Aspreva's CellCept misses endpoints in Ph III MG trial

Canada's Aspreva Pharmaceuticals says CellCept (mycophenolate mofetil) yielded disappointing results in a myasthenia gravis trial. The Phase III randomized, double-blind, placebo-controlled clinical study was designed to evaluate the efficacy and safety of the Roche-orginated immunosuppressant in maintaining or improving symptom control with reduced doses of corticosteroids. CellCept missed the primary endpoints, which included minimal disease activity while maintaining designated low doses of steroid and cholinesterase inhibitor, as well as missing the secondary endpoints. In 2003, Aspreva entered an accord with Roche for the exclusive global rights to develop its leading anti-rejection drug for autoimmune disorders. MG could have been its first approval for such an indication. On the day of the news, October 26, shares in Aspreva fell 10.8% to $19.75.