( LOUISVILLE Colo. March 06 2007 /PRN...)Replidyne Phase II Pediatric Trial Meets Primary Objective,Health

LOUISVILLE, Colo., March 06, 2007 /PRNewswire-FirstCall/ -- Replidyne, Inc. announced today that it has completed its Phase II clinical trial using faropenem medoxomil (faropenem) in pediatric patients with acute otitis media (AOM), a common infection of the middle ear. Initial analyses of the study results show that it met its primary objective to show that faropenem was effective in eradicating pathogens from the middle ear and to permit the dose selection for Phase III trials in AOM.

The study of over 300 pediatric patients examined four different doses of faropenem, administered twice daily as an oral suspension, and demonstrated a dose response in bacteriological eradication. All doses examined were well tolerated and there was no clear dose effect to tolerability. The trial included a double tap design where middle ear fluid is obtained both prior to and during treatment then submitted for culture. These cultures provide microbiologic documentation of faropenem's effectiveness in eradicating bacteria from the middle ear fluid.

"We are pleased with the positive results and rich bacteriological and clinical data generated from this study, and look forward to presenting these data in more detail at an upcoming scientific conference," said Kenneth J. Collins, Replidyne's President and CEO. "The results give us confidence that we will be able to select an appropriate dose for Phase III studies. We plan to meet with the FDA in the second quarter to share these data and discuss Phase III trial design for faropenem in pediatric AOM."

About Faropenem

Faropenem is a member of the penem subclass within the beta-lactam class of antibiotics. Beta-lactams are generally characterized by their favorable safety and tolerability profiles, as well as their broad spectrum of activity, and as a result are often used as first line therapy in many respiratory and skin infections in adult and pediatri
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