Cosmo Pharmaceuticals and Glenmark Specialty S.A., a subsidiary of Glenmark Pharmaceuticals Ltd.  have 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."

"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," remarked Glenn Saldanha, Chairman & Managing Director Glenmark Pharmaceuticals Ltd.

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.