- Significant regulatory milestone reached by Moberg,
paving the way for their commercial launch across 13 countries in
Europe
- Cipher holds exclusive Canadian rights to MOB-015 and sees
the approval in the European Union as an important step forward
towards approval in North
America
MISSISSAUGA, ON, July 5, 2023
/CNW/ - Cipher Pharmaceuticals Inc. (TSX: CPH) ("Cipher" or
"the Company") today announced that the Company's partner,
Moberg Pharma AB, ("Moberg Pharma") has obtained European Union
approval for MOB-015 (nail fungus treatment) as a result of
demonstrating superior levels of mycological cure (76% vs. 42% for
comparators) and a significantly better complete cure rate.
MOB-015 has been recommended for national approval in 13
European countries, which will be commercialized through partners
such as Bayer and Allderma, and is expected to be launched in
Nordic countries such as Sweden
during 2023.
Cipher holds the exclusive Canadian rights to MOB-015, a new
topical treatment of Onychomycosis (nail fungus) based on Moberg's
patented proprietary formulation of terbinafine. In Canada, according to IQVIA, the total
prescription market for Onychomycosis was greater than $82 million CDN at December 31, 2022 with a single product having
over 90% market share.
Craig Mull, Interim CEO of
Cipher commented, "This is a fantastic achievement whereby
the European Union has recognised MOB-015 as delivering quick
visible improvements to patients living with nail fungus. We are
excited about our partnership with Moberg Pharma, who have a strong
track record developing and commercializing nail fungus products
previously in both Europe and
North America. This approval is a
tremendous step in the right direction towards ultimately receiving
market approval in Canada and
the United States. We will
continue to work closely with Moberg in making this clinically
proven effective treatment available to Canadians as soon as
possible."
Moberg Pharma continues to invest and advance MOB-015 through an
additional phase 3 trial of a total of 350 patients with sites
across the United States and
Canada. The purpose of this study
is to facilitate market approval in North
America as well as further strengthen the product's clinical
evidence beyond the mycological and complete cure rates already
demonstrated to the European Union. Patient enrollment in the
clinical trial is progressing according to plan with full
enrollment expected in 2023.
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 and
Non-IFRS Measures
This document includes forward-looking statements within the
meaning of applicable securities laws. These forward-looking
statements include, among others, 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, 2022, 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.