– Will Represent Fourth Commercial Product
in Cipher's Growing Canadian Dermatology Business –
MISSISSAUGA, ON, Dec. 7, 2015 /PRNewswire/ - Cipher
Pharmaceuticals Inc. (NASDAQ:CPHR; TSX:CPH) ("Cipher" or "the
Company") today nnounced that Health Canada has approved
PrBeteflam™ (betamethasone valerate topical patch), a
novel, patent-protected treatment of mild to moderate plaque
psoriasis of the elbows and knees for a maximum duration of 30 days
in adult patients.
"We are pleased to make Beteflam available as a valuable new
treatment option to Canadian dermatologists and to the patients who
suffer from this disease," said Shawn O'Brien, President and
CEO of Cipher. "Psoriasis affects one million Canadians1
and can profoundly impact the quality of life for many patients.
Once the product is launched in Q2 2016, Beteflam is expected to be
our fourth marketed product in Canada behind Epuris®, Vaniqa®, and
Actikerall™. With potentially six commercial products on the
Canadian market by the end of 2016, we have multiple new near-term
revenue streams as we work toward our goal of reaching $50 million in annual sales in our Canadian
dermatology business."
Topical corticosteroids remain the primary treatment for
steroid-responsive inflammatory skin diseases, including mild to
moderate chronic plaque psoriasis. Occlusion with plastic film
dressings is a widely accepted procedure to enhance their efficacy,
especially in the treatment of psoriasis. Beteflam is a patch
that is applied once daily to the affected region and may be cut to
fit the particular size and shape of the psoriatic lesion thereby
reducing potential contact of the steroid with healthy areas of
skin.
Cipher licensed the Canadian rights to Beteflam from Institut
Biochimique SA ("IBSA"). The efficacy and safety of Beteflam was
demonstrated by two randomized, active-controlled studies involving
555 patients with mild-to-moderate chronic plaque psoriasis, of
which 281 patients received Beteflam. The results of the clinical
program demonstrated that the clinical efficacy of Beteflam
was superior to that of betamethasone valerate 0.1%
cream and comparable to that of Dovobet 50 µg calcipotriol plus 0.5
mg betamethasone dipropionate ointment. The commonly reported
adverse drug reactions that occurred in patients using Beteflam
were skin and subcutaneous tissue disorders, occurring in < 5%
of patients treated.
__________________ [1] Canadian Dermatology
Association
|
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 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.
About IBSA
IBSA Institut Biochimique SA was founded in 1945 by a group of
Swiss biologists with its head office in Lugano. IBSA Institut
Biochimique represents the headquarters of the IBSA group.
After an initial phase of consolidation at national level, IBSA
experienced a period of rapid expansion and even developed an
international reputation starting in 1985, the year in which the
current chairman took over as head of the company.
Under the new management the company adopted a strategy of
optimizing the use of active ingredients for developing innovative
pharmaceutical forms capable of improving patient compliance and
the treatment required. The activities cover 7 main treatment areas
(pain/inflammation, rheumatology, reproduction and fertility,
endocrinology, urology, dermatology and dermocosmetics,
respiratory), with over 60 exclusive patents.
Currently the IBSA group employs over 1,800 people and is
present in over 80 countries through partnerships and local
subsidiaries in Italy,
France, Hungary, Slovak Republic, Poland, Turkey, China
and Scandinavia.
The production facilities are in Switzerland, Italy and the Far East and all are in strict
compliance with the highest standards of quality and in line with
current regulations. By controlling the steps from production to
the delivery of the finished product, IBSA is capable of
guaranteeing high quality standards for all products from the
various therapeutic areas.
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.
PrBeteflam™ (betamethasone valerate topical
patch) Product Monograph, date of preparation: December 3, 2015
SOURCE Cipher Pharmaceuticals Inc.