MISSISSAUGA, ON, May 8, 2017 /CNW/ - Cipher Pharmaceuticals Inc. (TSX:CPH) today announced the Health Canada approval of OZANEX™ (ozenoxacin cream, 1%) a novel topical antibiotic indicated for the treatment of impetigo in patients aged 2 months and older1.
"The approval of OZANEX offers a new and effective treatment option for young children suffering with one of the most common and contagious bacterial skin infections," said Dr. Ian Landells, a Pediatric Dermatologist from St. John's, Newfoundland. "It's the first bacteriocidal topical antibiotic and has been shown to be effective against resistant bacteria such as MRSA."
OZANEX, which belongs to a new generation of non-fluorinated quinolones, offers a short 5-day BID dosing regimen and has shown bacteriological eradication as early as day 3 of treatment.
The Health Canada approval was based on two multicentre, randomized, placebo controlled Phase III studies involving 875 adult and pediatric subjects with impetigo. The results of the clinical program confirmed the efficacy of OZANEX cream on both clinical and bacteriological endpoints. OZANEX cream was shown to be safe and well tolerated in both the adult and pediatric population.
"We are pleased with the Health Canada approval and look forward to making OZANEX available in Canada later this year," said Robert Tessarolo, President and CEO of Cipher. "Our expanded dermatology portfolio reinforces our commitment to bringing innovative dermatology products to Canadians."
Cipher acquired the Canadian commercialization rights to ozenoxacin from Ferrer International SA ("Ferrer") in January 2015.
About Cipher Pharmaceuticals Inc.
Cipher (TSX:CPH) is a specialty pharmaceutical company with a robust and diversified portfolio of commercial and early to late-stage products. Cipher acquires products that fulfill unmet medical needs, manages the required clinical development and regulatory approval process, and markets those products either directly in Canada or indirectly through partners in Canada, the U.S., and South America. For more information, visit www.cipherpharma.com.
OZANEX™ Product Monograph. Cipher Pharmaceuticals Inc. May 1, 2017
Sladden MJ, Johnston GA, Common BMJ 329, 95-99 (2004)
Founded in 1959, Ferrer is a privately-held Spanish pharmaceutical company. It is present in more than 95 countries, with 24 international affiliates. Ferrer is active in the pharmaceutical, health, fine chemicals and food sectors; key areas for contributing to people's health and quality of life. The main therapeutic areas covered by Ferrer's pharmaceutical production are dermatology, cardiovascular, CNS, cancer, gastrointestinal, analgesics, bone metabolism, anti-infectives, immunology, diagnostics, OTC and dermocosmetics. www.ferrer.com
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SOURCE Cipher Pharmaceuticals Inc.