SHIRE PLC: FDA Approves LIALDA first once-daily mesalamine for UC

FDA Approves LIALDA™ (mesalamine), the First Oral Once-Daily Mesalamine    

         For Patients With Active, Mild to Moderate Ulcerative Colitis         

Basingstoke, UK and Philadelphia, US - January 16, 2007 - Shire plc (LSE: SHP,
NASDAQ: SHPGY, TSX: SHQ) announced today that the U.S. Food and Drug
Administration (FDA) has approved LIALDATM (mesalamine) with MMX® technology,
indicated for the induction of remission in patients with active, mild to
moderate ulcerative colitis. LIALDA is the first and only FDA-approved
once-daily oral formulation of mesalamine. Mesalamines are a part of a drug
class called aminosalicylates, which contain 5-aminosalicyclic acid (5-ASA), a
well-established drug of choice and often a first-line treatment for patients
with mild to moderate ulcerative colitis. Shire will launch LIALDA in the U.S.
in the first quarter of 2007.

Once-daily LIALDA with MMX technology contains the highest mesalamine dose per
tablet (1.2 g), so patients can take as few as two tablets once daily. Other
currently available mesalamines require three to four times daily dosing and 6
to 16 pills a day. A recent study conducted by the Crohn's and Colitis
Foundation of America (CCFA) found that 65 percent of patients with ulcerative
colitis are poorly compliant with their medication, citing pill burden and
inconvenience associated with the medication.

"As the first oral once-a-day treatment option for ulcerative colitis, the
approval of LIALDA in the United States is great news for patients and
physicians when managing this serious condition," said Matthew Emmens, Shire
Chief Executive Officer. "Once-daily LIALDA is one of several medicines Shire
expects to launch in the U.S. and Europe in 2007."

The FDA approval was based on the results of two Phase III clinical studies
that found LIALDA (2.4 g/day and 4.8 g/day) was effective in inducing remission
in patients with active, mild to moderate ulcerative colitis compared to
placebo after eight weeks of treatment. LIALDA is generally well tolerated and
has a similar safety profile to other currently available mesalamines.

"In clinical trials, LIALDA proved to be an effective medication, providing
superior rates of remission compared to placebo for people with ulcerative
colitis," said lead study investigator, Gary R. Lichtenstein, M.D., director of
the Center for Inflammatory Bowel Diseases at the Hospital of the University of
Pennsylvania. "This is the first new mesalamine treatment to enter the market
since 2000, filling a major void for physicians and people with ulcerative
colitis and simplifying treatment of this disease."

"The introduction of new treatments with more convenient dosing regimens may be
an important step in helping patients with ulcerative colitis remain compliant
with their medication," said Jonathan Braun, M.D., Ph.D., chair of CCFA's
National Scientific Advisory Committee.

Shire has licensed from Giuliani S.p.A. the exclusive rights to develop and
commercialize LIALDA in the U.S., Canada, Europe -- known as MEZAVANT™ --
(excluding Italy) and the Pacific Rim. Giuliani S.p.A. retains the development
and commercialization rights in Italy. Cosmo Pharmaceuticals S.p.A., Milan
developed the MMX technology and owns the trademark, MMX.

For more information on LIALDA, please visit www.LIALDA.com.

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 eight weeks has not been established.

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 and 4.8 g/day were headache (5.6 percent and 3.4 percent,
respectively) and flatulence (4 percent and 2.8 percent, respectively). Lialda
is contraindicated in patients with hypersensitivity to salicylates (including
mesalamine) or to any of the components of Lialda. Caution should be used in
patients with impaired hepatic or renal function.

MMX Technology

LIALDA is the only ulcerative colitis treatment that utilizes novel MMX
technology. LIALDA with MMX technology combines a pH dependant gastro-resistant
coating, which delays the release of the medication to the colon (the site of
the inflammation in ulcerative colitis) with a tablet core containing
mesalamine with hydrophilic and lipophilic excipients.

