MISSISSAUGA, ON,
March 22, 2022 /CNW/ -
Cipher Pharmaceuticals Inc. (TSX: CPH) ("Cipher" or "the
Company") today announced that the Company's partner, Moberg
Pharma AB, ("Moberg Pharma") has submitted a regulatory filing for
the next clinical Phase 3 study for MOB-015 (nail fungus treatment)
to the U.S. Food and Drug Administration ("FDA").
Cipher holds the exclusive Canadian rights to MOB-015, a new
topical treatment of onychomycosis based on Moberg's patented
proprietary formulation of terbinafine. In Canada, according to IQVIA, the total
prescription market for Onychomycosis was greater than $75 million CDN at December 31, 2021, with a single product having
over 90% market share.
The randomized, multicenter, vehicle-controlled Phase 3 study
will include approximately 350 patients in North America. The patients will be evaluated
over 52 weeks and the primary endpoint will be the proportion of
subjects achieving complete cure of their target nail. Moberg
Pharma expects to start enrolling patients in the second quarter of
this year. The study design builds on the experience gained from
the previous Phase 3 studies. Moberg Pharma will cooperate with the
same CRO, lead investigator and successful sites from the previous
North American study. The purpose of the new study is to facilitate
market approval in the US as well as strengthen the product's
clinical evidence and marketing claims globally.
"We are pleased to see the continued progress that Moberg is
making to commercialize MOB-015," said Craig Mull, Interim CEO of Cipher.
"The product is showing promising results and we look forward to
competing in this large market with an innovative topical product
that would provide a new safe and effective treatment option for
the many Canadians who suffer from onychomycosis," added Mr.
Mull.
About Moberg Pharma
Moberg Pharma AB is a Swedish pharmaceutical company focused on
commercializing proprietary innovations based on drug delivery of
proven compounds. The company's main asset, MOB-015, is a novel
topical treatment for onychomycosis. Data from phase 3 clinical
trials in more than 800 patients for MOB-015 indicate that the
product has the potential to become the future market leader in
onychomycosis. Moberg Pharma has agreements with commercial
partners in place in Europe and
Japan, among others, and the
company's goal is to receive its first market approval and launch
MOB-015 in 2023. Moberg Pharma is headquartered in Stockholm and the company's shares are listed
on the Small Cap list of the Nasdaq Stockholm (OMX: MOB).
www.mobergpharma.se
About Cipher Pharmaceuticals Inc.
Cipher Pharmaceuticals (TSX: CPH) is a specialty pharmaceutical
company with a robust and diversified portfolio of commercial and
early to late-stage products. Cipher acquires products that fulfill
unmet medical needs, manages the required clinical development and
regulatory approval process, and currently markets those products
either directly in Canada or indirectly through partners
in Canada, the U.S., and South America. For more
information, visit www.cipherpharma.com.
Forward-Looking Statements
This document includes forward-looking statements within the
meaning of applicable securities laws. These forward-looking
statements include, among others, statements with respect to the
impact of the Company's cost reduction plan, the potential for
improved profitability of our hospital business, increased adoption
of ABSORICA LD, discussions with Galephar regarding new product
opportunities, the impact of the partnership with Verity on the
Company's ability to manage its costs efficiently and drive
profitability within its hospital business, our objectives and
goals and strategies to achieve those objectives and goals, as well
as statements with respect to our beliefs, plans, expectations,
anticipations, estimates and intentions. 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.
By their very nature, forward-looking statements involve
inherent risks and uncertainties, both general and specific, which
give rise to the possibility that predictions, forecasts,
projections and other forward-looking statements will not be
achieved. 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. We
caution readers not to place undue reliance on these statements as
a number of important factors, many of which are beyond our
control, could cause our actual results to differ materially from
the beliefs, plans, objectives, expectations, anticipations,
estimates and intentions expressed in such forward-looking
statements. These factors include, but are not limited to, the
extent and impact of the coronavirus (COVID-19) outbreak on our
business including any impact on our contract manufacturers and
other third party service providers, our ability to enter into
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; our dependency on protection from patents that will
expire; 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, regulatory submissions and regulatory approvals;
reliance on third parties to manufacture our products and events
outside of our control that could adversely impact the ability of
our manufacturing partners to supply products to meet our demands;
we may be subject to future 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;
products in Canada may be subject
to pricing regulation; 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 and current
uncertainty surrounding health care regulation in the U.S.; 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; products may not be included on list of
drugs approved for use in hospitals; hospital customers may make
late payments or not make any payments; 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 we
operate; 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;
legacy risks from operations conducted in the U.S.; inability to
meet covenants under our long term debt arrangement; compliance
with privacy and security regulation; our policies regarding
returns, allowances and chargebacks may reduce revenues; certain
current and future 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; the difficulty for shareholders to realize in
the United States upon judgments
of U.S. courts predicated upon civil liability of the Company and
its directors and officers who are not residents of the United States; 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 if we issue
securities to raise capital; volatility of our share price; the
fact that we have 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 of the Company in the event of a liquidation,
dissolution or winding up.
We caution that the foregoing list of important factors that
may affect future results is not exhaustive. When reviewing our
forward-looking statements, investors and others should carefully
consider the foregoing factors and other uncertainties and
potential events. Additional information about factors that may
cause actual results to differ materially from expectations, and
about material factors or assumptions applied in making
forward-looking statements, may be found in the "Risk Factors"
section of the Company's Annual Information Form for the year ended
December 31, 2020, and elsewhere in
our filings with Canadian securities regulators. Except as required
by Canadian securities law, we do not undertake to update any
forward-looking statements, whether written or oral, that may be
made from time to time by us or on our behalf; such statements
speak only as of the date made. The forward-looking statements
included herein are expressly qualified in their entirety by this
cautionary language.
SOURCE Cipher Pharmaceuticals Inc.