Cosmo, Glenmark signs distribution and license pacts for Winlevi in Europe, South Africa

Cosmo Pharmaceuticals and Glenmark Specialty S.A., a subsidiary of Glenmark Pharmaceuticals 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 commercialize 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 Centralized Marketing Authorization 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. Winlevi has become the most prescribed branded topical acne drug in the US.; with over 15,000 US health care providers, representing 88% of total health care providers in dermatology, having prescribed Winlevi to date (per IQVIA MAT June 2023). The EU acne market is projected to grow from $928.7 million in 2021 to $1,297.0 million in 2028.

European guidelines discourage the use of topical antibiotics for comedonal acne due to the risk of antibiotic resistance, and despite the many treatments currently available there is still a clear unmet need. With its non-antibiotic approach and by targeting the androgen receptors directly in the skin, Winlevi addresses aspects of underlying acne causing disease pathways by decreasing sebum production and inflammation.