Basingstoke, UK and Philadelphia, PA, US March 19, 2007 Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) today announced the availability of LIALDA (mesalamine) with MMXTM Technology, indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis (UC), a type of inflammatory bowel disease. LIALDA is the first and only FDA-approved once daily oral formulation of mesalamine. The U.S. Food and Drug Administration (FDA) approved LIALDA on January 16, 2007.
LIALDA is available to patients by prescription for oral administration in dosages of 2.4 g/day and 4.8 g/day, allowing patients to take as few as two tablets once daily. Other currently available mesalamines require three to four times daily dosing and six to 16 pills a day. A study found that patients who are not compliant with their mesalamine medications have a five-fold greater risk of disease flares, a serious worsening of symptoms, than compliant patients.
"In clinical trials, LIALDA was superior to placebo in inducing remission. Additionally, LIALDA's convenient once daily dosing may help address the compliance issues facing so many ulcerative colitis patients," said Mike Cola, President of Shire's Specialty Pharmaceuticals business. "Shire is pleased to offer this latest advancement in the treatment of ulcerative colitis, which complements our existing GI portfolio and reinforces our commitment to improving the treatment of gastrointestinal diseases."
"Although not everyone's experience is the same, taking the pills for my disease seemed to consume my life - my next dosage was constantly on my mind," said Becky Pace, a LIALDA clinical trial patient. "I could not believe taking medication once a day would help as much as it did. LIALDA brought my disease into remission."
LIALDA is part of a drug class called aminosalicylates, which contain 5-aminosalicyclic acid (5-ASA). 5-ASA is a well-established dr
Contact: Lisa Koen