Under the terms of the agreement, Arcutis will receive an upfront payment of $30 million, and an additional $64.25 million if certain regulatory and sales milestones are achieved.

Arcutis Biotherapeutics, Inc. and Hangzhou Zhongmei Huadong Pharmaceutical Co. have entered into a strategic collaboration and licensing agreement for the development, manufacture, and commercialization of topical roflumilast in Greater China and Southeast Asia. 

Huadong will be responsible for development, manufacturing, and commercialization of cream and foam formulations of topical roflumilast, a next generation phosphodiesterase type 4 (PDE4) inhibitor, for multiple dermatological conditions including plaque psoriasis, seborrheic dermatitis, and atopic dermatitis, and potentially additional dermatological conditions in the future, in Greater China and Southeast Asia with the oversight of a joint steering committee comprised of individuals from both companies. Under the terms of the agreement, Arcutis will receive an upfront payment of $30 million, and an additional $64.25 million if certain regulatory and sales milestones are achieved. Arcutis is also eligible to receive tiered double-digit royalties.

Arcutis will continue to be responsible for the development and commercialization of ZORYVE in the United States and other geographies. The transaction is effective immediately upon the execution of the Collaboration and License Agreement.

“This collaboration provides Arcutis access to the second largest pharmaceutical market in the world, providing an unparalleled opportunity to help individuals in this region suffering from immune-mediated skin diseases, and provides meaningful non-dilutive capital for us. With Huadong’s deep dermatology and regional expertise, we are confident they are the ideal partner to develop and commercialize topical roflumilast for multiple dermatological indications in the Greater China and Southeast Asia markets,” says Frank Watanabe, President and Chief Executive Officer, Arcutis, in a news release. “This collaboration provides further validation of topical roflumilast’s potential to be an effective and well-tolerated steroid-free treatment option for millions of people.”

“Arcutis is a leader in medical dermatology with a successful launch of topical roflumilast cream in plaque psoriasis and three additional successful Phase 3 programs completed in seborrheic dermatitis, atopic dermatitis, and scalp and body psoriasis in the United States. We are honored to partner with Arcutis to bring topical roflumilast to the Greater China and Southeast Asia markets and continue to make an impact for those suffering from immune-mediated skin diseases,” adds Liang Lu, Chairman and CEO of Huadong Medicine.