Health Canada Approves BENLYSTA(TM)

MISSISSAUGA, ON, July 12, 2011 /CNW/ - For the first time in almost 50 years Canadians living with lupus have a new treatment option. Health Canada has approved BENLYSTATM (belimumab), a new drug specific for the treatment of systemic lupus erythematosus (SLE, or simply lupus). The announcement was made today by GlaxoSmithKline Inc. (GSK) and Human Genome Sciences (HGS) who are developing BENLYSTATM under a co-development and co-commercialization agreement entered into in 2006. BENLYSTATM is expected to become available to patients in Canada in September of this year.

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BENLYSTATM is indicated for use in addition to standard therapy for reducing disease activity in adult patients with active, autoantibody-positive systemic lupus erythematosus. The safety and efficacy of BENLYSTATM have not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. The efficacy of BENLYSTATM in patients of black African heritage has not been clearly established. Lupus is a serious, chronic and debilitating autoimmune illness that can affect many organs in the body with an unpredictable course; it impacts nine times more women than men, often in the prime of their lives (15 - 45 years). 1 Lupus can be difficult to diagnose since symptoms may be mistaken for other illnesses. Common symptoms may include extreme fatigue, painful and swollen joints, unexplained fever, skin rashes and kidney problems.2 "This is an important milestone in the treatment of lupus," said Dr. Murray Urowitz, Rheumatologist and Lupus Expert, in Toronto. "Lupus is often difficult to control because it can manifest in so many different ways. The drugs currently used were not originally developed for the intent of treating lupus. Studies have shown that BENLYSTATM plus standard of care can reduce disease activity more than standard of care alone. BENLYSTATM is a much needed addition to the treatment paradigm." Patients with active lupus may have elevated levels of a naturally-occurring protein called 'BLyS' (B-lymphocyte stimulator), a B cell survival factor. Autoreactive B cells produce antibodies that attack normal healthy tissue, which leads to inflammation (the body's normal response to injury or infection) in many parts of the body.3 BENLYSTATM, a human monoclonal antibody administered by intravenous infusion,4specifically binds to and inhibits the biological activity of BLyS which inhibits the survival of B cells, including autoreactive B cells5. "Lupus is a life-altering and life-threatening diagnosis" says Catherine Madden, Executive Director of Lupus Canada. "This incurable disease impacts and destroys many organs in the body and can cause constant pain, immobility, and organ failure just to name a few. Lupus is seriously under-recognized and under-funded but dedication to new therapies and new research fuels hope for a cure."

About Lupus - 'The Disease of 1,000 Faces'

• There are estimated to be 1 in 1,000 Canadians living with lupus.6 At least five million people worldwide live with a form of the disease.7
• Lupus is a complicated autoimmune disease - a disorder where the body's immune system creates autoantibodies that attack normal healthy tissue, leading to inflammation (the body's normal response to injury or infection) in many parts of the body.8,9
• The symptoms of lupus vary so greatly from person-to-person that it is commonly referred to as 'the disease of 1,000 faces.'1
• Lupus also can lead to arthritis, kidney failure, heart and lung inflammation, central nervous system abnormalities, inflammation of the blood vessels and blood disorders.11
• Lupus Canada is a national voluntary organization dedicated to improving the lives of people living with lupus through advocacy, education, public awareness, support and research. For more information on lupus, visit Link.

Clinical Trials

BENLYSTATM has been tested in the largest phase III clinical trial program ever successfully completed in patients with lupus. Two pivotal phase III trials randomized and treated 1,684 adult patients with active autoantibody-positive SLE. The primary efficacy endpoint was response rate as measured by the SLE Responder Index (SRI), which is a composite of three validated indices of SLE disease activity. Patients who were considered responders had to meet strict criteria in all three indices of the SRI at week 52. The safety of BENLYSTATM was evaluated in 2133 patients in three controlled studies.12

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