Arcutis And Sato Announce Strategic Collaboration And Licensing Agreement For Topical Roflumilast In Japan; The Arcutis To Receive A $25M Upfront Payment, And Is Eligible To Receive Potential Development And Commercial Milestone Payments Totaling $40M

Author: Benzinga Newsdesk | February 28, 2024 05:03pm

• Arcutis to receive a $25 million upfront payment, and is eligible to receive potential development and commercial milestone payments (totaling $40 million), as well as tiered, double-digit royalties
• Agreement offers pathway to potentially offering a novel non-steroidal topical option to the millions of Japanese patients suffering from inflammatory skin diseases

WESTLAKE VILLAGE, Calif. and TOKYO, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, and Sato Pharmaceutical Co., Ltd., a leading pharmaceutical company, today announced that the companies have entered into a strategic collaboration and licensing agreement for the development, manufacture, and commercialization of topical roflumilast in Japan. Sato will receive an exclusive license for both the cream and foam formulations of topical roflumilast, a next generation phosphodiesterase type 4 (PDE4) inhibitor, for multiple dermatological conditions including plaque psoriasis, seborrheic dermatitis, atopic dermatitis, and potentially additional dermatological conditions in the future.

"We are delighted to partner with Sato, who share our mission to provide meaningful innovation to individuals suffering from immune-mediated skin diseases. This partnership, built on topical roflumilast's strong product profile, expands the market opportunity for this effective and well-tolerated steroid-free treatment for multiple skin conditions, and provides meaningful non-dilutive capital for us," said Frank Watanabe, president and chief executive officer, Arcutis. "Sato's enduring corporate commitment to helping patients achieve a more positive and enjoyable life makes them an ideal partner to bring topical roflumilast to the millions of people suffering from inflammatory skin diseases in Japan."

"We are excited to partner with Arcutis, a leader in medical dermatology, on the heels of their successful U.S. launches of topical roflumilast in plaque psoriasis and seborrheic dermatitis. We eagerly anticipate the on-going clinical development and potential approvals in atopic dermatitis and scalp psoriasis. Topical roflumilast has been shown to effectively clear skin and reduce itch, with a safe and well-tolerated profile. With this collaboration, we believe we can make an impact for individuals suffering from immune-mediated skin diseases in Japan," said Seiichi Sato, president and chief executive officer, Sato.

Under the terms of the agreement, Arcutis will receive an upfront payment of $25 million, and potentially an additional $40 million if certain regulatory and sales milestones are achieved. Arcutis is also eligible to receive tiered, low double-digit percentage royalties.

Sato will be responsible for development, manufacturing, and commercialization of roflumilast cream and roflumilast foam and other topical roflumilast presentations in Japan. Arcutis will continue to be responsible for the development and commercialization of ZORYVE® (roflumilast) cream and ZORYVE® (roflumilast) foam in the United States and other geographies, excluding Greater China and Southeast Asia.

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