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Roche pulls trial of investigational cholesterol drug

Dalcetrapib no better than current statins

Roche Basel Switzerland

Roche has halted all studies investigating its cholesterol drug dalcetrapib after interim data suggested it was no better than current statins.

The dal-HEART series of trials was stopped after the phase III dal-OUTCOMES trial showed a 'lack of clinically meaningful efficacy' for dalcetrapib when added to existing standard treatments patients with stable coronary heart disease (CHD) following an acute coronary syndrome (ACS).

The drug, which Roche licensed from Japan Tobacco, had been the company's attempt to compete with cholesterol lowering medication such as Pfizer's Lipitor (atorvastatin) and Merck's Zocor (simvastatin), both of which are now open to generic competition.

Defined as a cholesterylester transfer protein (CETP) inhibitor, it was developed to raise levels of 'good' functional high-density lipoprotein cholesterol (HDL-C).

According to Roche, increased levels of this cholesterol would promote the removal of 'bad' cholesterol from a patient's blood vessels.

If the drug reached the market, analysts had predicted it could have annual sales of more than $1bn considering the increasing need to tackle high cholesterol.

Other drugs that act in similar ways to have faced issues during the clinical trail stage include Pfizer's torcetrapib, which the company abandoned due to safety issues.

CETP inhibitors currently in development include Merck & Co's anacetrapib and Eli Lilly's evacetrapib

In a statement, Roche's chief medical officer and head of global product development Dr Hal Barron said the company was “disappointed” by the study's results, but acknowledged that dalcetrapib was a high risk project given the success of existing statins.

He added: “We continue to be fully committed to the development of innovative medicines for people with cardiovascular disease.”

8th May 2012

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