Dublin, Ireland – 15 June 2016 – Cosmo Pharmaceuticals N.V. (SIX: COPN) announced today that Eleview™ had been granted the CE mark and the approval for marketing in the EU.
Eleview™ is an injectable liquid composition, stained with Methylene Blue, for use as a submucosal injection agent during endoscopic mucosal resection (EMR), endoscopic mucosal dissection (ESD) and polypectomy procedures in the gastrointestinal tract. The device is intended for use in endoscopic procedures in the upper and lower intestinal tract such as the esophagus, the stomach, the small intestine, the colon, the sigmoid colon and the rectum, as a submucosal injectable agent during the removal of polyps, adenomas, early stage cancers, and other pathological lesions by EMR, ESD or polypectomy. Eleview™ is injected by means of a standard commercially available endoscopic injection needle, which is inserted into the working channel of the endoscope. The agent, when injected, creates a cushion in situ by lifting the gastrointestinal mucosa from the submucosal layer, allowing the endoscopist to perform an easy and safe resection procedure. The staining allows a better distinction of the tissues that need to be extracted.
Alessandro Della Chà, CEO of Cosmo Pharmaceuticals, commented: “Another long wait worth waiting for since Eleview™ was approved for marketing in the USA last September. Now that we have the European approval endoscopists in the EU and USA will be able to do their resection procedures safer and faster than before. We now want to make Eleview™ a world franchise and will proceed to discussions with possible marketing partners in Europe and plan our expansion in the rest of the World.”
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 procedures during endoscopy. 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 Eleview™, a medical device for polyp excision, Rifamycin SV MMX® which has completed phase III clinical trials for the treatment of Colon infections and is developing Methylene Blue MMX®, a product for the detection of colon cancer and has a large shareholding in Cassiopea S.p.A., a clinical-stage specialty pharmaceutical company focused on developing and commercializing innovative and differentiated medical dermatology products. Cosmo’s MMX® products that have reached the market are Lialda®/Mezavant®/Mesavancol®, a treatment for Ulcerative Colitis that is licensed globally to Nogra and Shire Limited and Uceris®, the first glucocorticosteroid indicated for the induction of remission in active, mild to moderate Ulcerative Colitis, licensed in the USA to Santarus/Salix/Valeant and in the Rest of the World to Ferring. 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: www.cosmopharma.com
Next events
Half-year results 2016 29 July 2016
Contact
Dr. Chris Tanner, Head of Investor Relations
Cosmo Pharmaceuticals N.V.
Tel: +353 (1) 8170 370
ctanner@cosmopharma.com
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