Arcutis, Huadong enter collaboration agreement to develop, manufacture & commercialize topical roflumilast in Greater China & Southeast Asia

Arcutis Biotherapeutics, Inc., an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, and Hangzhou Zhongmei Huadong Pharmaceutical Co, a wholly owned subsidiary of Huadong Medicine Co., Ltd. (SZ.000963), announced that the companies have entered into a strategic collaboration and licensing agreement for the development, manufacture, and commercialization of topical roflumilast in Greater China (mainland China, Hong Kong, Macau, and Taiwan) and Southeast Asia (Indonesia, Singapore, The Philippines, Thailand, Myanmar, Brunei, Cambodia, Laos, Malaysia, and Vietnam).

Huadong 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, and atopic dermatitis, and potentially additional dermatological conditions in the future.

“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,” said Frank Watanabe, president and chief executive officer, Arcutis. “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 programmes completed in seborrheic dermatitis, atopic dermatitis, and scalp and body psoriasis in the United States. We are honoured 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,” said Liang Lu, chairman and CEO of Huadong Medicine.

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.

Huadong will be responsible for development, manufacturing, and commercialization of roflumilast cream 0.3% and other topical roflumilast presentations in Greater China and Southeast Asia with the oversight of a joint steering committee comprised of individuals from both companies. 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.

Arcutis is developing topical cream and foam formulations of roflumilast, a highly potent and selective PDE4 inhibitor being investigated as a once-daily, nonsteroidal, topical treatment for multiple dermatologic conditions. PDE4 – an established target in dermatology – is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators. Roflumilast foam is a once-daily foam formulation of roflumilast which the company is developing for both seborrheic dermatitis and scalp and body psoriasis.

Roflumilast cream 0.3% (Zoryve) is approved by the Food and Drug Administration (FDA) for the topical treatment of plaque psoriasis in adults and adolescents.

Zoryve (roflumilast) cream 0.3% is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is an early commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions.

Huadong Medicine Co., Ltd. is a leading Chinese pharmaceutical company based in Hangzhou, China. Founded in 1993, Huadong Medicine has fully integrated R&D, manufacturing, distribution, sales, and marketing capabilities. Huadong Medicine's product portfolio and pipeline are specialized in oncology, immune-dermatology, nephrology, and diabetes.

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