Press Releases & Company News

MEZAVANT XL™ launched in the UK

Lainate, Italy – November 20, 2007 – Cosmo Pharmaceuticals, (SWX:COPN) a specialty pharma company that aims to become a global leader in optimised therapies for certain gastro intestinal (GI) diseases, announced today that Shire has launched its Mesalamine (5-ASA) MMX™, which it has licensed globally to Giuliani and Shire, under the brand name of Mezavant XL™ in the UK. UK is the first European country following the launch of the drug under the brand name LIALDA™ in the U.S. in March this year. Mezavant XL™ is indicated for the induction and maintenance of remission in patients with active, mild to moderate ulcerative colitis. Mezavant XL™ is the first and only EU approved once-daily oral formulation of mesalamine 5-aminosalicyclic acid (5-ASA), a first-line treatment for patients with mild to moderate ulcerative colitis.

Cosmo invented the formulation (the active pharmaceutical ingredient mesalazine is off-patent) and licensed it to Giuliani in 2001 who licensed it further on to Shire Pharmaceuticals in 2002. Shire has licensed from Giuliani S.p.A. the exclusive rights to develop and commercialize MEZAVANT™ (Europe) respectively LIALDA™ (U.S. and Canada and the Pacific Rim). Giuliani S.p.A retains the development and commercialization rights in Italy and Latin America.

Mauro Ajani, CEO of Cosmo, stated, “The launch of Mezavant XL™ in the largest EU market is excellent news for Cosmo Pharmaceuticals, our partners Shire and Giuliani and for ulcerative colitis patients in the UK. We now look forward to the launch and availability of the product in the rest of the EU”. 

About Ulcerative Colitis
Ulcerative colitis is a type of inflammatory bowel disease (IBD) that produces inflammation and ulcers along the inside of the large intestine. The inflammation can interfere with the normal function of the colon, often causing cramping, bloating, diarrhoea, bleeding, fatigue, weight loss and frequent bowel movements which strongly affect the quality of life. It is believed that as many as 2.2 million people in Europe have IBD. Ulcerative colitis is a chronic relapsing-remitting illness for which there is no known cure. Patients can manage their symptoms. A known issue that arises with ulcerative colitis patients is medication compliance and excessive pill burden: many currently available ulcerative colitis treatments require multiple pills to be taken several times daily, and often involve inconvenient means of administration.

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 ulcerative colitis and Crohn’s disease, and colon infections. Cosmo’s first product is LIALDA™ / MEZAVANT™ 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

About Shire plc
Shire’s strategic goal is to become the leading specialty pharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit and hyperactivity disorder (ADHD), human genetic therapies (HGT), gastrointestinal and renal diseases. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire believes that a carefully selected portfolio of products with a strategically aligned and relatively small-scale sales force will deliver strong results.

Shire’s focused strategy is to develop and market products for specialty physicians. Shire’s in-licensing, merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe.
For further information on Shire, please visit the Company’s website: www.shire.com.

About Giuliani S.p.A
Giuliani S.p.A., founded in 1889, is a privately owned specialty pharmaceutical company strategically focused in gastroenterology and dermatology. It is currently marketing proprietary products for the treatment and management of ulcerative colitis, Crohn’s disease, food intolerances and dermatological disorders. Giuliani’s R&D pipeline includes new chemical entities and biotechnological products targeted to treat inflammatory and autoimmune diseases.

For more information please contact:
Dr. Chris Tanner, CFO and Head of Investor Relations
Cosmo Pharmaceuticals   
Tel: +39 02 9333 7614

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