By Fineline Cube Ireland-based Cosmo Pharmaceuticals NV (SWX: COPN) and China’s 3SBio Inc. (HKG: 1530) have signed a licensing agreement for Cosmo’s Winlevi (clascoterone) cream 1%, a topical therapy for acne. 3SBio will hold development and commercialization rights for Winlevi in Greater China, including mainland China, Hong Kong, Taiwan, and Macao.
Deal Details
The agreement includes a first-refusal option for 3SBio to acquire Greater China rights to Breezula (clascoterone 7.5% solution), currently in Phase III development for alopecia. Cosmo will receive an upfront payment of USD 6.5 million, with potential milestones totaling up to USD 63.5 million and royalties on net sales.
Drug Profile
Winlevi was approved by the US FDA in August 2020 to treat acne vulgaris in patients aged 12 and older. The drug, developed by Cosmo spin-off Cassiopea SpA, is an androgen receptor inhibitor targeting the androgen component of acne in sebaceous glands. It was the first acne drug with a new mechanism of action in 40 years.
Market Context
Despite acne affecting up to 100 million people annually in China, treatment rates remain low compared to Western markets. The partnership aims to address this unmet need by introducing Winlevi to Greater China.-Fineline Info & Tech