Clinical Studies

The approval of LIALDA was based on the results of two Phase III clinical
studies. The first study assessed the efficacy and safety of LIALDA2.4 g/day
given in divided doses twice daily and 4.8 g/day given once daily against
placebo in 262 patients. At eight weeks, both doses demonstrated superiority
over placebo in the induction of remission (34.1 percent with 2.4 g/day, 29.2
percent with 4.8 g/day, and 12.9 percent with placebo). The second study
assessed the efficacy and safety of LIALDA 2.4g/day and 4.8g/day (both given
once daily) against placebo in 255 patients. At eight weeks, both once daily
doses demonstrated superiority over placebo in the induction of remission (40.5
percent with 2.4 g/day, 41.2 percent with 4.8 g/day, and 22.1 percent with
placebo).

About Ulcerative Colitis

Ulcerative colitis is a type of inflammatory bowel disease that produces
inflammation and sores or ulcers along the inside of the large intestine, also
called the bowel or colon. The sores interfere with the normal digestive
process, often causing cramping, bloating, diarrhea, bleeding, fatigue, weight
loss and frequent bowel movements. This serious, chronic autoimmune disease
affects approximately 500,000 Americans. For an informative white paper on
ulcerative colitis, visit www.managinguc.com.

For further information please contact:

Investor Relations   Cléa Rosenfeld (Rest of the World)      [phone]  
                                                                               
                     Brian Piper (North America)             [phone]   
                                                                               
Media                Jessica Mann (Rest of the World)        [phone]  
                                                                               
                     Matthew Cabrey (North America)          [phone]   

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Notes to editors:

SHIRE PLC

Shire's strategic goal is to become the leading specialty pharmaceutical
company that focuses on meeting the needs of the specialist physician. Shire
focuses its business on attention deficit and hyperactivity disorder (ADHD),
human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. The
structure is sufficiently flexible to allow Shire to target new therapeutic
areas to the extent opportunities arise through acquisitions. Shire believes
that a carefully selected portfolio of products with a strategically aligned
and relatively small-scale sales force will deliver strong results.

Shire's focused strategy is to develop and market products for specialty
physicians. Shire's in-licensing, merger and acquisition efforts are focused on
products in niche markets with strong intellectual property protection either
in the US or Europe.

For further information on Shire, please visit the Company's website:
www.shire.com.

Guiliani S.p.A.

Giuliani S.p.A., founded in 1889, is a privately owned specialty pharmaceutical
company with Headquarters in Milan, Italy. It develops new products with high
unmet medical need and substantial market opportunity. It is focused on
developing and marketing products for the treatment and management of
gastrointestinal (ulcerative colitis and Crohn's disease), metabolic (food
intolerance) and dermatological (hair loss) disorders.

Cosmo S.p.A.

The formulation for LIALDA was developed by Cosmo S.p.A. Cosmo also owns the
drug delivery and process patents covering this compound. Cosmo S.p.A. is an R&
D pharmaceutical company. Its R&D covers advanced drug delivery with
applications in gastrointestinal disorders, new chemical entities and
biotechnology. In addition, it manufactures pharmaceuticals and offers
development services to other pharmaceutical companies. Cosmo is based in
Lainate (Milan), Italy, where its production plant and principal R&D
laboratories are situated. Its biotechnology R&D is located in La Jolla,
California, USA.

"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, Shire's results could be materially affected. 
The risks and uncertainties include, but are not limited to, risks associated
with: the inherent uncertainty of pharmaceutical research, product development,
manufacturing and commercialization; the impact of competitive products,
including, but not limited to the impact of those on Shire's Attention Deficit
and Hyperactivity Disorder (ADHD) franchise; patents, including but not limited
to, legal challenges relating to Shire's ADHD franchise; government regulation
and approval, including but not limited to the expected product approval dates
of SPD503 (guanfacine extended release) (ADHD), SPD465 (extended release
triple-bead mixed amphetamine salts) (ADHD), MEZAVANT™ (SPD476) (mesalazine) in
Europe, and VYVANSE™ (NRP104) (lisdexamfetamine dimesylate) (ADHD), including
its scheduling classification by the Drug Enforcement Administration in the
United States; Shire's ability to secure new products for commercialization and
/or development; and other risks and uncertainties detailed from time to time
in Shire's and its predecessor registrant Shire Pharmaceuticals Group plc's
filings with the Securities and Exchange Commission, particularly Shire plc's
Annual Report on Form 10-K for the year ended December 31, 2005.

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