Cosmo announces European approval of Qolotag® for sigmoidoscopies in IBD patients

Dublin – July 26, 2017 – Cosmo Pharmaceuticals N.V. (SIX: COPN) today announced that its medical device Qolotag® has been granted the CE mark and the approval for marketing in the EU.

Qolotag® is a liquid, blue coloured emulsion developed by Cosmo as an enema formulation to be used for the mechanical cleansing, and simultaneous staining, of the sigmoid colon and rectal mucosa to aid visualization of the structure and mucosal lesions by the endoscopist during flexible sigmoidoscopy evaluation. The product is a single packaged, ready to use enema formulation based on a Cosmo proprietary technology, and exerts a double action: it softens the faeces, allowing an easy bowel emptying and cleaning prior to the endoscopy, and meanwhile adheres to the mucosal walls, maximising the contact time between the dye (methylene blue) and the mucosa, for an improved staining. These product features allow for a faster and better enhancement of the detection of eventual small lesions or dysplasias.

Long-term IBD patients generally are monitored with endoscopic system for evaluating the activity of the disease and for dysplasia detection.

Cosmo intends to license Qolotag® for the EU and is currently assessing the regulatory pathway for an approval in the USA.

Alessandro Della Chà, CEO of Cosmo, commented: “This product was developed following a specific request by the gastroenterologists, to enable them an in-depth assessment of dysplasia in Inflammatory Bowel Disease patients, who do not wish to pursue the more expensive, invasive and cumbersome procedure of a colonoscopy. Qolotag®, the second innovative medical device product after Eleview® entirely developed by Cosmo to support the endoscopy line, will help to further expand our approved product offering within our gastrointestinal franchise to provide innovative solutions on unmet medical needs”.

About Cosmo Pharmaceuticals
Cosmo is a specialty pharmaceutical company that aims to become a global leader in the field of optimized therapies for selected Gastrointestinal Disorders and Endoscopic Procedures. The Company’s proprietary clinical development pipeline specifically addresses innovative treatments for IBD, such as Ulcerative Colitis and Crohn’s Disease, and Colon Infections. In addition, the Company has developed a medical device for polyp and adenoma excision and is has completed clinical trials of LuMeBlue™, a diagnostic drug for the detection of colon cancer as well as new chemical entities that are being developed by the associate company Cassiopea S.p.A. for the topical treatment of skin diseases. Cosmo’s MMX® products that have reached the market are Lialda®/Mezavant®/Mesavancol®, a treatment for IBD that is licensed globally to Giuliani and Shire Limited and Uceris®, the first glucocorticosteroid indicated for the induction of remission in active, mild to moderate Ulcerative Colitis, licensed in US to Santarus/Salix/Valeant and in the Rest of the World to Ferring as Cortiment®. Cosmo’s proprietary MMX® technology is at the core of the Company’s product pipeline and was developed from its expertise in formulating and manufacturing gastrointestinal drugs for international clients at its GMP (Good Manufacturing Practice) facilities in Lainate, Italy. The technology is designed to deliver active ingredients in a targeted manner in the colon. For further information on Cosmo, please visit the Company’s website:[1]

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John Manieri, Head of Investor Relations

Cosmo Pharmaceuticals N.V.                                  

Tel: +353 (1) 8170 370




Some of the information contained in this press release contains forward-looking statements. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those in the forward-looking statements as a result of various factors. Cosmo undertakes no obligation to publicly update or revise any forward-looking statements.


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