MONTREAL, QUÉBEC--(Marketwired - May 5, 2015) -
NOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES
Pediapharm Inc. (TSX VENTURE:PDP) ("Pediapharm" or the "Company") announced today that it has received a Notice of Deficiency - Withdrawal Letter from Health Canada regarding its New Drug Submission for Easyhaler Budesonide. The Company's file is eligible for the reconsideration process, which is part of normal regulatory actions available to sponsors. The Company will be filing such a request, as it believes that its filing has enough evidence to support regulatory approval.
"We are surprised and disappointed with Health Canada's letter, especially for a drug such as Budesonide, a clinically-proven and safe compound approved and commonly used for numerous years by adults and children in Canada. Furthermore, Easyhaler Budesonide is currently being used by millions of patients suffering from asthma in over 25 countries around the world, such as Germany, Finland and the United Kingdom", stated Sylvain Chretien, President and CEO of Pediapharm.
"In addition to our six products currently marketed in Canada and one product that is expected to be launched in the United States within the next 10 months via a commercial partner, we have a very strong pipeline. We continue to be excited and positively focused on the following three products to be filed with Health Canada in the next few months: (i) Cuvposa, indicated for excessive drooling in cerebral palsy patients; (ii) Duoxal, indicated for ear infections; and (iii) Rupatadine, a novel second generation antihistamine for the treatment of allergies" concluded Mr. Chretien.
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 portfolio of commercialized products includes NYDA®, a breakthrough treatment for head lice; Pediapharm Naproxen Suspension, the only prescription NSAID available in Canada; EpiCeram®, a non-steroid emulsion for eczema; KoolEffect® which reduces the symptoms of fever; and VapoLyptus®, a soothing vapour patch of Eucalyptus and Camphor.
Neither TSX Venture nor its Regulation Service Provider (as that term is defined in the policies of the TSX Venture) accepts responsibility for the adequacy or accuracy of this release.
The securities of Pediapharm being offered have not been, nor will be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons absent U.S. registration or an applicable exemption from U.S. registration requirements. This release does not constitute an offer for sale of securities in the United States.
Except for historical information contained herein, this news release contains forward-looking statements that involve risks and uncertainties, including without limitation, statements pertaining to the closing of the Offering including the intended use by the Company of the net proceeds of the Offering. Actual results may differ materially. Pediapharm will not update these forward-looking statements to reflect events or circumstances after the date hereof. More detailed information about potential factors that could affect financial results is included in the documents filed from time to time with the Canadian securities regulatory authorities by Pediapharm.
Contact Information:
President and Chief Executive Officer
Pediapharm Inc.
514-762-2626 ext. 201
sylvain.chretien@pedia-pharm.com
Roland Boivin
Chief Financial Officer
Pediapharm Inc.
514-762-2626 ext. 202
roland.boivin@pedia-pharm.com
Carl Desjardins
Relations Publiques Paradox Public Relations Inc.
514-341-0408
carldesjardins@paradox-pr.ca