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Shire Presented Results of a New Database Analysis on Lialda(R) (Mesalamine) and Other 5-ASAs for Ulcerative Colitis at Digestive Disease Week

CHICAGO, June 1 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, presented the results of a 5-aminosalicylic acid (5-ASA) persistency analysis entitled, "Twelve-month Persistence with 5-aminosalicylic Acid Therapy: Results from a Large Pharmacy Database," at Digestive Disease Week, on May 31, 2009. Results showed that after 12 months of therapy for continuing patients, 20 percent of Lialda patients were continually persistent, 9 percent of Asacol(R) (mesalamine) patients, 7 percent (250mg) and 10 percent (500mg) of Pentasa(R) (mesalamine) patients, 10 percent of balsalazide [combined results from generic balsalazide disodium and Colazal(R) (balsalazide disodium)] patients, and 10 percent (500mg) of Dipentum(R) (olsalazine sodium) patients were persistent. Continually persistent patients were defined as those who refilled their prescription within a period of up to twice the duration of the prescription that preceded the refill. Lialda is an FDA-approved, once-daily oral medication for the induction of remission in patients with active, mild to moderate ulcerative colitis (UC). Safety and effectiveness of Lialda beyond eight weeks have not been established.

"Patients who have UC often face adherence challenges, and persistency is an important consideration in disease management," said Sunanda Kane, MD, MSPH, AGAF, Associate Professor of Medicine, Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine and lead investigator on database analysis. "We are pleased to have shared the results of the database analysis, which help us understand how many, and how often, patients are refilling their mesalamine prescriptions."

The database analysis evaluated the persistency of UC patients who filled a prescription for the aforementioned 5-ASAs between March and September 2007. Persistency is defined as the proportion of patients who remained on their prescribed therapy over an extended period of time. The study evaluated a total of 44,191 5-ASA prescription and refill records (Lialda, n = 6,170; Asacol, n = 25,887; balsalazide, n = 4,557; Pentasa, n = 7,218; Dipentum, n = 359). Prescription and refill records were examined continually over 12 months after initial prescriptions were written.

Results also showed that after 12 months of therapy for continuing and restart patients, 32 percent of Lialda patients were persistent, 19 percent of Asacol patients, 15 percent (250mg) and 19 percent (500mg) of Pentasa patients, 19 percent of balsalazide patients, and 16 percent of patients receiving Dipentum were persistent. Restart patients were defined as those who refilled their prescription after the grace period of twice the duration of their prescription had elapsed.

This database analysis was neither designed nor intended to compare the safety and efficacy of the 5-ASA products and no such conclusions can be drawn from its results.


Important Safety Information

Lialda tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. Safety and effectiveness of Lialda beyond 8 weeks have not been established.

Lialda is contraindicated in patients with hypersensitivity to salicylates (including mesalamine) or to any of the components of Lialda. Caution should be exercised when treating patients with pyloric stenosis or those allergic to sulfasalazine. Mesalamine has been associated with an acute intolerance syndrome (3% of patients in clinical trials with mesalamine or sulfasalazine) that may be difficult to distinguish from a flare of inflammatory bowel disease.

If acute intolerance syndrome is suspected, prompt withdrawal is required. Mesalamine-induced cardiac hypersensitivity reactions (myocarditis and pericarditis) have been reported. Reports of renal impairment have been associated with mesalamine medications. In patients with renal impairment, caution should be exercised, and Lialda should be used only if the benefits outweigh the risks. No information is available for patients with hepatic impairment.

Lialda is generally well tolerated. The majority of adverse events in the double-blind, placebo-controlled trials were mild or moderate in severity. In clinical trials (N=535), the most common treatment-related adverse events with Lialda 2.4 g/day, 4.8 g/day and placebo were headache (5.6%, 3.4% and 0.6%, respectively) and flatulence (4%, 2.8% and 2.8%, respectively). Pancreatitis occurred in less than 1% of patients during clinical trials and resulted in discontinuation of therapy with Lialda.

    For further information please contact:

    Media    Blythe Bertolo  (GolinHarris)  +1 312 729 4463
             Matthew Cabrey  (Shire)        +1 484 595 8248


Shire'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 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. Shire's in-licensing, merger and acquisition efforts are focused on products in specialist 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.

For further information on Shire, please visit the Company's website:

About DDW

DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Analysis of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 30-June 4, 2009, at McCormick Place, Chicago, IL. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit


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, the Company'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 the Company'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 the Company's products; the Company's ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company's products; the Company's ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company'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 the Company's filings with the Securities and Exchange Commission.

Lialda(R) is a registered trademark of Shire LLC.

MMX(R) is a registered trademark owned by Cosmo Technologies Ltd, Ireland, a wholly-owned subsidiary of Cosmo Pharmaceuticals SpA.

Pentasa(R) is a registered trademark of Ferring A/S Corp.

Asacol(R) is a registered trademark of Medeva Pharma Suisse AG, used under license by Procter & Gamble Pharmaceuticals, Inc.

Dipentum(R) is a registered trademark of UCB Pharma Limited.

Colazal(R) is a registered trademark of Salix Pharmaceuticals, Inc.


Kane, Sunanda V. et al. "Twelve-Month Persistence With 5-Aminosalicylic Acid Therapy: Results From A Large Pharmacy Database." To be presented at Digestive Disease Week May 2009.

SOURCE Shire plc
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