WILMINGTON – Incyte announced recently that it has signed a deal with a Japanese dermatological product maker to commercialize its eczema cream in the Asian nation.
The quickly growing Alapocas-headquartered Incyte made its name on cancer treatments, but in the last few years it has repurposed its blockbuster drug into a treatment of atopic dermatitis, or eczema, known as Opzelura.
On April 28, Incyte announced a “Strategic Alliance Agreement” with Osaka-based Maruho Co. for the development, manufacturing and exclusive commercialization of the ruxolitinib cream, a novel cream formulation of Incyte’s selective JAK2 inhibitor, for treatment of autoimmune and inflammatory dermatology indications in Japan.
Under the terms of the agreement, Maruho will make an upfront payment to Incyte – the sum of which was not disclosed as of Wednesday. Incyte is also eligible to receive additional potential development, regulatory and commercial milestones and royalties on net sales of the licensed product 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, CEO of Incyte, in a statement announcing the deal. “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 health care providers in Japan access this innovative therapy.”
In the company’s first quarter earnings report, Hoppenot called Opzelura “an important growth driver for Incyte.” In the first three months of 2022, over 38,000 patients were prescribed the drug, and Incyte made “significant progress” with insurance companies on securing access for patients. Those prescriptions led to about $12.75 million in sales, the company reported.
Opzelura has been approved for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 or older, who don’t respond to other common topical treatments.
Incyte has increasingly begun targeting non-cancer diseases that might be helped by its small molecule drugs, including the skin pigmentation disease vitiligo and the hair loss condition alopecia. Hoppenot told Delaware Business Times last month that those uses have been explored as a natural extension of Incyte’s work into cancers.
“What we realized is that the research we are doing is the new way of thinking about cancer with immunotherapy. So instead of shooting at cancer, we are basically helping patients strengthen their immune system. All of that research on biology can be used outside of cancer for autoimmune diseases too,” he said.
Incyte never intended to branch into dermatological drugs, but its biologists highlighted the efficacy potential of treating conditions with its discovered drugs. They took a shot and won approval for Opzelura last year. Incyte hopes to earn U.S. Food & Drug Administration approval for Opzelura to treat vitiligo in July, as well as European Union approval this year.
By partnering with Maruho, Incyte is continuing to grow its presence and sales base in Asia. It launched a Japanese branch in 2017. Last year, Incyte Corp. signed a collaboration and license agreement valued at up to $117.5 million with InnoCare, a Chinese biopharmaceutical company. The deal gave the rights to develop and commercialize tafasitamab, also known by its brand name Monjuvi, in mainland China, Hong Kong, Macau and Taiwan.
In a statement, 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.”
