PEDIAPHARM RECEIVES HEALTH CANADA APPROVAL FOR OTIXAL™
MONTREAL, QUEBEC – December 12, 2016 – Pediapharm Inc. (the “Company”) is very pleased to announce Health Canada’s approval 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.
Otitis media (middle ear inflammation) is one of the most common early childhood infections in Canada2. In the first 3 years of life, 60% to 70% of children will have experienced at least 1 episode of acute otitis media (“AOM”), and recurrent episodes of AOM are common2. Children that have recurrent AOM may have tympanostomy tubes inserted through a small incision in the eardrum to help facilitate drainage of fluid from the middle ear. Tympanostomy tube insertion is the most common operation performed on children in Canada3.
According to Dr. Peter Spafford, head of the Otolaryngology Division at the University of Saskatchewan and President of the Canadian Society of Otolaryngology – Head and Neck Surgery, “The most common symptom of AOMT for many children is fluid drainage from the ear (otorrhea) and having a new medication to treat those children is more than welcome. Additionally, delivering drops into children’s ears is not always easy for parents. Otixal’s unique single-use, premeasured dosing helps assure an accurate dose every time. This will certainly help parents to be more compliant with the medication.’’
“Otixal™ represents a great opportunity to introduce innovation in a growing market that has not seen innovation for years” stated Richard Labelle, Pediapharm’s Vice-President of Sales and Marketing. He added: “Given its strong medical evidence and unique delivery mode, 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’’
“We are very pleased with the approval of Otixal™, which represents the second Health Canada approval within six months for us” said Sylvain Chretien President and CEO of Pediapharm. “With our strong infrastructure in place and with our track record in successfully launching drugs, we are very confident in our ability to make Otixal™ a success in Canada’’ concluded Mr. Chretien.
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 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 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.
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; Rupatadine, a new treatment for allergic rhinitis and urticaria; EpiCeram®, a non-steroid emulsion for eczema; Naproxen Suspension, indicated to treat pain and inflammation due to various conditions including Juvenile Idiopathic Arthritis; and a broad pipeline of products under registration.
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. The company 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. Additional information regarding Laboratorios SALVAT and its products is available at http://www.salvatbiotech.com
IMS Data, June 2015
Dube E & al. Burden of acute otitis media on Canadian families; Canadian Family Physician; Vol 57: January 2011
Schmelzle et al. Acute otitis media in children with tympanostomy tubes; Canadian Family Physician .Vol 54: August 2008
FORWARD LOOKING STATEMENTS
This news release contains forward-looking statements and other statements that are not historical. Such forward-looking statements are subject to known and unknown risks, uncertainties and assumptions that could cause actual results to vary materially from target results and the results or events predicted in these forward-looking statements. As a result, investors are cautioned not to place undue reliance on these forward-looking statements.
The forward-looking statements contained in this news release are made as of the date of this release. Except as required by applicable law, the Corporation disclaims any intention and assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Forward-looking information reflects the current expectations or belief of the Corporation based on information currently available and such information is subject to a number of assumptions, risks and uncertainties described in details at pp. 35 to 41 of the Management Information Circular of Chelsea Acquisition Corporation dated November 12, 2013 available on SEDAR at www.sedar.com and other risks associated with being a specialty pharmaceutical company.
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Sylvain Chretien, President and Chief Executive Officer
Tel.: 514-762-2626 ext. 201
E-mail: [email protected]
Roland Boivin, Chief Financial Officer
Tel.: 514-762-2626 ext. 202
E-mail: [email protected]
Direct Financial Strategies and Communication Inc.
E-mail: [email protected]