Cosmo and Hyundai Pharm Announce Signing of License Agreement for Winlevi® in Korea
Cosmo Pharmaceuticals N.V.
/ Key word(s): Agreement
Dublin, Ireland Seoul, Korea – 22 June 2023: Cosmo Pharmaceuticals N.V. (SIX: COPN, XETRA: C43) (“Cosmo”) and Hyundai Pharmaceutical Co., Ltd. (“Hyundai Pharm”) today announced the signing of a License Agreement for Winlevi® (clascoterone) cream 1% in the Republic of Korea. Under the terms of the agreement, Hyundai Pharm will receive from Cassiopea, a subsidiary of Cosmo, the exclusive right to register and commercialize Winlevi® in the Republic of Korea. Cosmo will be the exclusive supplier of the product. Cassiopea will receive an upfront payment in addition to potential regulatory and sales milestones and customary double-digit royalties on net sales. Winlevi® has been approved by the United States Food Drug Administration (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 the 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 FDA in 40 years. Winlevi® was launched in the US in November 2021 by Sun Pharma and is already the most prescribed branded topical acne drug in the US based on IQVIA data. Over 13,000 US physicians have prescribed Winlevi® to date. According to the prescriptions generated, Winlevi® has been one of the most successful US launches in the topical acne space in the last 15 years. For patients with moderate to severe acne, the widely recommended and commonly used topical retinoid therapy has shown a particularly high incidence of skin irritation among Asian female patients. Furthermore, the limited availability of treatment options specifically targeting androgens has led to the use of oral diuretics such as spironolactone or oral contraceptives. However, Korean patients have expressed a preference for alternative options due to the systemic effects of these treatments, resulting in unmet demand. With this license agreement, Hyundai Pharm aims to address this unmet medical need by offering a new treatment option for both male and female acne patients in South Korea. Based on data from the HIRA (Health Insurance Review and Assessment Service), a government agency responsible for reviewing, assessing, and pricing healthcare services covered by the National Health Insurance system, the number of acne patients in Korea in 2021 was reported as 109,684, indicating a market growth of 2.4% over the past five years. Diana Harbort, President of Cosmo’s Dermatology Division, said: “We are very pleased to partner with Hyundai Pharm. Their strong expertise in Korea gives us great confidence in their ability to gain regulatory approval and commercialize Winlevi®. The success of Winlevi® in the US has given us the opportunity to select the best partners in each region and to eventually make the product available to more patients around the globe”. SangJoon Lee, Chief Executive Officer of Hyundai Pharm, said “We are delighted to establish a strategic partnership through the licensing agreement with Cosmo and its subsidiary, Cassiopea. We have always been committed to finding new opportunities to enhance the quality of life for Korean patients. We have no doubt that the innovative new drug, Winlevi®, which has already demonstrated its value in the U.S. market, will strongly contribute to improving the quality of life for acne patients in Korea”.
About Cosmo
Disclaimer Contacts: Cosmo Hyundai Pharm
End of Media Release |
Language: | English |
Company: | Cosmo Pharmaceuticals N.V. |
Riverside 2, Sir John Rogerson’s | |
Dublin 2 Dublin | |
Ireland | |
Phone: | + 353 1 817 0370 |
E-mail: | [email protected] |
Internet: | https://www.cosmopharma.com/ |
ISIN: | NL0011832936 |
Listed: | SIX Swiss Exchange |
EQS News ID: | 1662715 |
End of News | EQS News Service |
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1662715 22.06.2023 GMT/BST