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Pediapharm Inc
Symbol PDP
Shares Issued 72,709,103
Close 2017-05-18 C$ 0.31
Market Cap C$ 22,539,822
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Pediapharm commercially launches Otixal in Canada

2017-05-18 16:34 ET - News Release

Mr. Sylvain Chretien reports

PEDIAPHARM ANNOUNCES THE COMMERCIAL LAUNCH OF OTIXAL IN CANADA

Pediapharm Inc. has commercially launch Otixal (ciprofloxacin 0.3 per cent and fluocinolone acetonide 0.025 per cent) otic solution for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients (aged six months and older) in Canada. 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 market. Pediapharm acquired the exclusive market rights of Otixal in Canada from Laboratorios SALVAT SA of 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 health care 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," said Alberto Bueno, chief executive officer 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."

About Otixal

Otixal (ciprofloxacin 0.3 per cent and fluocinolone acetonide 0.025 per cent) is indicated for the treatment of acute otitis media with tympanostomy tubes in pediatric patients (aged six months and older) due to Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Moraxella catarrhalis and Pseudomonas aeruginosa. Two phase 3 multicentre, randomized, double-blind, active-controlled, parallel group trials were conducted to assess the efficacy and safety of Otixal compared with ciprofloxacin otic solution and to fluocinolone acetonide otic solution. In total, 662 (331 in each study) pediatric patients (aged six 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 with 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.

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.

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