Pharma Focus Asia

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

Thursday, February 29, 2024

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) and Sato Pharmaceutical Co., Ltd. have announced a strategic collaboration and licensing agreement for the development, production, and commercialization of topical roflumilast in Japan. Roflumilast, a next-generation phosphodiesterase type 4 (PDE4) inhibitor, will be made available in cream and foam formulations to address various dermatological conditions such as plaque psoriasis, seborrheic dermatitis, and atopic dermatitis, with potential expansion to other conditions in the future.

Arcutis, expressed enthusiasm about the partnership with Sato, emphasizing their shared commitment to innovating treatments for immune-mediated skin diseases. He highlighted the significant market potential for topical roflumilast in Japan and the financial benefits for Arcutis.

Sato Pharmaceutical, echoed this sentiment, citing Arcutis' expertise and success in the dermatology field. He emphasized the potential impact of roflumilast in addressing the needs of patients with various inflammatory skin conditions in Japan.

As part of the agreement, Arcutis will receive an upfront payment of $25 million, with the possibility of an additional $40 million contingent on meeting certain regulatory and sales milestones. Arcutis will also be entitled to tiered, low double-digit percentage royalties.

Sato will take charge of the development, manufacturing, and commercialization of roflumilast cream and foam in Japan, while Arcutis will retain responsibility for these products in the United States and other regions, excluding Greater China and Southeast Asia.

Roflumilast, a potent PDE4 inhibitor, is being developed by Arcutis as a once-daily, nonsteroidal topical treatment for various dermatological conditions. The drug targets PDE4, an enzyme implicated in inflammation, offering a safe and effective alternative for patients.

ZORYVE cream and foam formulations have been indicated for the topical treatment of plaque psoriasis and seborrheic dermatitis, respectively, with specific safety information provided, including contraindications and common adverse reactions.

The collaboration between Arcutis and Sato represents a significant step forward in addressing the unmet needs of individuals suffering from immune-mediated skin diseases in Japan, leveraging the strengths and expertise of both companies to bring innovative treatments to patients.



magazine-slider-imageMFA + MMA 2024CPHI Chine || PMEC China 2024Asia Healthcare Week 2024Advance DoE WorkshopNitrosamine Advance Workshop 2024CPHI Korea 2024CHEMICAL INDONESIA 2024INALAB 2024 Thermo Scientific - DynaDrive and DynaSpinDigital Health Asia 2024Rehab Expo 2024ISPE Singapore Affiliate Conference & Exhibition 20242024 PDA Pharmaceutical Manufacturing & Quality Conference2024 PDA Cell and Gene Pharmaceutical Products Conference 2024 PDA Aseptic Manufacturing Excellence Conference2024 PDA Aseptic Processing of Biopharmaceuticals ConferencePharma Quality Excellence Awards 20244th Annual Pharma GMP Quality Management 20243rd World ADC Asia 2024LogiPharma Asia 2024