Licensing Deal

Incyte And CMS Announce Collaboration And License Agreement For Ruxolitinib Cream In Greater China And Southeast Asia

December 05,2022 05:37 AM
- By Admin

Incyte Corporation a dermatology medical aesthetic company and subsidiary of CMS 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 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