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Shire Announces Filing of VYVANSE(TM) (Lisdexamfetamine Dimesylate) for the Treatment of ADHD in Adults


PHILADELPHIA, Pennsylvania, June 29 /PRNewswire/ --     Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today
that it has submitted a supplemental New Drug Application (sNDA) to the U.S.
Food and Drug Administration (FDA) for VYVANSE(TM) (lisdexamfetamine
dimesylate) for the treatment of Attention Deficit Hyperactivity Disorder
(ADHD) in adults. This application is subject to a 10-month FDA review
period.

"ADHD is a treatable disorder that affects adults as well as children,"
said Matthew Emmens, Shire Chief Executive Officer. "We are pleased with the
results of VYVANSE studies conducted in adults and we believe this product
will meet an important need in the adult ADHD marketplace. VYVANSE is a
priority in our ADHD portfolio and we are committed to developing this next
generation ADHD medication so that adults diagnosed with ADHD may benefit
from treatment with VYVANSE."

VYVANSE is a prodrug stimulant that is therapeutically inactive
until metabolized in the body and active d-amphetamine is released. VYVANSE
is different from other oral long acting stimulants of amphetamine and
methylphenidate that rely on delivery systems which may be affected by pH and
GI transit time.

Shire plans to announce full results from its phase III clinical
trial for the treatment of ADHD in adults at a major scientific conference in
Q4 2007.

The FDA approved VYVANSE on February 23, 2007, to treat symptoms
of ADHD in children aged 6 to 12.

Additional information about VYVANSE and Full Prescribing Information are
available at www.vyvanse.com.

About ADHD

Approximately 7.8 percent of all school-age children, or about
4.4 million U.S. children aged 4 to 17 years, have been diagnosed with ADHD
at some point in their lives, according to the U.S. Centers for Disease
Control and Prevention (CDC). ADHD is one of the most common psychiatric
disorders in children and adolescents. The disorder is also estimated to
affect approximately 9.8 million adults across the U.S. based on a
retrospective survey of adults aged 18 to 34, projected to the full U.S.
adult population. ADHD is a neurobiological disorder that manifests as a
persistent pattern of inattention and/or hyperactivity-impulsivity that is
more frequent and severe than is typically observed in individuals at a
comparable level of development. To be properly diagnosed with ADHD, a child
needs to demonstrate at least six of nine symptoms of inattention; and/or at
least six of nine symptoms of hyperactivity/impulsivity; the onset of which
appears before age 7 years; that some impairment from the symptoms is present
in two or more settings (e.g., at school and home); that the symptoms
continue for at least six months; and that there is clinically significant
impairment in social, academic or occupational functioning and the symptoms
cannot be better explained by another psychiatric disorder.

Although there is no "cure" for ADHD, there are accepted treatments that
specifically target its symptoms. The most common standard treatments include
educational approaches, psychological or behavioral modification, and
medication.

About VYVANSE

Tell the doctor about any heart conditions, including structural
abnormalities, that you, your child, or a family member, may have. Inform the
doctor immediately if your child develops symptoms that suggest heart
problems, such as chest pain or fainting.

VYVANSE should not be taken if your child has advanced disease of the
blood vessels (arteriosclerosis); symptomatic heart disease; moderate to
severe high blood pressure; overactive thyroid gland (hyperthyroidism); known
allergy or unusual reactions to drugs called sympathomimetic amines (for
example, pseudoephedrine); seizures; glaucoma; a history of problems with
alcohol or drugs; agitated states; taken a monoamine oxidase inhibitor (MAOI)
within the last 14 days.

Tell the doctor before taking VYVANSE if your child is being treated for
or has symptoms of depression (sadness, worthlessness, or hopelessness) or
bipolar disorder; has abnormal thought or visions, hears abnormal sounds, or
has been diagnosed with psychosis; has had seizures or abnormal EEGs; has or
has had high blood pressure; exhibits aggressive behavior or hostility. Tell
the doctor immediately if your child develops any of these conditions or
symptoms while taking VYVANSE.

Abuse of amphetamines may lead to dependence. Misuse of amphetamine may
cause sudden death and serious cardiovascular adverse events. These events
have also been reported rarely with amphetamine use.

VYVANSE was generally well tolerated in clinical studies. The most common
side effects reported in studies of VYVANSE were decreased appetite,
difficulty falling asleep, stomachache, and irritability.

Aggression, new abnormal thoughts/behaviors, mania, growth suppression,
worsening of motion or verbal tics, and Tourette's syndrome have been
associated with use of drugs of this type. Tell the doctor if your child has
blurred vision while taking VYVANSE.

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 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.

THE "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 date of INTUNIV(TM) (guanfacine)
extended release (ADHD); Shire's ability to secure new products for
commercialization and/or development; Shire's ability to benefit from its
acquisition of New River Pharmaceuticals Inc.; the successful development of
JUVISTA(R), and other risks and uncertainties detailed from time to time in
Shire 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, 2006.

© PR Newswire Association LLC.

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