In c9713 sent today at 08:23e an error occurred at the end of
the third paragraph. "Q2 2012" should have read "Q2 2013".
Corrected copy follows:
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.