Cosmo Pharmaceuticals and Glenmark Specialty on Wednesday announced the signing of distribution and licence agreements for Winlevi, a clascoterone-based cream, in Europe and South Africa.

Glenmark said that the company will receive 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, from Cassiopeia, a subsidiary of Cosmo. Cassiopeia shall be responsible for the Centralised Marketing Authorisation at the European Medicines Agency (EMA), while Glenmark will be responsible for the registration of the product in South Africa and the UK.

Cassiopeia will receive an upfront payment of $5 million and agreed double-digit royalties on net sales. Cosmo will be the exclusive supplier of the product. Winlevi has been approved by the United States Food and Drug Administration (US FDA) for the topical treatment of acne in patients aged 12 years and older, the company said in a press release.

It is a 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 FDA since 1982. Winlevi has become the most prescribed branded topical acne drug in the US, the company added.

The EU acne market is projected to grow from $928.7 million in 2021 to $1,297 million in 2028. Across Europe, over 90 per cent of people aged 11 to 30 years are affected by acne, which is driving the market's growth. Glenmark Specialty is a subsidiary of Glenmark Pharmaceuticals Ltd.