Replidyne Files NDA to FDA for Orapem™

Replidyne, Inc., a biopharmaceutical company focused on the discovery and development of new anti-infective drugs, kicked off 2006 with a bang and has submitted a New Drug Application to the FDA for Orapem™ for the treatment of acute bacterial sinusitis, community acquired pneumonia, acute exacerbations of chronic bronchitis and uncomplicated skin and skin structure infections.

This NDA is the first marketing approval submission for Orapem™ worldwide and it is also the first NDA submission for Replidyne. The Orapem™ submission is primarily based on data from eleven Phase III clinical trials which assessed the clinical and microbiological efficacy as well as the safety and tolerability profile in treating respiratory tract and skin infections. The safety database included more than 5,000 Orapem™ treated patients from clinical trials.

Congratulations to Replidyne for achieving such a significant milestone. We are incredibly excited about the potential FDA approval and subsequent commercialization focus.