Glenmark Pharmaceuticals Ltd on Wednesday announced signing of distribution and licence agreements with Cosmo Pharmaceuticals NV for acne treatment ointment Winlevi for Europe and South Africa. The agreements were signed between company's arm Glenmark Specialty SA and Cosmo Pharmaceuticals NV, Glenmark Pharmaceuticals said in a statement.

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Winlevi has been approved by the United States Food & Drug Administration (USFDA) as a novel drug for the topical treatment of acne in patients aged 12 years and older, the company said.

"Under the terms of the agreements, Glenmark will receive from Cassiopea, a subsidiary of Cosmo, the exclusive right to commercialise Winlevi in 15 EU countries as well as in South Africa and the UK," the statement said.

The 15 EU countries are Bulgaria, Czech Republic, Denmark, Finland, France, Hungary, Iceland, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain and Sweden.

Cassiopea will be responsible for the centralised marketing authorisation at the European Medicines Agency (EMA), and Glenmark will be responsible for the registration of the product in South Africa and the UK, it added.

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"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," the company said.

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

Glenmark's "strong expertise in the commercialisation of pharmaceutical compounds gives us great confidence in their ability to successfully market Winlevi," Cosmo CEO Alessandro Della Chà said.

Glenmark said the EU market for acne treatment products is projected to grow from USD 928.7 million in 2021 to USD 1,297.0 million in 2028.

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