Advanced Life Sciences Holdings, Inc, a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, has applied to the US Food and Drug Administration for Fast-Track designation for Restanza, a novel once-daily oral antibiotic, for the treatment of community acquired bacterial pneumonia (CABP).

Fast Track designation by the US FDA is a process designed to expedite the review of new drugs that treat serious diseases and fill an unmet medical need. If there are existing therapies, a fast track drug must show some advantage over available treatment, such as superior effectiveness or avoiding serious side effects of an available treatment.

According to recent mortality data from the Centers for Disease Control and Prevention (CDC), pneumonia remains the leading cause of death for infectious disease in the US, accounting for over 55,000 deaths annually. Treatment of the disease is compounded by increasing rates of resistance to currently prescribed antibiotics. Recent surveillance data demonstrate that the primary etiologic pathogen, Streptococcus pneumoniae, has resistance rates approaching 40 per cent for macrolides.

The company believes that Restanza fulfills an unmet medical need in that it displays superior in vitro and in vivo efficacy against macrolide-resistant Streptococcus pneumoniae (MRSP) compared to macrolides, that it is also active against fluoroquinolone-resistant S. pneumoniae; and that it possesses a potentially better safety profile compared to existing oral antibiotics that may be used to treat MRSP infection in patients with CABP.

A clinical trial protocol using a superiority design to assess the safety and efficacy of Restanza compared to azithromycin in CABP patients with MRSP is currently being finalized in close collaboration with US FDA under the Special Protocol Assessment (SPA) process.

Advanced Life Sciences is a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, cancer and respiratory diseases.