Ferring announces European launch of CORTIMENT®MMX® (budesonide) for ulcerative colitis

Ferring Pharmaceuticals announced 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.

Ferring Pharmaceuticals announced 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® 9mg 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.

References:

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. J Crohn’s and Colitis 2013;7(4):322–37 DOI: 10.1016/j.crohns.2013.01.010.
4. Travis SP 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.