Systemic Lupus Erythematosus – Pipeline Review, Q1 2011
Systemic Lupus Erythematosus - Pipeline Review, Q1
2011
Reference Code: GMDHC033IDB
Publication Date: February 2011
Systemic Lupus Erythematosus – Pipeline Review, Q1 2011 GMDHC033IDB / Pub FEB 2011
© Global Markets Direct. This report is a licensed product and is not to be photocopied
Page(1)
Systemic Lupus Erythematosus – Pipeline Review, Q1 2011
Ta b le o f Co n te n ts
Table of Contents 2
List of Tables 5
List of Figures 6
Introduction 7
Global Markets Direct Report Coverage 7
Systemic Lupus Erythematosus Overview 8
Therapeutics Development 9
An Overview of Pipeline Products for Systemic Lupus Erythematosus 9
Systemic Lupus Erythematosus Therapeutics under Development by Companies 11
Systemic Lupus Erythematosus Therapeutics under Investigation by Universities/Institutes 14
Late Stage Products 17
Comparative Analysis 17
Mid Clinical Stage Products 18
Comparative Analysis 18
Early Clinical Stage Products 19
Comparative Analysis 19
Discovery and Pre-Clinical Stage Products 20
Comparative Analysis 20
Companies Involved in Systemic Lupus Erythematosus Therapeutics Development 21
Bristol-Myers Squibb Company 21
Boehringer Ingelheim GmbH 21
F. Hoffmann-La Roche Ltd. 22
Amgen Inc. 22
AstraZeneca PLC 23
Eli Lilly and Company 23
GlaxoSmithKline plc 24
Biotest AG 24
Novo Nordisk A/S 25
Plexxikon Inc. 25
Cephalon, Inc. 26
Human Genome Sciences, Inc. 26
Pfizer Inc. 27
UCB Group 27
Celgene Corporation 29
Onyx Pharmaceuticals, Inc. 29
Merck KGaA 30
Genesis Research and Development Corporation Ltd. 30
Hollis-Eden Pharmaceuticals, Inc. 31
Active Biotech AB 31
Idera Pharmaceuticals, Inc. 32
Compugen Ltd. 32
Dynavax Technologies Corporation 33
Protalex, Inc. 33
Neovacs SA 34
CREABILIS Therapeutics S.r.l. 34
MAT Biopharma 35
Argos Therapeutics, Inc. 35
Systemic Lupus Erythematosus – Pipeline Review, Q1 2011 GMDHC033IDB / Pub FEB 2011
© Global Markets Direct. This report is a licensed product and is not to be photocopied Page(2)
Systemic Lupus Erythematosus – Pipeline Review, Q1 2011
Astion Pharma A/S 36
Theraclone Sciences, Inc. 36
Cornerstone Therapeutics Inc. 37
ChemoCentryx, Inc. 37
Taligen Therapeutics Inc. 38
Anthera Pharmaceuticals‚ Inc. 38
SuppreMol GmbH 39
Advanced Cancer Therapeutics 39
Zenyaku Kogyo Co., Ltd. 40
Ampio Pharmaceuticals, Inc. 40
Universities/Institutes Involved in Systemic Lupus Erythematosus Therapeutics Development 41
Systemic Lupus Erythematosus - Therapeutics Assessment 43
Assessment by Monotherapy Products 43
Assessment by Combination Products 44
Assessment by Route of Administration 45
Assessment by Molecule Type 48
Late Stage Drug Profiles – Companies 51
Anti BAFF Human Antibody - Drug Profile 51
Product Description 51
Mechanism of Action 51
R&D Progress 51
Atacicept - Drug Profile 52
Product Description 52
Mechanism of Action 52
R&D Progress 52
Benlysta - Drug Profile 54
Product Description 54
Mechanism of Action 54
R&D Progress 54
Epratuzumab - Drug Profile 55
Product Description 55
Mechanism of Action 55
R&D Progress 55
Orencia - Drug Profile 57
Product Description 57
Mechanism of Action 57
R&D Progress 57
Prestara - Drug Profile 58
Product Description 58
Mechanism of Action 58
R&D Progress 58
Rituxan + Prednisone - Drug Profile 60
Product Description 60
Mechanism of Action 60
R&D Progress 60
Rituximab + Methylprednisolone - Drug Profile 61
Product Description 61
Mechanism of Action 61
Systemic Lupus Erythematosus – Pipeline Review, Q1 2011 GMDHC033IDB / Pub FEB 2011
© Global Markets Direct. This report is a licensed product and is not to be photocopied Page(3)
Systemic Lupus Erythematosus – Pipeline Review, Q1 2011
R&D Progress 61
Late Stage Drug Profiles – Universities/Institutes 62
Atorvastatin - Drug Profile 62
Product Description 62
Mechanism of Action 62
R&D Progress 62
azathioprine - Drug Profile 63
Product Description 63
Mechanism of Action 63
R&D Progress 63
cyclophosphamide - Drug Profile 64
Product Description 64
Mechanism of Action 64
R&D Progress 64
Cyclophosphamide - Drug Profile 65
Product Description 65
Mechanism of Action 65
R&D Progress 65
Infliximab + Azathioprine - Drug Profile 66
Product Description 66
Mechanism of Action 66
R&D Progress 66
Prevenar + Pneumo23 - Drug Profile 67
Product Description 67
Mechanism of Action 67
R&D Progress 67
Discontinued Products 68
Systemic Lupus Erythematosus - Featured News 69
1. Dec 14, 2010: Anthera Selects Merck BioManufacturing Network As Manufacturing Supplier For A-623 69
2. Dec 14, 2010: Immunomedics And UCB Initiate Phase III Program With Epratuzumab In Systemic Lupus Erythematosus 69
3. Dec 07, 2010: Argos Initiates Phase I Clinical Trial Of AGS-009 For Treatment Of Systemic Lupus Erythematosus 70
4. Dec 03, 2010: GSK And Human Genome Sciences Announce FDA Extension Of Benlysta PDUFA Target Date 71
5. Nov 16, 2010: Anthera Suspends Enrollment And Dosing In PEARL-SC Clinical Trial To Address Reports Of Vial Problems 71
6. Nov 16, 2010: Human Genome Sciences And GSK Announce Vote Of FDA Advisory Committee To Recommend Approval Of Benlysta
For Systemic Lupus Erythematosus 71
7. Nov 15, 2010: Neovacs Receives DSMB Authorization To Proceed To Fourth Dose Level Of Ifna-Kinoid In Phase I/II Trial In Lupus 72
8. Oct 06, 2010: Myrexis To Present Oral Anti-Interferon Program At American College of Rheumatology/Association Of Rheumatology
Health Professionals 72
9. Sep 27, 2010: Neovacs Receives DSMB Approval For IFNa-Kinoid In Phase I/II Study In Lupus Patients 73
10. Aug 19, 2010: HGS A