Medicines Co. Halts Drug Trial Over Irregular Heartbeat Risk

PARSIPPANY – Medicines Co. suspended enrollment in a trial of its Clevelox drug after patients who were given the medicine to lower blood pressure during cardiac surgery had a higher risk of irregular heartbeat. Shares fell 7.9 percent.

Clevelox was linked to atrial fibrillation, a form of irregular heartbeat that generally occurs in a third of patients on the second or third day after heart surgery, the Parsippany-based company said Monday. The study was designed to see whether Clevelox lowered complications such as kidney failure, heart attack, stroke and deaths compared with three other heart drugs.

The results will keep the company from seeking U.S. approval this year, Medicines said. Clevelox would be the second Medicines drug to reach the market, after the blood-thinner Angiomax. Sales of that product helped Medicines post its first profitable year in 2004. Peak sales of Clevelox might reach $52 million in 2012, said Pacific Growth Equities analyst Liana Moussatos.

“It’s not a big product for them,” Moussatos said in a telephone interview from San Francisco. She rates the shares “overweight” and doesn’t own the stock. “The development program isn’t dead yet, and the delay shouldn’t impact their valuation much.”

Shares of Medicines closed $1.90 to $22.27 in Nasdaq Stock Market composite trading. Medicines’ shares have lost 23 percent this year.

Clevelox, an experimental drug, is in the final stages of testing generally required for U.S. Food and Drug Administration approval.

There were more cases of atrial fibrillation among patients given Clevelox in the trial than in people taking nitroglycerin, sodium nitroprusside or nicardipine, according to an interim analysis of approximately half of the study’s participants.

While Clevelox patients had a higher rate of atrial fibrillation, it wasn’t above normal ranges, the company said.

“We’d originally guided toward filing a new drug application with the FDA toward the end of this year in the fourth quarter, and now we’re off that timeline,” spokesman Michael Mitchell said. After analyzing all data, a decision will be made on what trials are still needed, he added.