Promise of a New Lupus Treatment is a Groundbreaking Achievement

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Mon Nov 2, 2009 2:06am EST

BENLYSTA Successful in Second Pivotal Clinical Trial
WASHINGTON--(Business Wire)--
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 (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.

Lupus Foundation of America
Maggie Maloney, 202-212-6766
maloney@lupus.org
or
Duane Peters, 202-349-1145
peters@lupus.org



Copyright Business Wire 2009

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