MISSISSAUGA, ON, April 6, 2016 /PRNewswire/ - Cipher
Pharmaceuticals Inc. (NASDAQ:CPHR; TSX:CPH) ("Cipher" or "the
Company") today announced it has received Health Canada approvals
for SD Cream and AD Cream (also known as Dermadexin and
Pruridexin). Both products were approved in Canada by the Natural and Non-Prescription
Health Products Directorate. In addition European approval of
Helioclin® Pruritus SD Cream (also known as Pruridexin)
was achieved.
Helioclin® Dermatitis SD Cream (also known as
Dermadexin) was approved in Europe
in 2014 and with the approval of Helioclin® Pruritus SD
Cream last week as a Class III medical device, Cipher is now in a
position to partner to launch and grow a product line with
significant potential in the European market.
In Canada, the SD Cream is
a patent-protected topical barrier-repair cream for the management
and relief of the signs and symptoms of seborrheic dermatitis (such
as erythema, scaling and pruritis). AD Cream is a
patent-protected topical cream for the management and relief of the
signs and symptoms of atopic and contact dermatitis (such as
erythema, scaling and pruritus).
"We continue to deliver on our key regulatory milestones and our
plan to expand the Canadian product portfolio," said Shawn
O'Brien, President & Chief Executive Officer of
Cipher. "These products target chronic inflammatory conditions
that we believe are insufficiently addressed today. While we
finalize our commercialization plans in Canada, we are very focused on obtaining U.S.
approvals for both products, which we are targeting later this
year."
Cipher acquired the worldwide rights to these two products from
Astion Pharma A/S in February, 2015. Dermadexin has been tested in
two vehicle-controlled, multicenter clinical trials (452 patients)
where it displayed a marked and statistically significant effect on
the symptoms of facial seborrhoeic dermatitis. Pruridexin has been
tested in two vehicle-controlled, multicenter clinical trials (367
patients) and displayed a marked and statistically significant
effect on the pruritus.
In Canada, Cipher plans to
market the products through its internal sales team. The Company
expects to out-license Helioclin® Pruritus SD
Cream and Helioclin® Dermatitis SD
Cream in Europe.
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 completed seven transactions in 2015, including the
acquisition of Innocutis and its nine 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; we may be unsuccessful in evaluating
material risks involved in complete and future acquisitions; we may
be unable to identify, acquire or integrate acquisition targets
successfully; operations in the U.S.; and inability to meet
covenants on our credit facilities.. 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.