About This Report

Datamonitor surveyed 108 rheumatologists in the US in the wake of Benlysta’s approval, gauging current perceptions of the drug and the clinical impact that it will have. Lessons learned from the clinical trial program of Benlysta are already being applied to additional drug candidates, and large-scale international trials are becoming the norm.

What's Included in This Report?

Access Datamonitor’s independent clinical and commercial assessment of off-label, industry ed, and pipeline candidates for systemic lupus erythematosus.
Review findings from Datamonitor’s survey of 108 US rheumatologists following Benlysta’s March 2011 FDA approval.
Understand where Benlysta will be positioned in the industry and which pipeline candidates pose the greatest competitive threat.
Review important clinical developments for key pipeline agents with analysis of the latest clinical trial data.

Key Market Facts

On March 9, 2011, Benlysta became the first FDA approved treatment for systemic lupus erythematosus (SLE) in over 50 years. Datamonitor’s primary research of over 100 rheumatologists in the US reveals physician perception of the drug following its approval.
Following on from data on rheumatoid arthritis, Eli Lilly moved LY2127399 into Phase III for SLE in December 2010. Eli Lilly’s risky move could pay off if successful, as potential advantages over Benlysta, including the drug’s subcutaneous formulation, would lead to commercial success if it reaches the industry .
Several promising drug candidates remain in the late-stage pipeline for SLE. Immunomedics/UCB’s epratuzumab moved into Phase III in December 2010. If successful, it could reach the industry as early as 2015. ImmuPharma/Cephalon’s Lupuzor remains in Phase IIb, but positive data from an earlier trial have left rheumatologists eager to see more.

Why Should You Buy This Report?

How do rheumatologists in the US view Benlysta following its FDA approval?
How have late-stage clinical trial programs been influenced by the Phase III success of Benlysta?
Which late stage pipeline candidates offer the most promise for treating SLE, and how do they address unmet needs?
How do novel pipeline agents compare to current off-label treatment options?

Table Of Contents

Summary
Strategic scoping and focus
Datamonitor key findings
Related reports
OVERVIEW
Catalyst
Summary
MARKET DEFINITION AND OVERVIEW
Product overview
Primary research survey
MARKETED PRODUCT PROFILES
Approved: Benlysta (belimumab, Human Genome Sciences/GlaxoSmithKline)
Drug presentation
Drug pipeline analysis
SWOT analysis
Portfolio
Physician perception of Benlysta
Clinical and commercial attractiveness
Off-label: Rituxan/MabThera (rituximab, Biogen Idec/Roche/Zenyaku Kogyo)
Drug presentation
Drug pipeline analysis
SWOT analysis
Clinical and commercial attractiveness
Off-label: CellCept (mycophenolate mofetil, Roche/Vifor Pharma)
Drug presentation
Drug pipeline analysis
SWOT analysis
Clinical and commercial attractiveness
Off-label: Orencia (abatacept, Bristol-Myers Squibb)
Drug presentation
Drug pipeline analysis
SWOT analysis
Clinical and commercial attractiveness
PIPELINE PRODUCT PROFILES
Atacicept (Merck Serono/Bristol-Myers Squibb)
Drug presentation
Drug pipeline analysis
SWOT analysis
Clinical and commercial attractiveness
Epratuzumab (Immunomedics/UCB)
Drug presentation
Drug pipeline analysis
SWOT analysis
Clinical and commercial attractiveness
Lupuzor (forigerimod, ImmuPharma/Cephalon/SymBio Pharmaceuticals)
Drug presentation
Drug pipeline analysis
SWOT analysis
Clinical and commercial attractiveness
LY2127399 (Eli Lilly)
Drug presentation
Drug pipeline analysis
SWOT analysis
Clinical and commercial attractiveness
Other drugs in development for systemic lupus erythematosus
A-623 (Anthera Pharmaceuticals)
Laquinimod (Teva/Active Biotech)
Paquinimod (57-57, ABR-215757, Active Biotech)
BIBLIOGRAPHY
Journal papers
Websites
APPENDIX A - SURVEY INFORMATION
Primary research
APPENDIX B
Contributing experts
Datamonitor drug assessment scorecard methodology
Report methodology

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