Cosmo announces Cortiment® approval in Japan

Dublin, Ireland 28 June 2023: COSMO Pharmaceuticals N.V. (SIX: COPN, XETRA: C43) (Cosmo) today announced that its partner Ferring Pharmaceuticals (Ferring) has received the approval for Cortiment® (budesonide 9 mg MMX tablets) in Japan by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). First sales of Cortiment® in Japan are expected to begin by end of Q3 2023.

Cortiment® is used to help get active, mild to moderate Ulcerative Colitis (UC) under control (induce remission) and may help relieve its symptoms. UC is a form of inflammatory bowel disease (IBD) that produces inflammation and ulcers along the inside of the colon. The inflammation interferes with the normal function of the colon, often causing cramping, bloating, diarrhoea, bleeding, fatigue, weight loss and frequent bowel movements, which may also strongly affect quality of life. According to recent data, the prevalence of UC in Japan is estimated to be 0,1-0,2% of the overall population, making it one of the largest IBD markets in the world.

Cortiment® contains budesonide, a corticosteroid that has mainly topical anti-inflammatory activity with low systemic effects. It is a once-daily, oral extended-release tablet formulation containing 9 mg of budesonide per tablet, available only on prescription. Cortiment® utilizes Cosmos MMX® multi-matrix technology and is designed to precisely deliver the active substance in the target organ (the colon) and to release and distribute it in a controlled fashion throughout the length of the colon.

Cortiment® has been developed by Cosmo and is globally distributed by Ferring, with the exception of the US, where it is distributed by Bausch.

Alessandro Della Chà, CEO of Cosmo Pharmaceuticals, comments: We are very pleased with the new success our partner Ferring Pharmaceuticals has achieved with Cortiment®. Now Cortiment® is approved in 81 countries and filed in 3 additional countries, making it a real worldwide franchise for the benefit of the patients.

About Cosmo
Cosmo is a pharmaceutical company focused on developing and commercializing 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 www.cosmopharma.com.

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.

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