Pediapharm, Inc. and Merz Pharma Canada, Ltd. Enter Into a Distribution and Supply Agreement for CUVPOSA(TM …

Posted: Published on April 4th, 2014

This post was added by Dr Simmons

Pediapharm Inc. ("Pediapharm") (TSX VENTURE:PDP) and Merz Pharma Canada, Ltd. ("Merz") announce they have entered into an agreement regarding the Canadian rights to CUVPOSA (glycopyrrolate) oral solution intended for pediatric chronic severe drooling (sialorrhea) associated with neurologic conditions such as cerebral palsy. Pediapharm was granted exclusive commercial rights for the product in Canada.

"Merz is pleased to be expanding patient and physician access to Cuvposa (glycopyrrolate) oral solution through this new agreement with Pediapharm," said Bob Bennett, President and General Manager of Merz Pharma Canada. "We are dedicated to improving the quality of life for patients suffering from movement and neurological disorders such as cerebral palsy, and we look forward to collaborating with Pediapharm in order to achieve this goal."

Cerebral palsy (CP) is a lifelong condition that encompasses a group of non-progressive, neurological disorders affecting body movement and muscle coordination.

"Based on our discussions with experts in the field, chronic severe drooling is a poorly managed condition in up to 30% of children with CP. Because the treatment options available in Canada are limited, this may lead to various health issues and a decreased quality of life in that patient population", said Benot Hbert, Pediapharm's Vice President of Business Development and Licensing. "We are delighted to collaborate with Merz in bringing this opportunity to the Canadian market as this transaction is a good example of what Pediapharm can accomplish".

CUVPOSA was approved by the FDA in July 2010 and has been commercially available in the U.S. since April 2011. It is the only FDA-approved treatment to reduce chronic severe drooling in pediatric patients (aged 3-16) with neurologic conditions associated with problem drooling. Sialorrhea is a common problem for individuals with neurologic conditions, especially children with cerebral palsy.

"CUVPOSA will be an important addition to our portfolio of innovative products and further strengthens our commitment to becoming the recognized leader in the treatment of diseases and conditions affecting children" said Sylvain Chrtien, President and Chief Executive Officer of Pediapharm Inc. "This transaction reflects our desire to accelerate the growth of the corporation by offering to Canadian healthcare providers the necessary products to treat pediatric unmet medical needs."

Pediapharm intends to register the product with Health Canada during 2014 and, if approved, expects to launch the product in 2015.

About CUVPOSA

CUVPOSA is a competitive inhibitor of acetylcholine receptors that are located on certain peripheral tissues, including salivary glands. CUVPOSA indirectly reduces the rate of salivation by preventing stimulation of these receptors. CUVPOSA is available under prescription in the United States as a 1mg/5ml clear, cherry flavored oral solution.

Results of a randomized, double-blind, placebo-controlled Phase 3 study of 38 patients showed that 75% of children and adolescents, aged 3-16, treated with CUVPOSA experienced an improvement in symptoms of chronic severe drooling at week 8, versus 11% who received placebo. Dry mouth, vomiting, constipation, flushing and nasal congestion were the most commonly reported adverse reactions.

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Pediapharm, Inc. and Merz Pharma Canada, Ltd. Enter Into a Distribution and Supply Agreement for CUVPOSA(TM ...

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