Cosmo and Glenmark sign Winlevi distribution and license agreements for Europe and South Africa

27 Sep 2023 , 01:29 PM

On Wednesday, Cosmo Pharmaceuticals N.V. and Glenmark Specialty S.A., a division of Glenmark Pharmaceuticals Limited, announced that Winlevi (clascoterone cream 1%) distribution and license agreements had been signed throughout Europe and South Africa.

According to the agreements, Glenmark will receive from Cassiopea, a Cosmo subsidiary, the sole right to market Winlevi in 15 EU nations, including South Africa, the UK, Denmark, Finland, France, Hungary, Iceland, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, and the Czech Republic.

Glenmark will be in charge of the product’s registration in South Africa and the UK, while Cassiopea will be in charge of the Centralised Marketing Authorization at the European Medicines Agency (EMA). The only supplier of the goods will be Cosmo. In addition to additional double-digit regulatory and sales milestone payments and agreed-upon double-digit royalties on net sales, Cassiopea will also receive an upfront payment of USD 5 million.

The CEO of Cosmo, Alessandro Della Chà, stated, ‘We are delighted to cooperate with Glenmark. We have a lot of faith in their capacity to successfully commercialize Winlevi because of their extensive experience in the commercialization of medicinal substances. We anticipate eventually making Winlevi accessible to more patients worldwide.

The United States Food & Drug Administration (U.S. FDA) has authorised Winlevi as a new medication having a distinct mechanism of action for the topical treatment of acne in patients 12 years of age and older. It is the first new mechanism of action in acne approved by the U.S. FDA since 1982. It is a topical androgen receptor inhibitor that is a first-in-class treatment for the androgen hormone component of acne.

According to IQVIA MAT June 2023, Winlevi has approximately 15,000 U.S. healthcare providers, or 88% of all dermatology-related healthcare providers, who have prescribed it as their go-to brand-name topical acne medication.

According to projections, the EU acne market will increase from $928.7 million in 2021 to $1,297.0 million in 2028. Acne affects more than 90% of people in Europe between the ages of 11 and 30; the prevalence of acne among teenagers is on the rise, which is fueling the market’s expansion. Despite the numerous treatments currently available, there is still a glaring unmet need. European recommendations oppose the use of topical antibiotics for comedonal acne due to the danger of antibiotic resistance.

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