>> Abbott heart drugs show mixed results, shares fall
Mon Nov 14, 2005 04:42 PM ET By Bill Berkrot and Ransdell Pierson
DALLAS, Nov 14 (Reuters) - Researchers on Monday presented mixed results from clinical trials of two important Abbott Laboratories Inc. ( ABT ) heart drugs, sending shares of the drug maker to a low for the year.
Abbott shares fell more than 7 percent following a crazy quilt of favorable and unfavorable findings for the company's experimental heart-failure medicine Simdax and for its drug Tricor, which doctors prescribe to control harmful blood fats called triglycerides.
"Today's weakness in the stock is reflective of investors expecting more compelling and cleaner data from both trials," Banc of America Securities analyst Glenn Novarro said in a research note. The back-to-back results for Simdax, Abbott's most important experimental medicine, and for its lucrative Tricor were unveiled at the annual scientific meeting of the American Heart Association.
Researchers said Simdax, when added to standard treatments, was significantly more effective than the standard therapy alone in hospitalized patients. Heart-failure patients who received Simdax, also known as levosimendan, had a greater likelihood of clinical improvement and lower risk of deterioration than those who received only standard treatment, researchers said.
"We are really excited about our ability to demonstrate a favorable effect of this drug," said Dr. Milton Packer of Texas Southwestern Medical Center in Dallas and the lead author of the 600-patient study.
But Packer noted that the Abbott drug increased the incidence of potentially dangerous low blood pressure and heart rhythm problems. And more patients taking Simdax died than did those in the trial on standard therapy alone, although the difference was not considered statistically significant and the study was not designed to test survival advantages.
Packer said Simdax helped terribly sick patients -- ones who entered the hospital with a range of heart-failure symptoms, such as shortness of breath and a general inability to function -- to feel better sooner. "But the mortality issue remains somewhat of a concern," said Jon Hognason, a cardiologist from Landspitalinn University Hospital in Reykjavik, Iceland, who attended the meeting. He said he was awaiting results of another study, to be presented Wednesday, that will focus mainly on whether Simdax prolongs life in patients.
The Dallas meeting also put a spotlight on Tricor, which failed -- compared with placebos -- to meet its primary goal of reducing the combined incidence of heart attacks and coronary deaths in a large study of diabetic patients.
But patients taking Tricor, one of Abbott's best-selling medicines, fared better on a number of secondary measures, including a reduction in the need for procedures to clear clogged arteries and for laser treatments of eye disease.
"Clearly, the results of the trial were mixed," said Dr. Anthony Keech, an associate professor of medicine at the University of Sydney in Australia, the Tricor trial's lead researcher.
JP Morgan analyst Michael Weinstein, in a research note, said that while the headline results for Simdax were positive, "the underlying side effect and mortality profile raises a number of concerns and may put the drug's future in jeopardy."
If approved, it would be one of the few new drugs available for years in the United States to treat heart failure --a chronic condition in which the heart's ability to efficiently pump blood throughout the body is severely impaired.
Packer said the likelihood of clinical improvement among those taking Simdax in his trial was 33 percent higher and the likelihood of deterioration 30 percent lower over the course of five days in the hospital in patients who received the drug on top of standard therapy, researchers said.
Improvement in patients whose heart failure had worsened was measured by a lessening of symptoms. Deterioration was defined by the need for physician intervention or by death.
The Abbott drug was given by an initial injection followed by continuous intravenous infusion for 24 hours, but the trial covered the patients over five days. <<
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