ASPREVA ANNOUNCES CELLCEPT FAILS TO MEET TRIAL ENDPOINTS

Aspreva Pharmaceuticals has announced that, based on a preliminary review of trial data, CellCept (mycophenolate mofetil or MMF) in treating myasthenia gravis (MG) failed to meet both primary and secondary endpoints in a Phase III trial.

The randomized, double-blind, placebo-controlled clinical trial was designed to evaluate the efficacy and safety of MMF in maintaining or improving symptom control with reduced doses of corticosteroids in patients with myasthenia gravis over a treatment period of 36 weeks. The primary endpoint in the trial was minimal disease activity while maintaining a designated low steroid and cholinesterase inhibitor doses.

The preliminary analysis of the results from the trial indicates that MMF failed to meet both the primary and secondary endpoints. Aspreva's analysis also showed that MMF appeared to be generally well-tolerated by the patients in the study.

CellCept is Roche's leading immunosuppressant or 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 pediatric kidney transplantation.

Aspreva signed a collaboration agreement with Roche in 2003 for the exclusive worldwide rights to develop and, upon regulatory approval, commercialize CellCept for all autoimmune disease applications. CellCept has not been approved by the FDA for the treatment of any autoimmune disease.