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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 ultimately approve BENLYSTA, it would become the first drug successfully developed to specifically treat lupus since the disease was discovered more than a century ago.

"Lupus is a complex disease and not every therapy will be appropriate for all patients. Each person with lupus is unique and it is likely that successful management of lupus will require a number of therapies, perhaps used in combination with each other. The LFA and its Medical-Scientific Advisory Council urge the federal government and industry to greatly step up their research efforts on lupus so that physicians have a complete arsenal of therapies at their disposal to provide the individualized treatment that lupus requires.

"We are grateful to Human Genome Sciences and GlaxoSmithKline for their pioneering efforts to develop a new, safe, effective and tolerable treatment for lupus, to the physicians who have passionately committed to researching this disease, to the companies who continue to invest in finding new treatments, and to the thousands of people with lupus who have volunteered and participated in clinical studies over the years so discoveries such as this one could be possible.

"Meanwhile, the LFA will continue to implement its initiative entitled, A New 21(st) Century Approach to Lupus Healthcare, to ensure the ongoing advancement of the science and medicine of lupus to meet the multi-dimensional needs of people with lupus."

View a video of Sandra Raymond's remarks on the LFA website.

About Lupus

Lupus is an acute and chronic autoimmune disease in which the immune system is unbalanced, causing inflammation and tissue damage to virtually any organ in the body. Its health effects include heart attacks, strokes, seizures, miscarriages, and organ failure. Ninety percent of the people with lupus are women, and it is two to three times more common among African Americans, Hispanics/Latinos, Native Americans, and Asians. Lupus is unpredictable and potentially fatal, yet no satisfactory treatment or cure exists.

About the LFA

The LFA is the foremost national nonprofit voluntary health organization dedicated to finding the causes of and cure for lupus, and providing support, services, and hope to all people affected by lupus. Founded in 1977, the LFA has a nationwide network of nearly 300 chapters and support groups and operates programs of research, education, and advocacy.

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SOURCE Lupus Foundation of America
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