Pediapharm Inc.
TSX VENTURE : PDP

Pediapharm Inc.

July 21, 2016 08:30 ET

Pediapharm Receives Health Canada Approval for Rupatadine

MONTREAL, QUEBEC--(Marketwired - July 21, 2016) -

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Pediapharm Inc. (TSX VENTURE:PDP) (the "Company") is very pleased to announce Health Canada's approval of rupatadine (Tablet 10mg and Oral Solution 1mg/mL) for the relief of the symptoms associated with Seasonal Allergic Rhinitis (SAR), Perennial Allergic Rhinitis (PAR) and Chronic Spontaneous Urticaria (CSU) in patients 2 years of age and older.

Rupatadine is the first prescription (Rx) antihistamine being launched over the past decade with all 3 indications (SAR, PAR and CSU), including a formulation for children over 2 years of age. It will be launched in the Canadian antihistamine market estimated at $130 million1. Moreover, it will benefit from 8.5 years of market exclusivity granted by Health Canada's Office of Patented Medicines and Liaison under section C.08.004.1 of the Food and Drug Regulations.

Allergic rhinitis (SAR and PAR) is an inflammatory disease of the nasal mucous membranes and it is one of the most common chronic health conditions with 20 to 25% of Canadians being affected2. Chronic Spontaneous Urticaria (CSU) is a severe and distressing skin condition for which discomfort associated with this disorder can often pose a serious challenge to the treating clinician and a long-term hardship for patients and their families3,4.

According to Dr. Paul Keith, Associate Professor, Division of Clinical Immunology and Allergy, Department of Medicine, McMaster University ''Allergic Rhinitis and Chronic Urticaria are two conditions that can be challenging to treat. Many available treatments are not always effective or have undesired side effects, potentially leading to patients' frustration and non-adherence. A new antihistamine with a unique mode of action that could provide additional anti-inflammatory effect as well as rapid and effective relief of patients' symptoms is more than welcome and will certainly become an excellent addition to any physicians' treatment arsenal."

''Rupatadine represents a unique opportunity to introduce innovation in a growing prescription market as many patients and physicians remain unsatisfied with current over-the-counter treatment options," stated Richard Labelle, Pediapharm's Vice President of Sales and Marketing. ''Given its strong medical evidence and unique mode of action, rupatadine has the potential to significantly improve the quality of life of many patients suffering from allergies or urticaria."

Amongst children, first generation of antihistamine are still widely used to treat allergic rhinitis and urticaria but according to Dr. Estelle Simons, Professor in the Department of Pediatrics and Child Health and the Department of Immunology at the University of Manitoba ''Using modern non-sedating, non-impairing H1-antihistamines such as rupatadine is preferable to using old first-generation, potentially sedating and impairing H1-antihistamines." Dr. Simons also mentioned that "In extensive studies in adults and children with allergic rhinitis or urticaria, rupatadine has been confirmed to reduce symptoms and improve quality of life. It has a rapid onset of action and its efficacy does not decrease over time. It has an excellent safety profile and as importantly, rupatadine does not cause sedation or impairment of brain function."

''Pediapharm already has a solid infrastructure in place ready to take on new products like rupatadine," stated Sylvain Chretien, President and CEO of Pediapharm. "The approval of rupatadine is a major milestone for our company and it will have a substantial impact on our future growth. It also demonstrates our ability to obtain Health Canada approval for our pipeline products, which include two other dossiers submitted to Health Canada in the last 8 months."

About rupatadine

Rupatadine is a new second-generation antihistamine and platelet-activating factor (PAF) antagonist discovered and developed by Uriach, and currently available in 62 countries around the world. In addition to Canada, rupatadine is expected to be launched before the end of 2017 in other countries like Korea and Japan among others. The high potency, good efficacy and excellent safety profile of the product have been demonstrated under an extensive clinical development program. Rupatadine (Tablet 10mg and Oral Solution 1mg/mL) is indicated for the treatment of the symptoms associated with Seasonal Allergic Rhinitis (SAR), Perennial Allergic Rhinitis (PAR) and Chronic Spontaneous Urticaria (CSU) in patients 2 years of age and older.

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; and a broad pipeline of products under registration.

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. The group, already present in Spain, Italy and Portugal with its own subsidiaries, is expanding internationally and currently operates in more than 70 countries on a B2B basis. Born in 1838, since its founding, the company has maintained a model of sustainable and profitable business. Uriach currently consists of 700 professionals and two production sites in Barcelona. These sites focus both our own production and third parties. In 2015, Uriach had near 132 million euros turnover, of which 52% are coming from the domestic market and 48% is internationally generated. For more information about Uriach or its products, please visit www.uriach.com.

References

  1. IMS Data
  2. Keith P. et al. The burden of allergic rhinitis (AR) in Canada: perspectives of physicians and patients. Allergy, Asthma & Clinical Immunology 2012, 8:7
  3. Sussman et al. Insights and advances in chronic urticaria: a Canadian perspective Allergy, Asthma & Clinical Immunology 2015, 11:7
  4. Ben-Shoshan et al. Psychosocial factors and chronic spontaneous urticaria: a systematic review. Allergy 2013; 68: 131-1411

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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