MISSISSAUGA, ON, Dec. 10,
2024 /CNW/ - Cipher Pharmaceuticals Inc. (TSX: CPH)
(OTCQX: CPHRF) ("Cipher" or the "Company") announced
today that its partner, Moberg Pharma AB ("Moberg"), issued a news
release earlier today stating that MOB-015, a product for the
treatment of nail fungus, did not meet the primary endpoint in
the North American Phase 3 study being conducted by Moberg. The
results of the North American Phase 3 study communicated by Moberg
today confirm the initial indications previously informed to the
market by Moberg, and accordingly announced by Cipher, on
September 13, 2024.
The North American Phase 3 study involved reducing the dosage –
8 weeks daily dosing followed by weekly maintenance treatment for
40 weeks, compared to daily dosing throughout the entire treatment
period. The primary endpoint, achieving the desired complete cure
of the patient's target toenail at 52 weeks, was not achieved.
Complete cure requires both a completely clear nail and mycological
cure.
Moberg's full press release can be found here.
Cipher owns the Canadian marketing rights to Moberg's MOB-015
through a licensing agreement (the "Agreement") dated September 18, 2018, to commercialize, promote,
sell and distribute the product exclusively in Canada. Cipher has no further financial
obligations in respect of the Agreement if the applicable
development and regulatory milestones outlined in the Agreement are
not attained.
The Company will be reviewing the full results from the clinical
trial once they become available from Moberg and formulating its
decision with respect to moving forward with this pipeline product,
however this does not impact the sales and earnings profile of
Cipher's existing business today.
The Company continues to be focused on its recent acquisition of
the NatrobaTM business from ParaPRO LLC as announced on
July 29, 2024, as well as other
potential growth opportunities. The Company believes the growth
potential for the NatrobaTM product in the U.S. market
and other markets internationally is significant, and the
integration of this business into its existing profitable North
American platform, along with pursuing other potential growth
opportunities remains Cipher's focus and priority in the near
term.
About Cipher Pharmaceuticals Inc.
Cipher Pharmaceuticals (TSX: CPH) (OTCQX: CPHRF) is a
specialty pharmaceutical company with a robust and diversified
portfolio of commercial and early to late-stage products, mainly in
dermatology. Cipher acquires products that fulfill unmet medical
needs, manages the required clinical development and regulatory
approval process, and currently markets those products
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
clinical studies being conducted by Moberg, the results of such
studies and their potential impact on the Company, the Company's
expectations for NatrobaTM and the Company's plans for
NatrobaTM, 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 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, publication of negative results of clinical trials; 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; product approval
process by regulators which can be 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 with new competing product entrants; requirements for
additional capital to fund future operations; products may be
subject to pricing regulation; dependence on key managerial
personnel and external collaborators; certain of our products are
subject to regulation as controlled substances; limitations on
reimbursement in the healthcare industry; extent and impact of
health pandemic outbreaks on our business; unpredictable
development goals and projected time frames; rising insurance
costs; ability to enforce covenants not to compete; 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; compliance with privacy
and security regulation; our policies regarding product returns,
allowances and chargebacks may reduce revenues; additional
regulatory burden and controls over financial reporting; 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; 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; 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 our MD&A for the year
ended December 31, 2023 and the Company's Annual Information
Form, 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.
