Press Releases & Company News

Cosmo improves Licensing Agreement with Giuliani for LIALDA™ MMX™

Lainate, Italy – June 6, 2007 – Cosmo Pharmaceuticals SpA (SWX: COPN), the specialty pharma company that aims to become a global leader in optimised therapies for certain gastrointestinal diseases, announced today that it had come to an agreement with Giuliani SpA and Lehner SA to amend the terms of the license agreements of 2001 for LIALDA™/MEZAVANT™. The agreement had foreseen a cap of $67.5 million on cumulative royalty payments for sales in the US, Europe and Latin America from Giuliani to Cosmo Pharmaceuticals SpA and had foreseen an exchange rate adjustment clause. The new agreement eliminates the exchange rate adjustment clause and raises the cap for all royalties due and payable from sales in Japan to $15 million and for sales in the rest of the world to $80 million, raising the total to $95 million.

Shire plc, which has the sublicense from Giuliani/Lehner, launched LIALDA™ in the U.S. on March 19, 2007.  The European launch of MEZAVANT™ is scheduled shortly.  LIALDA™/MEZAVANT™ is the first and only FDA-approved once-daily oral formulation of mesalamine.  Mesalamines are a part of a drug class called aminosalicylates, which contain 5-aminosalicyclic acid (5-ASA), a well-established drug of choice and often a first-line treatment for patients with mild to moderate ulcerative colitis.

In 2006, the FDA also approved Cosmo’s new, highly automated plant built for the production of LIALDA™ for the US market.  Cosmo has entered into a manufacturing agreement with Shire plc as well as with Giuliani.

Commenting on today’s announcement, Mauro Ajani, CEO of Cosmo, said: “This new agreement is a testimony to the longstanding and excellent relationship between Giuliani and Cosmo.  The agreement improves our dollar based royalty income substantially and the foreign exchange risk is manageable due to the increased dollar requirements we will have in the future.”

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For more information please contact:

Cosmo Pharmaceuticals                                      Financial Dynamics
Dr. Chris Tanner, CFO and Head of IR                  Julia Phillips/Emma Thompson
Tel: +39 02 9333 7614                                          Tel:  +44 (0)207 831 3113
 

Notes to Editors:

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.

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 most advanced development product 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. Cosmo is listed on SWX Swiss Exchange. 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.

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.