Cosmo and Hyphens Announce Signing of License and Supply Agreements for Winlevi® in Southeast Asia
Ad hoc announcement pursuant to Art. 53 LR
Dublin, Ireland & Singapore – 21 December 2022: Cosmo Pharmaceuticals N.V. (SIX: COPN, XETRA: C43) (“Cosmo”) and Hyphens Pharma International Limited (SGX: 1J5) (“Hyphens”) today announced the signing of License and Supply Agreements for Winlevi® (clascoterone) cream 1% in Southeast Asia.
Under the terms of the agreements, Hyphens Pharma Pte. Ltd., a subsidiary of Hyphens, will receive from Cassiopea, a subsidiary of Cosmo, the exclusive right to develop and commercialize Winlevi® in Singapore, Indonesia, Malaysia, the Philippines, Vietnam, Thailand, Brunei, Cambodia, Laos and Myanmar. Cosmo will be the exclusive supplier of the product. Cassiopea will receive an upfront payment of US$1 million, potential regulatory and sales milestones totaling up to US$4 million 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 12,000 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.
Hyphens is Singapore’s leading specialty pharmaceutical and consumer healthcare group with a diverse footprint in Southeast Asia. Dermatology is a strategic therapeutic area for Hyphens. Today, Hyphens has a proprietary range of dermatological products for acne, atopic dermatitis, hyperpigmentation, and hair loss. These are available through doctors including dermatologists, pediatricians and general practitioners as well as major retail pharmacies.
In a study involving 3,888 Singapore Chinese subjects, the estimated prevalence of acne vulgaris is 53.8%. Acne can have profound social and psychological effects on adolescents or young adults when these affect their self-esteem. As the first novel acne drug in decades, Winlevi® has huge potential to revolutionize the acne treatment space.
Diana Harbort, President of Cosmo’s Dermatology Division, said: “We are very pleased to partner with Hyphens. Their strong expertise in Southeast Asia gives us great confidence in their ability to gain regulatory approval and commercialize Winlevi® in the region. 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.”
Lim See Wah, Executive Chairman and CEO of Hyphens Pharma, said: “Hyphens is very pleased to partner with Cosmo in this deal. We are delighted to be granted the exclusive right to commercialize Winlevi® in 10 countries across Southeast Asia. As a region of more than 600 million people with millions of them afflicted by Acne, Winlevi® will bring new hope to doctors and patients alike.”
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 Hyphens Pharma International Limited
Hyphens Pharma International Limited and its subsidiaries (the “Group”) is Singapore’s leading specialty pharmaceutical and consumer healthcare group, leveraging on its diverse footprint in ASEAN countries. The Group has a direct presence in Singapore, Vietnam, Malaysia, Indonesia and the Philippines, and is supplemented by a marketing and distribution network covering 10 other markets – Bangladesh, Brunei, Cambodia, China, Hong Kong S.A.R., Macau S.A.R., Myanmar, Oman, South Korea and Sri Lanka. Singapore is the Group’s regional headquarters, where its strategic planning, finance, regulatory affairs, research and development, legal, business development and logistics operations are based. The Group’s core business comprises the following segments: Specialty Pharma Principals, Proprietary Brands, and Medical Hypermart & Digital. Besides marketing and selling a range of specialty pharmaceutical products in selected ASEAN countries through exclusive distributorship or licensing and supply agreements with brand principals mainly from Europe and the United States, the Group also develops, markets and sells its own proprietary range of dermatological products and health supplement products. In addition, the Group operates a medical hypermart for healthcare professionals, healthcare institutions and retail pharmacies, to supply pharmaceutical products and medical supplies and an online pharmacy for doctors to prescribe and have medications delivered to their patients’ homes. www.hyphensgroup.com
Upcoming Calendar of Events
Preliminary 2022 Results February 16, 2023
2023 Credit Suisse London Healthcare Conference March 1, 2023
Full Year Results 2022 March 23, 2023
Annual General Meeting 2023 May 26, 2023
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.
Head of Investor Relations
Cosmo Pharmaceuticals N.V.
Tel: +353 1 817 03 70
Mr Derek Chng / Mr Gerald Woon
Cogent Media Pte. Ltd.
Tel (DID; Mobile): +65 6704 9285 ; +65 9638 8635 / +65 6704 9268 ; +65 9694 8364
 Heng AHS et al. Epidemiological Risk Factors Associated with Acne Vulgaris Presentation, Severity, and Scarring in a Singapore Chinese Population: A Cross-Sectional Study. Dermatology. 2022;238(2):226-235.
 Moosa AS et al. Primary care approach to managing acne. Singapore Med J. 2021 Nov;62(11):568-573.