Aspreva Pharmaceuticals Corporation (NASDAQ: ASPV; TSX: ASV) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CellCept (mycophenolate mofetil, MMF) for the treatment of lupus nephritis. Aspreva is currently evaluating CellCept for the treatment of lupus nephritis in a global phase III study.

The FDA’s Fast Track designation is designed to expedite the application and review process for products that have the potential to address a serious or life-threatening condition. There has been no new approved treatment for lupus in the United States in over thirty years.

In granting Fast Track designation, the FDA noted that type III-V lupus nephritis is a severe inflammation of the kidney associated with systemic lupus erythematosus, and is a life-threatening disease. They continued stating that the partnership between Aspreva and Roche shows a commitment to study clinically important outcomes including death, need of dialysis, or loss of renal function in this serious disease. Finally the FDA noted that CellCept received Fast Track designation on the basis that, given the current development program in lupus nephritis, it may have the potential to address an unmet medical need in patients with this disease.

“Lupus nephritis is one of the most serious manifestations of lupus, and if left untreated can result in progressive kidney failure”, said Dr. Usman Azam, Aspreva’s Executive Vice-President and Chief Medical Officer. “We believe that Fast Track designation from the FDA will be of great assistance in our efforts to bring an evidence-based treatment option to this patient population where there is a clear unmet medical need.”

 Aspreva’s lupus nephritis study is one of the largest phase III studies ever conducted in this disease. This two-phase induction to maintenance study was designed as a randomized open-label comparison of MMF with intravenous cyclophosphamide for the first six months (induction phase), followed by a double-blind comparison of MMF to azathioprine for up to three years (maintenance phase). The first patient of this study was treated in July 2005 and patient enrollment was completed at the end of September 2006. Preliminary results from the induction phase of this trial are expected towards the end of June 2007. Re-randomization into maintenance phase is complete and this phase of the study is ongoing.