Cosmo announces excellent phase II results for Methylene Blue MMX® in colon cancer diagnosis

Lainate, Italy – October 22, 2012 – Cosmo Pharmaceuticals, (SIX:COPN), announced today that its phase II clinical trials program for the evaluation of the polyp and adenoma detection rate in patients undergoing full colonoscopy after colonic staining with Methylene Blue MMX® tablets attained all the objectives and has generated the information required to complete the design of the phase III clinical trials.

In the tested patient population (n=96) the polyp detection rate in the whole colon was on average 1.8 polyps per patient and the adenoma detection rate was 0.9 detected adenomas per patient. Polyps were detected in 63.5% of patients, adenomas in 46.9% and serrated lesions in 27.1% of patients. According to literature, polyps are normally detected in 35% or less of patients, and according to an abstract published in 2012 by the Department of Colorectal Surgery, Digestive Disease Institute, Cleveland Clinic in Ohio USA, based on 18’003 colonoscopies, the adenoma detection was 31.5% and the serrated lesions detection rate was 20.6%

Patients took Methylene Blue MMX® tablets together with a bowel cleansing preparation. There were no drug related adverse events.

“In the 7 major markets around 500’000 persons get diagnosed with colon cancer every year. Around 150’000 persons die of the disease. The results attained in our phase II clinical study reinforce our belief that we will be able to help substantially reduce colon cancer by the early detection of a higher number of its precursors (polyps and adenomas),” said Mauro Ajani, Chairman and CEO of Cosmo Pharmaceuticals.

Alessandro Repici, the Head of Endoscopy Dept. at Istituto Clinico Humanitas, where the studies were performed said: “If the excellent results we saw in this clinical trial are confirmed in the phase III trials then I am convinced that besides me, most of my colleagues on a worldwide basis will be prescribing Methylene Blue MMX® tablets to all their patients.”

Cosmo is completing the preparations for the phase III trials. In the EU EMA has approved the access to the centralized procedure for the future Marketing Authori-zation; in the US, a Special Protocol Assessment (SPA) was requested from the FDA and an IND will follow. Barring unforeseen events, the phase III trials should end no later than H2 2013. Approximately 1500 patients will be screened, the majority of these are classical colon cancer screening patients but the clinical trials program will also include patients diagnosed with active ulcerative colitis for more than 8 years. Longstanding ulcerative colitis patients, have a higher risk of contracting colorectal cancer. The trials 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, containing Methylene Blue as manufactured by Prove-pharm. The tablets are formulated using a patented multimatrix technology MMX® that allows the delivery of the active ingredient directly inside the colon. With this technology, the selected local availability of the active ingredient and, consequently, the staining and contrasting effect are optimized and there is no absorption in the upper gastrointestinal tract.

Currently, methylene blue is used in human and veterinary medicine for a number of therapeutic and diagnostic procedures, as an anti-methaemoglobinemic, as an antiseptic and disinfectant. Methylene blue has the interesting property to stain the specialized columnar epithelium of the intestine with high accuracy. Methylene blue has been used to screen for colonic neoplasia, to diagnose villous atrophy and to screen for areas of dysplasia and carcinoma. In the gastrointestinal epithelium the dysplastic epithelium areas and cancers absorb methylene blue in a different way than the normal mucosa. Thus, after staining with methylene blue these abnorma-lities appear as areas of absent or light staining or as a heterogeneous staining pattern against a background of uniformly blue-stained mucosa.

Proveblue®, the substance that is used in CB-17-01, is also used in an injectable medicinal product developed by the Provepharm Company and approved by EMA for use as antidote to treat symptoms of acquired methaemoglobineamia in the EU. Cosmo and Provepharm have entered into an exclusive licensing agreement for Proveblue® that is manufactured under cGMP conditions and is compliant with European and US Pharmacopeias.

About Colon Diagnosis

According to the American Cancer Society, 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 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. 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 IBD, such as Ulcerative Colitis and Crohn’s Disease, and Colon Infections. In addition, the Company is developing a a diagnostic for the detection of colon cancer and a new chemical entity for the topical skin treatment. Cosmo’s first MMX® product that has reached the market is Lialda®/Mezavant®/Mesavancol®, a treatment for IBD that is licensed globally to Giuliani and Shire Limited. 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 intestines. For further information on Cosmo, please visit the Company’s website: www.cosmopharma.com

About Provepharm

Provepharm is a subsidiary of the Provence Technologies Group that is specialized in the development and commercialization of drug products incorporating active pharmaceutical ingredients synthesized and patented by its parent company. With Proveblue® active substance, Provepharm is seeking to confirm methylene blue properties in known indications including life-threatening illnesses and explore its activity in new healthcare fields. For further information on Provepharm, please visit the Company’s website: www.provepharm.com

Contact: Cosmo Pharmaceuticals S.p.A. Dr. Chris Tanner, CFO and Head of Investor Relations Tel: +39 02 9333 7614 ctanner@cosmopharma.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.