November 14, 2005
Abbott heart drugs show mixed results, shares fall
By Bill Berkrot and Ransdell Pierson
DALLAS (Reuters) - Researchers on Monday presented mixed
results from clinical trials of two important Abbott
Laboratories Inc. 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
"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
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
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
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.
Abbott shares closed down $3.21, or 7.3 percent, at $40.52
on the New York Stock Exchange.
(Additional reporting by Julie Steenhuysen in Chicago and
Lewis Krauskopf in New York)