Ferring Pharmaceuticals: CORTIMENT MMX, a new treatment for ulcerative colitis, receives European approval

SAINT PREX, Switzerland--(BUSINESS WIRE)--Ferring Pharmaceuticals announced today that its CORTIMENT MMX (budesonide) treatment for the induction of remission in patients with active, mild to moderate ulcerative colitis1 has received marketing approval from 27 European Union member states2 following the EU Mutual Recognition Procedure. CORTIMENT has been commercially available in the Netherlands since November 2013. Ferring plans to begin launching the product in the 27 additional European countries in the coming months.

CORTIMENT contains budesonide, a locally acting glucocorticosteroid, in a novel oral tablet formulation utilizing MMX multimatrix colonic delivery technology. The approved dosing regimen for adult patients is one 9 mg tablet taken once daily for up to 8 weeks. In phase III studies, 2.4 to 3.9 times more patients achieved clinical and endoscopic remission with CORTIMENT compared to placebo, and no clinically significant glucocorticosteroid side effects were seen versus placebo after eight weeks of treatment (CORE I study and CORE II study respectively). 3

CORTIMENT 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.

Dr. Simon Travis, Consultant Gastroenterologist at Oxford University and the John Radcliffe Hospital, UK said: Well over two million people in Europe suffer from ulcerative colitis. CORTIMENT, with its proven efficacy and safety profile, will provide an important new option for physicians treating active, mild to moderate ulcerative colitis.

Michel Pettigrew, President of the Executive Board and COO at Ferring commented: Bringing relief to sufferers of inflammatory bowel disease (IBD) is a key area of focus for Ferring as evidenced by our PENTASA (mesalazine) range of IBD treatments. With the launch of CORTIMENT, a new treatment with a novel formulation for active mild to moderate ulcerative colitis, we will expand our portfolio and build on our commitment to innovation in gastroenterology.

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About CORTIMENTMMX

CORTIMENT is a locally acting corticosteroid in a novel, patented, oral tablet formulation, which utilizes MMX multi-matrix technology and 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. CORTIMENT is indicated in adults for induction of remission in patients with mild to moderate active ulcerative colitis where 5-ASA (aminosalicylate) treatment is not sufficient. Some patients may benefit from initial treatment with CORTIMENT when recommended by their doctor.

CORTIMENT may be marketed under other names in some countries.

About Ulcerative Colitis

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Ferring Pharmaceuticals: CORTIMENT MMX, a new treatment for ulcerative colitis, receives European approval