Incyte (NASDAQ:INCY) and Maruho Co., Ltd. today announced that
the companies have entered into a Strategic Alliance Agreement for
the development, manufacturing and exclusive commercialization of
ruxolitinib cream, a novel cream formulation of Incyte’s selective
JAK2 inhibitor ruxolitinib, for treatment of autoimmune and
inflammatory dermatology indications in Japan.
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Under the terms of the agreement, Maruho 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 Japan.
Maruho will receive the rights to develop, manufacture and
exclusively commercialize ruxolitinib cream, and other potential
future topical formulations of ruxolitinib, in autoimmune and
inflammatory dermatologic diseases, including vitiligo and atopic
dermatitis, in Japan.
“Having successfully launched Opzelura™ (ruxolitinib cream) in
atopic dermatitis in the United States, and with a regulatory
decision for ruxolitinib cream in the U.S. and regulatory feedback
in Europe expected this year for vitiligo, we are eager to begin
our collaboration with Maruho, a company specialized in dermatology
in Japan,” said Hervé Hoppenot, Chief Executive Officer, Incyte.
“There remains a significant unmet need among patients living with
immune-mediated dermatologic diseases and we believe Maruho’s
expertise makes them an outstanding partner to support the
development of ruxolitinib cream and, if approved, help patients
and healthcare providers in Japan access this innovative
therapy.”
Maruho President and CEO, Atsushi Sugita said, "Incyte has
successfully launched ruxolitinib cream in the U.S. and provided a
new treatment for patients suffering from atopic dermatitis. As a
specialty pharmaceutical company in dermatology aimed at improving
the lives of patients, supporting the development of ruxolitinib
cream has great significance for Maruho. Leveraging our strengths,
we will support the development of ruxolitinib cream in Japan and
work to provide a new treatment option to patients suffering from
immune mediated dermatologic diseases beginning with atopic
dermatitis as soon as possible."
The transaction is effective immediately upon the execution of
the Strategic Alliance 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 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. Additionally,
in December 2021, Incyte announced the acceptance and priority
review of the supplemental New Drug Application (sNDA) for
ruxolitinib cream as a potential treatment for adolescents and
adults (age ≥12 years) with vitiligo.
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. 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 Maruho
Maruho Co., Ltd. has its headquarters in Osaka and leads Japan
in research and development, manufacturing and commercialization of
dermatological products. Founded in 1915, Maruho has 1,546
employees (as of the end of September 2021), and net sales were
approximately 87.03 billion yen in its fiscal year ended September
30, 2021. Pursuing its long-term corporate vision of "Excellence in
Dermatology," Maruho is striving to improve the health and quality
of life of people all over the world.
For more information, please visit
https://www.maruho.co.jp/english/
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 Japan or elsewhere; whether and when Maruho will bring
ruxolitinib cream to market in Japan; 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 Maruho 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 the Company'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 the Company’s clinical trials, supply
chain, other third-party providers and development and discovery
operations; determinations made by regulatory authorities; the
Company’s dependence on its relationships with its collaboration
partners; the efficacy or safety of the Company’s products and the
products of the Company’s collaboration partners; the acceptance of
the Company’s products and the products of the Company’s
collaboration partners in the marketplace; market competition;
sales, marketing, manufacturing and distribution requirements; and
other risks detailed from time to time in the Company’s reports
filed with the Securities and Exchange Commission, including its
annual report for the year ended December 31, 2021. The Company
disclaims any intent or obligation to update these forward-looking
statements.
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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 Maruho Media Corporate Planning Dept.
Public Relations Group +81-(0)6-6371-8831
kouhou@mii.maruho.co.jp
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