Cosmo and InfectoPharm Announce Signing of License and Distribution Agreement for Winlevi® in Germany, Italy and Austria

Ad hoc announcement pursuant to Art. 53 LR

Dublin, Ireland & Heppenheim, Germany – 04 October 2022: Cosmo Pharmaceuticals N.V. (SIX: COPN, XETRA: C43) (“Cosmo”) and InfectoPharm today announced the signing of a License and Distribution Agreement for Winlevi® (clascoterone) cream 1% in Germany, Italy and Austria. 

Under the terms of the agreement, Infectopharm will receive from Cassiopea, a subsidiary of Cosmo, the exclusive right to commercialize Winlevi® in Germany, Italy and Austria. Cosmo is responsible for the centralized procedure before the European Medicines Agency (EMA) aimed at obtaining a single Marketing Authorization for the product in the European Union and will be the exclusive supplier of same product. Cassiopea will receive an upfront payment of Euro 1 million, potential regulatory milestones totaling up to Euro 4.5 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 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. About 11,000 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.  

InfectoPharm is a well-established family-owned German company which operates internationally and enjoys high reputation among physicians, especially pediatricians and dermatologists. With sales of Euro 50 million, the dermatological range is an important pillar of the business. InfectoPharm is an experienced player in the field of acne. With Winlevi® InfectoPharm will complement its acne portfolio. As the first player in the European market, InfectoPharm sees a high potential of Winlevi® to become a game changer in the treatment of acne and thus provides a great benefit for patients.

Diana Harbort, President of Cosmo’s Dermatology Division, said: “We are very pleased to further grow Winlevi® franchise and partner with InfectoPharm, a company with strong expertise in the acne market in the selected countries. We look forward to making Winlevi® available to an ever larger number of patients once EU regulatory approval has been granted. The excellent performance of Winlevi® in the US provides a strong opportunity to expand the business to other geographic territories around the world.” 

Dr. Markus Rudolph, Managing Director of InfectoPharm commented: “We are very happy to partner with Cosmo and to enter a trustful and reliable partnership. Winlevi® with its new mode of action will be a perfect match to complete our acne portfolio. We are sure Winlevi® will be a significant change in the acne therapy and we are proud to introduce this topical acne drug in Europe. We are confident to continue the success story of the US and bring innovation in acne therapy to Europe.”

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®, Uceris®/Cortiment® 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. Cosmo has licensed Aemcolo® to Red Hill Biopharma Ltd. for the US and has licensed Relafalk® to Dr. Falk Gmbh for the EU and other countries. 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 InfectoPharm
InfectoPharm Arzneimittel und Consilium GmbH is Germany’s leading pharmaceutical company, especially for pediatrics and dermatology. For over 30 years, this medium-sized company has distinguished itself as a groundbreaking pioneer in various fields of indications. The portfolio currently comprises around 130 preparations with innovations in the fields of pediatrics, dermatology, infectious diseases, pneumology and allergology. The InfectoPharm Group is engaged in more than 30 international partnerships and is increasingly expanding into non-EU markets. Subsidiaries of the group in Austria and Italy operate with a selected part of the portfolio. The InfectoPharm Group further consists of two strategically matching German subsidiaries. Pädia GmbH offers a distinct pediatric OTC portfolio with about 25 prescription-free pharmaceuticals and Beyvers GmbH in Berlin is an internationally known full service-supplier for pharmaceuticals and cosmetics. The InfectoPharm Group achieves revenues of about Euro 215 million (2021) with an average sale growth of about 15 percent. Please visit https://en.infectopharm.com/ or www.infectopharm.com for additional information.

Contacts:

Cosmo
Hazel Winchester
Head of Investor Relations
Cosmo Pharmaceuticals N.V. 
Tel: +353 1 817 03 70
[email protected]

InfectoPharm
Florence Wiche 
Head of Global Sales & International Business
InfectoPharm Arzneimittel und Consilium GmbH
Tel: +49 6252 7170
[email protected]

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.