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First Potential Lupus-Specific Treatment in Sight
Date:7/19/2009

BENLYSTA(TM) SUCCESSFUL IN FIRST OF TWO PIVOTAL CLINICAL TRIALS

WASHINGTON, July 20 /PRNewswire-USNewswire/ -- Today, Human Genome Sciences (HGS) and GlaxoSmithKline (GSK) announced positive results from a year-long clinical trial of BENLYSTA for treating lupus. When the 52-week study concluded, the lupus patients who were treated with BENLYSTA had improvement in overall disease activity without clinically significant flare-ups in one or more isolated organs when compared to patients who received the placebo (inactive agent). The patients receiving BENLYSTA also were able to reduce their intake of steroid medications. The study is the largest ever to be completed for lupus and the first Phase III (late stage) trial of a new biologic immune therapy for lupus to succeed in meeting its primary endpoint and most of its secondary endpoints.

Sandra C. Raymond, President and Chief Executive Officer of the Lupus Foundation of America (LFA) issued the following statement.

"For people with lupus and their loved ones, this is an historic day! With no new drugs for more than 50 years, since the Eisenhower Administration, the news today indicates that it is possible to develop new, safe, and effective therapies for lupus. We are greatly encouraged by the positive top-line data which shows that HGS' 52-week BENLYSTA study met its primary endpoint. These results provide hope that this complex chronic autoimmune disease can be brought under control and that, eventually, a cure can be found for the estimated 1.5 million Americans and more than 5 million people worldwide living with lupus.

"We look forward to hearing the results, this fall, of a longer-term Phase III clinical study of BENLYSTA. The data from both studies will be evaluated by the U.S. Food and Drug Administration (FDA). Should the FDA ultimatel
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SOURCE Lupus Foundation of America
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