Saint-Prex, Switzerland - 20 October 2014 – 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.”
- ENDS -
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
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 colitis4.
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.
For more information:
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1. See about the CORTIMENT®MMX® section (above) for the full indication.
2. Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Finland, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovenia, Slovakia, Spain, Sweden, United Kingdom
3. 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. 2013; 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.e1
4. 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)