MISSISSAUGA, ON, July 12, 2016 /PRNewswire/ - Cipher
Pharmaceuticals Inc. (NASDAQ:CPHR; TSX:CPH) ("Cipher" or "the
Company") today announced that its New Drug Submission for
Ozenoxacin has been accepted for review by Health Canada.
Ozenoxacin is a topical treatment proposed for use in adult and
paediatric patients with impetigo, a highly contagious bacterial
skin infection. Cipher acquired the Canadian commercialization
rights to Ozenoxacin from Ferrer International SA ("Ferrer"),
a privately-held Spanish pharmaceutical company, in January
2015.
"This represents another important milestone on our path to
commercialization of this alternative treatment for one of the most
common bacterial skin infections in children – a condition that has
become more challenging with the emergence of treatment-resistant
bacterial pathogens," said Joan Chypyha, GM of Cipher Canada.
"As we continue to expand our Canadian product portfolio, we
believe Ozenoxacin has high potential in the topical impetigo
market, should it receive approval."
Ozenoxacin belongs to a new generation of non-fluorinated
quinolones that have demonstrated improved tolerability and safety
over fluorinated quinolones. Phototoxicity, photoallergenic
sensitization and articular toxicity were not observed in local
tolerability studies1. Ozenoxacin also
demonstrated in vitro and in vivo antibacterial activity against a
broad range of pathologically relevant bacteria, including
methicillin resistant Staphylococcus aureus (MRSA) strains and
clinical isolates of organisms with emerging resistance to
quinolones and other topical antibiotics.
In July 2015, Ferrer successfully
completed the second phase III clinical trial for Ozenoxacin. The
study, which involved Ozenoxacin formulated as a topical treatment
for impetigo in adults and peadiatric patients aged 2 months and
older, demonstrated the superiority of Ozenoxacin 1% cream, applied
twice daily for 5 days, versus placebo on both the clinical and
bacteriological endpoints by end of therapy visit (day 6-7). In
addition, Ozenoxacin 1% cream demonstrated superior bacteriological
cure compared to placebo as early as visit 2 (day 3-4).
Ozenoxacin 1% cream was shown to be safe and very well tolerated in
the adult and paediatric population.
About Ferrer
Founded in 1959, Ferrer is a
privately-held Spanish pharmaceutical company. It is present in
more than 90 countries, with 23 international affiliates. Ferrer is
active in the pharmaceutical, health, fine chemicals and food
sectors; key areas for contributing to people's health and quality
of life. The main therapeutic areas covered by Ferrer's
pharmaceutical production are dermatology, cardiovascular, CNS,
cancer, gastrointestinal, analgesics, bone metabolism,
anti-infectives, immunology, diagnostics, OTC and
dermocosmetics. www.ferrer.com
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 a
limited number of products; integration difficulties and other
risks if we acquire or in-license technologies or product
candidates; reliance on third parties for the marketing of certain
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;
we generate license 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; certain of our products are subject to
regulation as controlled substances; 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; we may be unsuccessful in evaluating
material risks involved in completed and future acquisitions; we
may be unable to identify, acquire or integrate acquisition targets
successfully; operations in the U.S.; inability to meet covenants
under our debt obligations; compliance with privacy and security
regulation; our policies regarding returns, allowances and
chargebacks may reduce revenues; certain regulations could restrict
our activities; additional regulatory burden and controls over
financial reporting; reliance on third parties to perform certain
services; general commercial litigation, class actions, other
litigation claims and regulatory actions; being a foreign private
issuer may limit the information available to U.S. shareholders; we
may lose our foreign private issuer status which could result in
significant additional costs; 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 laws; litigation in the pharmaceutical
industry concerning the manufacture and supply of novel and generic
versions of existing drugs; 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; our operating results may fluctuate
significantly; and our debt obligations will have priority over the
Common Shares in the event of a liquidation, dissolution or winding
up. 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 S.Itoh, S. Nakayama, H. Shimada, In vitro
photochemical clastogenicity of quinolone antibacterial agents
studied by a chromosomal aberration test with light irradiation,
Mutation Research 517 (2002) 113-121.
SOURCE Cipher Pharmaceuticals Inc.