Product Profiles: Systemic Lupus Erythematosus – Benlysta approval brings lessons and hope to market

Introduction

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.

Features and benefits

• Access Datamonitor’s independent clinical and commercial assessment of off-label, marketed, 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 market 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.

Highlights

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 market.

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 market 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.

Your key questions answered

• 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

Executive 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 profile
Development overview
SWOT analysis
Product positioning
Physician perception of Benlysta
Clinical and commercial attractiveness
Off-label: Rituxan/MabThera (rituximab; Biogen Idec/Roche/Zenyaku Kogyo)
Drug profile
Development overview
SWOT analysis
Clinical and commercial attractiveness
Off-label: CellCept (mycophenolate mofetil; Roche/Vifor Pharma)
Drug profile
Development overview
SWOT analysis
Clinical and commercial attractiveness
Off-label: Orencia (abatacept; Bristol-Myers Squibb)
Drug profile
Development overview
SWOT analysis
Clinical and commercial attractiveness

PIPELINE PRODUCT PROFILES
Atacicept (Merck Serono/Bristol-Myers Squibb)
Drug profile
Development overview
SWOT analysis
Clinical and commercial attractiveness
Epratuzumab (Immunomedics/UCB)
Drug profile
Development overview
SWOT analysis
Clinical and commercial attractiveness
Lupuzor (forigerimod; ImmuPharma/Cephalon/SymBio Pharmaceuticals)
Drug profile
Development overview
SWOT analysis
Clinical and commercial attractiveness
LY2127399 (Eli Lilly)
Drug profile
Development overview
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