Sol-Gel Technologies Collaboration Partner Filed First-to-File Paragraph IV Certification for Duobrii®
September 03 2020 - 7:05AM
Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a clinical-stage
dermatology company focused on identifying, developing and
commercializing branded and generic topical drug products for the
treatment of skin diseases, today announced that Bausch Health
Companies, Inc. (NYSE:BHC) initiated patent infringement action in
the U.S. District Court for the District of New Jersey on August
31, 2020 with regards to Perrigo Company plc (“Perrigo”) (NYSE;
TASE: PRGO) Abbreviated New Drug Application (“ANDA”) for a generic
version of Duobrii® (halobetasol propionate and tazarotene) lotion,
for the treatment of plaque psoriasis in adults1.
On July 23, 2020, Sol-Gel’s partner Perrigo filed a Notice of
first-to-file Paragraph IV Certification asserting that certain
U.S. patents, each of which is listed in the FDA's Orange Book for
Duobrii® (halobetasol propionate and tazarotene) lotion, are either
invalid, unenforceable and/or will not be infringed by the
commercial manufacture, use or sale of Perrigo’s generic
lotion.
Development of halobetasol propionate and tazarotene lotion is
covered under a previous collaboration
between Sol-Gel and Perrigo. Consistent with
Sol-Gel’s prior agreements with Perrigo, Perrigo will seek
regulatory approval with the U.S. Food and Drug Administration
(“FDA”) for the generic product candidate. If approved by the FDA,
Perrigo will lead the commercialization efforts for the generic
product candidate in the United States. Sol-Gel and Perrigo will
share the development costs and any gross profits generated from
potential sales of the generic product candidate.
Annual market sales of Duobrii® for the last 12 months ended
July 2020 amounted to $88.4 million2.
About Sol-Gel Technologies
Sol-Gel is a clinical-stage dermatology company focused on
identifying, developing and commercializing branded and generic
topical drug products for the treatment of skin
diseases. Sol-Gel leverages its proprietary
microencapsulation technology platform for the development of
Twyneo, under investigation for the treatment of acne vulgaris, and
Epsolay, under investigation for the treatment of papulopustular
rosacea. The Company’s pipeline also includes SGT-210, an
early-stage topical epidermal growth factor receptor inhibitor,
erlotinib, under investigation for the treatment
of palmoplantar keratoderma, and preclinical assets tapinarof
and roflumilast. For additional information, please
visit 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,
statements regarding that Perrigo will seek regulatory approval of
the generic product candidate. These forward-looking statements
include information about possible or assumed future results of our
business, financial condition, results of operations, liquidity,
plans and objectives. 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 expectation 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, risks relating to the
effects of COVID-19 (coronavirus), the timing of a launch of a
branded tapinarof product and the launch of a branded topical
roflumilast in the U.S., risks related to the timing of the
submission of an NDA for Epsolay and an NDA for Twyneo 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 and the possibility of adverse
regulatory or legal actions relating to our product candidates even
if regulatory approval is obtained; (v) our ability to
commercialize our pharmaceutical product candidates; (vi) our
ability to obtain and maintain adequate protection of our
intellectual property; (vii) our ability to manufacture our product
candidates in commercial quantities, at an adequate quality or at
an acceptable cost; (viii) our 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. These 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 24, 2020 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. Any such forward-looking
statements represent management’s estimates as of the date of this
press release. Except as required by law, we undertake no
obligation to update publicly any forward-looking statements after
the date of this press release to conform these statements.
For further information, please contact:
Sol-Gel Contact:Gilad MamlokChief Financial
Officer+972-8-9313433
Investor Contact:Lee M. SternSolebury Trout646-378-2922
lstern@soleburytrout.com
Source: Sol-Gel Technologies Ltd.
1 The patents-in-suit are U.S. Patent Nos. 8,809,307;
10,478,502; 10,251,895; and 10,426,787.
2 Source: Symphony Health
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