In Japan, Arcutis and Sato Enter Strategic Collaboration and Licensing Agreement for Topical Roflumilast

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Arcutis Biotherapeutics and Sato Pharmaceutical Co recently announced¹ that the companies have joined together in a strategic collaboration and licensing agreement with the aim of advancing the development, production, and distribution of topical roflumilast (Zoryve) in Japan. Sato will secure an exclusive license for both cream and foam formulations of topical roflumilast under the agreement.

The agreement outlines a structured partnership wherein Arcutis will receive an upfront payment of $25 million, with potential additional payments totaling $40 million contingent upon meeting specified regulatory and sales milestones. Additionally, Arcutis stands to benefit from tiered, low double-digit percentage royalties.

Sato will assume responsibility for the development, manufacturing, and commercialization of roflumilast cream and foam, as well as other topical presentations, within Japan. Meanwhile, Arcutis will continue to lead the development and commercialization efforts for roflumilast cream and foam in the United States and other designated regions, excluding Greater China and Southeast Asia.

“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 of Arcutis, in a news release.¹

“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,' Watanabe said.

The collaboration with Sato marks a continued effort of Arcutis to collaborate with pharmaceutical companies and license topical roflumilast in Asia.

In August, Arcutis announced a strategic collaboration and licensing agreement for roflumilast in Greater China and Southeast Asia with Hangzhou Zhongmei Huadong Pharmaceutical Co.²

In addition to Huadong's responsibility for the development, manufacturing, and commercialization of roflumilast cream 0.3% and other topical roflumilast presentations within Greater China and Southeast Asia, Huadong was also tasked with overseeing a joint steering committee for the initiative.²

Topical roflumilast, classified as a next-generation phosphodiesterase type 4 (PDE4) inhibitor, holds promise in addressing various dermatological conditions, including plaque psoriasis, seborrheic dermatitis, and atopic dermatitis.

"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," said Seiichi Sato, president and chief executive officer of Sato.¹ "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."

References

1. Arcutis and Sato announce strategic collaboration and licensing agreement for topical roflumilast in Japan. News release. Arcutis Biotherapeutics. February 28, 2024. Accessed February 29, 2024. https://www.arcutis.com/arcutis-and-sato-announce-strategic-collaboration-and-licensing-agreement-for-topical-roflumilast-in-japan/
2. Arcutis and Huadong announce strategic collaboration and licensing agreement for topical roflumilast in Greater China and Southeast Asia. News release. Arcutis Biotherapeutics. August 10, 2023. Accessed February 29, 2024. https://www.arcutis.com/arcutis-and-huadong-announce-strategic-collaboration-and-licensing-agreement-for-topical-roflumilast-in-greater-china-and-southeast-asia/