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Roche Halts Trials of Diabetes Drug on Safety Concern

Roche Halts Clinical Trials of Diabetes Drug on Safety Worry
The Roche Holding AG logo sits on a sign outside the company's headquarters in Basel. Photographer: Gianluca Colla/Bloomberg

July 10 (Bloomberg) -- Roche Holding AG halted testing of its most-advanced experimental diabetes drug over safety concerns and said it’s reassessing its research and development program for heart and metabolic diseases.

The Data and Safety Monitoring Board, an independent body, recommended halting the trial of the treatment, aleglitazar, on patients with recent heart trouble and type-2 diabetes because of concerns about the drug’s safety and effectiveness, the Basel, Switzerland-based drugmaker said in a statement today. Heart failure, kidney impairment and bone fractures were side effects in the study, spokesman Alexander Klauser said.

Roche, the world’s biggest maker of cancer drugs, has struggled to bring projects outside oncology to fruition. The company halted development of its cholesterol drug dalcetrapib last year and gave up on diabetes drug taspoglutide in 2011. Roche said in March 2010 it expected aleglitazar could have peak sales of 2 billion Swiss francs ($2.1 billion) to 5 billion francs.

“The demise of aleglitazar will likely increase the pressure on management to intensify their attempts to diversify their portfolio away from their oncology backbone,” Andrew Baum, a London-based analyst at Citigroup Inc., wrote in a note to investors. He cut his price estimate on the shares 6.7 percent to 280 francs and has a buy recommendation.

Research Review

The shares rose 0.1 percent to 244 francs at 3:22 p.m. in Zurich.

Because of the failure, Roche plans a review of the research area that included aleglitazar, Klauser said. It’s a reversal from five years ago, when Roche was testing about seven diabetes drug candidates with an eye to challenging companies such as Novo Nordisk A/S and Eli Lilly & Co.

“We will assess our position overall in our research and development programs for cardiometabolic diseases,” he said.

After dalcetrapib failed, Roche closed its research and development center in Nutley, New Jersey.

Like dalcetrapib, a medicine meant to help ward off heart attacks by boosting so-called good cholesterol, aleglitazar was a risky bet to begin with. Drugs in its class have a poor clinical track record, Alistair Campbell, a London-based analyst at Berenberg Bank, wrote in a research note today.

Market Dearth

Aleglitazar belongs to a group of drugs called dual PPAR agonists, which aim to control how fat and sugar is absorbed in the bloodstream by targeting two proteins in the body called PPAR receptors. No dual PPAR agonist has ever reached the market.

Some drugs, like GlaxoSmithKline Plc’s Avandia, target only one of the PPAR receptors. U.S. regulators limited the use of Avandia after a study showed an increased risk of heart attack in patients taking the medicine. A Food and Drug Administration advisory panel said last month those risks may have been overstated and restrictions on the drug should be eased.

Roche may have believed aleglitazar had a chance at reducing heart risk for patients because of data from another similar drug, Takeda Pharmaceutical Co.’s Actos, Berenberg’s Campbell wrote. He had assumed peak sales of 1.5 billion francs for aleglitazar, with a 50-50 chance of success.

“It was a reasonable logic that simply has not played out,” Campbell wrote. He has a buy recommendation on Roche’s shares.

Roche has four other heart and metabolic drugs in human trials, according to its website. Aleglitazar had anchored the program, with three of the other projects in less-advanced stages of testing and the fourth, a diabetes drug, managed by Roche’s partner Chugai Pharmaceutical Co.

About 10,000 patients were already enrolled in clinical trials on aleglitazar, Klauser said, and Roche had sought to expand that to more than 30,000 patients.

Roche is looking for partners for another of its heart drugs, a treatment designed to lower cholesterol by targeting the PCSK9 gene. That move is unrelated to the cancellation of aleglitazar research, Klauser said.

To contact the reporter on this story: Naomi Kresge in Berlin at nkresge@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

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