Replidyne Inc. has reported that the current phase III clinical trial comparing faropenem medoxomil (faropenem) to placebo and Ketek (telithromycin) in patients being treated for acute exacerbation of chronic bronchitis (AECB) is being temporarily stopped to consider the exclusion of the Ketek arm in the study.

This decision has been made in response to the findings from the December 14 and 15, 2006 joint Advisory Committee meeting of the FDA's Anti-Infective Drug and Drug Safety and Risk Management committees that considered the benefit risk of Ketek for the indication of AECB. The Advisory Committee recommended to the FDA that the risks of Ketek outweigh the benefits of using the drug for the treatment of patients with AECB in a 17 to 2 vote.

"We believe that stopping enrolment in this trial to consider the inclusion of Ketek in the study is the appropriate and responsible action at this time to consider the new scientific evidence presented at the recent FDA Advisory Committee meeting," said Kenneth J Collins, president and chief executive officer of Replidyne. "While this action will cause a delay in obtaining the results from this AECB study we do not expect that it will impact the total time to complete the clinical programme required to support the overall submission for the adult respiratory indications of Acute Bacterial Sinusitis (ABS), Community Acquired Pneumonia (CAP) and AECB. This action will not impact the development of our paediatric clinical programme for faropenem."

The phase III clinical trial for AECB is designed to compare faropenem to placebo and Ketek, an approved ketolide antibiotic. The primary objective of the study is to demonstrate superiority of faropenem to placebo. The additional comparison to Ketek represented a secondary analysis and was initially included primarily for commercial competitive reasons.

Replidyne's lead product candidate, faropenem medoxomil (faropenem), is a novel oral community antibiotic under development for the treatment of respiratory and other community infections.

Replidyne is a biopharmaceutical company focused on discovering, developing, in licensing and commercialising innovative anti-infective products.