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Pediapharm Inc. (“Pediapharm” or the “Company”) (TSX VENTURE:PDP) is pleased to announce today the Canadian commercial launch of Otixal™ (ciprofloxacin 0.3 % and fluocinolone acetonide 0.025 %) otic solution for the treatment of acute otitis media with tympanostomy tubes (“AOMT”) in pediatric patients (aged 6 months and older). Otixal™ is the first and only antibiotic and steroid combination ear drop available in single, sterile, preservative-free and unit-dose packaging. Otixal™ will be launched in a growing $20 million market1. Pediapharm acquired the exclusive market rights of Otixal™ in Canada from Laboratorios SALVAT S.A. Barcelona, Spain.
“Otixal is currently being distributed within the various wholesalers and pharmacy channels. Our Canada-wide sales force has been trained and is eager to present this innovation to healthcare providers” said Richard Labelle vice-president sales and marketing of Pediapharm. He added: “Given its strong medical evidence and its unique single-use, premeasured dosing that helps ensure an accurate dose every time, Otixal has the potential to significantly improve the quality of life of many young patients who have undergone tympanostomy tube insertion and are suffering from acute otitis media”.
“It is exciting to further expand the international commercial availability of Otixal through the partnership with Pediapharm Inc.” said Alberto Bueno, CEO of SALVAT. “This new launch of Otixal is a major milestone for SALVAT as we continue to grow our presence in the North American market”.
Otixal™ (ciprofloxacin 0.3 % and fluocinolone acetonide 0.025 %) is indicated for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients (aged 6 months and older) due to Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Moraxella catarrhalis and Pseudomonas aeruginosa. Two phase 3 multicenter, randomized, double-blind, active-controlled, parallel group trials were conducted to assess the efficacy and safety of Otixal™ compared to ciprofloxacin otic solution and to fluocinolone acetonide otic solution. In total 662 (331 in each study) pediatric patients (aged 6 months to 12 years old) with AOMT were included. In both trials, the Otixal™ treatment arms showed significantly shorter times to cessation of otorrhea in comparison to both the ciprofloxacin and fluocinolone acetonide alone arms. In Study 1 and Study 2 the median time to cessation of otorrhea in the Otixal™ group was 3.75 days and 4.94 days, respectively.
Laboratorios SALVAT is a privately owned pharmaceutical group closely identified with technological innovation and strongly committed to R&D. Founded in 1955, Salvat is headquartered in Barcelona (Spain) and is present in over 60 countries and keeps strengthening its international presence through the licensing of its own developments. Salvat launched CETRAXAL® (ciprofloxacin 0.2 %) otic solution in the US in 2009 and received FDA approval for OTOVEL® (ciprofloxacin 0.3 % and fluocinolone acetonide 0.025 %) otic solution in April 2016. OTOVEL® was commercially launched in the US market by Arbor Pharmaceuticals Ltd. in August 2016. Additional information regarding Laboratorios SALVAT and its products is available at http://www.salvatbiotech.com
About Pediapharm Inc.
Pediapharm is the only Canadian specialty pharmaceutical company dedicated to serving the needs of the pediatric community. Its mission is to bring to the Canadian market the latest innovative pediatric products with the objective to improve the health and the well-being of children in Canada. Since its debut in 2008, Pediapharm has entered into numerous commercial agreements with partners from Canada and other countries around the world. The Company’s innovative product portfolio includes NYDA®, a breakthrough treatment for head lice; EpiCeram®, a non-steroid emulsion for eczema; naproxen suspension, indicated to treat pain and inflammation due to various conditions, including Juvenile Idiopathic Arthritis; Rupall™, an innovative new allergy medication with a unique mode of action; Otixal™, the first and only antibiotic and steroid combination ear drop available in single, sterile, preservative-free and unit-dose packaging; and Cuvposa™, for severe drooling, which is under review with Health Canada.
1. IMS Data, June 2015
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