MISSISSAUGA, ON, Jan. 8, 2018 /CNW/ - Cipher Pharmaceuticals Inc. (TSX:CPH) today announced the Canadian launch of OZANEX™ (ozenoxacin cream, 1%), a novel bactericidal topical antibiotic cream indicated for the treatment of impetigo in patients aged 2 months and older1.
"OZANEX represents a new and important treatment alternative for one of the most common and contagious bacterial skin infections," said Dr. Ian Landells, a Pediatric Dermatologist from St. John's, Newfoundland. "Given the positive clinical data and the product's effectiveness against a broad range of bacteria including sensitive and resistant bacteria such as MRSA, which is a growing challenge, OZANEX has the potential to fulfill an important unmet medical need."
In two Phase III pivotal studies involving 875 adult and pediatric subjects, OZANEX demonstrated excellent antibacterial activity against Streptococcus pyogenes and Staphylococcus aureus, including methicillin-resistant (MRSA) strains. OZANEX has shown bacteriological eradication as early as day three of treatment and offers a short 5-day BID dosing regimen. OZANEX was also found to be negligibly absorbed, safe and well-tolerated in pediatric and adult patients aged 2 months and older.
"We are excited to make OZANEX available as a fast, effective and safe new treatment option for Canadians who suffer from impetigo," said Robert Tessarolo, President and CEO of Cipher. "Importantly, it kills bacteria quickly offering patients the shortest course of topical antibiotic treatment. OZANEX is our fifth dermatology product, and we are committed to further expanding our Canadian business by assembling a broad portfolio of prescription products that serve unmet medical needs."
Cipher acquired the exclusive Canadian commercialization rights to OZANEX from Ferrer International SA ("Ferrer") in January 2015 and the product received Health Canada approval in May 2017.
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.
Founded in 1959, Ferrer is a privately-held Spanish pharmaceutical company, with full vertical integration from R&D to distribution. 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. In recent years, it has concentrated on diversifying across the whole healthcare spectrum, including prescription drugs, hospital products, vaccines, molecular diagnostics, OTC and self-care. Visit www.ferrer.com.
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We caution that the foregoing list of important factors that may affect future results is not exhaustive. When reviewing our forward-looking statements, investors and others should carefully consider the foregoing factors and other uncertainties and potential events. Additional information about factors that may cause actual results to differ materially from expectations, and about material factors or assumptions applied in making forward-looking statements, may be found in the "Risk Factors" section of our Annual Information Form and in our Management's Discussion and Analysis of Operating Results and Financial Position for the year ended December 31, 2016, and elsewhere in our filings with Canadian securities regulators. Except as required by Canadian securities law, we do not undertake to update any forward-looking statements, whether written or oral, that may be made from time to time by us or on our behalf; such statements speak only as of the date made. The forward-looking statements included herein are expressly qualified in their entirety by this cautionary language.
OZANEX™ Product Monograph. Cipher Pharmaceuticals Inc. May 1, 2017
SOURCE Cipher Pharmaceuticals Inc.