Cosmo and Hyundai Pharm Announce Signing of License Agreement for Winlevi in Korea

Cosmo Pharmaceuticals N.V. / Key word(s): Agreement Cosmo and Hyundai Pharm Announce Signing of License Agreement for Winlevi in Korea 22.06.2023 / 06:15 GMT/BST 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.