Cosmo Pharmaceuticals and Glenmark Specialty SA, a subsidiary of Glenmark Pharmaceuticals, yesterday signed distribution and licence agreements for Winlevi (clascoterone cream 1 per cent) in Europe and South Africa, the companies said in a joint statement.
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 (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, the statement mentioned.
Alessandro Della Chà, CEO, Cosmo, said in the statement, “We are pleased to partner with Glenmark. Their strong expertise in the commercialisation 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 and Managing Director, Glenmark Pharmaceuticals, in the statement.
Cassiopea shall 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 in the UK. Cosmo will be the exclusive supplier of the product. Cassiopea will receive an upfront payment of $5 million, further double-digit regulatory and sales milestones and agreed double-digit royalties on net sales, the statement added.
Professor Alison Layton, Associate Medical Director — Research, Harrogate and District NHS Foundation Trust, concluded in the statement, “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.”
