Incyte (NASDAQ:INCY) and CMS Aesthetics, a dermatology medical
aesthetic company and subsidiary of CMS (HKEX: 00867), today
announced that the companies have entered into a Collaboration and
License Agreement for the development and commercialization of
ruxolitinib cream, a novel cream formulation of Incyte’s selective
JAK inhibitor ruxolitinib, for the treatment of autoimmune and
inflammatory dermatologic diseases in Greater China and certain
countries in Southeast Asia.
Under the terms of the agreement, CMS will make an upfront
payment to Incyte and Incyte is eligible to receive additional
potential development, regulatory and commercial milestones and
royalties on net sales of the licensed product in CMS’
territory.
CMS will receive an exclusive license to develop and
commercialize and a non-exclusive license to manufacture
ruxolitinib cream, and potentially other future topical
formulations of ruxolitinib, in autoimmune and inflammatory
dermatologic diseases, including vitiligo and atopic dermatitis,
for patients in mainland China, Hong Kong, Macau, Taiwan and
certain countries in Southeast Asia.
“We are excited to partner with CMS and leverage their
Dermatology expertise to expand the global opportunities for
ruxolitinib cream as a potential treatment for patients with
immune-mediated dermatologic conditions in China,” said Hervé
Hoppenot, Chief Executive Officer, Incyte. “We have a great
appreciation for the significant burden of disease experienced by
patients living with these conditions and the treatment challenges
faced by health care providers. To date, we have successfully
launched ruxolitinib cream (Opzelura™) in atopic dermatitis and
vitiligo in the United States, to help address these challenges. In
partnership with CMS, we believe that, if approved, ruxolitinib
cream will be an innovative therapeutic option poised to also help
patients and healthcare providers in Greater China.”
“Incyte is a leading innovative global biopharmaceutical
company, with a strong and growing foothold in the dermatology
field. We are very honored to partner with Incyte on ruxolitinib
cream in Greater China and Southeast Asia. To meet the clinical
need for safe and effective topical drugs among patients with
nonsegmental vitiligo and mild to moderate atopic dermatitis in the
territory, CMS will seek to leverage clinical development and
commercialization opportunities to achieve the marketing approval
and commercialization of ruxolitinib cream in Greater China and
Southeast Asia as soon as possible,” said Mr. Lam Kong, Chairman,
Chief Executive and President of CMS. “We will continue to expand
and deepen our collaboration with leading innovative forces in the
world, like Incyte, to benefit more and more patients and provide
them with quality and accessible innovative medicines.”
The transaction is effective immediately upon the execution of
the Collaboration and License Agreement.
About Ruxolitinib Cream (Opzelura™) Ruxolitinib cream
(Opzelura™), a novel cream formulation of Incyte’s selective
JAK1/JAK2 inhibitor ruxolitinib, is the first and only topical JAK
inhibitor approved for use in the United States, indicated for the
topical treatment of nonsegmental vitiligo in adult and pediatric
patients 12 years of age and older and for the topical short-term
and non-continuous chronic treatment of mild to moderate atopic
dermatitis (AD) in non-immunocompromised patients 12 years of age
and older whose disease is not adequately controlled with topical
prescription therapies, or when those therapies are not advisable.
Use of Opzelura in combination with therapeutic biologics, other
JAK inhibitors, or potent immunosuppressants, such as azathioprine
or cyclosporine, is not recommended.
In October 2021, Incyte announced the validation of the European
Marketing Authorization Application (MAA) for ruxolitinib cream as
a potential treatment for adolescents and adults (age >12 years)
with non-segmental vitiligo with facial involvement.
Incyte has worldwide rights for the development and
commercialization of ruxolitinib cream, marketed in the United
States as Opzelura.
Opzelura is a trademark of Incyte.
About Incyte Dermatology Incyte’s science-first approach
and expertise in immunology has formed the foundation of the
company. In Dermatology, the Company’s research and development
efforts are focused on leveraging our knowledge of the JAK-STAT
pathway to identify and develop topical and oral therapies with the
potential to modulate immune pathways driving uncontrolled
inflammation and help restore normal immune function.
