2013 31
GTx, Inc., H1 2013 32
Rigel Pharmaceuticals, Inc., H1 2013 33
AEterna Zentaris Inc., H1 2013 34
Ligand Pharmaceuticals Incorporated, H1 2013 35
Calzada Limited, H1 2013 36
Palatin Technologies, Inc., H1 2013 37
Cytokinetics, Inc, H1 2013 38
Santhera Pharmaceuticals Holding AG, H1 2013 39
Asubio Pharmaceuticals, Inc., H1 2013 40
Helsinn Healthcare S.A., H1 2013 41
AnaptysBio, Inc., H1 2013 42
Alder Biopharmaceuticals Inc., H1 2013 43
KangLaiTe USA, H1 2013 44



Fate Therapeutics, Inc., H1 2013 45
Elixir Pharmaceuticals, Inc., H1 2013 46
Vicus Therapeutics, LLC, H1 2013 47
OHR Pharmaceutical Inc., H1 2013 48
Progenra, Inc., H1 2013 49
XBiotech USA, Inc., H1 2013 50
Acacia Pharma Ltd., H1 2013 51
Rhythm Pharmaceuticals, H1 2013 52
Assessment by Monotherapy Products, H1 2013 53
Assessment by Combination Products, H1 2013 54
Assessment by Stage and Route of Administration, H1 2013 56
Assessment by Stage and Molecule Type, H1 2013 58
Muscle Wasting Disorders Therapeutics ' Drug Profile Updates 115
Muscle Wasting Disorders Therapeutics ' Discontinued Products 130
Muscle Wasting Disorders Therapeutics ' Dormant Products 131
Muscle Wasting Disorders Therapeutics ' Dormant Products (Contd..1) 132

List of Figures

Number of Products under Development for Muscle Wasting Disorders, H1 2013 12
Products under Development for Muscle Wasting Disorders ' Comparative Analysis, H1 2013 13
Products under Development by Companies, H1 2013 14
Products under Investigation by Universities/Institutes, H1 2013 17
Late Stage Products, H1 2013 18
Mid Clinical Stage Products, H1 2013 19
Early Clinical Stage Products, H1 2013 20
Discovery and Pre-Clinical Stage Products, H1 2013 21
Assessment by Monotherapy Products, H1 2013 53
Assessment by Combination Products, H1 2013 54
Assessment by Route of Administration, H1 2013 55
Assessment by Stage and Route of Administration, H1 2013 56
Assessment by Molecule Type, H1 2013 57
Assessment by Stage and Molecule Type, H1 2013 58


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