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Late-stage blow to Roche's diabetes ambitions

Halts development of aleglitazar on safety and efficacy concerns

Roche Basel Switzerland

Roche has discontinued development of its phase III diabetes candidate aleglitazar following safety concerns with one of the drug's trials.

The AleCardio trial had been evaluating aleglitazar's safety and efficacy in patients with a recent acute coronary syndrome event and type 2 diabetes.

However, following a regular safety review of the trial, the independent Data and Safety Monitoring Board (DSMB) recommended Roche halt the trial due to "safety signals and lack of efficacy".

Roche said that based on the DSMB's recommendation, it decided to terminate the AleCardio trial and all other trials involving aleglitazar.

Hal Barron, Roche's chief medical officer and head, global product development, said: “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.

“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.”

The decision will be a particular disappointment to Roche, coming less than a year after aleglitazar was picked out as one part of a rich pipeline to balance out its cancer drug patent losses.

Aleglitazar is a peroxisome proliferator activated receptor agonist, like Dr Reddy's Laboratories' balaglitazone and Takeda's older Actos (pioglitazone).

Both these products have encountered their own problems, with Dr Reddy's deeming its drug to be commercially unviable and Takeda struggling to overcome its own safety concerns.

The primary endpoint of the AleCardio trial had been to measure the major adverse cardiovascular event rate at 4.5 years (composite of cardiovascular mortality, non-fatal myocardial infarction and stroke).

Roche said data from the trial would be further analysed to fully understand the findings and will be made available at a future medical meeting.

10th July 2013

From: Research

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