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Incyte and CMS Announce Collaboration and License Agreement for Ruxolitinib Cream in Greater China and Southeast Asia

INCY

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.