The Dutch Regulatory Agency (MEB) reverses decision and approves Cosmo’s Cortiment™ MMX Freitag, 01. Februar 2013 - 06:59
The Dutch Regulatory Agency (MEB) reverses decision and approves Cosmo’s Cortiment™ MMX
Lainate, Italy – February 1, 2013 – Cosmo Pharmaceuticals, (SIX:COPN) announces that it was informed by the Dutch Regulatory Agency (MEB) that the Appeals Committee put in place to review the MEBs decision of August 8, 2012 has now approved Cortiment™ (budesonide with Cosmo’s MMX™ technology), indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis for marketing in the Netherlands.
Mauro Ajani, Chairman and Chief Executive Officer of Cosmo Pharmaceuticals, said: “I am very glad that MEB has come back on its decision. This will pave the way for making available a low risk steroid which fills a critical need of the around 900’000 patients suffering from ulcerative colitis in the EU. Given the complex framework of EU regulations we will now assess the best means to pursue approval for the marketing of Cortiment™ MMX in the other EU member states so that Ferring, our licensee partner can start marketing Cortiment™ MMX as quickly as possible.”
About Ulcerative Colitis
Ulcerative colitis is a form of inflammatory bowel disease (IBD) that produces inflammation and ulcers along the inside of the colon. The inflammation can interfere with the normal function of the colon, often causing cramping, bloating, diarrhea, bleeding, fatigue, weight loss and frequent bowel movements, which may also strongly affect quality of life. It is believed that as many as 0.7 million people in the U.S. and as many as 0.9 million people in the EU have Ulcerative Colitis.
Ulcerative Colitis is a chronic relapsing-remitting illness for which there is no known cure, but with appropriate treatment patients can manage their symptoms. However, it is estimated that up to 30% of patients with mild or moderate ulcerative colitis do not respond to aminosalicylate (5-ASA) drugs and require a different or add on therapy. Patients refractive to treatment with 5-ASA drugs typically receive a course of a systemically absorbed corticosteroid, the success of which may be limited by significant side effects. For moderate to severe cases of ulcerative colitis, immunosuppressant drugs or biologic drugs may be prescribed. If the condition does not respond to pharmaceutical therapy and the symptoms are severe, the patient may be referred for surgery.
About Cosmo Pharmaceuticals
Cosmo is a speciality pharmaceutical company that aims to become a global leader in the field of optimized 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. In addition, the Company is developing a diagnostic for the detection of colon cancer and a new chemical entity for the topical skin treatment. 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 and on January 14, 2013 the FDA approved Uceris™, licensed to Santarus, for the induction of remission in patients with mild to moderate ulcerative colitis. 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. The technology is designed to deliver active ingredients in a targeted manner in the intestines. For further information on Cosmo, please visit the Company’s website: www.cosmopharma.com
About Ferring Pharmaceuticals
Headquartered in Switzerland, Ferring Pharmaceuticals is a research-driven specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology and endocrinology. Ferring has its own operating subsidiaries in more than 50 countries and markets its products in more than 90 countries. To learn more about Ferring or our products please visit www.ferring.com.
Contact: Cosmo Pharmaceuticals S.p.A.
Dr. Chris Tanner, CFO and Head of Investor Relations Tel: +39 02 9333 7614 ctanner@cosmopharma.com
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.