FDA agrees with Cosmo's proposed design of phase III trial for Methylene Blue MMX Lainate, Italy - June 14, 2013 - Cosmo Pharmaceuticals, (SIX:COPN), announced today that the US Food and Drug Administration (FDA) agrees that the design and planned analysis of the study proposed by Cosmo adequately address the objectives necessary to support a regulatory submission for Marketing authorization of the product. The FDA based its review on the clinical documentation including the protocol titled "The Safety and Efficacy of Methylene Blue MMX® modified release tablets administered to subjects undergoing screening or surveillance colonoscopy" submitted by Cosmo in a request for a special protocol assessment (SPA). "Methylene Blue MMX intends to improve adenoma and polyp detection rates in the more than 30 million colonoscopies that are performed every year. Though it is a very large market, no drugs are currently available for this. We are now very pleased that the FDA has agreed to our clinical trial design," said Mauro Ajani, Chairman and CEO of Cosmo Pharmaceuticals. Cosmo is now completing the preparations for the phase III clinical trial. EMA has previously approved the access to the centralized procedure for the future Marketing Authorization. The trial will be conducted in major North American and European hospitals. About Methylene Blue MMX® CB-17-01, i.e. Methylene Blue MMX® tablet, is an oral colon-release formulation, in the form of coated tablets. The tablets are formulated using a patented multimatrix technology, MMX®, that allows the active ingredient to be spread directly on the whole colonic mucosa. With this technology, the selected local availability of the active ingredient and, consequently, the staining and contrasting effect are optimized. Methylene blue is a vital dye that has the interesting property to stain the specialized columnar epithelium of the intestine. Methylene blue has been used with other technologies to screen for colonic neoplasia, to diagnose villous atrophy and to screen for areas of dysplastic and neoplastic cells. About Colon Cancer Diagnosis The American Cancer Society currently states that, because there is a lack of effective diagnostic tools, fewer than 10% of persons with colon cancer are diagnosed at the early stage I when patients have a higher likelihood of cure. The American Cancer Society currently recommends that a flexible sigmoidoscopy should be done every 5 years or a full colonoscopy every 10 years to detect lesions and polyps at a precancerous or early cancer stage. Good practice requires that suspicious polyps and adenomas are excised during colonoscopy. It is estimated that around 30 million colonoscopies are performed every year in the 7 major markets. Optical magnification endoscopy and chromendoscopy have gained renewed interest as means for the early detection of minute lesions in patients referred for colonic cancer screening. Chromoendoscopy is a technique in which different dyes are topically applied to the gastrointestinal mucosa during endoscopy in order to better characterise and highlight specific changes in the mucosa. This staining method allows visualization of certain mucosal features that would otherwise not be evident and, thus, improves the accuracy of the endoscopic examination. About Cosmo Pharmaceuticals Cosmo is a speciality 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 colonic inflammatory and infective diseases. In addition, the Company is developing a diagnostic for the detection of colon cancer and a new chemical entity in the dermatogical area for the topical treatment of Acne, Alopecia and Hirsutism. Cosmo's first product in the market is Lialda®/Mezavant®/Mesavancol®, a treatment for mild to moderate Ulcerative Colitis that is licensed globally to Giuliani and Shire. Cosmo's second product is Uceris(TM)/Cortiment(TM), a steroid without the typical side effects of systemic steroids, that is indicated for Ulcerative Colitis patients and is licensed globally to Santarus and 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 lower part of intestines. For further information on Cosmo, please visit the Company's website: www.cosmopharma.com Contact: Cosmo Pharmaceuticals S.p.A. Dr. Chris Tanner, CFO and Head of Investor Relations Tel: +39 02 9333 7614 email@example.com 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. Media Release (PDF) Provider Channel Contact Tensid Ltd., Switzerland newsbox.ch Provider/Channel related enquiries www.tensid.ch www.newsbox.ch firstname.lastname@example.org +41 41 763 00 50
FDA agrees with Cosmo's proposed design of phase III trial for M
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