ZURICH–Roche Holding AG (RHBBY) said Wednesday it is halting development of a diabetes drug partly because of serious side effects, raising questions about a category of medicines that has already seen other pharmaceutical giants cancel similar projects.
Basel-based Roche said an independent safety committee had recommended the company discontinue a late-stage clinical trial of aleglitazar, which caused kidney and heart failure in some patients. Roche also said the drug, which is designed to lower both blood sugar and so-called bad cholesterol, hadn’t proved as effective as initially hoped.
“We are disappointed by this outcome as we hoped that aleglitazar would provide significant benefit for patients with Type 2, or late-stage, diabetes who are at risk of cardiovascular disease,” Hal Barron, Head of Roche’s Global Product Development said in a statement.
Roche’s decision to cancel the trial, which involved more than 7,000 patients suffering from heart problems and Type 2 diabetes, is the latest setback for a class of drugs with similar mechanisms. Once considered promising, so-called dual PPAR agonists have failed in earlier trials, causing companies, including AstraZeneca and Bristol-Myers Squibb, to scrap their programs and pull back from the drug class.
The setback is also likely to weigh on a regulators’ decision on Avandia, a similar diabetes medicine made by British rival GlaxoSmithKline PLC and a one-time big seller. Use of the drug in the U.S. was restricted by the Food and Drug Administration, while European regulators banned it in 2010 over concerns it could lead to heart risks.
A U.S. government panel last month called for easing restrictions on the drug, which Glaxo maintains is safe.
Drug companies have been trying to develop better treatments for diabetes, a group of chronic metabolic diseases which can lead to a wide range of complications. Diabetes affects about 47 million people worldwide, according to the World Health Organization and is expected to be the seventh leading cause of death in 2030.
The failure marks a stumbling block for Roche as it tries to move beyond its key cancer-drug business and follows the 2010 discontinuation of taspoglutide, which treated similar indications.
Roche didn’t quantify the impact of its decision to halt the development of aleglitazar or say how much it had invested in the compound.
Before the halt, analysts estimated aleglitazar sales might have peaked at between 2 billion and 4 billion Swiss francs ($2.1 billion to $4.1 billion) if the compound was approved. They also said Roche may now have to re-evaluate its diabetes portfolio, where the company still has two compounds.
Alexander Klauser, Roche’s chief spokesman, said the company “will assess its portfolio and R&D efforts in the metabolic diseases area” and added the company remains committed to expanding into areas beyond oncology.
Zurich-based analyst David Kaegi with J. Safra Sarasin said in a note to investors that aleglitazar was regarded as one of Roche’s more attractive pipeline products. Mr. Kaegi has a buy rating on Roche stock.
At 1100 GMT, Roche shares were little affected, gaining 0.1% at CHF244.
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