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Lupus Foundation of America Statement on Results for Clinical Study,of CellCept Released by Aspreva Pharmaceutical Company

Statement by Sandra C. Raymond, President & CEO of the Lupus Foundation of America, Inc.

WASHINGTON, June 27, 2007 /PRNewswire-USNewswire/ -- The Lupus Foundation of America, Inc. and more than 1.5 million Americans with lupus have been awaiting the preliminary findings of the Phase III clinical trials for CellCept(R), a potential treatment for lupus kidney disease being tested by Aspreva Pharmaceutical Company. Development of new treatments for lupus patients is critical because many of the drugs currently used to treat the disease are toxic and can cause serious medical complications or side effects, sometimes worse than the disease itself.

Preliminary data from the 24-week induction phase show that CellCept achieved results that are equivalent to those achieved with intravenous Cyclophosphamide (IVC), a chemotherapy which has been used to treat patients with lupus kidney disease (lupus nephritis) since the 1970s. However, while IVC has been referred to as the "standard of care" for treatment of lupus nephritis it has never been approved by the FDA as a treatment for lupus.

In order to meet the primary endpoint, the FDA required Aspreva Pharmaceutical Company to show that CellCept was superior in efficacy to IVC. The LFA contends that this bar was unreasonably set too high by the FDA. Equal efficacy and less severe side effects would be a compelling rationale for approving a drug for this underserved disease, which would be welcomed by people with lupus and their physicians. Furthermore, if more agents could be developed with less toxicity, there would be improved opportunities for combination therapies in the treatment of nephritis.

An additional concern is that if CellCept induces 52% remission and IVC induces the same percentage of remission, it may be that each is covering a different subset of the population. Thus having the alternative treatments available might be an important
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