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.
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.
Glenn Saldanha, chairman & managing director, Glenmark Pharmaceuticals, said: ?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.?
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. FDA since 1982. Winlevi? has become the most prescribed branded topical acne drug in the U.S..
The EU acne market is projected to grow from $928.7 million in 2021 to $1,297 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.
Glenmark Pharmaceuticals is a global innovation-driven pharmaceutical company with presence across specialty, generics and OTC businesses.
Net profit of the company declined by 18% year-on-year to Rs 173.1 crore in Q1 FY24, while total revenue from operations increased by 22.48% to Rs 3,401.6 crore.
The scrip rose 0.77% to currently trade at Rs 768.45 on the BSE.
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