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Shire Presents Results of Five Lialda(R) (mesalamine) Analyses at ACG 2009 Annual Scientific Meeting
Date:10/26/2009

SAN DIEGO, Oct. 26 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, presented the results of three 5-aminosalicylic acid (5-ASA) persistency analyses at ACG 2009 Annual Scientific Meeting, evaluating persistency of Lialda® (mesalamine), Asacol® (mesalamine), Pentasa® (mesalamine) (250mg and 500mg), balsalazide [combined results from generic balsalazide disodium and Colazal® (balsalazide disodium)], and Dipentum® (olsalazine sodium) (500mg). Additionally, on October 27, 2009, Shire will present results of a Lialda patient experience survey as well as the results of a study that evaluated the impact of oral 5-ASAs on all-cause health care utilization and costs among ulcerative colitis (UC) patients with active disease.

"Persistency plays a significant role in the management of UC, and this data shows us just how challenging adherence can be for UC patients," said Roger Adsett, senior vice president of Shire's GI business unit. "The results of the Lialda and 5-ASA persistency analyses will provide insights as to how UC patients manage their mesalamine prescription refills."

Lialda is an FDA-approved, once-daily oral medication for the induction of remission in patients with active, mild to moderate UC. The safety and effectiveness of Lialda beyond eight weeks have not been established.

Factors Affecting Persistence with Mesalamine Therapy: Results from a Large Pharmacy Database

Poster Presentation: October 25, 2009, San Diego Convention Center (#293)

Results of a long-term persistency analysis showed that after 18 months of treatment, 13 percent of Lialda patients (n=6,170) were persistent (continuing). Also, 5 percent of Asacol patients (n=25,887), 6 percent (250mg) and 10 percent (500mg) of Pentasa patients (n=7,218), 6 percent of balsalazide [combined results from generic balsalazide disodium and Colazal] patients (n=4,557), and 6 percent (500mg) of Dipentum patients (n=359) were persistent (continuing).

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. Continuing 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. 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.

Lialda is an FDA-approved, once-daily oral medication for the induction of remission in patients with active, mild to moderate UC. The safety and effectiveness of Lialda beyond eight weeks have not been established.

Persistence with Mesalamine Therapy: Long-term Results in Patients Persistent with Therapy at Outset

Poster Presentation: October 25, 2009, San Diego Convention Center (#290)

Results of a long-term persistency analysis showed that among continuing and restart patients who were persistent (continuing) after three months of therapy, the persistency rates at 12 and 18 months were as follows: Lialda patients (n=3,687) were 47 and 35 percent persistent (continuing), respectively; Asacol patients (n=10,727) were 34 and 25 percent persistent (continuing); Pentasa patients who took 250mg (n=555) were 33 and 23 percent persistent (continuing), and Pentasa patients who took 500mg (n=2,331) were 34 and 25 percent persistent (continuing); balsalazide patients (n=1,972) were 34 and 24 percent persistent (continuing) [combined results from generic balsalazide disodium and Colazal]; and Dipentum patients (500mg) (n=126) were 36 and 27 percent persistent (continuing). A total of 19,398 patients were identified as persistent (continuing) patients after three months of therapy and were included in this analysis.

Persistent (continuing) 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. Restart patients were defined as those who refilled their prescription after the grace period of twice the duration of their prescription had elapsed. Refill records for patients who were considered persistent (continuing) over the initial 3 months of treatment were analyzed at 12 and 18 months. 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.

Lialda is an FDA-approved, once-daily oral medication for the induction of remission in patients with active, mild to moderate UC. The safety and effectiveness of Lialda beyond eight weeks have not been established.

Continuing Persistence with Mesalamine Therapy: Results from Patients Persistent with Long-term Therapy

Poster Presentation: October 25, 2009, San Diego Convention Center (#292)

A long-term persistency analysis evaluated patients who were persistent (continuing) at month 12 and followed them for an additional six months. At month 18, results showed 66 percent were persistent (continuing) with Lialda (n=1,247), 58 percent with Asacol (n=2,384), 49 percent with Pentasa (250mg) (n=122) and 59 percent with Pentasa (500mg) (n=542), 59 percent with balsalazide (n=445), and 56 percent with Dipentum (500 mg) (n=36).

