Mumbai, India and Dublin (ots/PRNewswire) – Cosmo Pharmaceuticals NV. (SIX: COPN), (XETRA: C43) (“Cosmo”) and Glenmark Specialty SA, a subsidiary of Glenmark Pharmaceuticals Ltd. (“Glenmark”), today announced the signing of distribution and licensing agreements for Winlevi® (Clascoterone Cream 1 %) known in Europe and South Africa.
Under the terms of the agreements, Glenmark will receive from Cassiopea, a subsidiary of Cosmo, the exclusive right to distribute Winlevi® in 15 EU countries (Bulgaria, Denmark, Finland, France, Iceland, Netherlands, Norway, Poland, Portugal, Romania, Sweden, Slovakia, Spain, Czech Republic and Hungary) as well as in South Africa and Great Britain. Cassiopea will be responsible for central authorization at the European Medicines Agency (EMA), while Glenmark will be responsible for registering the product in South Africa and the United Kingdom. Cosmo will be the exclusive supplier of the product. Cassiopea will receive an upfront payment of $5 million, additional 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 extensive experience in marketing active pharmaceutical ingredients gives us great confidence in their ability to successfully market Winlevi®. We look forward to eventually making Winlevi® available to more patients around the world.”
“We are pleased to have entered into this exclusive licensing agreement with Cosmo Pharmaceuticals. Winlevi® is the perfect addition to our European dermatology portfolio, and we look forward to leveraging our over half a century of experience in dermatology to make this novel option available to patients and address currently unmet medical needs of acne,” said 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 been a significant unmet need. Sebum is an essential part of the pathophysiology of all grades of acne. While there are effective systemic therapies, including oral isotretinoin for severe acne and hormonal treatments for women, these are not endorsed or tolerated by all acne patients. Clascoterone offers a novel topical approach to treating acne. In vitro testing suggests that it is the first topical agent to reduce androgen-regulated lipid and inflammatory cytokine production in primary human sebocytes. It can be prescribed as monotherapy or as part of an acne treatment with solid topical combinations and/or systemic antibiotics. All patient groups with acne could potentially be treated with and benefit from clascoterone.”
Winlevi® has been approved by the United States Food and Drug Administration (US FDA) as a novel drug with a unique mechanism of action for the topical treatment of acne in patients 12 years of age and older. It is the first-in-class topical androgen receptor inhibitor that targets the androgen hormone component of acne and is the first new mechanism of action for acne to be approved by the FDA since 1982. Winlevi® is now the most commonly prescribed topical acne medication in the United States. More than 15,000 U.S. healthcare providers, representing 88% of all healthcare providers in dermatology, have prescribed Winlevi® to date (according to IQVIA MAT June 2023). Based on prescriptions tracked by IQVIA, Winlevi® has been one of the most successful topical acne launches in the U.S. over the past 15 years.
The EU acne market is expected to grow from USD 928.7 million in 2021 to USD 1,297.0 million in 2028. Across Europe, acne affects over 90% of people aged 11 to 30, with prevalence increasing among teenagers, driving market growth.
European guidelines recommend against 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. Using its non-antibiotic approach and by directly targeting the androgen receptors in the skin, Winlevi® addresses aspects of the underlying disease pathways that cause acne by reducing 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.
Some statements in this press release may be forward-looking statements or statements about future expectations based on currently available information. Such statements are inherently subject to risks and uncertainties. Factors such as general economic developments, future market conditions, unusual catastrophic events, changes in the capital markets and other circumstances could cause actual results or outcomes to differ materially from those anticipated in these statements. Cosmo makes no representation or warranty, express or implied, that this information is accurate, complete or current. Therefore, in no event shall Cosmo and its affiliates be liable to anyone for any decision or action taken in connection with the information and/or statements in this press release or for any damages related thereto.
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