Product to be launched as Epuris™
Toronto Stock Exchange Symbol: DND
MISSISSAUGA, ON, Nov. 20, 2012 /CNW/ - Cipher Pharmaceuticals Inc. (TSX: DND; OTC: CPHMF) announced today that Health Canada has approved the Company's New Drug Submission (NDS) for Epuris™, Cipher's novel, brand formulation of the acne medication isotretinoin, for the treatment of severe acne. Cipher expects to launch Epuris™ in Canada in Q2 2013.
Epuris™ is indicated for the treatment of severe, recalcitrant, nodular acne in patients 12 years of age and older. The product is available by prescription and is administered orally, once or twice daily, for a treatment period of approximately five months. Compared to the other currently available isotretinoin products (including the brand original, Accutane®, distributed by Hoffman- La Roche Ltd.), Epuris™ provides more reliable absorption under varying dietary conditions. While the rate and the extent of absorption of Epuris™ is equivalent to Accutane® under high-fat, fed conditions, Epuris™ is 83% more bioavailable than Accutane® when taken without food.
"We are pleased to make Epuris™ available as a valuable option to Canadian dermatologists and patients who require treatment for severe recalcitrant nodular acne," said Larry Andrews, President and CEO of Cipher. "The approval of Epuris™ is a critical milestone in our plans to create a commercial presence in dermatology and other specialty markets in Canada. Pre-commercial activities have commenced, including the addition, in the coming months, of a specialized dermatology sales and marketing team in preparation for the launch in Q2 2013."
Acne affects more than five million Canadians1, with 80 per cent of those between the ages of 12 and 242. Although acne is most commonly seen as a stage of puberty, it can also begin in adulthood, with 75 per cent of adult acne occurring in women2. For severe nodular acne, isotretinoin is the most commonly prescribed medication, with a market size of approximately $15 million in sales in Canada.
About Cipher Pharmaceuticals Inc.
Cipher Pharmaceuticals (TSX: DND; OTC: CPHMF) is a growing specialty pharmaceutical company that commercializes novel formulations of successful, currently marketed molecules. Cipher's strategy is to in-license clearly differentiated products, advance them through the clinical development and regulatory approval stages, and out-license to international marketing partners. The Company's first product is a fenofibrate formulation marketed in the United States as Lipofen®. Cipher's second product, an extended-release tramadol, is marketed in the United States as ConZip® and in Canada as Durela®. Cipher's third product, a novel formulation of the acne treatment isotretinoin, was recently introduced to the U.S. market under the trade name Absorica™ and will be launched inCanada in 2013 as Epuris™. For more information, please visit www.cipherpharma.com.
(1)(2) Source: Canadian Dermatology Association. Acne Brochure: Quick facts about acne.
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