BRONCHITIS TREATMENT TRIAL ON HOLD

Replidyne reported Dec. 26 that the current Phase III clinical trial comparing faropenem medoxomil to placebo and Ketek 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 Dec. 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 and risk of Ketek (telithromycin) 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 17-2 vote.

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. Faropenem is a member of the penem sub-class 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 typically first-line therapy in many respiratory and skin infections in adult and pediatric patients.