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
Cosmo is a pharmaceutical company focused on developing and commercialising products to treat selected gastrointestinal disorders, to improve endoscopy quality measures through aiding the detection of colonic lesions and to treat selected dermatological conditions. Cosmo develops and manufactures products which are distributed globally by selected partners including Lialda®/Mezavant®/Mesavancol®, Uceris®/Cortiment®, Aemcolo®/ Relafalk® and Winlevi®. Cosmo has also developed medical devices for endoscopy and has a partnership with Medtronic for the global distribution of GI Genius™ which uses artificial intelligence to help detect potential signs of colon cancer. The company also has a rich development pipeline. For additional information on Cosmo and its products please visit the Company’s website: www.cosmopharma.com

About Hyundai Pharm
Hyundai Pharm is a listed pharmaceutical company headquartered in Seoul, South Korea, and has been operating in the pharmaceutical industry for nearly 60 years. Hyundai Pharm has integrated capabilities in drug development, clinical research, regulatory affairs, manufacturing, sales, and marketing. Through global collaborations, Hyundai Pharm has introduced therapeutics in various treatment areas that target hormone mechanisms to the Korean market. The company is engaged in businesses focused on improving the quality of life, including treatments for androgenetic alopecia, menopausal hormone therapy, and other areas.
http://www.hyundaipharm.co.kr/english/index.jsp

Disclaimer
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. 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.

Contacts:

Cosmo
Hazel Winchester
Head of Investor Relations
Cosmo Pharmaceuticals N.V. 
Tel: +353 1 817 03 70
hwinchester@cosmopharma.com

Hyundai Pharm
Chi-yong Kim
Chief Financial Officer
Hyundai Pharmaceutical Co., Ltd.
Tel: +82 2 2600 3860
cykim@hdpharm.co.kr