Replidyne, Inc. and Forest Laboratories, Inc. announced that they have ended the February 2006 collaboration for the commercialisation of faropenem medoxomil (faropenem), a novel community antibiotic in late-stage clinical development. As a result of this termination, Replidyne will re-acquire all US adult and paediatric rights previously granted to Forest.

"We remain confident in the viability of faropenem. As the first oral penem community antibiotic developed in the US, supported by a favourable tolerability profile, faropenem could offer important advantages over current therapy. Though the regulatory requirements for the approval of antibiotics have changed, we believe that faropenem can meet these new standards and are we working closely with the FDA to define a regulatory pathway for faropenem approval," stated Kenneth J Collins, Replidyne's president and CEO. "Upon approval, faropenem has the potential to be a valuable asset in a market which should have limited promoted competition at that time."

In October 2006, the FDA issued a non-approvable letter for faropenem for four adult indications: acute bacterial sinusitis (ABS), community-acquired pneumonia (CAP), acute exacerbation of chronic bronchitis (AECB) and uncomplicated skin and skin structure infections (SSSI). In the non-approvable letter, the FDA recommended further clinical studies for all indications including studies using a superiority design for the indications of ABS and AECB, more extensive microbiologic confirmation, and consideration of alternate dosing regimens. The FDA did not raise any safety concerns or chemistry, manufacturing or controls (CMC) issues related to the product.

Faropenem is a member of the penem subclass within the beta-lactam class of antibiotics. Beta-lactams are generally characterized by their favourable 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 paediatric patients.

Faropenem medoxomil is an investigational compound being developed for oral treatment of community-acquired respiratory infections and uncomplicated skin and skin structure infections. Community antibiotics are generally used to treat infections acquired in a public setting, rather than at the hospital.