Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early
commercial-stage biopharmaceutical company focused on developing
meaningful innovations in immuno-dermatology, and Hangzhou Zhongmei
Huadong Pharmaceutical Co, a wholly owned subsidiary of Huadong
Medicine Co., Ltd. (SZ.000963), today announced that the companies
have entered into a strategic collaboration and licensing agreement
for the development, manufacture, and commercialization of topical
roflumilast in Greater China (mainland China, Hong Kong, Macau, and
Taiwan) and Southeast Asia (Indonesia, Singapore, The Philippines,
Thailand, Myanmar, Brunei, Cambodia, Laos, Malaysia, and Vietnam).
Huadong 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, and atopic dermatitis, and potentially additional
dermatological conditions in the future.
“This collaboration provides Arcutis access to the second
largest pharmaceutical market in the world, providing an
unparalleled opportunity to help individuals in this region
suffering from immune-mediated skin diseases, and provides
meaningful non-dilutive capital for us. With Huadong’s deep
dermatology and regional expertise, we are confident they are the
ideal partner to develop and commercialize topical roflumilast for
multiple dermatological indications in the Greater China and
Southeast Asia markets,” said Frank Watanabe, President and Chief
Executive Officer, Arcutis. “This collaboration provides further
validation of topical roflumilast’s potential to be an effective
and well-tolerated steroid-free treatment option for millions of
people.”
“Arcutis is a leader in medical dermatology with a successful
launch of topical roflumilast cream in plaque psoriasis and three
additional successful Phase 3 programs completed in seborrheic
dermatitis, atopic dermatitis, and scalp and body psoriasis in the
United States. We are honored to partner with Arcutis to bring
topical roflumilast to the Greater China and Southeast Asia markets
and continue to make an impact for those suffering from
immune-mediated skin diseases,” said Liang Lu, Chairman and CEO of
Huadong Medicine.
Under the terms of the agreement, Arcutis will receive an
upfront payment of $30 million, and an additional $64.25 million if
certain regulatory and sales milestones are achieved. Arcutis is
also eligible to receive tiered double-digit royalties.
Huadong will be responsible for development,
manufacturing, and commercialization of roflumilast cream 0.3% and
other topical roflumilast presentations in Greater China and
Southeast Asia with the oversight of a joint steering committee
comprised of individuals from both companies. Arcutis will continue
to be responsible for the development and commercialization of
ZORYVE in the United States and other geographies. The transaction
is effective immediately upon the execution of the Collaboration
and License Agreement.
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. Roflumilast foam is a once-daily foam
formulation of roflumilast which the Company is developing for both
seborrheic dermatitis and scalp and body psoriasis.
Roflumilast cream 0.3% (ZORYVE®) is approved by the Food and
Drug Administration (FDA) for the topical treatment of plaque
psoriasis in adults and adolescents.
About ZORYVE (roflumilast) Cream 0.3%ZORYVE
(roflumilast) cream 0.3% is indicated for topical treatment of
plaque psoriasis, including intertriginous areas, in patients 12
years of age and older.
IMPORTANT SAFETY INFORMATION The use of ZORYVE
is contraindicated in patients with moderate to severe liver
impairment (Child-Pugh B or C).
The most common adverse reactions (≥1%) include diarrhea (3%),
headache (2%), insomnia (1%), nausea (1%), application site pain
(1%), upper respiratory tract infection (1%), and urinary tract
infection (1%).
Please see full Prescribing Information.
About ArcutisArcutis Biotherapeutics, Inc.
(Nasdaq: ARQT) is an early 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 that harnesses 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, seborrheic dermatitis, and alopecia
areata. For more information, visit www.arcutis.com or
follow Arcutis on LinkedIn, Facebook, and Twitter.
About Huadong Medicine
Huadong Medicine Co., Ltd. (SZ.000963) is a leading Chinese
pharmaceutical company based in Hangzhou, China. Founded in 1993,
Huadong Medicine has fully integrated R&D, manufacturing,
distribution, sales, and marketing capabilities. Huadong Medicine's
product portfolio and pipeline are specialized in oncology,
immune-dermatology, nephrology, and diabetes. The company has
14,000 employees and one of the most extensive commercial coverage
and marketing capabilities in China. 'Patient Centered, Science
Driven' is Huadong Medicine's value. For additional information,
please visit www.eastchinapharm.com/en.
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 ZORYVE to
simplify disease management for care of plaque psoriasis; the
potential of real-world use results of topical roflumilast, as well
as the commercial launch of ZORYVE in plaque psoriasis in the
United States and other geographies. 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 28, 2023, 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
InvestorsEric McIntyre, Head of Investor
Relationsemcintyre@arcutis.com
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