FERRING Canada announces the launch of CORTIMENT® MMX (budesonide) a new treatment for ulcerative colitis

CORTIMENT®MMX Health Canada approval brings a new approach to treating a disease that affects over 104,000 Canadians.1

TORONTO, July 28, 2016 /CNW/ - Ferring Canada, a subsidiary of Ferring Pharmaceuticals announced today the availability in Canada of CORTIMENT® MMX (budesonide delayed and extended release tablets) treatment for the induction of remission in patients with active, mild to moderate ulcerative colitis (UC), one of the two most common types of inflammatory bowel disease (IBD). Canada has among the highest reported rates of IBD in the world. Ulcerative colitis is a condition that can be very debilitating and significantly compromise quality of life. Approximately 104,000 Canadians are living with UC.1

CORTIMENT®MMX contains budesonide, a partly locally acting glucocorticosteroid, in a novel oral tablet formulation utilizing a delivery technology that is designed to result in the controlled release and distribution of budesonide. The mode of action of CORTIMENT®MMX is based on a local action in the gut.2

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®MMX 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).3,4

"Ulcerative colitis is a chronic relapsing condition for which new treatment options are needed. Systemic steroids are effective for inducing remission, but have significant side effects that limit their use. New alternatives that are orally administered, and have good safety and tolerability, will be welcomed by people with ulcerative colitis across Canada," said John Marshall, MD, Professor of Medicine (Division of Gastroenterology), McMaster University, Ontario, Canada.

"Crohn's and Colitis Canada is excited that there is a new treatment available for patients living with ulcerative colitis in Canada. Canada has one of the highest rates of ulcerative colitis and Crohn's disease in the world -- impacting 1 in every 150 Canadians. These chronic diseases are debilitating, lead to multiple hospitalizations and surgeries, and have a tremendous impact on the quality of life for the nearly 250,000 adults and children living with Crohn's and colitis in Canada. These diseases are very complex and often require a personalized approach and multiple treatment options to bring about remission. Crohn's and Colitis Canada is advocating for improved coverage and timely access to new treatments on public and private drug plans," said Mina Mawani, President & CEO of Crohn's and Colitis Canada.

"Evidence from clinical trials is promising, in that CORTIMENT®MMX resolves inflammation with few side effects in persons with mild to moderate ulcerative colitis," said Gail Attara, President & CEO of the Gastrointestinal Society. "This is great news for patients who suffer with this disease that has no cure. We trust that private and public drug plans will see the benefit of CORTIMENT®MMX and cover this new medicine." The Gastrointestinal Society offers medically sound information on all areas of the digestive tract on www.badgut.org.

Michael Seckler, General Manager at Ferring Canada commented: "Bringing relief to sufferers of IBD is a key area of focus for Ferring as evidenced by our PENTASA® (mesalazine) range of IBD treatments. We are delighted by the Canadian launch of CORTIMENT®MMX, a new treatment with a novel formulation for active mild to moderate ulcerative colitis. The launch marks an important milestone for Canadian patients and Ferring alike as we continue to deliver on our commitment for innovation in gastroenterology."

CORTIMENT®MMX has been developed by Cosmo Pharmaceuticals SpA. Ferring is the licensee in the EU, Asia, Japan, Middle East, Australia, Canada, Latin America and Africa. In the United States, where the product is available as UCERIS®, the licensee is Salix Pharmaceuticals Inc., a division of Valeant Pharmaceuticals International, Inc.

