Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company
pioneering treatments for patients with severe skin conditions,
conducting a Phase 3 clinical trial of SGT-610 (patidegib gel, 2%)
for Gorlin syndrome, and with two approved large-category
dermatology products, TWYNEO® and EPSOLAY®, today announced that
Padagis Israel Pharmaceuticals Ltd (“Padagis”), Sol-Gel’s
collaboration partner, submitted a first-to-file Abbreviated New
Drug Application (“ANDA”) to the U.S. Food and Drug Administration
(“FDA”) for Roflumilast Cream, 0.3%, a drug product generic to
Zoryve® Cream (roflumilast cream, 0.3%), indicated for the
treatment of plaque psoriasis in patients six years of age and
older. On March 26, 2024, Arcutis Biotherapeutics, Inc. (Nasdaq:
ARQT) (“Arcutis”) initiated a patent infringement action in the
U.S. District Court for the District of New Jersey regarding the
Padagis Roflumilast Cream, 0.3% ANDA.
Annual market sales for Zoryve Cream, 0.3% were
approximately $95 million in the 12 months ended in January 2024,
as measured by IQVIA. Should its ANDA for Roflumilast Cream, 0.3%
be approved by the FDA, Padagis believes that its product may be
entitled to 180 days of generic market exclusivity. If approved,
Sol-Gel and Padagis will share gross profit generated from
potential sales of Roflumilast Cream, 0.3% (calculated after the
deduction of certain development costs).
“According to recent leading analysts’ reports,
Zoryve Cream is estimated to generate net revenue exceeding $500
million by the end of 2030. Submissions such as
Padagis’s Roflumilast Cream, 0.3% ANDA demonstrate the historic
value of Sol-Gel’s partnership with Padagis. Though Sol-Gel exited
the majority of the partnership in the generic divestment deal
announced on November 4, 2021, the Roflumilast Cream, 0.3% project
was maintained because of the potential value to both companies,”
stated Mr. Mori Arkin, Executive Chairman of the Board of
Sol-Gel.
Mr. Arkin continued, “Given the market potential
of Padagis’s ANDA product, Sol-Gel is exploring all options to
maximize the value of this opportunity.”
As reported by Arcutis, Q4/2023 net product
revenues for Zoryve Cream were $13.5 million, a 357% increase
compared to the fourth quarter of 2022 and a 67% increase compared
to the third quarter of 2023, driven by sequential improvement in
gross-to-net in the mid 60% range, as well as sustained demand
growth.
About Sol-Gel Technologies
Sol-Gel Technologies, Ltd. is a dermatology company focused
on identifying, developing and commercializing or partnering drug
products to treat skin diseases. Sol-Gel developed TWYNEO
which is approved by the FDA for the treatment of acne vulgaris in
adults and pediatric patients nine years of age and older; and
Epsolay, which is approved by the FDA for the treatment of
inflammatory lesions of rosacea in adults. Both drugs are
exclusively licensed to and commercialized by Galderma in the US,
and Searchlight in Canada.
The Company’s pipeline also includes Phase 3
clinical trial of Orphan and breakthrough drug candidate SGT-610,
which is a new topical hedgehog inhibitor being developed to
prevent the new basal cell carcinoma lesions in patients with
Gorlin syndrome that is expected to have an improved safety profile
compared to oral hedgehog inhibitors as well as topical drug
candidate SGT-210 under investigation for the treatment
of rare hyperkeratinization disorders.
For additional information, please visit our new website:
www.sol-gel.com
Forward-Looking Statements
This press release contains “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995. All statements contained in this press release
that do not relate to matters of historical fact should be
considered forward-looking statements, including, but not limited
to obtaining regulatory approval for the generic drug product to
Zoryve® Cream (roflumilast cream, 0.3%), and the market potential
of the Zoryve® Cream, and of the generic drug product to Zoryve®
Cream (roflumilast cream, 0.3%). In some cases, you can identify
forward-looking statements by terminology such as “believe,” “may,”
“estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,”
“expect,” “predict,” “potential,” or the negative of these terms or
other similar expressions. Forward-looking statements are based on
information we have when those statements are made or our
management’s current expectations and are subject to risks and
uncertainties that could cause actual performance or results to
differ materially from those expressed in or suggested by the
forward-looking statements. Important factors that could cause such
differences include, but are not limited to, a delay in the timing
of our clinical trials, the success of our clinical trials, and an
increase in our anticipated costs and expenses, as well as the
following factors: (i) the adequacy of our financial and other
resources, particularly in light of our history of recurring losses
and the uncertainty regarding the adequacy of our liquidity to
pursue our complete business objectives; (ii) our ability to
complete the development of our product candidates; (iii) our
ability to find suitable co-development partners; (iv) our ability
to obtain and maintain regulatory approvals for our product
candidates in our target markets, the potential delay in receiving
such regulatory approvals and the possibility of adverse regulatory
or legal actions relating to our product candidates even if
regulatory approval is obtained; (v) our collaborators’ ability to
commercialize our pharmaceutical product candidates; (vi) our
ability to obtain and maintain adequate protection of our
intellectual property; (vii) our collaborators’ ability to
manufacture our product candidates in commercial quantities, at an
adequate quality or at an acceptable cost; (viii) our
collaborators’ ability to establish adequate sales, marketing and
distribution channels; (ix) acceptance of our product candidates by
healthcare professionals and patients; (x) the possibility that we
may face third-party claims of intellectual property infringement;
(xi) the timing and results of clinical trials that we may conduct
or that our competitors and others may conduct relating to our or
their products; (xii) intense competition in our industry, with
competitors having substantially greater financial, technological,
research and development, regulatory and clinical, manufacturing,
marketing and sales, distribution and personnel resources than we
do; (xiii) potential product liability claims; (xiv) potential
adverse federal, state and local government regulation in the
United States, Europe or Israel; and (xv) loss or
retirement of key executives and research scientists; (xvi) general
market, political and economic conditions in the countries in which
the Company operates; and, (xvii) the current war between Israel
and Hamas and any deterioration of the war in Israel into a broader
regional conflict involving Israel with other parties.
These factors and other important factors discussed in the
Company's Annual Report on Form 20-F filed with the Securities
and Exchange Commission (“SEC”) on March 13, 2024, and our
other reports filed with the SEC, could cause actual
results to differ materially from those indicated by the
forward-looking statements made in this press release. Except as
required by law, we undertake no obligation to update any
forward-looking statements in this press release.
For further information, please
contact:
Sol-Gel Contact:Gilad MamlokChief Financial
Officerinfo@sol-gel.com +972-8-9313433
Source: Sol-Gel Technologies Ltd.
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