Shire plc: Lialda® (Mesalamine) Now Approved in U.S. for Maintenance of Remission of Ulcerative Colitis

PHILADELPHIA, July 18, 2011 /PRNewswire/ --

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved Lialda^® (mesalamine) Delayed Release Tablets for the maintenance of remission in patients with ulcerative colitis. This approval is based on results from a six-month study demonstrating the safety and effectiveness of Lialda in maintaining endoscopic remission in adult patients. This approval follows the previous indication of Lialda approved by the FDA in 2007 for the induction of remission in patients with active, mild to moderate ulcerative colitis.

"At Shire, we strive to create meaningful therapies for patients with our clinical programs, and this approval based on our large clinical trial underscores our commitment and dedication to the ulcerative colitis community," said Roger Adsett, Senior Vice President of Shire's Gastrointestinal business. "This new indication is an important milestone for Lialda as it provides a once-daily option for both inducing remission in patients with active, mild to moderate ulcerative colitis and maintaining remission of ulcerative colitis."  

Lialda's new indication is based on results from a multicenter, randomized, double-blind, active comparator, non-inferiority study conducted in 826 adult patients in remission from ulcerative colitis. Maintenance of remission was assessed using a modified Ulcerative Colitis Disease Activity Index (UC-DAI) and was based on maintaining endoscopic remission defined as a modified UC-DAI endoscopy subscore of less than or equal to 1. The endoscopy subscore of less than or equal to 1 represented normal or mild disease with no friability.

Of the patients receiving Lialda 2.4 g/day (n=343) administered once daily, 83.7% maintained remission at Month 6, which was similar to that seen using the comparator, mesalamine delayed-release 1.6 g/day (n=336) administered as 0.8 g given twice daily (81.5%; 95% confidence interval for difference: -3.9%, 8.1%).

Safety of Lialda in the maintenance of remission of ulcerative colitis was evaluated in three studies, one being the six-month, double-blind, non-inferiority, comparator study and two being 12- to 14-month open-label studies. The most common adverse reactions with Lialda in the maintenance arms of these three trials were ulcerative colitis, headache, abnormal liver function test and abdominal pain. The most common severe adverse reactions were gastrointestinal disorders, most of which are consistent with symptoms associated with ulcerative colitis.

In 2007, Lialda gained FDA approval for the induction of remission in patients with active, mild to moderate ulcerative colitis as a result of two eight-week, placebo-controlled clinical studies demonstrating safety and effectiveness.

Important Safety Information

You should not take Lialda if you are allergic to salicylates (including mesalamine, aspirin, or aspirin-containing products) or to any of the ingredients of Lialda.  

Reports of problems with kidney function have been associated with mesalamine-containing products like Lialda. Tell your doctor if you have or have had problems with your kidneys. It is recommended that all patients have their kidney function checked before starting Lialda and periodically while on therapy.

Products that contain mesalamine, like Lialda, have been associated with a condition that may be difficult to distinguish from an ulcerative colitis flare-up. Symptoms include cramping, stomach ache, bloody diarrhea, fever, headache, and rash. If you experience any of these symptoms, talk to your doctor immediately. Your doctor may decide to discontinue your medication.  

Tell your doctor if you are allergic to sulfasalazine, as you may also be allergic to Lialda or drugs that contain or are converted to mesalamine. Some patients taking Lialda or mesalamine-containing products have reported heart-related allergic reactions, such as inflammation of the heart muscle and inflammation of the lining of the heart.  Tell your doctor if you have or have had a history of myocarditis or pericarditis as this may predispose you to these types of reactions.  

Reports of liver failure have been associated with mesalamine-containing products like Lialda in patients that have or have had liver disease. Tell your doctor if you have a problem with your liver.

Tell your doctor if you have a stomach blockage, as this may delay the release of medication.

In clinical trials, common side effects reported with Lialda included ulcerative colitis, headache, gas, abnormal liver function test results, and stomach ache. Inflammation of the pancreas was reported which in some cases led to discontinuation of Lialda therapy. Other side effects may occur.  

Before starting Lialda, tell your doctor about all medications you are taking.  Mesalamine may increase the risk of kidney problems when used with non-steroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, naproxen). Mesalamine may increase the risk of blood disorders when used with azathioprine and 6-mercaptopurine.  

Please see Full Prescribing Information.

Additional information about Lialda is available at http://www.Lialda.com.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.FDA.gov/medwatch, or call 1-800-FDA-1088.

About Lialda

Lialda is indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis. Lialda is available as a delayed-release tablet containing 1.2 g mesalamine. For the induction of remission in patients with active, mild to moderate ulcerative colitis, the recommended dosage is two or four 1.2 g tablets taken once daily with a meal. The recommended dosage for the maintenance of remission of ulcerative colitis is two 1.2 g tablets taken once daily with a meal.

About Ulcerative Colitis

Ulcerative colitis is a type of inflammatory disease. It only affects the colon, producing chronic inflammation and sometimes sores or ulcers along the inside lining of the colon. It is characterized by diarrhea, which is generally bloody, and often painful cramping in the abdomen. Currently, there is no cure available with medical treatment, and the cause of the disease is unknown.

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: http://www.shire.com.

"SAFEHARBOR" 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 Pharmaceuticals 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.

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    Matthew Cabrey ([email protected])                        +1-484-595-8248
    Ingrid Jansen ([email protected])                         +32-14-404-360
    Meredith Butler ([email protected]) (GolinHarris
    for Shire)                                                +1-919-381-6936

SOURCE Shire plc