Wed Nov 16, 2005 01:53 PM ET By Bill Berkrot and Ransdell Pierson
DALLAS, Nov 16 (Reuters) - Abbott Laboratories Inc.'s experimental heart failure drug, Simdax, failed to significantly improve survival over the current standard treatment for the sickest patients after 180 days, according to a new study presented on Wednesday.
The drug showed some survival benefit after five days and also after one month in the 1,327 patient study comparing it with dobutamine, which was also statistically insignificant.
Simdax fell short of the main goal of reducing death by 25 percent after six months, instead reducing the rate by 8 percent, researchers who presented the data said at the American Heart Association annual scientific meeting in Dallas. The results, which come only two days after mixed findings in another study of Simdax that showed symptom improvement, spurred a renewed sell-off in Abbott's stock.
Shares of the company, which is based in suburban Chicago, slumped 2.7 percent to a new low for the year. They fell more than 7 percent on Monday, as investors focused on side effects such as dangerously low blood pressure and hearth-rhythm problems seen in the symptom-relief study.
At least one analyst said the latest findings will kill the chances of Simdax -- the most important drug in Abbott's developmental pipeline -- being approved in the United States. Simdax is already approved in many other countries.
"This product likely won't make it to market," said JP Morgan analyst Michael Weinstein, who cited the lack of a survival benefit and continued heart rhythm irregularities. Weinstein said U.S. regulators will likely require more trial data on the drug's safety and effectiveness, particularly in view of recent questions about the safety of Johnson and Johnson's ( JNJ ) Natrecor medicine for heart failure.
"While the ambitious end-point for the trial was not met, important survival trends attributed to levosimendan (Simdax) were seen early in the trial," Dr. Alexandre Mebazaa, the study's lead investigator, said at the heart meeting. Mebazaa said the slight "trend" toward survival soon after treatment and the symptom relief seen in the earlier trial, were signs the drug is working.
Heart failure is a hard-to-treat condition in which the weakened heart is unable to adequately pump blood, causing shortness of breath and extreme weakness that cause millions of hospitalizations each year in the United States. Dobutamine, which helps the heart contract, for years has been the standard of care for the sickest heart failure patients, but has limited benefits and has not been widely studied despite its wide usage.
In the separate trial described on Monday, patients with worsening heart failure taking Simdax and a standard treatment were found to have a greater likelihood of clinical improvement and lower risk of deterioration than those who received a range of standard treatments.
The medicine is sold in some European markets by Finnish drugmaker Orion, which licensed the U.S. rights to Abbott. Orion shares fell 9.7 percent in Helsinki.
Since mid-July, Abbott's shares have fallen nearly 20 percent, compared with the American Stock Exchange Pharmaceutical Index , which is down nearly 5 percent for the period. <<
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