Huadong Medicine Co., Ltd (SHE: 000963) has announced a significant licensing agreement with Arcutis (NASDAQ: ARQT), securing exclusive rights to develop, file for regulatory approval, manufacture, and commercialize Arcutis’ Daxas (roflumilast, including cream ZORYVE and foam agent ARQ-154) external preparations in Greater China and South-East Asia.
Financial Terms and Commitments
Under the terms of the agreement, the Chinese firm will pay an upfront fee of USD 30 million to the US-based company and is committed to potential milestone payments of up to USD 64.25 million, in addition to tiered double-digit sales royalties.
Roflumilast’s Mechanism of Action and Indications
Roflumilast is a phosphodiesterase4 (PDE4) inhibitor, an intracellular enzyme that can increase the production of pro-inflammatory mediators and reduce the production of anti-inflammatories. The product ZORYVE is available in three concentrations: 0.3%, 0.15%, and 0.05%, corresponding to three indications—plaque psoriasis, atopic dermatitis in patients over 6 years old, and atopic dermatitis in patients between 2 and 5 years old. The plaque psoriasis indication has received marketing approval in the United States and Canada, while the other two indications are in Phase III clinical trials in the US.
ARQ-154’s Indications and Clinical Trials
ARQ-154, with a concentration of 0.3%, is indicated for seborrheic dermatitis and has an NDA submission in the United States. Additionally, the product is undergoing Phase III clinical trials for indications related to scalp and body psoriasis in the US.-Fineline Info & Tech
