Portfolio Press Release
Aspreva and Roche conclude Special Protocol Assessment and reach agreement with FDA
Victoria, B.C., Canada - September 29, 2005 — Aspreva Pharmaceuticals Corporation (NASDAQ: ASPV; TSX: ASV), today announced that the company and its partner Roche have successfully concluded the special protocol assessment (SPA) with the Cardio-Renal Division of the U.S. Food and Drug Administration (FDA) for the phase III clinical trial of CellCept® (mycophenolate mofetil) for the treatment of lupus nephritis.
Aspreva's Lupus Management Study is one of the largest phase III studies conducted in lupus nephritis. The global study aims to enrol 358 patients with biopsy proven lupus. The first patient in this study was treated in July 2005.
"Successful completion of the SPA process for this trial puts us in a favourable position for pursuing a new indication for CellCept," says Richard M. Glickman, Aspreva's Chairman and Chief Executive Officer. "We are looking forward to learning more about the efficacy and safety of CellCept for encouraging remission in patients with lupus nephritis. We expect results from the first phase of the study at the end of 2006."
A SPA is intended to document the agency's agreement that the design and planned analysis of a study adequately addresses objectives in support of a regulatory submission. However, final determinations by the FDA can only be made after a complete review of a marketing application, and are based on the entire data in the application.
The two-phase induction to maintenance study is a randomized open label comparison of CellCept with the current standard of care, cyclophosphamide, for the first six months, followed by a double-blind comparison of CellCept to azathioprine for up to three years. The study will assess the efficacy and safety of CellCept in inducing and maintaining remission in patients with lupus nephritis.
About Lupus Nephritis
Systemic lupus erythematosus (SLE), commonly called lupus, is a chronic autoimmune disease that causes the body to attack its own tissues and joints.
Lupus nephritis is the most serious manifestation of the disease, which, if left untreated, can lead to kidney failure, requiring dialysis. It is a complicated disease as patients typically fluctuate between periods of intense disease activity when the patient's own immune system is actively attacking and causing damage in their kidney, interspersed with periods of remission. Clinicians estimate that one third to one half of lupus patients have lupus nephritis.
There has been no new approved treatment for SLE or lupus nephritis in the United States in over thirty years. Current treatments involve the off-label use of existing cancer drugs such as cyclophosphamide, steroids, and other immunosuppressant drugs such as azathioprine.
About CellCept
CellCept is an immunosuppressant or "anti-rejection" drug used in combination with other immunosuppressive drugs (cyclosporine and corticosteroids) for the prevention of rejection in patients receiving heart, kidney and liver transplants. CellCept was first approved for use in combination therapy for the prevention of acute organ rejection in kidney transplantation in 1995 and has since been approved worldwide for prevention of organ rejection in adult kidney, heart and liver transplantation. In some countries, it has also been approved for paediatric kidney transplantation. This therapeutic success represents 10 years of clinical experience and patient benefits, including reduced toxicities and prolonged graft and patient survival. Over the last decade, CellCept has become the world's most widely studied immunosuppressant and research is ongoing both in organ transplantation and related areas, such as autoimmune disease, to help provide clinical benefit to a wider range of patients.
CellCept is not currently approved for the treatment of either lupus erythematosus or lupus nephritis.
About Aspreva Pharmaceuticals
Aspreva is an emerging pharmaceutical company focused on identifying, developing and upon regulatory approval, commercializing new indications for approved drugs and late stage drug candidates for underserved patient populations. Aspreva's "indication partnering" strategy allows its partners to maintain core brand focus while extending the benefits of their medicines to a broader patient population. Aspreva is listed on the Nasdaq National Market under the trading symbol "ASPV" and on the Toronto Stock Exchange under the trading symbol "ASV".
For further information please contact:
Sage Baker
Director, Corporate Communications
Aspreva Pharmaceuticals
250-744-2488 ext. 270
sbaker@aspreva.com