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Replidyne stops its drug trial over concerns about Ketek

Rachel Brand, Rocky Mountain News

Published December 26, 2006 at midnight

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Louisville drugmaker Replidyne once again stopped its most promising drug's key clinical trial, this time due to safety concerns about a competitor's medicine.

Replidyne suspended testing its antibiotic faropenem against Sanofi Aventis' drug Ketek, after a clinical advisory panel said Ketek's risks outweighed its benefits. The drug had been linked to liver damage and at least nine deaths. Replidyne was in the final phase of testing faropenem for chronic bronchitis.

CEO Ken Collins said today's news won't slow down Replidyne's testing process. "We do not expect that it will impact the total time to complete the clinical program," he said.

On Dec. 15, a U.S. Food and Drug Administration advisory panel said Ketek should not be used to treat chronic bronchitis due to risks of liver damage. It okayed the drug for pneumonia, a more serious condition. The FDA hasn't yet spoken on the matter. It doesn't have to heed its advisors, but it usually does.

In October, Replidyne's efforts to get faropenem to market were delayed by at least two years after the FDA requested more studies to judge the drug's merits. The company hopes to prove faropenem can be used to treat acute bronchitis, community-acquired pneumonia, skin infections and children's ear infections.