6-K CIPHER PHARMACEUTICALS INC filed this Form 6-K on 07/30 Cipher Pharmaceuticals Announces Successful Completion of Second Phase III for Ozenoxacin
- Company expects to submit Ozenoxacin for regulatory approval in Canada in the first quarter of 2016 -
MISSISSAUGA, ON, July 30, 2015 /CNW/ - Cipher Pharmaceuticals Inc. (NASDAQ:CPHR; TSX:CPH) ("Cipher" or "the Company") today announced that Ferrer International SA ("Ferrer") successfully completed the second phase III clinical trial for Ozenoxacin, a topical treatment for adult and paediatric patients with impetigo, a highly contagious bacterial skin infection. Cipher acquired the Canadian commercialization rights to Ozenoxacin from Ferrer, a privately-held Spanish pharmaceutical company, in January 2015.
"The successful completion of the second phase III trial for Ozenoxacin moves us one step closer to an alternative treatment for one of the most common bacterial skin infections in children worldwide, amidst the emergence of treatment resistant bacterial pathogens," said Shawn Patrick O'Brien, President and CEO, Cipher Pharmaceuticals. "We look forward to the regulatory submission to Health Canada anticipated for the first quarter of 2016."
The study, which involved Ozenoxacin formulated as a topical treatment for dermatological infectious conditions 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.
The trial was conducted at 44 centres in the United States, Puerto Rico, South Africa, Germany, Romania, Russia, and Spain, and involved 412 adult and paediatric patients aged 2 months and older with a clinical diagnosis of bullous or non-bullous impetigo.
In 2013 Ferrer successfully completed a first phase III clinical trial of Ozenoxacin in adult and paediatric patients aged 2 years and older with impetigo in which Ozenoxacin demonstrated superiority on both clinical and bacteriological endpoints to placebo by end of therapy visit (days 6-7) and a more rapid microbial clearance than placebo and retapamulin at visit 2 (day 3-4), ref: Future Microbiol (2014) 9(9), 1013 - 1023.
Ferrer expects a first regulatory filing of Ozenxacin in Europe in the first quarter of 2016 and expects their U.S. license partner to file for U.S. regulatory approval also in the first quarter of 2016.