Cosmo, Glenmark Sign Distribution and License Agreements for Winlevi in Europe and South Africa

Cassiopea will receive an upfront payment of USD $5 million, further double-digit regulatory and sales milestones and agreed double-digit royalties on net sales. 

Glenmark Pharmaceuticals Ltd., now has exclusive rights to commercialize Winlevi (clascoterone cream 1%) 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.

Winlevi maker Cassiopea is 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 USD $5 million, further double-digit regulatory and sales milestones and agreed double-digit royalties on net sales. 

Winlevi is approved by the United States Food and Drug Administration 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 U.S. FDA since 1982. 

"We are very pleased to partner with Glenmark. Their strong expertise in the commercialization of pharmaceutical compounds gives us great confidence in their ability to successfully market Winlevi,” says Alessandro Della Chà, CEO of Cosmo, in a news release. “We look forward to eventually making Winlevi available to more patients around the globe."

"We are delighted to have undertaken this exclusive licensing agreement with Cosmo Pharmaceuticals. Winlevi is the perfect addition to our European dermatology portfolio and we look forward to leveraging our half-century long experience in dermatology to make this novel option available to patients and fill the current unmet medical need in treating acne,"adds Glenn Saldanha, Chairman & Managing Director Glenmark Pharmaceuticals Ltd.

“Clascoterone offers a novel topical approach for acne. In vitro testing suggests it is the first topical agent to reduce androgen-regulated lipid and inflammatory cytokine production in human primary sebocytes,” says Professor Alison Layton, an Associate Medical Director for Research, Harrogate and District NHS Foundation Trust s:  It could be prescribed as monotherapy or as part of an acne regime including fixed topical combinations and / or systemic antibiotics. All patient populations with acne could potentially receive and benefit from clascoterone."