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Ferring announces European launch of CORTIMENT (budesonide) for ulcerative colitis, and new data re-confirms safety and efficacy

has announced the European launch of CORTIMENTMMX (budesonide), the first and only approved oral controlled release budesonide treatment for active mild-to-moderate (UC) where mesalazine (5-ASA) treatment is not sufficient. Simultaneously, new data from the CONTRIBUTE trial showed that adding CORTIMENTMMX 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 at the 10th Congress of the European Crohn’s and Colitis Organisation (ECCO).1

“The data confirm the efficacy and safety of CORTIMENTMMX 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,” said Dr David Rubin, Professor of Medicine at the University of Chicago Medicine and lead CONTRIBUTE author. “CORTIMENTMMX 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

CORTIMENTMMX 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 commented: “With the European launch of CORTIMENTMMX, 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.”

CORTIMENTMMX 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.

About CORTIMENTMMX

CORTIMENTMMX 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 CORTIMENTMMX 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

CORTIMENTMMX 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 CORTIMENTMMX when recommended by their doctor.6

CORTIMENTMMX may be marketed under other names in some countries.

Source

1. Rubin 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

2. Dignass 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

3. Burisch 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)

4. Travis 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

5. Sandborn WJ, Travis S, Moro L et al. Once-daily budesonide MMX(R) extended-release tablets induce remission in patients with mild to moderate ulcerative colitis: results from the CORE I study. Gastroenterology. 2012;143:1218-26

6. Ferring Pharmaceuticals. CORTIMENT 9 mg SmPC. Date of Revision Text: October 2014.

Source: Ferring Pharmaceuticals