Once-Daily INTUNIV(TM) (guanfacine) Extended Release Tablets Now Available in Pharmacies Nationwide

Once-Daily INTUNIV(TM) (guanfacine) Extended Release Tablets Now Available in
Pharmacies Nationwide
In clinical studies, INTUNIV, a nonscheduled treatment for ADHD, demonstrated
significant improvement in reducing ADHD symptoms which can be disruptive at
home and at school

PHILADELPHIA, Nov. 9 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, Nasdaq:
SHPGY), the global specialty biopharmaceutical company, today announced the
availability of INTUNIV(TM) (guanfacine) Extended Release Tablets in
pharmacies across the United States for the treatment of
Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents
ages 6 to 17. INTUNIV, a once-daily formulation of guanfacine, is the first
and only nonscheduled alpha-2A receptor agonist approved for the treatment of
ADHD. In clinical trials, INTUNIV provided significant efficacy across the
spectrum of ADHD symptoms that can be disruptive, such as being easily
distracted, interrupting others, running around excessively, arguing with
adults, and losing temper.

"INTUNIV has been shown to improve a range of ADHD symptoms and provides
prescribers and patients with another treatment option for this complex
disorder," said Rakesh Jain, MD, MPH, Director of Psychopharmacology Research
at R/D Clinical Research, Inc, in Lake Jackson, Texas. "In clinical studies,
INTUNIV was shown to provide significant ADHD symptom improvement across a
full day, as reported by parents at approximately 6 pm, 8 pm, and 6 am the
next morning. These findings suggest that INTUNIV may be an important
treatment option for children and adolescents with ADHD who are faced with the
complexities of the disorder, both at school and at home. Because of this,
many clinicians such as myself, have been highly anticipating its
availability."

The US Food and Drug Administration (FDA) approved INTUNIV on September 2,
2009. Once-daily INTUNIV is now available in US pharmacies in four dosage
strengths (1 mg, 2 mg, 3 mg, and 4 mg) and is marketed in the United States by
the existing Shire ADHD sales team of nearly 600 representatives. INTUNIV is
not a controlled substance and has no known potential for abuse or dependence.

"INTUNIV is the newest ADHD treatment to receive FDA approval and the latest
addition to the Shire ADHD portfolio. The availability of INTUNIV now allows
physicians to prescribe the first and only nonscheduled alpha-2A receptor
agonist indicated for the treatment of ADHD to help their patients manage a
range of ADHD symptoms," said Michael Yasick, Senior Vice President of the
ADHD Business Unit at Shire. "Shire is proud to provide physicians and the
ADHD community with a novel treatment choice, which expands the range of
available treatment options, allowing physicians to optimize the management of
ADHD."

The commitment of Shire to making INTUNIV available for ADHD patients is
consistent with the company's strategy to expand and diversify its ADHD
portfolio, which now consists of four ADHD treatment options of scheduled and
nonscheduled medicines in the United States and three medicines approved for
the treatment of ADHD outside the United States.

About INTUNIV
The efficacy of INTUNIV in the treatment of ADHD was established in two,
similarly designed, placebo-controlled clinical trials in children and
adolescents aged 6 to 17 years who met Diagnostic and Statistical Manual of
Mental Disorders-IV (DSM-IV®) criteria for ADHD. Statistically significant
improvements were reported by investigators, parents, and teachers.

The first pivotal trial was a phase III, double-blind, parallel-group trial,
in which investigators randomized 345 children aged 6 to 17 years to either a
placebo or a fixed 2-mg, 3-mg, or 4-mg dose of INTUNIV given once daily during
an eight-week period. The second pivotal trial was a phase III, double-blind,
parallel-group trial, in which investigators randomized 324 children aged 6 to
17 years to either a placebo or a fixed 1-mg, 2-mg, 3-mg, or 4-mg dose of
INTUNIV given once daily during a nine-week period, with the 1 mg assigned
only to patients weighing less than 50 kg (110 lbs).

In both trials, doses were increased in increments of 1 mg per week, and
investigators evaluated participants' signs and symptoms of ADHD on a
once-weekly basis using the clinician administered and scored ADHD Rating
Scale-IV (ADHD-RS-IV), a scale frequently used in ADHD clinical trials that
assesses hyperactive, impulsive, and inattentive symptoms. The primary outcome
was the change in total ADHD-RS-IV scores from baseline to end point in both
studies.

