[caption id="attachment_224455" align="aligncenter" width="1200"] The U.S. Food and Drug Administration has approved Incyte's Opzelura as its first treatment of vitiligo. | PHOTO COURTESY OF INCYTE[/caption]
WILMINGTON – Seeking to grow its international market for a skin cream that can treat a variety of conditions from eczema to vitiligo, Incyte has signed a collaboration and license agreement with a Chinese firm.The deal with CMS Aesthetics, a dermatology medical aesthetic subsidiary of Shanghai-based China Medical System (CMS), is for development and commercialization of ruxolitinib cream, a version of Incyte’s blockbuster drug Jakafi known commercially as Opzelura.Under the terms of the agreement, CMS will make an undisclosed upfront payment to Incyte, and the Wilmington-based public company is eligible to receive additional development, regulatory and commercial milestones and royalties on net sales of the licensed product in CMS’ territory should targets be reached.CMS will receive an exclusive license to develop and commercialize and a non-exclusive license to manufacture Opzelura for 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. It marks the second major deal for Opzelura in Asia for Incyte, after negotiating a deal for Japan this past spring. Incyte also inked a deal valued at up to $117.5 million with InnoCare, a Chinese biopharmaceutical company, to develop and commercialize tafasitamab, also known by its brand name Monjuvi, in Greater China.
[caption id="attachment_221823" align="alignleft" width="300"] Incyte CEO Herve Hoppenot said that clinical advancements had led the company to investigate dermatological drugs. | DBT PHOTO BY JACOB OWENS[/caption]
“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, CEO of Incyte, in a statement. “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 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.”Lam Kong, chairman, CEO and president of CMS, complimented the growth of Incyte’s dermatology program and said his company was honored to bring Opzelura to the Chinese market.“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,” he said. “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.”Hoppenot reported in November that over 62,000 units of Opzelura were shipped in the third quarter with growth fueled by both atopic dermatitis and vitiligo, producing quarterly revenue of $38 million.“This strong demand, coupled with an expansion of reimbursement coverage, positions Opzelura to become a meaningful long-term growth driver for Incyte,” he told investment analysts.Employing more than 1,000 people in Delaware, Incyte is best known for its blockbuster small-molecule drug Jakafi that is used in the treatment of rare bone marrow cancer, blood diseases and in certain bone marrow donations. Last year, sales and royalties from Jakafi totaled more than $2.4 billion, or more than 80% of the company’s revenues.In its research for new cancer drugs, Incyte researchers discovered that Jakafi, known generically as ruxolitinib, was effective in treating non-cancer, autoimmune diseases, including vitiligo and eczema. Last year, it won U.S. Food & Drug Administration approval for Opzelura for eczema in some patients and this summer became the first to win FDA approval of a vitiligo treatment.The company is not stopping with those conditions, as it is preparing Phase 2 trials evaluating Opzelura in lichen planus, a recurrent inflammatory condition affecting the skin and mucosal surfaces that can result in itchy, purple bumps on the skin, and lichen sclerosus, a chronic inflammatory skin disease most commonly affecting women and can result in painful ulcers and intense itching.Meanwhile, CMS has operated in the dermatological space in China for many years. Through 2020, its sales and promotion network has covered more than 50,000 hospitals and medical institutions, over 200,000 retail pharmacies, and about 12,000 dermatologists, using more than 500 professional dermatology promotion staff.