Eyes On the Prize: From Sicilian Roots to FDA Approval
Historically, SIFI has been a modest local player focused on ophthalmic products, but in recent years the company has set some ambitious goals for itself—becoming a leading force in European…
Address: Via C. Colombo 1, I – 20020 Lainate,Italy
Tel: +39 02 9333 7614
Web: http://www.cosmopharmaceuticals.com/
Cosmo is a specialty pharmaceutical company that aims to become a global leader in the market of optimized therapies for selected gastro-intestinal diseases. The company’s proprietary clinical development pipeline specifically addresses innovative treatments for the gastro-intestinal tract, specifically Inflammatory Bowel Diseases (IBD), colon infections and colon diagnosis, as well as selected topically treated Skin Disorders.
Cosmo’s lead product Lialda®, the first product based on MultiMatrix Technology (‘MMX®’), was launched into the US market by Shire Pharmaceuticals plc on 19 March 2007. Another product, a nutraceutical, Zacol NMX®, is marketed in Italy and selected Eastern European countries. In addition the company has five pharmaceutical product candidates for the colon: Budesonide MMX® which has successfully completed phase III and has been filed for registration in the EU and US, Rifamycin SV MMX® which is in clinical phase III, LMW Heparin MMX® in phase II, Naloxon MMX®, which is in phase I and Blue Methylene MMX® which is in phase II. These products will address unmet needs in the diagnosis and treatment of colon diseases. This market is expected to grow, primarily because old and less effective products will be replaced by more effective ones. CB-03-01, the first new chemical entity the Company is developing is targeted at the acne, hirsutism and alopecia market and is presently in phase II.
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 gastro-intestinal pharmaceutical products for international clients at its GMP (Good Manufacturing Practice) facilities in Lainate, Italy.
Cosmo has a deep and broad expertise in the development of gastro-intestinal (GI) pharmaceutical products with a specific focus on Inflammatory Bowel Disease, based on the company’s innovative and proprietary MMX® technology. Most recently the Company has extended its expertise to other colon applications and to skin disorders where it is developing a new molecule.
The Company has built a successful and profitable pharmaceutical manufacturing business manufacturing products for international companies and in 2006 trebled its manufacturing capacity by adding a state-of-the-art, FDA-approved plant (for the production of Lialda®/Mezavant®), intended for the manufacturing of its own products.
The company’s proprietary MMX® technology is at the core of the product pipeline and was developed from its expertise in formulating and manufacturing GI pharmaceutical products for international clients. The research led to new patents that increased the efficacy of existing pharmaceutical products by modifying their formulations and tailoring their optimized delivery systems.
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