Both trials demonstrated statistically significant improvements in ADHD-RS-IV
scores in patients taking INTUNIV beginning one to two weeks after patients
began receiving once-daily doses of INTUNIV. In the first pivotal trial, the
mean reduction in ADHD-RS-IV total scores at end point were -16.7 for INTUNIV
compared to -8.9 for placebo (P<.0001); the mean reduction in ADHD-RS-IV total
scores in the second pivotal trial were -19.6 for INTUNIV and -12.2 for
placebo (P=.0040). Placebo-adjusted LS mean changes from baseline were
statistically significant for all INTUNIV doses in the randomized treatment
groups in both studies.

Additional secondary efficacy outcome measures included the Conners' Parent
Rating Scale-Revised: Short Form (CPRS-R) and the Conners' Teacher Rating
Scale-Revised: Short Form (CTRS-R). CPRS-R and CTRS-R are comprehensive
scales that use parent and teacher observer and self-report ratings to help
assess ADHD symptoms and behaviors in children and adolescents. Among some of
the symptoms measured were: inattentiveness/being easily distracted, running
around or climbing excessively, arguing with adults, losing temper, and
interrupting or intruding on others. Significant improvements in mean day
total scores were seen on both scales: based on the CPRS-R, parents reported
significant improvement across a full day (as measured at 6 pm, 8 pm, and 6 am
the next morning); based on the CTRS-R, which was used only in the first
pivotal trial, teachers reported significant improvement throughout the school
day (as measured at 10 am and
2 pm).

Safety was also evaluated during these pivotal trials and safety data showed
that adverse events reported by participants using INTUNIV were generally mild
to moderate in severity. Treatment-related adverse events greater than 10
percent included somnolence (32 percent), headache (26 percent), fatigue (18
percent), upper abdominal pain (14 percent), and sedation (13 percent).
Sedation-related, treatment emergent adverse events were among the most common
and were usually transient and mild to moderate in severity. Small to modest
changes in blood pressure, pulse rate, and ECG parameters were observed.

Additional information about INTUNIV and Full Prescribing Information are
available at http://www.intuniv.com.

Important Safety Information
INTUNIV is indicated for the treatment of Attention Deficit Hyperactivity
Disorder (ADHD) in children and adolescents aged 6 to 17. Efficacy was
established in two controlled clinical trials (8 and 9 weeks in duration). The
physician electing to use INTUNIV for extended periods should periodically
reevaluate its long-term usefulness for the individual patient.

INTUNIV should not be used in patients with a history of hypersensitivity to
guanfacine or any of its inactive ingredients or by patients taking other
products containing guanfacine.

Hypotension, bradycardia, and syncope were observed in clinical trials. Use
INTUNIV with caution in treating patients who have experienced hypotension,
bradycardia, heart block, or syncope, or who may have a condition that
predisposes them to syncope; are treated concomitantly with antihypertensives
or other drugs that can reduce blood pressure or heart rate or increase the
risk of syncope. Heart rate and blood pressure should be measured prior to
initiation of therapy, following dose increases, and periodically while on
therapy. Patients should be advised to avoid becoming dehydrated or
overheated.

Sedation and somnolence were commonly observed in clinical trials. The
potential for additive sedative effects with CNS depressant drugs should be
considered. Patients should be cautioned against operating heavy equipment or
driving until they know how they respond to INTUNIV. Avoid use with alcohol.

Common adverse reactions in patients taking INTUNIV that may be dose related
over the range of 1 to 4 mg/day include somnolence, sedation, abdominal pain,
dizziness, hypotension/decreased blood pressure, dry mouth, and constipation.

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).

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.

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, 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

Investor Relations, Clea Rosenfeld (Rest of the World), +44 1256 894 160, or
Eric Rojas (North America), +1-617-551-9715, or Media, Jessica Mann (Rest of
the World), +44 1256 894 280, or Matthew Cabrey (North America),
+1-484-595-8248, or Debra Gemme of Porter Novelli for Shire, +1-212-601-8342