MISSISSAUGA, ON, Feb. 16, 2016 /PRNewswire/ - Cipher
Pharmaceuticals Inc. (NASDAQ:CPHR; TSX:CPH) ("Cipher" or "the
Company") today announced that its New Drug Submission for
Sitavig™ has been accepted for review by Health Canada.
Sitavig (acyclovir mucoadhesive buccal tablets) is proposed for the
treatment of recurrent herpes labialis (cold sores) in adults.
"Cold sores are one of the most common viral skin infections,
affecting one in five Canadians," said Shawn O'Brien,
President and CEO of Cipher. "In addition to the pain, this is a
highly stigmatizing disorder. If approved, Sitavig will represent
an attractive treatment option for the many Canadians who suffer
from cold sores and another key addition to our growing Canadian
dermatology portfolio."
In the United States,
Sitavig® is approved as a single-dose prescription cold
sore treatment. Based on proprietary Lauriad® technology
from Onxeo S.A, Sitavig is a 50 mg mucoadhesive tablet, which the
patient places inside the lip on the upper gum and, in clinical
trials, has been seen to deliver acyclovir to the site of the cold
sore infection.
"The Health Canada submission for Sitavig is a joint achievement
for Cipher and Onxeo that reflects great collaboration and
regulatory work by the two companies over the past several months,"
said Judith Greciet, CEO of Onxeo S.A. "Should Sitavig
receive approval in Canada, it
will strengthen the brand in North
America and increase the availability of the product for
patients suffering from cold sores."
Cipher acquired the North American distribution rights to
Sitavig with the April 2015
acquisition of INNOCUTIS Holdings LLC, which originally licensed
the product from Onxeo S.A. Cipher plans to market Sitavig through
its Canadian sales force.
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 Onxeo
Onxeo has the vision to become a global
leader and pioneer in oncology, with a focus on orphan or rare
cancers, through developing innovative therapeutic alternatives
designed to "make the difference". The Onxeo team is determined to
develop innovative medicines that provide patients with hope and
significantly improve their lives.
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.