-- Primary endpoint achieved --
LAINATE, Italy - July 4, 2007 - Cosmo Pharmaceuticals SpA (SWX:COPN) announced today positive preliminary results from its phase II/III study with CB-01-11 (Rifamycin SV MMX(tm)) in infectious diarrhoea. CB-01-11 is a broad spectrum, semi-synthetic antibiotic that is not absorbed when taken in tablet form. Through the use of Cosmo's MMX(tm) technology, which delivers the active ingredient into the colon, bacteria in the gastro intestinal tract that are important for vitamin synthesis are not sterilized. Given that it is practically not absorbed CB-01-11 is potentially applicable for the treatment of long term infections in the colon.
In the placebo controlled, randomized, double blind trial 120 patients in 8 sites in South Africa were treated with a 200mg tablet, 4 times per day for 3 days. The trial assessed non-inferiority versus Normix® (rifaximin) and the primary endpoint was the time from first ingestion of tablet to the last unformed stool. According to the preliminary reports CB-01-11 met this primary endpoint.
Mauro Ajani, CEO of Cosmo Pharmaceuticals, commented: "We are very encouraged about these preliminary results since many of the needs of patients are not adequately met with products currently on the market. Infections of the colon affect many more persons than colon inflammations and this is consequently a substantially larger market. We believe that our proprietary MMX(tm) technology will enable us to improve a range of products in colon infections and thus better meet patients' requirements."
Further analysis of the data is ongoing.
About Cosmo Pharmaceuticals
Cosmo is a speciality pharma company that aims to become a global leader in optimised therapies for certain gastrointestinal diseases. The company's proprietary clinical development pipeline specifically addresses innovative treatments for IBD, such as ulce rative colitis and Crohn's disease, and colon infections. Cosmo's first MMX(tm) product that has reached the market is LIALDA(tm) / MEZAVANT(tm), a treatment for IBD that is licensed globally to Giuliani and Shire Pharmaceuticals. Cosmo's proprietary MMX(tm) 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. For further information on Cosmo, please visit the Company's website: www.cosmopharmaceuticals.com
Dr. Chris Tanner, CFO and Head of Investor Relations
Cosmo Pharmaceuticals SpA
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.
Claire Rowell Manager Financial Communications
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