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
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.
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.
For further information:
The Equicom Group
(416) 815-0700 ext 278
(416) 815-0080 fax
President and CEO
(905) 602-5840 ext 324
(905) 602-0628 fax