Shire Reports Findings From an Analysis Examining Emotional Lability in Children With ADHD Taking Vyvanse(R) (lisdexamfetamine dimesylate) Capsules CII

Shire Reports Findings From an Analysis Examining Emotional Lability in
Children With ADHD Taking Vyvanse(R) (lisdexamfetamine dimesylate) Capsules
CII
Post hoc analysis of Phase 3 study data presented at national psychiatric
meeting

PHILADELPHIA, Nov. 12 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, Nasdaq:
SHPGY), the global specialty biopharmaceutical company, announced findings
from a post hoc analysis examining emotional lability from Phase 3 study data
with Vyvanse®. In this study, Vyvanse demonstrated significant improvement in
Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms as measured by the
ADHD Rating Scale IV (ADHD-RS IV) and Connors' Parent Rating Scale-Revised
Short (CPRS-RS) in children with ADHD aged 6 to 12 years. The post hoc
analysis showed that patients demonstrated an improvement in emotional
lability composite CPRS-RS scores while taking Vyvanse as compared to placebo.
These results were presented recently at a psychiatric meeting in Honolulu.

"Children taking ADHD medications can experience emotional lability, often
described as frequent changes in emotions or mood. Therefore, evaluating the
impact of ADHD treatments, including Vyvanse, on children's emotional lability
may be important for parents and health care professionals when assessing a
child's treatment plan," said Ann C. Childress, MD, study investigator and
president of the Center for Psychiatry and Behavioral Medicine, Inc. in Las
Vegas.

About the Analysis and Study

This post hoc analysis was based on a Phase 3, randomized, double-blind,
placebo-controlled trial with forced-dose escalation of Vyvanse (30, 50, or 70
mg/d) or placebo in 285 children aged 6 to 12 years with ADHD. The primary
end point of the study was the ADHD-RS IV, and secondary end points included
CPRS-RS and safety. The CPRS-RS scale in its entirety contains 27 items to
evaluate children's behaviors based on parents' responses. Each of the
CPRS-RS 27 items is scored from zero as "Not At All True/Never, Seldom" up to
three as "Very Much True/Very Often, Very Frequent." Parents completed the
CPRS at 10 AM, 2 PM, and 6 PM at study start and on the day before their
children made the weekly study visits. In the post hoc analysis, the
children's emotional lability score was determined based on the sum of their
average scores from three items on the CPRS-RS: angry/resentful, loses
temper, and irritable. Patients were then grouped into those with and without
prominent emotional lability at study start (scores greater than three versus
scores of three or less) so that each group could be evaluated separately.

Overall, the children's average emotional lability scores significantly
improved with Vyvanse treatment compared with placebo across the day (10 AM, 2
PM, and 6 PM) from study start to end (all P less than or equal to .0004).

As expected, treatment with Vyvanse, compared to placebo, did not result in
significant improvements in emotional lability scores from study start to end
in those without prominent emotional lability prior to treatment. However,
treatment with Vyvanse, compared to placebo, yielded significant improvements
in the emotional lability scores of those children with prominent emotional
lability (P<.0001).

The most common treatment-emergent adverse events reported in this study for
patients taking Vyvanse were decreased appetite, insomnia, upper abdominal
pain, headache, irritability, vomiting, weight decrease, nausea, dizziness,
and dry mouth.

Vyvanse, which was introduced in the United States in July 2007 for the
treatment of ADHD in children aged 6 to 12 years and approved in April 2008 to
treat ADHD in adults, is currently available in six dosage strengths of 20 mg,
30 mg, 40 mg, 50 mg, 60 mg, and 70 mg.

Vyvanse is a therapeutically inactive prodrug stimulant, in which
d-amphetamine is covalently bonded to l-lysine, and after oral ingestion it is
converted to pharmacologically active d-amphetamine. The conversion of
Vyvanse to d-amphetamine is not affected by gastrointestinal pH and is
unlikely to be affected by alterations in GI transit times.

Additional information about Vyvanse and Full Prescribing Information,
including the Medication Guide, are available at http://www.vyvanse.com.

About Vyvanse

Vyvanse is indicated for the treatment of ADHD. Efficacy based on two
controlled trials in children aged 6 to 12 and one controlled trial in adults.

Vyvanse should not be taken by patients who have advanced arteriosclerosis;
symptomatic cardiovascular disease; moderate to severe hypertension;
hyperthyroidism; known hypersensitivity or idiosyncrasy to sympathomimetic
amines; agitated states; glaucoma; a history of drug abuse; or during or
within 14 days after treatment with monoamine oxidase inhibitors (MAOIs).

Sudden death has been reported in association with CNS stimulant treatment at
usual doses in children and adolescents with structural cardiac abnormalities
or other serious heart problems. Sudden death, stroke, and myocardial
infarction have been reported in adults taking stimulant drugs at usual doses
in ADHD. Physicians should take a careful patient history, including family
history, and physical exam, to assess the presence of cardiac disease.
Patients who report symptoms of cardiac disease such as exertional chest pain
and unexplained syncope should be promptly evaluated. Use with caution in
patients whose underlying medical condition might be affected by increases in
blood pressure or heart rate.

New psychosis, mania, aggression, growth suppression, and visual disturbances
have been associated with the use of stimulants. Use with caution in patients
with a history of psychosis, seizures or EEG abnormalities, bipolar disorder,
or depression. Growth should be monitored in children during treatment with
stimulants, and patients who are not growing (gaining height or weight) as
expected may need to have their treatment interrupted.

Amphetamines have a high potential for abuse. Administration of amphetamines
for prolonged periods of time may lead to drug dependence. Particular
attention should be paid to the possibility of subjects obtaining amphetamines
for non-therapeutic uses or distribution to others and the drugs should be
prescribed or dispensed sparingly. Misuse of amphetamine may cause sudden
death and serious cardiovascular adverse events.

The most common adverse events reported in clinical studies of Vyvanse were:
pediatric - decreased appetite, insomnia, abdominal pain, and irritability;
adult - decreased appetite, insomnia, and dry mouth.

About ADHD

ADHD is one of the most common psychiatric disorders in children and
adolescents. Worldwide prevalence of ADHD is estimated at 5.3 percent (with
large variability), according to a comprehensive systematic review of this
topic published in 2007 in the American Journal of Psychiatry. In the United
States, approximately 7.8 percent of all school-aged children, or about 4.4
million children aged 4 to 17 years, have been diagnosed with ADHD at some
point in their lives, according to the Centers for Disease Control and
Prevention (CDC). The disorder is also estimated to affect 4.4 percent of US
adults aged 18 to 44 based on results from the National Comorbidity Survey
Replication. When this percentage is extrapolated to the full US population
aged 18 and over, almost 10 million adults are believed to have ADHD.

ADHD is a psychiatric behavioral 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. The specific etiology of ADHD is unknown and there is no single
diagnostic test for this disorder. Adequate diagnosis requires the use of
medical and special psychological, educational, and social resources,
utilizing diagnostic criteria such as Diagnostic and Statistical Manual of
Mental Disorders-IV (DSM-IV®) or International Classification of Diseases 10
(ICD-10).

Although there is no cure for ADHD, there are accepted treatments that
specifically target its symptoms. Standard treatments include educational
approaches, psychological or behavioral modification, and/or medication.

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 Web site:
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 Pharmaceutical 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.

SOURCE Shire plc

Matthew Cabrey, Shire North America, +1-484-595-8248, or Mindy Huber, Porter
Novelli for Shire, +1 212 601 8330, or +1 917 653 6134 (mobile)