VICTORIA, BC, July 19 /PRNewswire-FirstCall/ - Aspreva Pharmaceuticals Corporation , reports that Mycophenolate Mofetil (MMF, CellCept(R)) has been approved for the treatment of lupus nephritis in Malaysia. On July 11, 2006, Roche Malaysia received a letter of approval from the Drug Control Authority (DCA) in Malaysia granting them approval to include lupus nephritis as an additional indication for MMF in the induction and maintenance treatment of lupus nephritis (used concomitantly with corticosteroids). Malaysia is the first country to have regulatory approval of MMF in any autoimmune disease.
The supporting documents used in the application consisted of published clinical papers and the expert clinical report prepared by key opinion leader Dato Dr. Zaki Morad, Head of Nephrology at Hospital Kuala Lumpur. Dato Dr. Morad’s report on the clinical trial of MMF in lupus nephritis was published in the October 2005 issue of the journal Nephrology. The trial was conducted at eight centres in Malaysia, comparing intravenous cyclophosphamide to MMF in the induction therapy of proliferative lupus nephritis.
Aspreva is conducting a global phase III study to assess the efficacy and safety of MMF in inducing response and maintaining remission in patients with lupus nephritis. Aspreva’s two-phase induction and maintenance study is a randomized, open label comparison of MMF to intravenous cyclophosphamide in the first six months or induction phase, followed by a double-blind comparison of MMF to azathioprine for up to three years during the maintenance phase. The first patient in the Aspreva study was treated in July 2005, and completion of the induction phase of the trial is expected in early 2007.
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 F. Hoffmann-La Roche’s (Roche) leading 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.
In July 2003, Aspreva signed a collaboration agreement with Roche for the exclusive worldwide rights (excluding Japan) to develop and, upon regulatory approval, commercialize CellCept for all autoimmune disease applications.
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 patients living with less common diseases. Aspreva is listed on the NASDAQ Global Select Market under the trading symbol “ASPV” and on the Toronto Stock Exchange under the trading symbol “ASV”. For further information on Aspreva, please visit www.aspreva.com.
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CONTACT: Sage Baker, Executive Director, Corporate & Investor Affairs, Aspreva Pharmaceuticals, (250) 744-2488, sbaker@aspreva.com
Aspreva Pharmaceuticals
CONTACT: Sage Baker, Executive Director, Corporate & Investor Affairs,Aspreva Pharmaceuticals, (250) 744-2488, sbaker@aspreva.com
