07 Jun 2011
Health Canada grants MEZAVANT® new expanded indication for maintenance of remission of Ulcerative Colitis
SAINT-LAURENT, QC, June 7, 2011 - Shire Canada Inc., a division of Shire plc (LSE: SHP), (NASDAQ: SHPGY), the global specialty biopharmaceutical company, is proud to announce that MEZAVANT®* (mesalamine delayed and extended release tablets), the first and only once-daily mesalamine (5-aminosalicylic acid, 5-ASA) indicated for the induction of clinical and endoscopic remission in patients with mild-to-moderate, active ulcerative colitis (UC), has received an expanded indication to include maintenance of clinical and endoscopic remission (mucosal healing) in patients with ulcerative colitis.
MEZAVANT, with MMX®* Multi Matrix System Technology, is the first and only once-daily treatment indicated for the maintenance of clinical and endoscopic remission (mucfosal healing) in patients with UC. Whereas other mesalamine options require multiple daily doses (up to eight pills per day), MEZAVANT can offer patients a convenient once-daily treatment option, with as few as two tablets daily.
"In a chronic disease such as UC, consistent use of medication is required to maintain remission," states Dr. Hillary Steinhart, Head, Division of Gastroenterology, Mount Sinai Hospital. "However, the lack of symptoms during remission and the complicated treatment regimens associated with most 5-ASAs may lead to non-adherence and in turn, increased disease activity and reduced quality of life."
The expanded indication has been based on MEZAVANT's demonstrated efficacy and long-term safety profile during maintenance clinical trials of up to 12 months1,2. The primary efficacy endpoint in the randomized study SPD476-304 (n=679) was the proportion of subjects in endoscopic remission at Month 6. Endoscopic remission (mucosal healing) was defined by a modified UC-DAI endoscopy component score of ≤1. Clinical trials demonstrated that patients taking once-daily MEZAVANT maintained both clinical remission and mucosal healing3.
From a patient perspective, having a once-daily 5-ASA option with the ability to maintain remission is a positive step forward. "As patients, we tend to get lulled into a sense of false security the longer we go without a flare, which unfortunately may lead to a certain level of complacency," says James Mireau, an ulcerative patient from Edmonton, Alberta. "Ultimately, it is the responsibility of both the person living with UC and the gastroenterologist to find a treatment regimen that works with each individual's lifestyle without inhibiting quality of life and leaving a patient susceptible for challenges."
"For any treatment to be effective, patients must take their medication as prescribed by their physician. As such, we are very pleased that a convenient, once-daily option is now available for our patients to help them maintain remission," concludes Dr. Steinhart.
Important Safety Information
In the pooled safety analysis of patients with UC who participated in the clinical studies (short- and long-term, n=1368), the majority of subjects did not experience treatment-emergent adverse events associated with MEZAVANT. The most frequently reported adverse drug reactions were colitis, headache, abdominal pain, abnormal liver function test, diarrhea and nausea.4
About Ulcerative Colitis
Ulcerative colitis is a type of inflammatory bowel disease that produces inflammation and sores or ulcers along the inside of the large intestine, also called the bowel or colon. The sores may disrupt the normal digestive process, often causing cramping, bloating, diarrhea, bleeding, fatigue, weight loss and frequent bowel movements. This serious, chronic immune disease affects approximately 65,000 Canadians, with approximately 4,000 new cases reported annually. For more information on ulcerative colitis, please visit www.ccfc.ca.
MEZAVANT is indicated for the induction of clinical and endoscopic remission in patients with active, mild-to-moderate UC and for the maintenance of clinical and endoscopic remission (mucosal healing) in patients with UC. MEZAVANT has been shown to be effective with once-daily dosing. MEZAVANT is a high-dose 5-ASA medication that uses a MMX Multi Matrix System Technology to distribute mesalamine throughout the colon over an extended period of time.5
About Shire plc (www.shire.com)
Shire plc's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit and hyperactivity disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire's in-licensing, merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.
About Shire Canada Inc.
Shire Canada Inc. is a division of Shire plc. Shire Canada Inc.'s operations are headquartered in Saint-Laurent, Québec. For further information about Shire Canada Inc., please visit the company's website: www.shirecanada.com
"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire's results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of Shire's Specialty Pharmaceutical and Human Genetic Therapies products, as well as the ability to secure and integrate new products for commercialization and/or development; government regulation of Shire's products; Shire's ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on Shire's products; Shire's ability to register, maintain and enforce patents and other intellectual property rights relating to its products; Shire's ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in Shire's filings with the Securities and Exchange Commission.
*MEZAVANT® is a registered trade-mark used under licence from Giuliani International Limited.
*MMX® is a registered trade-mark used under licence from Cosmo Technologies, Ltd.
1 MEZAVANT Product Monograph. Shire Canada Inc. May 3, 2011; 22-24.
2 Kamm, MA., Lichtenstein, GR., Sandborn, WJ., Schreiber, S., Lees, K., Barrett, K., & Joseph, R. Randomized trial of once- or twice-daily MMX mesalazine for maintenance of remission in ulcerative colitis. Gut. 2008;57:893-902.
3 MEZAVANT Product Monograph. Shire Canada Inc. May 3, 2011; 22-24.
4 MEZAVANT Product Monograph. Shire Canada Inc. May 3, 2011; 8.
5 MEZAVANT Product Monograph. Shire Canada Inc. May 3, 2011; 11-12.
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