Tuesday, July 9, 2013

Reuters: Regulatory News: UPDATE 1-Roche stops diabetes drug trial after safety issues

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Reuters: Regulatory News
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UPDATE 1-Roche stops diabetes drug trial after safety issues
Jul 10th 2013, 06:01

Wed Jul 10, 2013 2:01am EDT

ZURICH, July 10 (Reuters) - Roche said it would stop developing aleglitazar, a diabetes treatment, due to undesired side effects and lack of effectiveness.

"Roche is working with investigators to support the management of patients and their transition from aleglitazar treatment to other blood sugar control therapies," Roche's chief medical offer and head of product development Hal Barron said in a statement on Wednesday.

Patients in a late-stage trial of the drug suffered side effects affecting organs such as their kidneys and hearts, a spokesman for the Basel-based drugmaker said.

The spokesman said Roche could not yet quantify the financial impact of the move.

Last year, Roche scrapped development of dalcetrapib - a medicine aimed at boosting levels of "good" HDL cholesterol - which some industry analysts had estimated could have achieved $10 billion in annual sales.

Experts had viewed Roche's decision to advance aleglitazar into late-stage trials as a gamble, following the failure of other experimental drugs from other drugmakers to prevent heart problems caused by diabetes.

Astra Zeneca scrapped development of one such drug in 2006, the same year as Bristol Myers Squibb ended development of another after regulatory setbacks.

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