Represents Fourth Product in Cipher's
Growing Canadian Portfolio
MISSISSAUGA, ON, April 5, 2016 /PRNewswire/ - Cipher
Pharmaceuticals Inc. (NASDAQ:CPHR; TSX:CPH) ("Cipher" or "the
Company") today announced the Canadian launch of Beteflam™
(betamethasone valerate), a novel, patent-protected patch,
indicated for the treatment of mild to moderate plaque psoriasis of
the elbows and knees for a maximum duration of 30 days in adult
patients1.
"We're pleased to introduce Beteflam, a unique treatment option
for Canadians suffering from plaque psoriasis, a very common and
persistent skin disorder, affecting as many as a million
Canadians2," said Joan
Chypyha, GM of Cipher Canada. "We continue to deliver on our
portfolio expansion plans and our commitment to delivering unique
Dermatology products. Beteflam represents our fourth marketed
product, and we expect to continue our growth with six products
targeted for the Canadian market in 2016 and eight in 2017."
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
topical 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
treated1.
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.
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.
1 BETEFLAM™ Product
Monograph. Cipher Pharmaceuticals Inc. December 3,
2015
2 Canadian
Dermatology Association
SOURCE Cipher Pharmaceuticals Inc.