On April 28, 2022 Incyte (NASDAQ:INCY) and Maruho Co., Ltd. reported 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 (Press release, Incyte, APR 28, 2022, View Source [SID1234613234]).
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"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"
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.