Pediapharm Inc.
TSX VENTURE : PDP

Pediapharm Inc.

January 25, 2017 08:00 ET

Pediapharm Announces the Commercial Launch of Rupall™ (Rupatadine) in Canada

MONTREAL, QUEBEC--(Marketwired - Jan. 25, 2017) -

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Pediapharm Inc. ("Pediapharm" or the "Company") (TSX VENTURE:PDP) announced today the commercial launch of Rupall™ (rupatadine) in Canada. This innovative allergy medication is now available to patients suffering from allergy and urticaria through physician prescriptions.

"Rupall is currently being distributed within the various wholesalers and pharmacy channels. Our Canada-wide sales force has been trained and is eager to communicate with health care providers on this new and unique allergy medication" said Richard Labelle vice-president and marketing of Pediapharm.

Rupall (rupatadine) comes in two dosage forms; the tablet 10mg and Oral Solution 1mg/mL, and is indicated 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.

Rupall (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.

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.

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: 131-141

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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