Cytokinetics skids on heart failure drug data

Cytokinetics tumbles after heart failure drug doesn't meet main goal in mid-stage trial

Associated Press

NEW YORK (AP) -- Shares of Cytokinetics slumped Tuesday after the company's heart failure drug did not meet its main goal in a clinical trial.

THE SPARK: Cytokinetics and its partner Amgen said the drug, omecativ mecarbil, did not work better than a placebo in treating shortness of breath in patients with acute heart failure. The mid-stage study compared three different doses of omecativ mecarbil to a placebo in 613 patients.

Cytokinetics Inc. said there were some positive results from the trial, as patients who received the largest dose of the drug did improve, compared with patients who were given a placebo. Both Cytokinetics and Amgen said they were pleased with the results.

Overall the rates of side effects were similar. Cytokinetics said there were seven heart attacks in the group of patients treated with omecativ mecarbil and three in a placebo group, but the drug was not linked to heart rate or blood pressure problems, irregular heart rhythms, or heart damage.

THE BIG PICTURE: Cytokinetics is based in South San Francisco, Calif., and it does not have any approved drugs. Its most advanced experimental products are omecativ mecarbil and a muscle disorder drug called tirasemtiv.

Cytokinetics and biotech giant Amgen Inc. are studying oral and intravenous versions of omecativ mecarbil. In June, Amgen agreed to pay at least $25 million to expand that collaboration. Cytokinetics could get another $50 million in additional payments from the expanded deal, which covers Japan — the only country excluded from their initial collaboration.

THE ANALYSIS: Cowen and Co. analyst Simos Simeonidis said he is not surprised that the drug did not meet its overall goal in the study, because the lowest dose of the drug was expected to be ineffective. He said Cytokinetics and Amgen have suggested their top priority was demonstrating the safety of omecativ mecarbil, and there are positive trends in the study data.

He added that Amgen probably would not have expanded its marketing deal with Cytokinetics without seeing this data, so Amgen is likely satisfied with the results of the study. Simeonidis kept an "Outperform" rating on Cytokinetics shares.

SHARE ACTION: The stock dropped $2.65, or 25.3 percent, to $7.82 in morning trading. As of Friday's close, Cytokinetics shares had more than doubled in value in 2013.

Amgen shares rose $2.53, or 2.3 percent, to $111.47.

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