Sol-Gel Technologies Announces Agreements with Perrigo Company for Three New Generic Product Candidates
June 29 2020 - 7:00AM
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 it has entered
into collaborative agreements with Perrigo Company plc (“Perrigo”)
(NYSE; TASE: PRGO), for the development, manufacturing and
commercialization of three new, generic product candidates.
Consistent with Sol-Gel’s prior agreements with Perrigo, Perrigo
will seek regulatory approval with the U.S. Food and Drug
Administration (“FDA”) for these generic product candidates. If
approved by the FDA, Perrigo will lead the commercialization
efforts for the generic product candidates 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
candidates.
“Just a year ago, Sol-Gel entered into a seventh agreement with
Perrigo to develop, manufacture and commercialize two generic
formulations and we are thrilled to now expand the collaboration to
cover these three, new product candidates,” stated Dr. Alon
Seri-Levy, Chief Executive Officer of Sol-Gel. “Our collaboration
with Perrigo is generating meaningful revenue for Sol-Gel as we
continue to focus on the submission and commercialization of our
own branded product candidates Epsolay® and Twyneo®, which we
expect to file NDAs for in the second quarter and second half of
this year, respectively.”
Separately, Sol-Gel notes that Bausch Health Companies, Inc.
(NYSE:BHC) filed a patent infringement action regarding Perrigo’s
Abbreviated New Drug Application (“ANDA”) for a generic version of
Bryhali® (halobetasol propionate) lotion, 0.01%, for the treatment
of plaque psoriasis in adults. The halobetasol propionate
lotion, 0.01%, development is covered under a previous
collaboration between Sol-Gel and Perrigo.
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 Twyneo, for the
treatment of acne vulgaris, and Epsolay, for the treatment of
papulopustular rosacea. The Company’s pipeline also includes
SGT-210, an early-stage topical epidermal growth factor receptor
inhibitor, erlotinib, 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 the timing of the submission of an NDA for
Epsolay and an NDA for Twyneo and the development of our generic
product candidates in collaboration with Perrigo. 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
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