MUMBAI, India and DUBLIN, Sept. 27, 2023 /PRNewswire/ --  Cosmo Pharmaceuticals N.V. (SIX: COPN), (XETRA: C43) ('Cosmo') and Glenmark Specialty S.A., a subsidiary of Glenmark Pharmaceuticals Ltd. ('Glenmark'), today announced the signing of distribution and license agreements for Winlevi® (clascoterone cream 1%) in Europe and South Africa..

孟买，印度和都柏林，2023年9月27日/PRNewswire/-Cosmo Pharmaceuticals N.V.（六：COPN），（XETRA:C43）（'Cosmo'）和Glenmark Pharmaceuticals Ltd.（'Glenmark'）的子公司Glenmark Specialty S.A.今天宣布在欧洲和南非签署Winlevi®（clascoterone cream 1%）的分销和许可协议。。

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.

根据协议条款，Glenmark将从Cosmo的子公司Cassiopea收到，Winlevi®在15个欧盟国家（保加利亚，捷克共和国，丹麦，芬兰，法国，匈牙利，冰岛，荷兰，挪威，波兰，葡萄牙，罗马尼亚，斯洛伐克，西班牙和瑞典）以及南非和英国.Cassiopea应负责欧洲药品管理局（EMA）的集中销售许可，Glenmark将负责该产品在南非和英国的注册。

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. .

Cosmo将成为该产品的独家供应商。Cassiopea将获得500万美元的预付款，进一步的两位数监管和销售里程碑，并同意净销售额的两位数版税。 .

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.'.

Cosmo首席执行官AlessandroDellaChà说：“我们非常高兴与Glenmark合作。他们在药物化合物商业化方面的强大专业知识使我们对成功销售Winlevi®的能力充满信心。我们期待最终使Winlevi®适用于全球更多的患者。

'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..

“我们很高兴与Cosmo Pharmaceuticals签订了这项独家许可协议。主席Glenn Saldanha说，Winlevi®是我们欧洲皮肤科产品组合的完美补充，我们期待利用我们半个世纪的皮肤病学经验，为患者提供这种新颖的选择，并满足目前治疗痤疮的未满足的医疗需求。总经理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.

Alison Layton教授（哈罗盖特和地区NHS基金会信托基金研究副主任）总结道：“到目前为止，用局部药物减少痤疮皮脂的能力一直是一个重要的未满足的需求。皮脂在所有痤疮严重程度的病理生理学中是不可或缺的。虽然有有效的全身治疗，包括口服异维A酸治疗严重痤疮和激素治疗女性，这些不提倡或容忍所有痤疮患者。

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.

Clascoterone为痤疮提供了一种新颖的局部治疗方法。体外试验表明，它是第一种减少人原代皮脂细胞中雄激素调节脂质和炎性细胞因子产生的局部药物。它可以作为单一疗法或作为痤疮方案的一部分开处方，包括固定的局部组合和/或全身抗生素。

All patient populations with acne could potentially receive and benefit from clascoterone.'.

所有患有痤疮的患者都可能从克拉斯特罗中获得并受益。

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. It is a first-in-class topical androgen receptor inhibitor that tackles the androgen hormone component of acne and is the first new mechanism of action in acne approved by the U.S.

Winlevi®已被美国食品和药物管理局（美国FDA）批准为一种新型药物，具有独特的作用机制，可用于12岁及以上患者的痤疮局部治疗。它是一种一流的局部雄激素受体抑制剂，用于治疗痤疮的雄激素激素成分，是美国批准的痤疮中第一种新的作用机制。

FDA since 1982. Winlevi® has become the most prescribed branded topical acne drug in the U.S.; with over 15,000 U.S. health care providers, representing 88% of total health care providers in dermatology, having prescribed Winlevi® to date (per IQVIA MAT June 2023). According to the prescriptions generated as measured by IQVIA data, Winlevi® has been one of the most successful U.S.

FDA自1982年以来。Winlevi®已成为美国处方最多的品牌外用痤疮药物。；拥有超过15000名美国医疗保健提供者，占皮肤科医疗保健提供者总数的88%，迄今为止已开具Winlevi®（根据IQVIA MAT 2023年6月）。根据IQVIA数据生成的处方，Winlevi®是美国最成功的药物之一。

launches in the topical acne space in the last 15 years..

在过去15年中在局部痤疮空间推出。。

The EU acne market is projected to grow from USD 928.7 million in 2021 to USD 1,297.0 million in 2028. Across Europe, over 90% of people aged 11 to 30 years are affected by acne; with a rising prevalence among teenagers, which is driving the market's growth.

欧盟痤疮市场预计将从2021年的9.287亿美元增长到2028年的1.297亿美元。在整个欧洲，超过90%的11至30岁的人受到痤疮的影响；随着青少年患病率的上升，推动了市场的增长。

European guidelines discourage 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. With its non-antibiotic approach and by targeting the androgen receptors directly in the skin, Winlevi® addresses aspects of underlying acne causing disease pathways by decreasing sebum production and inflammation.

由于存在抗生素耐药性的风险，欧洲指南不鼓励使用局部抗生素治疗粉刺痤疮，尽管目前有许多治疗方法，但仍存在明显未满足的需求。Winlevi®采用非抗生素方法，直接在皮肤中靶向雄激素受体，通过减少皮脂生成和炎症来解决潜在的痤疮引起疾病途径的各个方面。

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..

它有可能成为40多年来欧洲患者可获得的具有创新作用机制的第一个产品。。

Disclaimer

免责声明

Some of the statements in this press release may be forward-looking statements or statements of future expectations based on currently available information. Such statements are naturally subject to risks and uncertainties. Factors such as the development of general economic conditions, future market conditions, unusual catastrophic loss events, changes in the capital markets and other circumstances may cause the actual events or results to be materially different from those anticipated by such statements. Cosmo does not make any representation or warranty, express or implied, as to the accuracy, completeness or updated status of such statements.

本新闻稿中的一些陈述可能是基于当前可用信息的前瞻性陈述或未来期望陈述。这些陈述自然会受到风险和不确定性的影响。诸如一般经济状况的发展，未来的市场状况，异常的灾难性损失事件，资本市场的变化和其他情况等因素可能导致实际事件或结果与本声明预期的实质性事件或结果大不相同。对于此类陈述的准确性，完整性或更新状态，Cosmo不作任何明示或暗示的陈述或保证。

Therefore, in no case whatsoever will Cosmo and its affiliate companies be liable to anyone for any decision made or action taken in conjunction with the information and/or statements in this press release or for any related damages..

因此，Cosmo及其附属公司对任何与本新闻稿中的信息和/或声明相关的决定或采取的行动或任何相关损害概不负责。。

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SOURCE Glenmark Pharmaceuticals Ltd

来源：格兰马克制药有限公司