Shire to Present Scientific Data Across a Range of Psychiatric Disorders at American Psychiatric Association Annual Meeting

Philadelphia (ots/PRNewswire) -

Research explores data on treatments for psychiatric disorders;
health

economics and outcomes research also to be presented

Shire plc , the global specialty biopharmaceutical company,
announces that it will present scientific data in 7 poster
presentations at the American Psychiatric Association (APA) 166th
Annual Meeting in San Francisco, May 18-22. The data being presented
represent Shire's ongoing commitment to the clinical research of
Vyvanse(R) (lisdexamfetamine dimesylate) Capsules, (CII) and
INTUNIV(R) (guanfacine) Extended-Release Tablets, its approved
prescription medicines for Attention-Deficit/Hyperactivity Disorder
(ADHD). Data being presented include post-hoc analyses from several
of its phase 2 clinical studies investigating potential new
psychiatric uses of Vyvanse for the adjunctive treatment for Major
Depressive Disorder (MDD) and for the treatment of Binge Eating
Disorder (BED). Shire also will present health economic data on
INTUNIV and outcomes research in ADHD. Vyvanse and INTUNIV should
only be used to treat ADHD.

"Shire is committed to research in the field of neuroscience and
developing treatment options for conditions that have significant
unmet patient need, such as MDD and BED," said Arnaud Partiot, MD,
PhD, Shire senior vice president, Research and Development.

Vyvanse is a once-daily prescription medication for patients ages
6 and above with Attention-Deficit/Hyperactivity disorder (ADHD) and
may be used as part of a total treatment program that may include
counseling or other therapies.

Vyvanse is a Schedule II controlled substance. CNS stimulants
(amphetamines and methylphenidate-containing products) have a high
potential for abuse and dependence. Assess the risk of abuse prior to
prescribing and monitor for signs of abuse and dependence.

INTUNIV is indicated for the treatment of ADHD as monotherapy and
as adjunctive therapy to stimulant medications in children and
adolescents ages 6 to 17. The effectiveness of INTUNIV for more than
8 weeks has not been systematically evaluated. The physician electing
to use INTUNIV for extended periods should periodically reevaluate
its long-term usefulness for the individual patient.

Patients with a history of hypersensitivity to INTUNIV, its
inactive ingredients, or other products containing guanfacine should
not take INTUNIV. Hypotension, bradycardia, and syncope were observed
in clinical trials. Somnolence and sedation were commonly reported
adverse reactions in clinical studies.

The titles, dates, and times of the APA scientific presentations
are noted below. Specific information about the data contained in
these scientific presentations is embargoed until the respective
presentation sessions have occurred at the meeting.

Lisdexamfetamine Dimesylate (Investigational New Uses)

- Sunday, May 19, 2013; 8:00am - 9:30am

Poster #NR4-25: "Lisdexamfetamine Dimesylate Safety and Efficacy
on Binge Eating Days/Episodes and Behavior in Adults With Moderate to
Severe Binge Eating Disorder"

Presenter: Susan McElroy, MD

- Monday, May 20, 2013; 2:00pm - 4:00pm

Poster #NR9-20: "Effects of Lisdexamfetamine Dimesylate
Augmentation on Sexual Function in Adults With Fully or Partially
Remitted Major Depressive Disorder"

Presenter: Anita Clayton, MD

- Monday, May 20, 2013; 2:00pm - 4:00pm

Poster #NR9-41: "Response to Lisdexamfetamine Dimesylate
Augmentation in Major Depression in People With or Without Baseline
Executive Function Impairment"

Presenter: Andrew Cutler, MD

- Monday, May 20, 2013; 2:00pm - 4:00pm

Poster #NR9-30: "Lisdexamfetamine Dimesylate Augmentation Therapy
in Anxious or Nonanxious Major Depressive Disorder"

Presenter: Bryan Dirks, MD

- Monday, May 20, 2013; 2:00pm - 4:00pm

Poster #NR9-38: "Post Hoc Analysis of Lisdexamfetamine Dimesylate
Augmentation Therapy Effects on Sleep-Related Endpoints in Adults
With Major Depressive Disorder"

Presenter: Angelo Sambunaris, MD

Guanfacine Extended Release (Health Economics and Outcomes
Research)

- Monday, May 20, 2013; 11:30pm - 1:00pm

Poster #NR8-51: "Period Prevalence of Stimulant Augmentation Among
Adolescents With ADHD in a U.S. Managed Care Population During 2009
and 2010"

Presenter: Vanja Sikirica, PharmD, MPH

ADHD Outcomes Research

- Monday, May 20, 2013; 11:30am - 1:00pm

Poster #NR8-29: "Long-Term Outcomes in
Attention-Deficit/Hyperactivity Disorder (ADHD): A Systematic Review
of Self Esteem and Social Functioning"

Presenter: Paul Hodgkins, PhD

ABOUT VYVANSE (lisdexamfetamine dimesylate)

Vyvanse, which was introduced in the United States in July 2007
for the treatment of ADHD in children ages 6 to 12 years, approved in
April 2008 to treat ADHD in adults, approved in November 2010 to
treat ADHD in adolescents ages 13 to 17, approved in January 2012 for
maintenance treatment in adults, and approved in April 2013 for
maintenance treatment in children and adolescents, is currently
available in the USA in six once-daily dosage strengths of 20 mg, 30
mg, 40 mg, 50 mg, 60 mg, and 70 mg. In addition to being available in
the USA and Canada, Vyvanse is approved in Brazil (brand name
Venvanse), Ireland (brand name Tyvense), and Denmark, Germany,
Norway, and the United Kingdom (brand name Elvanse). The efficacy and
tolerability of Vyvanse have been studied in clinical trials in both
the USA and Europe.

