MISSISSAUGA, ON, July 12, 2016 /PRNewswire/ - Cipher Pharmaceuticals Inc. (NASDAQ:CPHR; TSX:CPH) ("Cipher" or "the Company") today announced that its New Drug Submission for Ozenoxacin has been accepted for review by Health Canada. Ozenoxacin is a topical treatment proposed for use in adult and paediatric patients with impetigo, a highly contagious bacterial skin infection. Cipher acquired the Canadian commercialization rights to Ozenoxacin from Ferrer International SA ("Ferrer"), a privately-held Spanish pharmaceutical company, in January 2015.
"This represents another important milestone on our path to commercialization of this alternative treatment for one of the most common bacterial skin infections in children – a condition that has become more challenging with the emergence of treatment-resistant bacterial pathogens," said Joan Chypyha, GM of Cipher Canada. "As we continue to expand our Canadian product portfolio, we believe Ozenoxacin has high potential in the topical impetigo market, should it receive approval."
Ozenoxacin belongs to a new generation of non-fluorinated quinolones that have demonstrated improved tolerability and safety over fluorinated quinolones. Phototoxicity, photoallergenic sensitization and articular toxicity were not observed in local tolerability studies1. Ozenoxacin also demonstrated in vitro and in vivo antibacterial activity against a broad range of pathologically relevant bacteria, including methicillin resistant Staphylococcus aureus (MRSA) strains and clinical isolates of organisms with emerging resistance to quinolones and other topical antibiotics.
In July 2015, Ferrer successfully completed the second phase III clinical trial for Ozenoxacin. The study, which involved Ozenoxacin formulated as a topical treatment for impetigo in adults and peadiatric patients aged 2 months and older, demonstrated the superiority of Ozenoxacin 1% cream, applied twice daily for 5 days, versus placebo on both the clinical and bacteriological endpoints by end of therapy visit (day 6-7). In addition, Ozenoxacin 1% cream demonstrated superior bacteriological cure compared to placebo as early as visit 2 (day 3-4). Ozenoxacin 1% cream was shown to be safe and very well tolerated in the adult and paediatric population.