Clinical Data and Interviewed Thought Leaders Indicate Benlysta Has Advantages Over Sales-Leading CellCept For the Treatment of Systemic Lupus Erythematosus

Through 2020, the Systemic Lupus Erythematosus Market Will Experience Dramatic Growth, Increasing from $300 Million to $2.8 Billion, According to Findings from Decision Resources

April 24, 2012—Burlington, Mass.—Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that surveyed U.S. rheumatologists and managed care organization (MCO) pharmacy directors agree that reducing disease activity is one of the attributes that most influences their decisions regarding prescribing and formulary status determinations, respectively, in moderate to severe systemic lupus erythematosus (SLE), excluding severe active renal and severe active CNS manifestations. Clinical data and the opinions of interviewed thought leaders indicate that IV belimumab (Human Genome Sciences/GlaxoSmithKline’s Benlysta) has advantages over sales-leading mycophenolate mofetil (Roche/Galenica’s CellCept, generics) on this attribute.

Decision Resources’ analysis of the SLE drug market also finds that, based on clinical data and the opinions of interviewed thought leaders, IV belimumab has earned Decision Resources’ proprietary clinical gold standard status for the treatment of SLE, owing to its strongest clinical profile among key marketed products that treat moderate to severe SLE. However, due to its competitive advantages in delivery, Human Genome Sciences/GlaxoSmithKline’s subcutaneous formulation of belimumab (SC belimumab) will displace IV belimumab and will earn proprietary clinical gold-standard status for moderate to severe SLE in 2015, following its launch for the indication that same year.

The findings also reveal that surveyed U.S. rheumatologists and MCO pharmacy directors indicate that reducing disease activity is one of the greatest unmet needs in moderate to severe SLE. According to clinical data and interviewed thought leaders, Immunomedics/UCB’s epratuzumab has demonstrated the potential to partially fulfill this unmet need.

The SLE market will experience dramatic growth, increasing from approximately $300 million in 2010 to $2.8 billion in 2020 in the United States, France, Germany, Italy, Spain, United Kingdom and Japan. Growth will be driven in part by the launch and uptake of Eli Lilly’s tabalumab and ImmuPharma/SymBio Pharmaceuticals’ forigerimod. Following its expected launch in 2015 in the United States, 2016 in Europe and 2017 in Japan, tabalumab is forecast to earn major market sales of approximately $320 million in 2020. Forigerimod is expected to launch in 2016 in the United States and Europe, and will earn major market sales of almost $170 million in 2020. The strongest growth will be driven by the launch and uptake of Benlysta. As the first formally approved agent for SLE in more than 50 years, Benlysta’s demonstration of efficacy in clinical trials will drive it to earn blockbuster sales of $1.2 billion in 2020.

“The launch and availability of a subcutaneous formulation of Benlysta – SC belimumab – in addition to its currently marketed intravenous formulation, will provide a more convenient delivery option and will give it an additional competitive advantage over other emerging intravenous agents for SLE,” said Decision Resources Analyst Edward Wydysh, Ph.D.

Decision Resources’ Robust Market Forecast and Opportunities Analysis
Decision Resources provides a comprehensive view of what is happening in a specific drug market now and in the decade ahead. The research includes analysis of the unmet need and near-term drug development opportunities that exist within a drug market powered by primary research from physicians and payers. The robust market forecast and opportunities analysis is comprised of the Pharmacor 2012 advisory service and the DecisionBase 2012 report series.

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Christopher Comfort
Decision Resources Group
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