Cosmo's licensee in the US Santarus receives FDA approval of UCERIS(TM) for the induction of remission in patients with active, mild to moderate ulcerative colitis Lainate, Italy - January 15, 2013 - Cosmo Pharmaceuticals, (SIX:COPN) today announced that its licensee in the USA, Santarus (NASDAQ:SNTS) announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for UCERIS(TM) (budesonide) extended release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis. Santarus expects the commercial launch of UCERIS to begin in March 2013. UCERIS(TM) contains budesonide, a corticosteroid, in a novel oral tablet formulation that utilizes proprietary MMX® multi-matrix system colonic delivery technology. The approved dosing regimen for adult patients is one 9 mg tablet taken orally once daily in the morning for up to 8 weeks. UCERIS(TM) was developed in collaboration with Cosmo Technologies Limited, a subsidiary of Cosmo Pharmaceuticals S.p.A. "The FDA approval of UCERIS(TM) provides an important new therapeutic option to patients and physicians for the treatment of active, mild to moderate ulcerative colitis," said William J. Sandborn, M.D., chief, division of Gastroenterology, director, University of California San Diego (UCSD) IBD Center and professor of clinical medicine, UCSD Health System. "Specifically, UCERIS(TM) is indicated for use in the induction of remission of active disease, an acute phase of the disease often characterized by cramping, bloating, diarrhea, bleeding, fatigue, weight loss and frequent bowel movements." Mauro Ajani, Chairman and CEO of Cosmo Pharmaceuticals SpA, the parent of Cosmo Technologies Ltd said: "This approval documents the versatility of the MMX technology for colonic applications. Uceris(TM) is the only corticosteroid approved for treatment of patients with active mild to moderate ulcerative colitis in the USA. We are very pleased to have contributed to US patients' now having an important treatment option". 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. 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 Contact: Cosmo Pharmaceuticals S.p.A. Dr. Chris Tanner, CFO and Head of Investor Relations Tel: +39 02 9333 7614 email@example.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. Press release (PDF) Provider Channel Contact Tensid Ltd., Switzerland newsbox.ch Provider/Channel related enquiries www.tensid.ch www.newsbox.ch firstname.lastname@example.org +41 41 763 00 50
Cosmo's licensee Santarus receives FDA approval of UCERIS(TM)
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