WILMINGTON, Delaware & OSAKA, Japan, April 28, 2022–(BUSINESS WIRE)–Incyte (NASDAQ:INCY) and Maruho Co., Ltd. announced today that the companies have entered into a strategic alliance agreement for the exclusive development, manufacturing and commercialization of ruxolitinib cream, a new cream formulation of Incyte’s selective JAK2 inhibitor ruxolitinib, for the treatment of autoimmune and inflammatory dermatological 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 developments, regulatory and commercial milestones, and royalties on net sales of the licensed product in Japan.
Maruho will receive exclusive development, manufacturing and marketing rights to ruxolitinib cream and other potential future topical formulations of ruxolitinib, in autoimmune and inflammatory dermatological diseases, including vitiligo and atopic dermatitis, in Japan.
“After successfully launching Opzelura™ (ruxolitinib cream) in atopic dermatitis in the US, and with a regulatory decision for ruxolitinib cream in the US and a regulatory return expected in Europe this year for vitiligo, we look forward to starting our collaboration with Maruho, a specialist dermatology company in Japan,” said Hervé Hoppenot, CEO of Incyte. “There remains a significant unmet need among patients with immune-mediated dermatological diseases and we believe Maruho’s expertise makes them an exceptional partner to support the development of ruxolitinib cream and, if approved, help patients and healthcare providers in Japan to access this innovative therapy. “
Maruho President and CEO Atsushi Sugita said, “Incyte successfully launched ruxolitinib cream in the United States and provided a new treatment for patients with atopic dermatitis. As a dermatology specialty pharmaceutical company aiming to improve the lives of patients, supporting the development of Ruxolitinib Cream means a lot to Maruho. Leveraging our strengths, we will support the development of ruxolitinib cream in Japan and work to provide a new treatment option for patients with immune-mediated dermatological diseases beginning with atopic dermatitis as soon as possible.
The transaction is effective upon signature of the strategic alliance agreement.
About ruxolitinib cream (Opzelura™)
Ruxolitinib cream (Opzelura™), a new 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 treatment topical short-term and chronic non-continuing mild to moderate atopic dermatitis (AD) in nonimmunocompromised patients 12 years of age and older whose disease is not adequately controlled by topical prescription treatments, or when these treatments are not not recommended. The use of Opzelura in combination with biological therapeutic agents, other JAK inhibitors or strong immunosuppressants, such as azathioprine or cyclosporine, is not recommended.
In October 2021, Incyte announced approval of the European Marketing Authorization Application (MA) for ruxolitinib cream as a potential treatment for adolescents and adults (age ≥ 12 years) with vitiligo not segmental 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 to develop and commercialize ruxolitinib cream, marketed in the United States as Opzelura.
Opzelura is a registered trademark of Incyte.
About Incyte Dermatology
Incyte’s scientific approach and expertise in immunology formed the foundation of the company. In dermatology, the company’s research and development efforts focus on leveraging our knowledge of the JAK-STAT pathway to identify and develop topical and oral therapies that can modulate the immune pathways that drive uncontrolled inflammation and help restore normal immune function.
Currently, Incyte is exploring the potential of JAK inhibition for other immune-mediated dermatological conditions with high unmet medical need, including hidradenitis suppurativa. To learn more, visit the Dermatology section of Incyte.com.
Incyte is a global biopharmaceutical company based in Wilmington, Delaware, focused on finding solutions to serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutic products. For more information about Incyte, please visit Incyte.com and follow @Incyte.
Maruho Co., Ltd. is headquartered in Osaka and is a leader in Japan in the research and development, manufacturing and marketing of dermatological products. Founded in 1915, Maruho has 1,546 employees (as of the end of September 2021) and had net sales of approximately 87.03 billion yen in its fiscal year ended September 30, 2021. Continuing its A long-term corporate vision of “excellence in dermatology”, Maruho strives to improve the health and quality of life of people everywhere.
For more information, please visit https://www.maruho.co.jp/english/
Incyte Forward-Looking Statements
Except for historical information presented here, 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; if and when Maruho will market ruxolitinib cream in Japan; the potential of ruxolitinib cream to treat patients with atopic dermatitis, vitiligo or for any other indication; the ability for Incyte to receive royalties and payments from Maruho for development, regulatory and commercial milestones; and the ability of Incyte to expand its ability to bring new medicines to patients in Asia and elsewhere, to 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 could cause actual results to differ materially, including unforeseen developments and risks relating to: unforeseen delays; continued research and development and the results of clinical trials that may be unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll a sufficient number 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 vendors and development and discovery operations; decisions 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; market acceptance of the Company’s products and the products of the Company’s collaboration partners; 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 fiscal year ended December 31, 2021. The Company disclaims any intention or obligation to update update these forward-looking statements.
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