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Press Release

Pediapharm Announces the Commercial Launch of Cuvposa™ in Canada


Posted on: 03 Apr 18

NOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES

MONTREAL, April 03, 2018 (GLOBE NEWSWIRE) -- Pediapharm Inc. (the “Company” or "Pediapharm") (TSX VENTURE:PDP) (OTCQB:PDDPF) is very pleased to announce the Canadian commercial launch of 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)).

“Cuvposa is currently being distributed within the various wholesalers and pharmacy channels. Our sales force has been trained and is eager to communicate with health care providers and ultimately, help children with CP, many of whom are facing the burden of chronic severe drooling on a daily basis.” said Richard Labelle vice-president and marketing of Pediapharm.

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 people 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 in Canada, approximately 5,000 patients affected by sialorrhea could be treated with Cuvposa.

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.’’

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; Relaxa™, an osmotic laxative used to treat constipation; 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.

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.

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.

PEDIAPHARM CONTACT INFORMATION:

Sylvain Chretien, President and Chief Executive Officer
Pediapharm Inc.
Tel.: 514-762-2626 ext. 201
E-mail: sylvain.chretien@pedia-pharm.com

Roland Boivin, Chief Financial Officer
Pediapharm Inc.
Tel.: 514-762-2626 ext. 202
E-mail: roland.boivin@pedia-pharm.com

Frank Candido
Direct Financial Strategies and Communication Inc.
Tel.: 514-969-5530
E-mail: frank.candido@pedia-pharm.com 

GlobeNewswire
globenewswire.com

Last updated on: 03/04/2018

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