Promise of a New Lupus Treatment Is a Groundbreaking Achievement

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Mon Nov 2, 2009 2:18am EST

BENLYSTA(TM) Successful in Second Pivotal Clinical Trial

WASHINGTON, Nov. 2 /PRNewswire-USNewswire/ -- Human Genome Sciences (HGS) and
GlaxoSmithKline (GSK) today announced positive results from BLISS-76, the
second of two large-scale phase III clinical trials of BENLYSTA(TM)
(belimumab) for treating systemic lupus.  A full presentation of results from
BLISS-52 was recently shared at the 73rd Annual Scientific meeting of the
American College of Rheumatology.  Both trials succeeded in meeting their
primary endpoints, which should make BENLYSTA eligible for approval by the
U.S. Food and Drug Administration (FDA).  

Both trials demonstrate that treatment with BENLYSTA plus standard of care was
superior to that of placebo (inactive agent) plus standard of care. BENLYSTA
significantly reduced disease activity. If approved by the FDA, BENLYSTA would
be the first drug ever developed and approved specifically for the treatment
of lupus.  

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

"We are truly excited to receive this groundbreaking news! Individuals with
lupus and their families have waited more than 50 years to hear that it is
possible to develop therapies that control the disease. We believe that this
is a significant first step in developing the full arsenal of therapies and
personalized treatment lupus requires.

"Conducting clinical trials in lupus has been extremely difficult due to many
factors including the heterogeneity of the disease, the selection of
appropriate clinical trial endpoints, and the confounding role of required
background medications given to clinical trial participants. Human Genome
Sciences and GlaxoSmithKline have proven that these barriers, while
formidable, can be overcome.

"For decades the entire lupus research community has worked hard to better
understand the causes and consequences of the disease. The fruits of that
labor are starting to emerge.  However, now is not the time for complacency.
We must band together for lupus and continue to capitalize on the decades of
research made possible through the efforts of the many dedicated researchers,
physicians, people with lupus, and advocates. 

"This announcement by HGS and GSK and the Overcoming Barriers to Drug
Development in Lupus report, commissioned by the Lupus Foundation of America
to outline recommendations on ways to overcome the barriers to lupus research,
combine to serve as a call to action for a national coordinated effort to
accelerate the pace of discovery, to develop more tolerable and effective
treatments, and to ultimately find a cure for this perilous disease.  

"We congratulate HGS and GSK on reaching this important milestone in lupus
research and in the development of new therapies for lupus. We also extend our
appreciation to the researchers and study volunteers who made this achievement
possible: the physicians who have passionately committed to researching this
disease, and the companies that continue to invest in finding new and
necessary treatments for this devastating disease." 

The next step in the process is for HGS and GSK to submit marketing
applications in the United States, Europe and other regions during the first
half of 2010. The LFA will closely follow this process, and continue to keep
its constituents apprised of developments. 

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. 

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.








SOURCE  Lupus Foundation of America

Maggie Maloney, maloney@lupus.org, +1-202-212-6766, or Duane Peters,
peters@lupus.org, +1-202-349-1145, both of LFA
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