Persistent (continuing) 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. In total, 4,776 patients were identified as being persistent (continuing) with mesalamine therapy over 12 months and were included in this analysis. 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.

Lialda is an FDA-approved, once-daily oral medication for the induction of remission in patients with active, mild to moderate UC. The safety and effectiveness of Lialda beyond eight weeks have not been established.

Preliminary Outcomes from a Patient Experience Program on Ulcerative Colitis Treatment with Lialda® (mesalamine)

Poster Presentation: October 27, 2009, San Diego Convention Center (#1123)

Results of a patient experience survey showed that patients reported that their adherence to Lialda was 88 percent. Of the 319 patients initiating Lialda therapy who were invited to participate in the survey, 110 patients completed the baseline and 60-day surveys. Patient self-assessment revealed that both symptom severity and interference with daily activities were reduced following treatment with Lialda.

Patients were surveyed using a secure Web site or automated telephone system, where they completed a questionnaire on perceived symptom severity, self-assessed disruption to daily activities, prior UC medication and treatment satisfaction, at baseline and at approximately 30 and 60 days post-baseline. Patients were also questioned about their understanding of UC and management of the disease.

The Impact of Oral 5-ASA Adherence on All-Cause Health Care Costs among Ulcerative Colitis Patients

Poster Presentation: October 27, 2009, San Diego Convention Center (#1105)

Results of a database analysis showed that adherence with 5-ASAs for UC patients reduces total all-cause health care utilization and associated costs. Adherent patients had significantly lower mean all-cause total costs compared to non-adherent patients ($11,331 vs. $15,177, P<.05). Although mean pharmacy costs for adherent patients were almost twice as much as those of non-adherent patients ($4,450 vs. $2,794, P<.05), costs were offset by significant reductions in all other costs sectors. Adherent patients had fewer inpatient hospitalizations on average (0.32 vs. 0.46, P<.05), shorter length of stay (8.4 vs. 12.1 days, P<.05), and significantly lower mean inpatient costs ($2,793 vs. $7,019, P<.05). The mean costs associated with Emergency Department visits ($76 vs. $134, P<.05) and other outpatient ancillary services ($3,092 vs. $4,231, P<.05) also were significantly lower.

Insurance claims from the PharMetrics Integrated Outcomes Database were analyzed. Patients who were 18 or older with greater than or equal to 1 claims for a UC diagnosis (ICD-9 556.xx) between June 1997 and August 2005, with greater than or equal to 30 days of oral 5-ASA treatment and greater than or equal to 1 corticosteroid prescription (proxy for active disease) within 12 months following 5-ASA initiation (n=1,693) were identified for the study. Patients had continuous enrollment for greater than or equal to 6 months prior to and greater than or equal to 12 months following 5-ASA initiation.

Cumulative exposure to oral 5-ASAs over a 12-month period was calculated using the Medication Possession Ratio (MPR), defined as total 5-ASA days supplied during the period divided by 365 days. Patients with an MPR of at least 0.80 were classified as adherent. All-cause resource utilization and costs were computed over the 12-month follow-up period and compared between adherent and non-adherent patients.

About Lialda

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 percent 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 percent, 3.4 percent and 0.6 percent, respectively) and flatulence (4 percent, 2.8 percent and 2.8 percent, respectively). Pancreatitis occurred in less than 1 percent of patients during clinical trials and resulted in discontinuation of therapy with Lialda.

Additional information about Lialda and Full Prescribing Information are available at Lialda.com.

For further information, please contact:

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

Notes to editors

SHIRE PLC

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: www.shire.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, 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® is a registered trademark of Shire LLC.

MMX® is a registered trademark owned by Cosmo Technologies Ltd, Ireland, a wholly owned subsidiary of Cosmo Pharmaceuticals SpA.

Pentasa® is a registered trademark of Ferring A/S.

Asacol® is a registered trademark of Medeva Pharma Schweiz AG.

Dipentum® is a registered trademark of UCB Pharma Limited.

Colazal® is a registered trademark of Salix Pharmaceuticals, Inc.

SOURCE Shire plc


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