Currently, Incyte is exploring the potential of JAK inhibition
for additional immune-mediated dermatologic conditions with a high
unmet medical need, including hidradenitis suppurativa, lichen
planus and lichen sclerosis. To learn more, visit the Dermatology
section of Incyte.com.
About Incyte Incyte is a Wilmington, Delaware-based,
global biopharmaceutical company focused on finding solutions for
serious unmet medical needs through the discovery, development and
commercialization of proprietary therapeutics. For additional
information on Incyte, please visit Incyte.com and follow
@Incyte.
About CMS Aesthetics Upholding a scientific mindset and a
rigorous attitude, CMS Aesthetics provides consumers with diverse
and safe branded products, including dermatology prescription
medicine, light medical aesthetic products, energy based medical
aesthetic devices and dermatology grade skincare products, to meet
consumers’ diverse needs for skin health and beauty.
About CMS CMS is an open platform company linking
pharmaceutical innovation and commercialization with strong product
lifecycle management capability. The Group has been deeply engaged
in specialty therapeutic fields, such as cardio-cerebrovascular,
gastroenterology, central nervous system, dermatology and medical
aesthetics, ophthalmology and pediatrics, dedicated to providing
competitive products and services to meet the unmet medical
needs.
Incyte Forward-Looking Statements Except for the
historical information set forth herein, the matters set forth in
this press release, including statements regarding whether and when
ruxolitinib cream will be approved for use in Greater China or
Southeast Asia; whether and when CMS will bring ruxolitinib cream
to market in Greater China or Southeast Asia; the potential of
ruxolitinib cream to treat patients with atopic dermatitis,
vitiligo or for any other indication; the potential for Incyte to
receive royalties and payments from CMS for development, regulatory
and commercial milestones; and the potential for Incyte to broaden
its ability to bring new medicines to patients in Asia and
elsewhere, contain predictions, estimates and other forward-looking
statements.
These forward-looking statements are based on Incyte’s current
expectations and are subject to risks and uncertainties that may
cause actual results to differ materially, including unanticipated
developments in and risks related to: unanticipated delays; further
research and development and the results of clinical trials
possibly being unsuccessful or insufficient to meet applicable
regulatory standards or warrant continued development; the ability
to enroll sufficient numbers of subjects in clinical trials; the
effects of the COVID-19 pandemic and measures to address the
pandemic on Incyte’s clinical trials, supply chain, other
third-party providers and development and discovery operations;
determinations made by regulatory authorities; Incyte’s dependence
on its relationships with its collaboration partners; the efficacy
or safety of Incyte’s products and the products of its
collaboration partners; the acceptance of Incyte’s products and the
products of its collaboration partners in the marketplace; market
competition; sales, marketing, manufacturing and distribution
requirements; and other risks detailed from time to time in
Incyte’s reports filed with the Securities and Exchange Commission,
including its annual report and the quarterly report on Form 10-Q
for the quarter ended September 30, 2022. Incyte disclaims any
intent or obligation to update these forward-looking
statements.
CMS Forward-Looking Statements This report contains the
disclosure of some forward-looking statements. Except for
statements of facts, all other statements can be regarded as
forward-looking statements, that is, about CMS or CMS’s
management's intentions, plans, beliefs, or expectations that will
or may occur in the future. Such statements are assumptions and
estimates made by CMS’s management based on its experience and
knowledge of historical trends, current conditions, expected future
development and other related factors. This forward-looking
statement does not guarantee future performance, and actual
results, development and business decisions may not match the
expectations of the forward-looking statement. These
forward-looking statements are also subject to a large number of
risks and uncertainties, which may affect our short-term and
long-term performance.
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Incyte
Media Catalina Loveman +1 302 498 6171
cloveman@incyte.com
Investors Christine Chiou +1 302 274 4773
cchiou@incyte.com
CMS
Investor Relations +86 755 82416868 ir@cms.net.cn
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