Saint-Prex, Switzerland, 20 February 2015 – Ferring Pharmaceuticals announced today the European launch of CORTIMENT®MMX® (budesonide), the first and only approved oral controlled release budesonide treatment for active mild-to-moderate ulcerative colitis (UC) where mesalazine (5-ASA) treatment is not sufficient. Simultaneously, new data from the CONTRIBUTE trial showed that adding CORTIMENT®MMX® 9 mg was significantly more effective than placebo at inducing combined clinical and endoscopic remission in patients with ulcerative colitis experiencing a flare up despite oral 5-ASA therapy. The data were presented today at the 10th Congress of the European Crohn’s and Colitis Organisation (ECCO).1
"The data confirm the efficacy and safety of CORTIMENT®MMX® in patients experiencing an active flare of UC despite initial oral 5-ASA therapy, and in a controlled setting that is consistent with clinical practice and the ECCO treatment guidelines,2" said Dr David Rubin, Professor of Medicine at the University of Chicago Medicine and lead CONTRIBUTE author. "CORTIMENT®MMX® is an important new option for treating active mild-to-moderate ulcerative colitis."
Ulcerative colitis, which affects over 2 million people in Europe,3 is a life-long chronic inflammatory condition affecting the colon and rectum. Where treatment with oral 5-ASA is not sufficient to induce remission, patients are currently treated with systemic corticosteroids, which are associated with significant side effects.2 CORTIMENT®MMX® therefore fulfils an unmet need, providing gastroenterologists with an orally administered alternative to systemic corticosteroids with an adverse event profile comparable to placebo.4
A spokesperson for the European Federation of Crohn's and Ulcerative Colitis Associations (EFCCA) said, "Ulcerative colitis can be a difficult condition to manage, particularly during a flare up, with many unpleasant symptoms on a daily basis. There are also significant emotional, societal and economic costs. Any new treatment which can induce remission with fewer side effects will be welcomed by people with ulcerative colitis across Europe and beyond."
Michel Pettigrew, President of the Executive Board and COO at Ferring commented: "With the European launch of CORTIMENT®MMX®, a new treatment with a novel formulation for active, mild-to-moderate ulcerative colitis, we are expanding our portfolio and delivering on the Ferring commitment to innovation in gastroenterology."
CORTIMENT®MMX® has been developed by Cosmo Pharmaceuticals SpA. Ferring is the licensee in the EU and Asia (excluding Japan), Australia, Canada, Latin America and Africa. In the United States, where the product is available as UCERIS®, the licensee is Salix Pharmaceuticals, Inc.
- ENDS -
CORTIMENT®MMX® contains budesonide, a locally acting glucocorticosteroid, in a novel, patented, oral tablet formulation utilizing MMX® multimatrix colonic delivery technology that is designed to result in the controlled release and distribution of budesonide throughout the length of the colon. Budesonide has mainly topical anti-inflammatory activity and due to its high first pass metabolism, it has low systemic bioavailability. In phase III studies, 2.4 to 3.9 times more patients achieved clinical and endoscopic remission with CORTIMENT®MMX® compared to placebo, and no clinically significant glucocorticosteroid side effects were seen versus placebo after eight weeks of treatment (CORE I trial and CORE II trial respectively).4,5
CORTIMENT®MMX® is indicated in adults for induction of remission in patients with active mild-to-moderate active ulcerative colitis where 5-ASA (aminosalicylate) treatment is not sufficient. The approved dosing regimen for adult patients is one 9 mg tablet taken once daily for up to 8 weeks. Some patients may benefit from initial treatment with CORTIMENT®MMX® when recommended by their doctor.6 CORTIMENT®MMX® may be marketed under other names in some countries.
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, diarrhoea, bleeding, fatigue, weight loss and frequent bowel movements, which may also strongly affect quality of life. It is believed that 1.5 million in European Union and 2.1 million in the total European population suffer from ulcerative colitis.3
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 sufficiently 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 Ferring Pharmaceuticals
Headquartered in Saint-Prex, 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, endocrinology and orthopaedics. Ferring has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries. To learn more about Ferring or its products please visit www.ferring.com.
FERRING, CORTIMENT and PENTASA are trademarks of Ferring B.V. MMX is a trademark of Cosmo Pharmaceuticals SpA. UCERIS is a registered trademark of Santarus, Inc, a wholly owned subsidiary of Salix Pharmaceuticals, Inc.
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1Rubin R et al. Budesonide MMX® 9 mg for Inducing Remission in Patients with Mild-to-Moderate Ulcerative Colitis Not Adequately Controlled with Oral 5-ASAs. Abstract Number: A-1402, presented (OP011) at 10th Congress of ECCO, 20.02.2015
2Dignass A, Lindsay JO, Sturm A et al. Second European evidence-based consensus on the diagnosis and management of ulcerative colitis part 2: current management. J Crohn’s Colitis. 2012;6:991-1030
3Burisch J, Jess T, Martinato M, Lakatos P on behalf of ECCO –EpiCom. The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis - 1 May 2013 (Vol. 7, Issue 4, Pages 322-337, DOI: 10.1016/j.crohns.2013.01.010)
4Travis SP, Danese S, Kupcinskas L et al. Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: results from the randomised CORE II study. Gut 2014;63:433-41
5Sandborn WJ, Travis S, Moro L et al. Once-daily budesonide MMX® extended-release tablets induce remission in patients with mild to moderate ulcerative colitis: results from the CORE I study. Gastroenterology. 2012;143:1218-26
6Ferring Pharmaceuticals. CORTIMENT® 9 mg SmPC. Date of Revision Text: October 2014.