Cosmo unveils new product addressing major unmet need in colonos

Cosmo unveils new product addressing major unmet need in colonoscopies  targeted for launch in early 2015  Lainate, Italy - June 3, 2014 - Cosmo Pharmaceuticals S.p.A. (SIX: COPN) today presents its new product SIC 8000 at the Jefferies Global Health Care Conference in New York.  SIC stands for Submucosal Injectable Composition and allows an easier and faster removal of polyps/adenomas/early cancers during colonoscopies.  Colon Cancer is one of the four most frequent cancers in the world. It is believed that all colon cancers were previously polyps which then mutate to adenomas and subsequently full cancer. Of all cancers, colon cancer can be most reduced by early diagnosis, if polyps are detected and removed early on.  During colonoscopy, endoscopists strive to identify all polyps and remove those potentially dangerous. Removal of polyps can be challenging, especially if the polyp is flat or positioned in difficult areas. Endoscopists have therefore constantly been looking for a device that would lift the polyp, making its removal easier and thus reducing the risk of colon perforation.  SIC 8000 is injected during colonoscopy under the polyp. It creates a lasting cushion elevating the polyp thus separating it from the underlying colonic wall. In order to allow better recognition of tissues and polyp margins and diminish colon perforation risk SIC 8000 is additionally dyed with Methylene Blue MMX®.  SIC 8000 is classified as a medical device with a very short regulatory approval path. Cosmo expects therefore to be able to launch this product in North America and the EU in H1 2015.  Currently, no FDA-approved products are available for such purpose. Cosmo believes that the availability of a new, long-lasting, FDA-approved product will cover a significant unmet need, greatly improving effectiveness and safety of polyp removal.  Approximately, 32 million colonoscopies are performed every year in the USA & EU. Polyps/adenomas/cancerous lesions are found in approximately 20% of all colonoscopies and up to 35% of these lesions may require removal with a sub-mucosal injectable composition.  Alessandro Della Chà, CEO, commented: "Cosmo works hand-in-hand with some of the leading KOLs in endoscopy and together we specifically target unmet needs. This is why I believe SIC 8000 will be warmly welcomed by endoscopists, as it will make their life easier. I also see the opportunity of the combination between Methylene Blue MMX® and SIC 8000. Cosmo will help: on one hand, to identify precancerous lesions with Methylene Blue MMX®; on the other hand, to remove them with SIC 8000. This should greatly assist endoscopists in their quest for colon cancer reduction at the lowest possible cost. I am proud that all this has been developed in-house".  The presentation is available for download at:  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 and topically treated Skin Disorders. 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 is developing a diagnostic for the detection of colon cancer and a medical device for polyp excision as well as a new chemical entity for the topical skin treatment. 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 Salix and in the Rest of the World except for Japan 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:  Next events  Half-year results 2014 30 July 2014  Contact  Dr. Chris Tanner, CFO and Head of Investor Relations  Cosmo Pharmaceuticals S.p.A.  Tel: +39 02 9333 7614  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.  Press Release (PDF)  Provider                  Channel         Contact Tensid Ltd., Switzerland      Provider/Channel related enquiries                                              +41 41 763 00 50  
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