Shire to Present Important Study Findings on its ADHD Treatments at a Major Psychiatric Meeting on October 29 and 30

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Thu Oct 29, 2009 2:07pm EDT

Shire to Present Important Study Findings on its ADHD Treatments at a Major
Psychiatric Meeting on October 29 and 30



HONOLULU, Oct. 29 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, Nasdaq:
SHPGY), the global specialty biopharmaceutical company, announced today that
it will present key scientific data on its Attention-Deficit/Hyperactivity
Disorder (ADHD) treatments, INTUNIV(TM) (guanfacine) Extended Release Tablets,
Vyvanse®( ) (lisdexamfetamine dimesylate) Capsules CII, and Daytrana®( )
(methylphenidate transdermal system) CII, at a national meeting of
psychiatrists to be held October 27 - November 1 in Honolulu.

"Shire is committed to the advancement of ADHD treatment research and is
leading the way in developing a diverse range of safe and effective ADHD
treatments," said Michael Yasick, Senior Vice President of the Shire ADHD
Business Unit. "We are excited to provide new scientific data on our ADHD
portfolio, which includes the newest FDA-approved ADHD treatment INTUNIV;
Vyvanse, the first prodrug stimulant for the treatment of ADHD; and Daytrana,
the only patch approved for the treatment of ADHD.  We are proud to provide
important contributions to the growing body of research on our ADHD portfolio
to the medical community."

Following is a summary of the key Shire scientific presentations.  Information
about these data presentations mentioned in this media alert is embargoed
until the respective presentation sessions have taken place at the meeting.

INTUNIV (guanfacine) Extended Release Tablets

October 29, 2009; 6:30 pm to 9:00 pm ET / 12:30 pm to 3:00 pm HT
Effects of Guanfacine Extended Release in Children Aged 6 to 12 With
Oppositional Symptoms and a Diagnosis of ADHD
Poster Presentation # 3.8

October 29, 2009; 6:30 pm to 9:00 pm ET / 12:30 pm to 3:00 pm HT
Twenty-Four-Month Effectiveness of Guanfacine Extended Release in Children and
Adolescents Aged 6 to 17 Years With ADHD 
Poster Presentation # 3.24

Vyvanse (lisdexamfetamine dimesylate) Capsules CII

October 29, 2009; 6:30 pm to 9:00 pm ET / 12:30 pm to 3:00 pm HT
The Effects of Lisdexamfetamine Dimesylate on Emotional Lability in Children 6
to 12 Years of Age With ADHD in a Double-Blind, Placebo-Controlled Trial 
Poster Presentation # 3.6

October 29, 2009; 6:30 pm to 9:00 pm ET / 12:30 pm to 3:00 pm HT
Reading Performance as a Function of Treatment With Lisdexamfetamine
Dimesylate in Elementary School Children Diagnosed With ADHD 
Poster Presentation # 3.19

October 29, 2009; 6:30 pm to 9:00 pm ET / 12:30 pm to 3:00 pm HT
Clinical Response and Symptomatic Remission in Children Treated With
Lisdexamfetamine Dimesylate for ADHD 
Poster Presentation # 3.20

October 29, 2009; 6:30 pm to 9:00 pm ET / 12:30 pm to 3:00 pm HT 
Cardiovascular Outcomes in Children and Adults Treated With Lisdexamfetamine
Dimesylate for ADHD 
Poster Presentation # 3.23

Daytrana (methylphenidate transdermal system) CII

October 30, 2009; 3:00 pm to 5:30 pm ET / 9:00 am to 11:30 am HT
Pharmacokinetics of Methylphenidate Transdermal System and Osmotic-Release
Oral System Methylphenidate in Children and Adolescents With ADHD
Poster Presentation # 4.52

October 30, 2009; 3:00 pm to 5:30 pm ET / 9:00 am to 11:30 am HT
Pharmacokinetic Predictors of Abuse-Related Liking With Transdermal and
Subcutaneous Methylphenidate
Poster Presentation # 4.54

October 30, 2009; 3:00 pm to 5:30 pm ET / 9:00 am to 11:30 am HT
Evaluation of the Tolerability and Effectiveness of the Methylphenidate
Transdermal System Over 6 Months in Adolescents With ADHD
Poster Presentation # 4.55

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

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

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

INTUNIV 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. 

VYVANSE IMPORTANT SAFETY INFORMATION
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.

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 you or your child develops symptoms that suggest
heart problems, such as chest pain or fainting.

Vyvanse should not be taken if you or 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 you or 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 you or 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.

Talk to your health care provider if your child experiences slowing of growth
(height and weight).  Children should have their height and weight checked
periodically while taking Vyvanse.  Your health care provider may stop Vyvanse
treatment if a problem is found during these check-ups.

Vyvanse was generally well tolerated in clinical studies.  The most common
side effects reported in studies of Vyvanse were: children -- decreased
appetite, difficulty falling asleep, stomachache, and irritability; adult --
decreased appetite, difficulty falling asleep, and dry mouth.  

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 you or your
child has blurred vision while taking Vyvanse.

DAYTRANA IMPORTANT SAFETY INFORMATION
Daytrana is indicated for the treatment of ADHD in children aged 6 to 12
years.

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

Daytrana should not be used if the child has: significant anxiety, tension, or
agitation; allergies to methylphenidate or other ingredients of Daytrana;
glaucoma; discontinued in the last 14 days or is taking a monoamine oxidase
inhibitor (MAOI); tics, or family history or diagnosis of Tourette's syndrome.

Tell your doctor before using Daytrana if the child: is being treated for or
has symptoms of depression (e.g. sadness, worthlessness, or hopelessness) or
bipolar disorder; has family history of tics; has abnormal thoughts 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 your doctor immediately if the child
develops any of these conditions/symptoms while using Daytrana.

In clinical studies, side effects were generally mild to moderate. The most
common side effects reported with Daytrana were decreased appetite,
sleeplessness, sadness/crying, twitching, weight loss, nausea, vomiting, tics,
and affect lability (mood swings). Aggression, new abnormal
thoughts/behaviors, mania, and growth suppression have been associated with
use of drugs of this type. Talk to your health care provider if your child
experiences slowing of growth (height and weight). Children should have their
height and weight checked periodically while taking Daytrana. Your healthcare
provider may stop Daytrana treatment if a problem is found during these
check-ups. Tell your doctor if the child has blurred vision while using
Daytrana.

Abuse of Daytrana can lead to dependence.

Daytrana should be applied daily to clean, dry skin, which is free of any cuts
or irritation. Skin redness or itching is common with Daytrana. Allergic skin
rash may occur.

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 syndrome.  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

Media: Matthew Cabrey (Shire North America), +1-484-595-8248; Debra Gemme
(Porter Novelli for Shire), +1-212-601-8342, +1-703-298-4030 (mobile), or
Mindy Huber (Porter Novelli for Shire), +1-212-601-8330, +1-917-653-6134
(mobile)
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