WESTLAKE VILLAGE, Calif. - Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a commercial-stage biopharmaceutical company, has announced a strategic collaboration and licensing agreement with Sato Pharmaceutical Co., Ltd. for the development and commercialization of topical roflumilast in Japan. The deal, which focuses on a non-steroidal treatment for inflammatory skin diseases, includes an upfront payment of $25 million to Arcutis, with the potential for additional milestone payments totaling $40 million, as well as tiered, double-digit royalties.
Roflumilast, a potent phosphodiesterase type 4 (PDE4) inhibitor, is being developed in cream and foam formulations for conditions such as plaque psoriasis, seborrheic dermatitis, and atopic dermatitis. The agreement grants Sato an exclusive license to these formulations in Japan, with the responsibility for their development, manufacture, and commercialization.
Frank Watanabe, President and CEO of Arcutis, expressed enthusiasm for the partnership, citing Sato's commitment to improving patient lives and the opportunity to expand the market for roflumilast. Seiichi Sato, President and CEO of Sato, highlighted the potential impact of the collaboration for those suffering from immune-mediated skin diseases in Japan.
Arcutis will continue to handle the development and commercialization of roflumilast cream and foam in the United States and other markets, excluding Greater China and Southeast Asia. The company has a growing portfolio with two FDA-approved products and multiple clinical programs for various dermatological conditions.
The safety information for ZORYVE cream and foam includes contraindications for patients with moderate to severe liver impairment and warnings about flammability. Common adverse reactions are diarrhea, headache, insomnia, nausea, application site pain, upper respiratory tract infection, urinary tract infection, nasopharyngitis, and headache.
This strategic collaboration aims to offer a novel treatment option to millions of Japanese patients, furthering Arcutis' mission to address the needs of individuals living with dermatological diseases.
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