Pediapharm Inc.
TSX VENTURE : PDP

Pediapharm Inc.

November 01, 2017 08:30 ET

Pediapharm Receives Health Canada Approval for Cuvposa™

MONTREAL, QUEBEC--(Marketwired - Nov. 1, 2017) -

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Pediapharm Inc. (the "Company") (TSX VENTURE:PDP) is very pleased to announce Health Canada's notice of compliance (approval) for Cuvposa™ (Glycopyrrolate oral solution 1 mg/ 5 mL) which is indicated to reduce chronic severe drooling in patients aged 3-18 years with neurologic conditions associated with problem drooling (e.g. cerebral palsy (CP)).

Chronic drooling, or excessive production of saliva (sialorrhea), is a common condition found in children with CP but it may also be diagnosed in patients with other neurological disorders (i.e. severe developmental delay, autism spectrum disorders, sensory impairments, traumatic brain injuries as well as neurogenetic and metabolic disorders.)

It is estimated that the cerebral palsy prevalence ranges from 110-150 out of 100 000 person in the population1 while prevalence of chronic drooling in children with CP vary from 37.4% to 58%2. It has been estimated that 25% to 35% of children with cerebral palsy drool to varying degrees, and 10% of these children have chronic severe drooling3. The Company estimates that the total market potential for Cuvposa is approximately 5,000 patients in Canada.

According to Dr. Pierre Marois, Pediatric Physiatrist at Montreal's Ste-Justine Hospital ''Often underestimated, sialorrhea implies clinical and social consequences, and has several impacts related to the overall health of children with CP, regarding dysphagia and respiratory health, their socio-emotional development, and emotional and work overload for families and caregivers". Furthermore, Dr. Marois added that "due to the limited treatment options available, sialorrhea is an all-too-often poorly managed condition in pediatric patients suffering from neurologic disorders such as cerebral palsy. Cuvposa is an important advancement in the treatment of chronic severe drooling in children with neurologic disorders."

"The approval of Cuvposa in Canada is another example of how we are guided by our mission to improve the health and well-being of Canadian children" stated Richard Labelle, Pediapharm's Vice-President of Sales and Marketing. ''Cuvposa represents a unique opportunity to introduce innovation for children with CP, many of whom are facing the burden of chronic severe drooling on a daily basis."

"Cuvposa, our third product approved by Health Canada in the last 15 months, has an estimated annual peak sale of $4-5 million and will be a significant contributor in our goal to achieve $30-35 million of annual revenue within the next 5-7 years" stated Sylvain Chretien, President and CEO of Pediapharm. "We strongly believe in the value we have created with our strong product pipeline and our goal is to continue to add strategic products to our portfolio."

Pediapharm's partner, Merz, acquired the product in 2012. Although Cuvposa had already been made available in the United States, Merz successfully increased awareness of the possibility of treating chronic drooling to the benefit of the underserved patient population.

"At Merz, we continue to look for ways to bring our products to patients who need them," said Bob Bennett, President and General Manager of Merz Pharma Canada. "Our partnership with Pediapharm, Canada's leading pediatric pharmaceutical company, signifies our commitment and we are thrilled that they will be commercializing Cuvposa for appropriate patients in Canada."

About Cuvposa™

Cuvposa (glycopyrrolate) is indicated to reduce chronic severe drooling in patients aged 3 -18 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy).

Cuvposa is available as a 1 mg/ 5 ml cherry flavored oral solution.

Glycopyrrolate is a competitive inhibitor of acetylcholine muscarinic receptors that are located on certain peripheral tissues, including salivary glands. Glycopyrrolate indirectly reduces the rate of salivation by preventing the stimulation of these receptors.

Results of a randomized, double-blind, placebo-controlled Phase 3 study of 38 patients showed that 75% of children and adolescents 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.

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 Idiopathic Arthritis; Rupall™, an innovative new allergy medication with a unique mode of action; Otixal®, the first and only antibiotic and steroid combination ear drop available in single, sterile, preservative-free and unit-dose packaging; and Cuvposa™, for chronic severe drooling, a condition affecting a significant proportion of cerebral palsy patients.

About Merz Pharma.

Merz North America is a specialty healthcare company dedicated to the development and marketing of innovative quality products for physicians and patients across the United States and Canada. Merz products are distributed through two divisions, Aesthetics and Neurosciences, and are developed with the goal of improving patients' health and quality of life by delivering therapies that bring about real progress. Merz North America is a privately-held company based in Raleigh, North Carolina. To learn more about Merz North America, please visit www.merzusa.com. For more information about Merz Pharma Canada, Ltd. or their products, please visit www.merzcanada.com.

REFERENCES

1 Mapping Connections: An understanding of neurological conditions in Canada
http://www.phac-aspc.gc.ca/publicat/cd-mc/mc-ec/section-3-eng.php
2 Walshe M. & al., Interventions for drooling in children with cerebral palsy (review),
The Cochrane Library 2012, Issue 11
3 Drooling in children, Paediatric Child Health Vol 4 No 6 September 1999

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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