Pediapharm Inc.

Pediapharm Inc.

December 31, 2015 08:00 ET

Health Canada Upholds Notice of Deficiency-Withdrawal Letter Regarding Easyhaler Budesonide

MONTREAL, QUEBEC--(Marketwired - Dec. 31, 2015) -


Pediapharm Inc. ("Pediapharm" or the "Company") (TSX VENTURE:PDP) announces that Health Canada has upheld the May 2015 Notice of Deficiency - Withdrawal Letter regarding Easyhaler Budesonide, without prejudice to re-filing.

Health Canada's decision, communicated through a letter received by Pediapharm in the afternoon of December 24, 2015, is based on recommendations contained in a report issued by a reconsideration panel and Health Canada's Office of Science. The reconsideration panel was responsible to hear arguments from Pediapharm and Health Canada's Allergy and Respiratory Drugs Division on November 20, 2015, and to submit recommendations to the Director General, who accepted them in a letter sent to Company.

"We are very disappointed with Health Canada's decision and we will take the appropriate time to analyze the available documents and notes with our team of consultants and partner that have accompanied us during this process. We will assess our alternatives and intend on communicating our plan of action by the end of March 2016. As previously stated, budesonide is a clinically-proven and safe active ingredient approved and commonly used 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. We feel this decision by no means undermines the efficacy and safety of Easyhaler Budesonide, and are convinced of the benefits the product could bring to numerous patients should they have access to it", stated Sylvain Chretien, President and CEO of Pediapharm.

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 Idiopathis Arthrits; and a broad pipeline of products under registration.


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 and other risks associated with being a specialty pharmaceutical company.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

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