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Cosmo and Glenmark Announce UK MHRA Approval of Winlevi for Treatment of Acne

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Dublin, Ireland and Mumbai, India | London, U.K: Cosmo Pharmaceuticals N.V. (SIX: COPN, XETRA: C43) (โ€œCosmoโ€) and Glenmark Pharmaceuticals Limited (Glenmark), a global research-led pharmaceutical company, today announced that Glenmark had received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) to market Winleviยฎ in the United Kingdom. Winleviยฎ is a topical treatment for acne vulgaris in patients aged 12 years and older, marking a significant milestone in the commitment of both companies to providing innovative, patient-focused dermatology solutions.

As part of the agreement signed in September 2023, Glenmark has in-licensed the product from Cosmo Pharmaceuticals for distribution in Europe and South Africa. This collaboration underscores Glenmarkโ€™s and Cosmoโ€™s dedication to expanding its dermatology portfolio and addressing the unmet needs of patients with acne vulgaris, a condition that affects millions of individuals worldwide and can cause both physical discomfort and psychological distress.

Giovanni Di Napoli, Chief Executive Officer of Cosmo, commented: โ€œWe are thrilled that Winleviยฎ has been approved for the UK market, bringing an innovative approach to acne treatment. This milestone underscores our commitment, alongside Glenmark, to providing patients with breakthrough solutions that address not just the physical symptoms of acne, but also its emotional impact. We take great pride in expanding access to this game-changing therapy and making a real difference in patientsโ€™ lives.โ€

“We are excited to receive the approval and bring Winleviยฎ to the UK market, offering patients a new and efficacious treatment for acne,” said Christoph Stoller, President & Business Head – Europe and Emerging Markets, Glenmark Pharmaceuticals. “This approval by the MHRA represents a significant step forward in our mission to enhance dermatology care. Our partnership with Cosmo Pharmaceuticals plays an important role in enabling us to expand our dermatology portfolio, and we are proud to offer this new treatment to market that can improve the quality of life for those living with acne.”

โ€œThe approval of Winleviยฎ for the UK market marks a crucial milestone in Glenmarkโ€™s ongoing efforts to evolve dermatology treatments,โ€ said Xavier Mesrobian, Executive Vice President and Business Head โ€“ Europe, Glenmark SA. โ€œWe are focused on delivering therapies that address the clinical needs of patients and with Winleviยฎ, we are looking forward to offering an efficacious treatment option for individuals managing acne, a condition that can significantly impact self-confidence and daily life.โ€

Acne vulgaris is one of the most common skin conditions, impacting more than 90% of the worldโ€™s population at some point in their lives. It can have both physical and emotional consequences, affecting individualsโ€™ self-esteem and mental health.

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