Cosmo and Glenmark announce the signing of Distribution and License Agreements for Winlevi in Europe and South Africa

Cosmo Pharmaceuticals N.V. (“Cosmo”) and Glenmark Specialty S.A., a subsidiary of Glenmark Pharmaceuticals Ltd. (“Glenmark”), 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 USD 5 million, further double-digit regulatory and sales milestones and agreed double-digit royalties on net sales.

Alessandro Della Chà, CEO of Cosmo, said, “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. We look forward to eventually making Winlevi available to more patients around the globe.”

Glenn Saldanha, Chairman & Managing Director Glenmark Pharmaceuticals Ltd., said, “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.”

Professor Alison Layton (Associate Medical Director for Research, Harrogate and District NHS Foundation Trust) concludes: “The ability to reduce sebum in acne with a topical agent has up until now been a significant unmet need. Sebum is integral in the pathophysiology of all acne severities. Whereas there are effective systemic therapies including oral isotretinoin for severe acne and hormonal treatments for females, these are not advocated or tolerated by all people with acne. 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. 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.”

Winlevi has been approved by the United States Food & Drug Administration (U.S. 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 U.S. FDA since 1982. Winlevi has become the most prescribed branded topical acne drug in the U.S.; with over 15,000 U.S. health care providers, representing 88% of total health care providers in dermatology, having prescribed Winlevi to date (per IQVIA MAT June 2023). According to the prescriptions generated as measured by IQVIA data, Winlevi has been one of the most successful U.S. launches in the topical acne space in the last 15 years.

The EU acne market is projected to grow from USD 928.7 million in 2021 to USD 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.

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. It has the potential to be the first product with an innovative mechanism of action to be available to patients in Europe in over 40 years.

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