Vifor Pharma, the pharma business sector of the Galenica Group, and Roche announced that the maintenance phase of the Aspreva Lupus Man-agement Study (ALMS) has successfully achieved its primary endpoint. The trial demonstrates the superiority of Roche's CellCept (mycophenolate mofetil) versus azathioprine (AZA) in de-laying treatment failure in patients with Lupus Nephritis (LN). ALMS is one of the largest studies ever conducted in LN.
ALMS Maintenance was designed to establish the efficacy of CellCept compared to AZA as maintenance therapy in LN patients who had successfully responded to induction treatment (ALMS Induction, reported June 2007) with either CellCept or intravenous cyclophosphamide (IVC). Topline primary endpoint results for the trial indicate that CellCept was superior to AZA in delaying the time to treatment failure (p=0.003). The safety profiles of both drugs were consistent with those previously re-ported with no new safety signals observed. Vifor Pharma plans to present these results at the ninth International Congress on Systemic Lupus Erythematosus (SLE) to be held in Vancouver, Canada from June 24 to 27 2010. Additional analyses are ongoing.
Dr Ellen Ginzler, chief of Rheumatology and professor of Medicine, SUNY Downstate Medical Center New York, USA and lead investigator for the study in the US, said, "Despite recent advances in the treatment of Lupus, the disease may still relapse after successful treatment and is very difficult to study. These ALMS Study results are promising for patients who need treatment options as it has been more than 50 years since a new treatment for Lupus has been approved by the US FDA."
In light of these positive topline results, and assuming the final results are consistent, Vifor Pharma and Roche are assessing the potential to seek regulatory approval in the US, Europe and other major markets for the use of CellCept in the treatment of LN.
Systemic lupus erythematosus (SLE), commonly called lupus, is a chronic autoimmune disease that causes the body to attack its own tissues and joints.
CellCept (mycophenolate mofetil) is an immunosuppressant approved for use in combination with other immunosuppressive drugs (cyclosporine and corticosteroids) for the prevention of rejection in patients receiving kidney, heart and liver transplants.
Galenica is a diversified Group active throughout the health care market which, among other things, develops, manufactures and markets pharmaceutical products, runs pharmacies, provides logistical and database services and sets up networks.
Vifor Pharma, the Pharma business sector of the Galenica Group, researches, develops, manufac-tures and markets pharmaceutical products, with focus on the treatment of iron deficiency, where Vifor Pharma is one of the leading companies.