Gouty Arthritis (Gout) – Pipeline Review, H2 2011
Gouty Arthritis (Gout) - Pipeline Review, H2 2011
Reference Code: GMDHC1383IDB
Publication Date: September 2011
Gouty Arthritis (Gout) – Pipeline Review, H2 2011 GMDHC1383IDB / Pub September 2011
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Gouty Arthritis (Gout) – Pipeline Review, H2 2011
Ta b le o f Co n te n ts
Table of Contents 2
List of Tables 6
List of Figures 7
Introduction 8
Global Markets Direct Report Coverage 8
Gouty Arthritis (Gout) Overview 9
Therapeutics Development 10
An Overview of Pipeline Products for Gouty Arthritis (Gout) 10
Gouty Arthritis (Gout) Therapeutics under Development by Companies 12
Gouty Arthritis (Gout) Therapeutics under Investigation by Universities/Institutes 14
Late Stage Products 15
Comparative Analysis 15
Mid Clinical Stage Products 16
Comparative Analysis 16
Early Clinical Stage Products 17
Comparative Analysis 17
Discovery and Pre-Clinical Stage Products 18
Comparative Analysis 18
Gouty Arthritis (Gout) Therapeutics - Products under Development by Companies 19
Gouty Arthritis (Gout) Therapeutics - Products under Investigation by Universities/Institutes 21
Companies Involved in Gouty Arthritis (Gout) Therapeutics Development 22
Novartis AG 22
Mitsubishi Tanabe Pharma Corporation 22
Savient Pharmaceuticals, Inc. 23
3SBio Inc. 23
Addex Pharmaceuticals 24
Ardea Biosciences, Inc. 24
BioCryst Pharmaceuticals, Inc. 25
Regeneron Pharmaceuticals, Inc. 25
XOMA Ltd. 26
LG Life Sciences, Ltd 26
Metabolex, Inc 27
Wellstat Therapeutics Corporation 27
Opsona Therapeutics Ltd. 28
PLx Pharma Inc. 28
Nuon Therapeutics, Inc. 29
Gouty Arthritis (Gout) - Therapeutics Assessment 30
Assessment by Monotherapy Products 30
Assessment by Combination Products 31
Assessment by Route of Administration 32
Assessment by Molecule Type 34
Drug Profiles 36
RDEA594 - Drug Profile 36
Product Description 36
Mechanism of Action 36
R&D Progress 36
RDEA684 - Drug Profile 38
Gouty Arthritis (Gout) – Pipeline Review, H2 2011 GMDHC1383IDB / Pub September 2011
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Gouty Arthritis (Gout) – Pipeline Review, H2 2011
Product Description 38
Mechanism of Action 38
R&D Progress 38
Ilaris - Drug Profile 39
Product Description 39
Mechanism of Action 39
R&D Progress 39
MBX-102 - Drug Profile 42
Product Description 42
Mechanism of Action 42
R&D Progress 42
PNXXXX - Drug Profile 43
Product Description 43
Mechanism of Action 43
R&D Progress 43
BCX4208 - Drug Profile 44
Product Description 44
Mechanism of Action 44
R&D Progress 44
Arcalyst - Drug Profile 46
Product Description 46
Mechanism of Action 46
R&D Progress 46
Krystexxa - Drug Profile 48
Product Description 48
Mechanism of Action 48
R&D Progress 48
Y-700 - Drug Profile 50
Product Description 50
Mechanism of Action 50
R&D Progress 50
Y-700 - Drug Profile 51
Product Description 51
Mechanism of Action 51
R&D Progress 51
PL 4100 Indomethacin - Drug Profile 52
Product Description 52
Mechanism of Action 52
R&D Progress 52
XOMA 052 - Drug Profile 53
Product Description 53
Mechanism of Action 53
R&D Progress 53
NU1618 - Drug Profile 55
Product Description 55
Mechanism of Action 55
R&D Progress 55
Pegsitacase - Drug Profile 56
Gouty Arthritis (Gout) – Pipeline Review, H2 2011 GMDHC1383IDB / Pub September 2011
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Gouty Arthritis (Gout) – Pipeline Review, H2 2011
