Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a
commercial-stage biopharmaceutical company focused on developing
meaningful innovations in immuno-dermatology, and Sato
Pharmaceutical Co., Ltd., a leading pharmaceutical company, today
announced that the companies have entered into a strategic
collaboration and licensing agreement for the development,
manufacture, and commercialization of topical roflumilast in Japan.
Sato will receive an exclusive license for both the cream and foam
formulations of topical roflumilast, a next generation
phosphodiesterase type 4 (PDE4) inhibitor, for multiple
dermatological conditions including plaque psoriasis, seborrheic
dermatitis, atopic dermatitis, and potentially additional
dermatological conditions in the future.
“We are delighted to partner with Sato, who share
our mission to provide meaningful innovation to individuals
suffering from immune-mediated skin diseases. This partnership,
built on topical roflumilast’s strong product profile, expands the
market opportunity for this effective and well-tolerated
steroid-free treatment for multiple skin conditions, and provides
meaningful non-dilutive capital for us,” said Frank Watanabe,
president and chief executive officer, Arcutis. “Sato’s enduring
corporate commitment to helping patients achieve a more positive
and enjoyable life makes them an ideal partner to bring topical
roflumilast to the millions of people suffering from inflammatory
skin diseases in Japan.”
“We are excited to partner with Arcutis, a leader
in medical dermatology, on the heels of their successful U.S.
launches of topical roflumilast in plaque psoriasis and seborrheic
dermatitis. We eagerly anticipate the on-going clinical development
and potential approvals in atopic dermatitis and scalp psoriasis.
Topical roflumilast has been shown to effectively clear skin and
reduce itch, with a safe and well-tolerated profile. With this
collaboration, we believe we can make an impact for individuals
suffering from immune-mediated skin diseases in Japan,” said
Seiichi Sato, president and chief executive officer, Sato.
Under the terms of the agreement, Arcutis will
receive an upfront payment of $25 million, and potentially an
additional $40 million if certain regulatory and sales milestones
are achieved. Arcutis is also eligible to receive tiered, low
double-digit percentage royalties.
Sato will be responsible for development,
manufacturing, and commercialization of roflumilast cream and
roflumilast foam and other topical roflumilast presentations in
Japan. Arcutis will continue to be responsible for the development
and commercialization of ZORYVE® (roflumilast) cream and ZORYVE®
(roflumilast) foam in the United States and other geographies,
excluding Greater China and Southeast Asia.
About Topical RoflumilastArcutis
is developing topical cream and foam formulations of roflumilast, a
highly potent and selective PDE4 inhibitor being investigated as a
once-daily, nonsteroidal, topical treatment for multiple
dermatologic conditions. PDE4 – an established target in
dermatology – is an intracellular enzyme that increases the
production of pro-inflammatory mediators and decreases production
of anti-inflammatory mediators.
INDICATIONSZORYVE cream 0.3% is
indicated for topical treatment of plaque psoriasis, including
intertriginous areas, in patients 6 years of age and older.
ZORYVE foam, 0.3%, is indicated for treatment of
seborrheic dermatitis in adult and pediatric patients 9 years
of age and older.
IMPORTANT SAFETY INFORMATION
ZORYVE is contraindicated in patients with moderate to severe liver
impairment (Child-Pugh B or C).
Flammability: The propellants in ZORYVE foam are
flammable. Avoid fire, flame, and smoking during and immediately
following application.
The most common adverse reactions (≥1%) for ZORYVE
cream include diarrhea (3.1%), headache (2.4%), insomnia (1.4%),
nausea (1.2%), application site pain (1.0%), upper respiratory
tract infection (1.0%), and urinary tract infection (1.0%).
The most common adverse reactions (≥1%) for ZORYVE
foam include nasopharyngitis (1.5%), nausea (1.3%), and headache
(1.1%).
Please see full Prescribing Information for ZORYVE
cream and full Prescribing Information for ZORYVE foam.
About ArcutisArcutis
Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical
dermatology company that champions meaningful innovation to address
the urgent needs of individuals living with immune-mediated
dermatological diseases and conditions. With a commitment to
solving the most persistent patient challenges in dermatology,
Arcutis has a growing portfolio including two FDA approved products
that harness our unique dermatology development platform coupled
with our dermatology expertise to build differentiated therapies
against biologically validated targets. Arcutis’ dermatology
development platform includes a robust pipeline with multiple
clinical programs for a range of inflammatory dermatological
conditions including scalp and body psoriasis, atopic dermatitis,
and alopecia areata. For more information,
visit www.arcutis.com or follow Arcutis on LinkedIn,
Facebook, and X.
About SatoSato Pharmaceutical Co.,
Ltd., operating under its corporate philosophy of “Healthcare
Innovation,” is a pharmaceutical company that provides effective,
safe, and high-quality products for practicing selfcare, while
always keeping the health of its customers in mind. In addition to
its main consumer healthcare business, Sato Pharmaceutical also
develops and provides highly original products primarily in the
field of dermatology.
Forward Looking StatementsArcutis
cautions you that statements contained in this press release
regarding matters that are not historical facts are forward-looking
statements. These statements are based on the Company’s current
beliefs and expectations. Such forward-looking statements include,
but are not limited to, statements regarding the potential for
topical roflumilast to simplify disease management; the potential
of real-world use results of topical roflumilast, as well as the
commercial launch of ZORYVE cream in plaque psoriasis and ZORYVE
foam in seborrheic dermatitis in the United States and other
geographies. These forward-looking statements also include
statements about the development and commercialization of topical
roflumilast by our new partner in Japan, the potential receipt of
payments associated with achievement of certain milestones, and the
potential royalties from sales of commercialized products in Japan.
These statements are subject to substantial known and unknown
risks, uncertainties and other factors that may cause our actual
results, levels of activity, performance, or achievements to be
materially different from the information expressed or implied by
these forward-looking statements. Risks and uncertainties that may
cause our actual results to differ include risks inherent in our
business, reimbursement and access to our products, the impact of
competition and other important factors discussed in the "Risk
Factors" section of our Form 10-K filed with U.S. Securities and
Exchange Commission (SEC) on February 27, 2024, as well as any
subsequent filings with the SEC. You should not place undue
reliance on any forward-looking statements in this press release.
We undertake no obligation to revise or update information herein
to reflect events or circumstances in the future, even if new
information becomes available. All forward-looking statements are
qualified in their entirety by this cautionary statement, which is
made under the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995.
Contacts:MediaAmanda Sheldon,
Head of Corporate Communicationsasheldon@arcutis.com
InvestorsDerek ColeInvestor
Relations Advisory Solutionsderek.cole@iradvisory.com
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