Press Releases & Company News

Cosmo’s Rifamycin SV MMX™ meets clinical endpoints in Phase II trial for infectious diarrhoea

Phase II trial for Clostridium Difficile to commence in Europe

Lainate, Italy – November 29, 2007 – Cosmo Pharmaceuticals SpA (SWX:COPN), announced today that according to the final data report released by an independent clinical research organisation Rifamycin SV MMX™ has achieved its clinical end point of non inferiority vs Normix®, in a Phase II trial for the treatment of infectious diarrhoea. The two treatments did not differ in terms of rate and frequency of therapeutic success and Rifamycin SV MMX™ was found to be as safe and tolerable as Normix®. On the basis of these results, the Company is proceeding with preparations for Phase III trials and expects to treat the first patients in H208.

Cosmo also announced that Minimal Inhibitory Concentration (MIC) analyses conducted by the Company and independent labs have demonstrated Rifamycin SV MMX™ to be substantially more effective than vancomycin and metronidazole, the two main drugs that are currently standard treatment for Clostridium Difficile Associated Diarrhoea (CDAD). On the basis of these results, Cosmo will now initiate a Phase II dose finding study against CDAD in Europe.

In MIC analyses a series of drugs are tested against each other by testing the minimal concentration required by each drug to inhibit bacterial growth. In the tests carried out both standard cultured bacteria strains and patient isolated bacteria strains were used.

CDAD is a serious illness caused by infection of the lining of the colon by clostridium difficile bacteria. The illness is caused by various toxins that are produced by the clostridium difficile and results in infection, diarrhoea and, in serious cases, death of the patient. CDAD is most frequently acquired by elderly persons in hospital and nursing home settings taking broad spectrum antibiotics. Treatment includes discontinuing the offending drug and switching to specific oral antibiotics such as metronidazole or vancomycin. In the US 500,000 patients are estimated to be affected every year. This results in longer hospital stays and increases patient costs by $3,600 to $10,000 (in severe cases) per patient. In Europe the estimated cost of treating the disease is approximately $3.8 billion p.a.

Mauro Ajani, CEO of Cosmo Pharmaceuticals, commented: “We are very encouraged by the CDAD MIC announced today. CDAD is considered to be a nosocomial (hospital acquired) infection that has caused major damage in the US, the UK and Germany and we consider it highly unlikely that this condition is contained to these territories. Additionally, the spread of CDAD from hospitals to nursing homes appears to be an increasing problem, making it even more dangerous. We have known for quite some time that Rifamycin SV MMX™ has far fewer side effects than vancomycin and metronidazole because, when taken as a tablet, Rifamycin SV MMX™ is not absorbed into the systemic circulation. Furthermore, through the use of our MMX™ technology, the saprophytic bacterial flora in the gastro intestinal tract that is important for vitamin synthesis is not sterilized. It is now our objective to confirm these lab results in our own clinical trials and to bring the product to the market as quickly as possible”.

About Cosmo Pharmaceuticals
Cosmo is a speciality pharmaceutical 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 ulcerative colitis and Crohn’s disease, and colon infections. Cosmo’s first MMX™ product that has reached the market is LIALDA™ / MEZAVANT™, a treatment for IBD that is licensed globally to Giuliani and Shire Pharmaceuticals. 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. For further information on Cosmo, please visit the Company’s website: www.cosmopharmaceuticals.com

Contact:
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.

Most computers will open PDF documents automatically, but you may need to download Adobe Reader.