- Acceptance marks first regulatory filing
with FDA since Absorica® in 2011 -
MISSISSAUGA, ON, Aug. 4, 2015 /PRNewswire/ - Cipher
Pharmaceuticals Inc. (NASDAQ:CPHR; TSX:CPH) ("Cipher" or "the
Company") today announced that it has received an Acceptance Review
Notification for its 510(k) submission for Dermadexin™ to the U.S.
Food & Drug Administration ("FDA"). The Notification
confirms that the submission contains all of the necessary elements
and information needed to proceed with the substantive
review. Dermadexin™ is a patent-protected topical
barrier-repair cream, targeting seborrheic dermatitis, an
inflammatory skin disorder affecting the scalp, face, and torso,
and contains the ingredient P3GCM.
Earlier this year, Cipher acquired the worldwide rights to
Dermadexin™ and Pruridexin™, two late stage products, as well as
ASF-1096, a product candidate in phase II, from Astion Pharma. All
three products are focused on inflammatory dermatological
diseases.
"The acceptance of our Dermadexin™ submission marks Cipher's
first regulatory filing with the FDA since Absorica® in 2011," said
Shawn Patrick O'Brien, President and
CEO, Cipher Pharmaceuticals. "A key component of our strategy is to
expand our U.S. portfolio of commercialized products and leverage
our strong U.S. commercialization capability to accelerate
growth. In addition to Dermadexin™, we are planning a 510(k)
submission to the FDA for Pruridexin™ in the coming weeks. Each of
these products represents an excellent opportunity to target
common, chronic conditions that are insufficiently addressed
today."
Dermadexin™ was approved in the European Union (EU) in
2014 as a Class III medical device for the alleviation of symptoms
of facial dermatitis such as redness, scaling and itching.
About Seborrheic Dermatitis
The term seborrheic dermatitis relates to the distribution of
skin lesions in areas rich in sebaceous glands, such as the scalp,
face, and upper trunk. Seborrheic dermatitis is a chronic,
relapsing form of dermatitis characterized by red lesions covered
with greasy-looking yellowish scales. It may be accompanied by
pruritus as well as stinging and burning sensations of the skin.
Seborrheic dermatitis is most commonly located in the nasolabial
folds, the eyebrows and glabella as well as the scalp. Lesions are
less commonly located in the presternal and interscapular regions
and the flexures. Dandruff is a mild form of seborrheic dermatitis
of the scalp with minimal inflammation. The diagnosis of seborrheic
dermatitis is usually made clinically, based on the appearance and
location of the lesions.
About Cipher Pharmaceuticals Inc.
Cipher Pharmaceuticals (NASDAQ:CPHR; TSX:CPH) is a rapidly
growing specialty pharmaceutical dermatology company with a
diversified portfolio of commercial-stage products with the goal of
becoming the most customer-centric dermatology company in
North America.
Cipher has completed seven transactions in 2015, including the
acquisition of Innocutis and its seven branded dermatology
products, to build its U.S. commercial presence, expand its
Canadian dermatology franchise and broaden its pipeline. Cipher is
well-capitalized to drive long-term, sustained earnings growth by
leveraging its proven clinical development capabilities and
efficient commercial execution. For more information, visit
www.cipherpharma.com.
Forward-Looking Statements
Statements made in this news release 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, Form 40-F and other filings with Canadian and
U.S. securities regulatory authorities. These factors include, but
are not limited to our ability to enter into in-licensing,
development, manufacturing and marketing and distribution
agreements with other pharmaceutical companies and keep such
agreements in effect; our dependency on three products;
integration difficulties and other risks if we acquire or
in-license technologies or product candidates; reliance on
third parties for the marketing of our products; the product
approval process is highly unpredictable; the timing of
completion of clinical trials; reliance on third parties to
manufacture our products; we may be subject to product liability
claims; unexpected product safety or efficacy concerns may arise;
generate revenue from a limited number of distribution and supply
agreements; the pharmaceutical industry is highly competitive;
requirements for additional capital to fund future operations;
dependence on key managerial personnel and external
collaborators; no assurance that we will receive regulatory
approvals in the U.S., Canada or
any other jurisdictions; limitations on reimbursement in the
healthcare industry; limited reimbursement for products by
government authorities and third-party payor policies;
various laws pertaining to health care fraud and abuse; reliance on
the success of strategic investments and partnerships; the
publication of negative results of clinical trials; unpredictable
development goals and projected time frames; rising insurance
costs; ability to enforce covenants not to compete; risks
associated with the industry in which it operates; foreign currency
risk; the potential violation of intellectual property rights of
third parties; our efforts to obtain, protect or enforce our
patents and other intellectual property rights related to our
products; changes in U.S., Canadian or foreign patent law;
litigation in the pharmaceutical industry concerning the
manufacture and supply of novel versions of existing drugs that are
the subject of conflicting patent rights; inability to protect our
trademarks from infringement; shareholders may be further diluted;
volatility of our share price; a significant shareholder; we do not
currently intend to pay dividends; and our operating results may
fluctuate significantly. All forward-looking statements presented
herein should be considered in conjunction with such filings.
Except as required by Canadian or U.S. 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.