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Roche Drops After Halting Cholesterol Drug Development

Roche Holding AG (ROG) fell the most in almost seven months in Zurich trading after the drugmaker abandoned development of an experimental cholesterol drug as a late-stage trial showed it wasn’t working.

An independent group of experts recommended stopping the study of dalcetrapib “due to a lack of clinically meaningful efficacy,” Basel, Switzerland-based Roche said in a statement today. The company had planned a six-trial development program that could have eventually put more than 35,000 patients on the drug, which was intended to boost so-called good cholesterol.

Dalcetrapib was one of nine medicines with potential sales of more than 1 billion Swiss francs ($1.1 billion) each that Roche planned to introduce by 2016. Gbola Amusa, an analyst at UBS AG, had predicted the drug could generate $6.8 billion in revenue by 2020 and given it a one-in-four chance of succeeding.

The heart drug “was potentially one of the largest new assets they had in the late-stage pipeline,” Karl Heinz Koch, an analyst at Helvea SA in Zurich, said in a telephone interview today. “In that sense it does leave a large gap.” He said he maintained his sales forecasts because he had assumed a negative outcome. Koch rates the stock neutral.

The shares fell as much as 4.5 percent, trading 3.5 percent lower at 159.30 francs as of 12:10 p.m. in Zurich.

Approach Questioned
Dalcetrapib’s failure is the latest in a series of trials to raise questions over whether boosting good cholesterol, or HDL, actually helps patients. A similar medicine from Pfizer Inc. (PFE) (PFE), torcetrapib, was scrapped in 2006 after more of the patients who took it in a study died. In May of last year, a study found an Abbott Laboratories (ABT) (ABT) drug to raise good cholesterol didn’t prevent heart attacks.

Still, Roche boosted some investors’ hopes last year with data from a pair of smaller tests that showed dalcetrapib didn’t raise blood pressure, setting some safety concerns to rest.

Results from a more than 15,000-patient trial called dal- Outcomes had been expected to show by next year whether dalcetrapib could help keep patients alive and block heart attacks and strokes in people who had already had acute coronary syndrome. Roche then started recruiting patients in January for what was to have been a 20,000-person test on a broader group of patients, including those at risk for cardiovascular disease who hadn’t had heart attacks yet.

Clearing Arteries
HDL flushes fat deposits in arteries out of the body via the liver. That’s different from the way statins such as Pfizer’s Lipitor work to decrease levels of bad cholesterol, or LDL, which clogs arteries.

“While we have always stated that dalcetrapib is a high- risk project, we are disappointed by the fact that this drug didn’t provide benefit to the patients in our study,” Chief Medical Officer Hal Barron said in the statement.

The Data and Safety Monitoring Board made the recommendation after assessing interim results of the dal- Outcomes trial. The board didn’t report safety signals related to the trial, Roche said. The Swiss company licensed dalcetrapib from Japan Tobacco Inc. (2914) in 2004.

Eli Lilly & Co. (LLY) (LLY) and Merck & Co. (MRK) (MRK) are still working on medicines that target HDL.

To contact the reporters on this story: Simeon Bennett in Geneva at [e-mail]; Naomi Kresge in Berlin at [e-mail]

To contact the editor responsible for this story: Phil Serafino at [e-mail]