Safety issues cause Roche to halt investigation of aleglitazar for diabetes

Swiss drug major Roche (ROG: SIX) revealed this morning (July 10)that it is terminating the Phase III AleCardio study and all other trials of its diabetes drug candidate aleglitazar following the results of a regular safety review. As a result of this, the independent Data and Safety Monitoring Board (DSMB) has recommended halting the trial due to safety signals and lack of efficacy.

“The safety of patients is our first priority. Roche is working with investigators to support the management of patients and their transition from aleglitazar treatment to other blood sugar control therapies,” said Hal Barron chief medical officer and head, global product development at Roche, adding: “We are disappointed by this outcome as we hoped that aleglitazar would provide significant benefit for patients with type 2 diabetes who are at risk of cardiovascular disease.”

Roche said in March 2010 it expected aleglitazar could have peak sales of between 2 billion Swiss francs ($2.1 billion) and 5 billion francs, according to a Bloomberg report this morning.