Glenmark, Cosmo partner to bring acne treatment Winlevi to Europe, S Africa

Glenmark Specialty SA, a subsidiary of Glenmark Pharmaceuticals, and Cosmo Pharmaceuticals NV, on Wednesday, announced the signing of distribution and licence agreements for Winlevi (clascoterone cream 1 per cent, used to treat acne vulgaris) in Europe and South Africa.

This agreement grants Glenmark the exclusive right to commercialise Winlevi in 15 EU countries, South Africa, and the UK. Cosmo's subsidiary, Cassiopea, will be responsible for the Centralised Marketing Authorization at the European Medicines Agency and is set to receive an initial payment of $5 million, along with royalties on net sales while Glenmark will oversee product registration in South Africa, and the UK. Cosmo will be the sole supplier of the product.

Alessandro Della Cha, CEO of Cosmo, said, “We are very pleased to partner with Glenmark. We look forward to eventually making Winlevi available to more patients around the globe.”

Glenn Saldanha, chairman & managing director of Glenmark Pharmaceuticals, 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.”

Winlevi has already gained approval from the United States Food & Drug Administration as a topical treatment for acne in patients aged 12 years and older. Winlevi has become the most prescribed branded topical acne drug in the US, representing 88 per cent of total health care providers in dermatology (per IQVIA MAT June 2023).

Glenmark Pharmaceuticals is an integrated, research-led, global pharmaceutical company, with a presence across branded, generic, and OTC segments, with a focus on therapeutic areas of respiratory, dermatology, and oncology.

Sun Pharma Canada Inc, a wholly owned subsidiary of Sun Pharmaceutical Industries also announced today that they are now offering PRWINLEVI (clascoterone cream 1 per cent) in the Canadian market. PRWINLEVI is an androgen receptor inhibitor approved for the topical treatment of acne vulgaris (acne) in patients aged 12 and above.