About CORTIMENT®MMX
CORTIMENT®MMX is a partly locally acting corticosteroid in a novel, patented, oral tablet formulation, which utilizes a unique delivery technology and is designed to result in the controlled release (delayed and extended) of budesonide. Budesonide has mainly topical anti-inflammatory activity and due to its high first pass metabolism, it has low systemic bioavailability.  CORTIMENT®MMX is indicated in adults for induction of remission in patients with mild to moderate active ulcerative colitis. The approved dosing regimen for adult patients is one 9mg tablet taken once daily for up to 8 weeks.2

About Ulcerative Colitis
Ulcerative colitis is a form of inflammatory bowel disease (IBD) that produces inflammation and ulcers along the inside of the colon.5 The inflammation can interfere with the normal function of the colon, often causing cramping, bloating, diarrhea, bleeding, fatigue, weight loss and frequent bowel movements, which may also strongly affect quality of life.6-8 Ulcerative colitis is a chronic relapsing-remitting illness for which there is no known cure, but with appropriate treatment patients can manage their symptoms.9 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.10 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.11,12 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.13

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.

About Ferring Canada
Ferring Canada is the Canadian subsidiary of Ferring Pharmaceuticals. Ferring Canada started its operations in 1987 with just three employees. Today, the company employs nearly 90 employees and sees considerable growth ahead as it continues to bring valuable new products to the Canadian marketplace. The company's therapeutic focus is on gastroenterology, urology and reproductive health. Ferring Canada is committed to providing innovative medicines that will help Canadians have an even better quality of life in the years to come.

To learn more about Ferring or its products, visit www.ferring.ca

FERRING is a registered trademark of Ferring Inc., CORTIMENT and PENTASA are registered trademarks of Ferring B.V.

References

  1. Crohn's and Colitis Canada, Impact of IBD in Canada, 2012.
  2. Product Monograph (Ferring Pharmaceuticals. Product Monograph, CORTIMENT® MMX (budesonide). June 17, 2016.)
  3. Sandborn 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.e1.
  4. Travis SPL, 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; 63:433-441.
  5. de Mattos BR, Garcia MP, Nogueira JB, Paiatto LN, Albuquerque CG, Souza CL, Fernandes LG, Tamashiro WM, Simioni PU (2015) Inflammatory Bowel Disease: An Overview of Immune Mechanisms and Biological Treatments. Mediators Inflamm 2015:493012. Epub 2015 Aug 3.
  6. Danese S, Fiocchi C. Ulcerative colitis. N engl J Med 2011;365:1713-25.
  7. Ford AC, Moayyedi P, Hanauer SB (2013) Ulcerative colitis. BMJ 346 f432.
  8. CCFC (2012) The Impact of Inflammatory Bowel Disease in Canada: 2012 Final Report and Recommendations. Crohn's and Colitis Foundation of Canada. Available at: http://www.isupportibd.ca/pdf/ccfc-ibd-impact-report-2012.pdf.
  9. Cioffi M, Rosa AD, Serao R, Picone I, Vietri MT (2015) Laboratory markers in ulcerative colitis: Current insights and future advances. World J Gastrointest Pathophysiol 6 (1):13-22.
  10. Katz S, Lichtenstein GR, Safdi MA. 5-ASA Dose-Response: Maximizing Efficacy and Adherence. Gastroenterology & Hepatology. 2010;6(2 Suppl 4):1-16.
  11. Dignass A, Lindsay JO, Sturn A, et al. Second European-evidence-based consensus on the management of ulcerative colitis. J Crohns Colitis 2012;6:991-1030.
  12. Ford AC, Bernstein CN, Khan KJ, et al. Glucocorticosteriod therapy in inflammatory bowel disease: systemic review and meta-analysis. Am J Gastroentrol 2011;106:590-9.
  13. Danese S, Siegel CA, Peyrin-Biroulet L (2014) Review article: integrating budesonide-MMX into treatment algorithms for mild-to-moderate ulcerative colitis. Aliment Pharmacol Ther 39 (10):1095-1103.

 

SOURCE Ferring Pharmaceuticals

Image with caption: "Ferring Pharmaceuticals (CNW Group/Ferring Pharmaceuticals)". Image available at: http://photos.newswire.ca/images/download/20160728_C5095_PHOTO_EN_742796.jpg

For further information: Rick Maddalena, NATIONAL Public Relations (for Ferring Canada), 416-848-1425, rmaddalena@national.ca


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