US specialty drug firm Medimetriks Pharmaceuticals has entered into a licensing agreement with Ferrer, a privately-held Spanish pharmaceutical company, for the commercialization rights to ozenoxacin, a novel non-fluorinated quinolone antibacterial 1% cream for impetigo, in the USA.
Last year, Ferrer successfully completed the first Phase III Clinical Trial of Ozenoxacin in adult and pediatric patients with impetigo (The Pharma Letter June 5, 2013). The study demonstrated the superiority of ozenoxacin, applied topically twice daily for five days, versus placebo on both the clinical and bacteriological endpoints by the end of therapy. In addition, ozenoxacin demonstrated a superior bacteriological cure compared to placebo, typically by day four. Ozenoxacin was shown to be very well tolerated in both adult and pediatric populations. Development plans include an additional Phase III clinical trial.
In preclinical in vitro and in vivo studies, ozenoxacin has shown excellent antibacterial activity against a broad range of bacteria, including organisms with emerging resistance to other commonly prescribed topical antibiotics.
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