Pediapharm Inc.
TSX VENTURE : PDP

Pediapharm Inc.

December 18, 2014 08:30 ET

Pediapharm and Uriach Enter Into a License and Supply Agreement for a Novel Product Developed to Efficiently Treat the Symptoms of Allergy and Urticaria in Both Adults and Children

This is Pediapharm's fourth exclusive agreement since April 1, 2014 and reflects once more the Company's commitment to expand its portfolio of specialty products, particularly one that includes a liquid formulation specifically intended for the pediatric population.

BARCELONA, SPAIN and MONTREAL, QUEBEC--(Marketwired - Dec. 18, 2014) -

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Pediapharm Inc. ("Pediapharm") (TSX VENTURE:PDP) and J. Uriach y Compañía S.A., Ltd. ("Uriach") announced today they have entered into an agreement to grant Pediapharm the exclusive Canadian rights to rupatadine, a novel second generation antihistamine with a broad profile of anti-inflammatory properties. Pediapharm intends to register both the adult and pediatric products for the following indications: allergic rhinitis and urticaria. As a reference, rupatadine tablets are already registered and authorized in more than 70 countries while the pediatric solution is already authorized in 43 countries. In Spain and Italy, the product captured approximately 16% market share while capturing up to 27% market share in other territories.

Currently, the Canadian second-generation anti-histamine market is estimated to be $105 million; of which $17 million from products with a prescription (Rx) status, which are growing at a rate of approximately 15%. The entire antihistamine market was approximately $120 Million in 2013.

The following are key attributes of rupatadine based on Pediapharm's assessment.

  • Novel potent second generation antihistamine, non-sedating, with a rapid onset of action, and once a day oral administration (tablets and pediatric solution);

  • Unique dual activity: blocking of both histamine H1 and platelet-activating factor (PAF) receptors; thus, providing additional anti-allergic benefits to patients;

  • Taken with or without food;

  • No effect on driving ability at the therapeutic dose;

  • Cardiac safety up to 10 times therapeutic dose based on results from a clinical study designed as per the ICH guidelines.

Commenting on the deal, Oriol Segarra, Chief Executive Officer of Uriach stated: "The expansion of the international market position and worldwide presence of rupatadine are two of the key strategic goals for Uriach, and 2014 has been particularly a very successful year for us. We opened the year with the signature of a big deal for Japan, the biggest anti-histamine market in the world, and now we close it with the execution of this promising agreement with Pediapharm, who will take care of the product in the Canadian market. We are very enthusiastic with this new transaction and strongly believe that Pediapharm has the expertise, experience, resources and capabilities to make rupatadine a commercial success in Canada".

"This transaction is consistent with Pediapharm's business strategy to expand its portfolio on innovative specialty products, and in particular, those intended for the pediatric population. Rupatadine is very strategic for Pediapharm as we had been looking for the right product for allergic disorders such as allergic rhinitis and urticaria to complement our portfolio in atopic dermatitis and asthma. Together with rupatadine, we now complete the pipeline addressing what is referred to as the atopic triad. The ever increasing incidence of allergic disorders made this a very attractive medical target", said Benoît Hébert, Pediapharm's Vice President of Business Development and Licensing. "As we reviewed the rupatadine dossier, it became clear for Pediapharm that the extensive clinical development program performed by Uriach to market both formulations of rupatadine is second to none."

"This transaction, our fourth in the last 9 months, confirms once again the great potential of Pediapharm as leading specialty pharmaceutical Company in Canada. We are serious about partnering with innovative companies and this is another good example" said Sylvain Chrétien, President and Chief Executive Officer of Pediapharm. "From a commercial standpoint, this agreement is very strategic as we have been interacting with the allergist audience for the past 5 years with EpiCeram™. In our view, this market segment has been underserved for several years, especially in children. Rupatadine, given its unique attributes, will provide clinicians with a novel solution to better serve their patient population." concluded Mr. Chrétien.

Pediapharm intends to register the product with Health Canada in 2015 and, if approved, expects to launch the product by the end of 2016.

About rupatadine

Rupatadine is a new second generation antihistamine and platelet-activating factor (PAF) antagonist fully discovered and developed by Uriach. The high potency, good efficacy and excellent safety profile of the product have been demonstrated under an extensive clinical development program.

The prescription product, once approved, will be commercialized as tablets indicated for the symptomatic treatment of allergic rhinitis and urticaria in adults and adolescents (over 12 years of age). It will also be available in a children friendly oral solution indicated for the symptomatic treatment of allergic rhinitis and urticaria in children aged 2 to 11 years.

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.

About Uriach.

Uriach is a family-owned pharmaceutical company dedicated to improving the health, quality of life and well-being of people worldwide. The company is comprised of four business areas: Consumer Health (OTC and Natural Care), Generic (which includes Business to Business), Branded (NCE's and others) and Contract Manufacturing.

In international expansion, the group is currently in over 70 countries.

Born in 1838, since its founding, the company has maintained a model of sustainable and profitable business. Uriach currently consists of 500 professionals and two production centers in Barcelona. These centers focus both our own production and third parties.

In 2013, Uriach had a near 110 million euros turnover, of which 66% are national turnover and 34% internationally generated.

For more information about Uriach or its products, please visit www.uriach.com.

FORWARD LOOKING STATEMENTS FOR PEDIAPHARM

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.

For more information about Pediapharm or its products, please visit www.pedia-pharm.com.

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