Shire Canada receives expanded indication for MEZAVANT for treatment of ulcerative colitis

Jun 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 (mucosal 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 months.

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.