Cipher Pharmaceuticals Announces Health Canada Approval of CIP-Isotretinoin

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 in Canada in 2013 as Epuris™.  For more information, please visit www.cipherpharma.com.

(1)(2) Source: Canadian Dermatology Association. Acne Brochure: Quick facts about acne.
http://www.dermatology.ca/wp-content/uploads/2012/01/Teen-Acne2009EN.pdf

Forward-Looking Statements

Statements made in this news release, other than those concerning historical financial information, may be forward-looking and therefore subject to various risks and uncertainties. The words "may", "will", "could", "should", "would", "suspect", "outlook", "believe", "plan", "anticipate", "estimate", "expect", "intend", "forecast", "objective", "hope" and "continue" (or the negative thereof), and words and expressions of similar import, are intended to identify forward-looking statements. Certain material factors or assumptions are applied in making forward-looking statements and actual results may differ materially from those expressed or implied in such statements.  Factors that could cause results to vary include those identified in the Company's Annual Information Form and other filings with Canadian securities regulatory authorities. These factors include, but are not limited to losses; the applicability of patents and proprietary technology; possible patent litigation; approval of products in the Company's pipeline; marketing of products; meeting projected drug development timelines and goals; product liability and insurance; dependence on strategic partnerships and licensees; concentration of the Company's revenue; substantial competition and rapid technological change in the pharmaceutical industry; the publication of negative results of clinical trials of the Company's products; the ability to access capital; the ability to attract and retain key personnel; changes in government regulation or regulatory approval processes; dependence on contract research organizations; third party reimbursement; the success of the Company's strategic investments; the achievement of development goals and time frames; the possibility of shareholder dilution; market price volatility of securities; and the existence of significant shareholders. All forward-looking statements presented herein should be considered in conjunction with such filings. Except as required by Canadian securities laws, the Company does not undertake to update any forward-looking statements; such statements speak only as of the date made.

SOURCE: Cipher Pharmaceuticals Inc.

Craig Armitage
Investor Relations
The Equicom Group
[phone] ext 278
[phone] fax
[email protected]    

Larry Andrews
President and CEO
Cipher Pharmaceuticals
[phone] ext 324
[phone] fax
[email protected]