2012 R&D Day: Cosmo updates investors and analysts on progress and new developments in its R&D pipeline in Lainate

- First time data on colon cancer diagnostic
- Clinical development plan for its topical acne and alopecia product
- Update of approval process time line of Cortiment® and Uceris®  

LAINATE – January 19, 2012. Cosmo Pharmaceuticals S.p.A. (SIX: COPN) will present to its shareholders, analysts and the financial press a comprehensive update on its clinical pipeline and its commercial implications at its R&D day to be held today at its headquarters in Lainate starting at 11:00 CET.

Highlights will include:
Presentation of first results of phase I and phase II clinical studies for its new colon cancer diagnostic Methylene Blue MMX. CSO Dr. Luigi Moro will present first data from the phase I and phase II trials. Prof Dr. Alessandro Repici of Humanitas Hospital in Milano will present his experience of conducting colon cancer diagnosis with the Methylene Blue MMX tablet. CEO Mauro Ajani will explain the business case and describe the time line to market.
The IND for CB-03-01 for acne will be filed in the next weeks-. CSO Dr. Luigi Moro will inform about the well advanced pre-clinical work, the clinical trial design and the prospective time line for acne and alopecia.
The MAA for Cortiment was filed in the EU in May 2011, and the NDA for Uceris was filed in the USA in December 2011. CSO Dr. Luigi Moro will inform about the prospective time line and expected market entry of these two products.

Mauro Ajani, CEO of Cosmo Pharmaceuticals, said, “Currently we have one important product in the market, Lialda®, and we are profitable. If things go well three new products will enter the market in the next 24 months. These would change the face of the Company totally. We are particularly enthusiastic about the Methylene Blue MMX project. Given its potential at substantially improving early colon cancer detection, interest and support from leading gastroenterologists has been very high. A colonoscopy takes less than an hour and more than 25 million colonoscopies are performed in the USA and EU every year. Clinical trials can thus be conducted so quickly that we believe that we can develop the product and could be in the market in about 24 months. Additionally we will inform about our new topical steroidal anti androgen acne and alopecia project where we believe that the new confirmatory findings in preclinical studies convincingly eliminate the common fears associated with anti androgens and steroids.”


Overview new disclosure:
First time discussion of clinical trial results of Cosmo’s new diagnostic colon cancer and its financial prospects.

The R&D day is expected to end around 16:00 CET.


Presentation online available on http://www.cosmopharmaceuticals.com/ir/presentations.aspx


About Cosmo Pharmaceuticals

Cosmo is a speciality pharmaceutical company that aims to become a global leader in optimised 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. 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 its 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. More information about Cosmo is available on the company’s website at www.cosmopharma.com.