Earlier this week, Human Genome Sciences Inc. (HGSI) announced that its eagerly anticipated lupus drug Benlysta is expected to cost patients about $20,000 a year. The actual price might also be slightly more than the figure.

Consequently, the drug could reach $1 billion in annual sales if taken by 50,000 patients, which represents a small fraction of those affected by the disease.

In July 2009, Human Genome Sciences and GlaxoSmithKline PLC (GSK) announced that Benlysta met the primary endpoint in BLISS-52, the first of two pivotal phase III trials in patients with serologically active systemic lupus erythematosus (SLE).

In the placebo-controlled BLISS-52 study, the results showed that Benlysta plus standard of care achieved a clinically and statistically significant improvement in patient response rate at Week 52 compared with standard of care alone. Study results also showed that Benlysta was generally well tolerated, with adverse event rates comparable between belimumab and placebo treatment groups.

We remind investors, that Human Genome and GlaxoSmithKline is co-developing Benlysta as a potential treatment for SLE. Benlysta is a human monoclonal antibody that specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator (BLyS). BLyS is a naturally occurring protein discovered by HGS that is required for the development of B-lymphocyte cells into mature plasma B cells. Plasma B cells produce antibodies, the body’s first line of defense against infection.

In lupus, rheumatoid arthritis and certain other autoimmune diseases, elevated levels of BLyS are believed to contribute to the production of autoantibodies — antibodies that attack and destroy the body’s own healthy tissues. The presence of autoantibodies appears to correlate with disease severity. Preclinical and clinical studies demonstrate that B-cell antagonists can reduce autoantibody levels and help control autoimmune disease activity.

In February and May 2007, Human Genome initiated BLISS-76 and BLISS-52, two pivotal phase III trials of Benlysta. Both phase III trials are double-blind, placebo-controlled, multi-center phase III superiority trials to evaluate the efficacy and safety of Benlysta plus standard of care, versus placebo plus standard of care, in the treatment of patients with active SLE.

Human Genome has completed the enrollment and initial dosing of 826 patients in BLISS-76 in August 2008. Data from BLISS-76 are expected in November 2009. Positive results should lead to a Biologics License Application (BLA) filing in the United States in the first half of 2010.We expect the US approval in early 2011

Positive data from the Bliss-52 study takes the company one step closer to being the first to have a new lupus drug approved in 50 years. Lupus affects about 1.5 million people in the United States and 5 million worldwide.
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