Product Description 56
Mechanism of Action 56
R&D Progress 56
Rizaben + Uloric - Drug Profile 57
Product Description 57
Mechanism of Action 57
R&D Progress 57
RDEA594 + Allopurinol - Drug Profile 58
Product Description 58
Mechanism of Action 58
R&D Progress 58
RDEA594 + Febuxostat - Drug Profile 60
Product Description 60
Mechanism of Action 60
R&D Progress 60
Apremilast - Drug Profile 62
Product Description 62
Mechanism of Action 62
R&D Progress 62
IL1R1 NAM - Drug Profile 63
Product Description 63
Mechanism of Action 63
R&D Progress 63
BCX4208 + Allopurinol - Drug Profile 64
Product Description 64
Mechanism of Action 64
R&D Progress 64
Zoledronate - Drug Profile 65
Product Description 65
Mechanism of Action 65
R&D Progress 65
NanoActive Indomethacin - Drug Profile 66
Product Description 66
Mechanism of Action 66
R&D Progress 66
Inflammasome Modulator Program - Drug Profile 67
Product Description 67
Mechanism of Action 67
R&D Progress 67
XO Inhibitor - Drug Profile 68
Product Description 68
Mechanism of Action 68
R&D Progress 68
Next Generation URAT1 Inhibitor - Drug Profile 69
Product Description 69
Mechanism of Action 69
R&D Progress 69
Gouty Arthritis (Gout) Therapeutics – Drug Profile Updates 70
Gouty Arthritis (Gout) – Pipeline Review, H2 2011 GMDHC1383IDB / Pub September 2011
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Gouty Arthritis (Gout) – Pipeline Review, H2 2011
Gouty Arthritis (Gout) Therapeutics - Discontinued Products 77
Gouty Arthritis (Gout) - Featured News 78
Sep 07, 2011: Ardea Biosciences Announces Positive End-of-Phase II Meetings With FDA For Lesinurad 78
Aug 29, 2011: FDA Requests Additional Clinical Data On Novartis Drug ACZ885 For Treatment Of Gouty Arthritis 78
Aug 16, 2011: Savient Pharmaceuticals Announces Publication Of Phase III KRYSTEXXA Data In JAMA For Refractory Chronic Gout
Patients 79
Jun 22, 2011: FDA Panel Rejects Novartis Drug ACZ885 For Gouty Arthritis Indication 80
May 26, 2011: BioCryst Presents New Analyses Of BCX4208 Phase II Studies In Patients With Gout At Annual European Congress Of
Rheumatology 81
May 26, 2011: Savient Pharmaceuticals Marketing Authorization Application For KRYSTEXXA Accepted For Review By European
Medicines Agency 82
May 25, 2011: Novartis Announces Positive Results From Two Pivotal Phase III Trials Of ACZ885 In Patients With Severe Gouty Arthritis
83
May 25, 2011: Novartis's Data Shows ACZ885 For Severe Gouty Arthritis Provided Better Pain Relief And Reduced Risk Of New Attacks
By Up To 68% versus Steroid 84
May 25, 2011: Ardea Biosciences Provides Additional Results From Phase IIb Study Of Lesinurad In Combination With Allopurinol At
Annual European Congress Of Rheumatology 86
May 25, 2011: Ardea Biosciences Announces Results From Phase Ib Study Evaluating Combination Of RDEA594 And Febuxostat 87
Appendix 88
Methodology 88
Coverage 88
Secondary Research 88
Primary Research 88
Expert Panel Validation 89
Contact Us 89
Disclaimer 89
Gouty Arthritis (Gout) – Pipeline Review, H2 2011 GMDHC1383IDB / Pub September 2011
© Global Markets Direct. This report is a licensed product and is not to be photocopied Page(5)
Gouty Arthritis (Gout) – Pipeline Review, H2 2011
Lis t o f Ta b le s
Number of Products Under Development for Gouty Arthritis (Gout), H2 2011 10
Products under Development for Gouty Arthritis (Gout) – Comparative Analysi