Shire Announces Top-line Results of the PREVENT2 Trial

Philadelphia, Pennsylvania (ots/PRNewswire) -

Shire plc , the global specialty biopharmaceutical company, today
announced top-line results of the PREVENT2 trial, a phase 3
investigational study of once-daily SPD476, MMX(R) mesalamine in
patients with a history of diverticulitis.[1] The study, conducted in
10 countries worldwide including the United States, did not meet the
primary endpoint in reducing the rate of recurrence of diverticulitis
over a 2-year treatment period. In addition, SPD476, MMX mesalamine
did not show a significant difference compared to placebo on the key
secondary endpoint of the study.[1]

"PREVENT2, a large, well-controlled trial, provided us with
important information regarding diverticulitis." said Dr Jeffrey
Jonas, Senior Vice President of Research and Development for Shire's
Specialty Pharmaceuticals and Regenerative Medicine businesses. "We
will continue to analyze these data and those of the second study,
PREVENT1, which was similar in design to PREVENT2 and will report
later in the year. Although the results of the second trial are
pending, it is our current intention not to pursue a regulatory
filing for this indication for MMX(R) mesalamine."

The objective of the PREVENT2 investigational study was to
evaluate the safety and efficacy of SPD476, MMX mesalamine versus
placebo in reducing the incidence of recurrent attacks of
diverticulitis in patients with a history of at least one prior
attack.[1]

The primary efficacy measure was the proportion of patients
without a recurrence of diverticulitis between three doses of SPD476,
MMX mesalamine and placebo at week 104. Recurrence of diverticulitis
was defined as: 1) the presence of each and all of the following
three items: abdominal pain, a 15% increase in white blood cell count
from baseline, and bowel wall thickening (>5mm) and/or fat stranding
as evidenced by spiral computerized axial tomography (CT) scan, or 2)
surgical intervention for diverticular disease. The key secondary
endpoint evaluated recurrence based on CT scan only.[1] There were no
new safety observations identified in the PREVENT2 trial.

About the PREVENT program

The PREVENT investigational program consists of two trials,
PREVENT1 and PREVENT2. These are phase 3, randomized, double-blind,
dose-response, stratified, placebo-controlled studies with an
identical design. PREVENT2 randomized 592 subjects to receive
once-daily SPD476, MMX mesalamine 1.2g, 2.4g or 4.8g, or placebo,
over a period of 104 weeks.[1] The PREVENT1 trial results are
expected later this year.

About SPD476, MMX mesalamine[2,3]

SPD476, MMX mesalamine is an anti-inflammatory drug, with each
delayed-release tablet containing 1.2g of 5-aminosalicylic acid
(5-ASA; mesalamine). In the U.S., SPD476, MMX mesalamine is
registered as Lialda(R) (mesalamine) and is approved for the
induction of remission in patients with active, mild to moderate
ulcerative colitis and for the maintenance of remission of ulcerative
colitis. In Europe, it is registered as Mezavant(R)/Mezavant XL(R)
and is approved for the induction of clinical and endoscopic
remission in patients with mild to moderate, active ulcerative
colitis and for maintenance of remission. SPD476, MMX mesalamine
should be taken once daily with food.[2,3]

MMX is a registered trademark of Cosmo Technologies, Ltd.,
Ireland.

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 increase your likelihood of
having 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 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
[http://pi.shirecontent.com/PI/PDFs/Lialda_USA_ENG.pdf ].

References

1. DoF corresponding to PREVENT2 topline data presentation.

2. Lialda (mesalamine delayed release tablets) Prescribing
Information. Wayne, PA: Shire US, Inc; 2011.

3. Mezavant XL, 1200mg, gastro-resistant, prolonged release
tablets. Summary of Product Characteristics. Shire Pharmaceuticals
Limited, 2010.

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, human genetic therapies, gastrointestinal
diseases and regenerative medicine 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.

"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 Pharmaceuticals, Human Genetic Therapies and Regenerative
Medicine products, as well as the ability to secure 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:
Investor Relations
Eric Rojas, erojas@shire.com, +1-781-482-0999
Sarah Elton-Farr, seltonfarr@shire.com, +44-1256-894157
Media
Jessica Mann (Corporate), jmann@shire.com, +44-1256-894-280
Gwen Fisher (Specialty Pharma), gfisher@shire.com, +1-484-595-9836

ots Originaltext: Shire Pharmaceuticals Group Plc
Im Internet recherchierbar: http://www.presseportal.de