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.

For further information please
contact:

Media

    Matthew Cabrey (mcabrey@shire.com)                        +1-484-595-8248
    Ingrid Jansen (ijansen@shire.com)                         +32-14-404-360
    Meredith Butler (mbutler@golinharris.com) (GolinHarris
    for Shire)                                                +1-919-381-6936

SOURCE Shire plc