Ireland-based Cosmo Pharmaceuticals N.V. and Glenmark Specialty S.A., a subsidiary of Mumbai-based Glenmark Pharmaceuticals have announced the signing of distribution and license agreements for Winlevi (clascoterone cream 1%) in Europe and South Africa.

Under the terms of the agreements, Glenmark will receive from Cassiopea, a subsidiary of Cosmo, the exclusive right to commercialise Winlevi in 15 EU countries (Bulgaria, the Czech Republic, Denmark, Finland, France, Hungary, Iceland, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain and Sweden) as well as in South Africa and the UK. 

Cassiopea shall be responsible for the Centralised Marketing Authorisation at the European Medicines Agency (EMA), and Glenmark will be responsible for the registration of the product in South Africa and in the UK. Cosmo will be the exclusive supplier of the product. Cassiopea will receive an upfront payment of $5 million, further double-digit regulatory and sales milestones and agreed double-digit royalties on net sales. 

Winlevi has been approved by the United States Food & Drug Administration (US FDA) as a novel drug with a unique mechanism of action for the topical treatment of acne in patients aged 12 years and older. It is a first-in-class topical androgen receptor inhibitor that tackles the androgen hormone component of acne and is the first new mechanism of action in acne approved by the US FDA since 1982.  

The EU acne market is projected to grow from $928.7 million in 2021 to $1,297.0 million in 2028. Across Europe, over 90% of people aged 11 to 30 years are affected by acne; with a rising prevalence among teenagers, which is driving the market's growth.