Vyvanse may be used as part of a total treatment program that may
include counseling or other therapies.

INDICATION

Vyvanse is indicated for the treatment of ADHD in patients ages 6
and above. Efficacy was established in short-term controlled studies
in children aged 6 to 17 and in adults. Vyvanse is also approved as a
maintenance treatment for patients ages 6 and above with ADHD based
on one maintenance study in patients aged 6 to 17 and one maintenance
study in adults.

IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE

- CNS stimulants (amphetamines and methylphenidate-containing products) have
a high potential for abuse and dependence.

Assess the risk of abuse prior to prescribing and monitor for
signs of abuse and dependence while on therapy.

Contraindications:

- Known hypersensitivity to amphetamines or other ingredients in Vyvanse.
Anaphylactic reactions, Stevens - Johnson syndrome, angioedema, and urticaria have
been observed in postmarketing reports.
- Concurrent administration of monoamine oxidase inhibitors (MAOI) or
administration of Vyvanse within 14 days of the last MAOI dose. Hypertensive
crisis can occur.
- Educate patients about abuse and periodically re-evaluate the need for
Vyvanse.
- Sudden death, stroke and myocardial infarction have been reported in
adults with CNS stimulant treatment at recommended doses. Sudden death has been
reported in children and adolescents with structural cardiac abnormalities and other
serious heart problems taking CNS stimulants at recommended doses for ADHD. Prior to
treatment assess for the presence of cardiac disease. Avoid use in patients with known
structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary
artery disease, and other serious heart problems. Further evaluate patients who
develop exertional chest pain, unexplained syncope, or arrhythmias during Vyvanse
treatment.
- CNS stimulants cause an increase in blood pressure (mean increase about 2-4 mm
Hg) and heart rate (mean increase about 3-6 bpm). Monitor all patients for tachycardia
and hypertension.
- Use of stimulants may cause psychotic or manic symptoms in patients with no
prior history, or exacerbation of symptoms in patients with preexisting psychosis.
Clinical evaluation for bipolar disorder is recommended prior to stimulant use.
- CNS stimulants have been associated with weight loss and slowing of growth
rate in pediatric patients. Monitor weight and height in children during treatment
with Vyvanse. Treatment may need to be interrupted in children not growing as
expected.
- The most common adverse reactions (greater than or equal to5% and at least
twice the rate of placebo) reported in clinical trials were:
- Children aged 6 to 12: decreased appetite, insomnia, upper abdominal pain,
irritability, vomiting, decreased weight, nausea, dry mouth and dizziness;
- Adolescents aged 13 to 17: decreased appetite, insomnia, and decreased
weight;
- Adults: decreased appetite, insomnia, dry mouth, diarrhea, nausea, anxiety
and anorexia.

Please click here for Full Prescribing Information
[http://pi.shirecontent.com/PI/PDFs/Vyvanse_USA_ENG.pdf ] for
Vyvanse, including Boxed WARNING regarding Potential for Abuse and
Dependence.

ABOUT INTUNIV (guanfacine)

Once-daily INTUNIV is available in four doses-1 mg, 2 mg, 3 mg,
and 4 mg. The active ingredient in INTUNIV is guanfacine. INTUNIV is
not a central nervous system (CNS) stimulant or a controlled
substance, and has no known potential for abuse or dependence.
INTUNIV is a selective alpha-2A agonist. The mechanism of action of
guanfacine in ADHD is not known.

INDICATION

- INTUNIV is indicated for the treatment of ADHD as monotherapy and as
adjunctive therapy to stimulant medications in children and adolescents ages 6 to 17.
The effectiveness of INTUNIV for more than 8 weeks has not been systematically
evaluated. The physician electing to use INTUNIV for extended periods should
periodically reevaluate its long-term usefulness for the individual patient.

IMPORTANT SAFETY INFORMATION

- Patients with a history of hypersensitivity to INTUNIV, its inactive
ingredients, or other products containing guanfacine should not take INTUNIV.
- Hypotension, bradycardia, and syncope were observed in clinical trials.
Decreases in blood pressure and heart rate were dose-dependent and were less
pronounced over time of treatment. Heart rate and blood pressure should be measured
prior to initiation of therapy, following dose increases, and periodically while on
therapy. Use INTUNIV with caution in patients with a history of hypotension, heart
block, bradycardia, cardiovascular disease, 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. Advise patients to avoid becoming dehydrated or overheated.
- Somnolence and sedation were commonly reported adverse reactions in clinical
studies. The potential for additive sedative effects with CNS depressant drugs should
be considered. Caution patients against operating heavy equipment or driving until
they know how they respond to INTUNIV. Advise patients to avoid use with alcohol.
- The most common adverse reactions (incidence greater than or equal to5% and at
least twice the rate for placebo) in the monotherapy trials with INTUNIV were
somnolence, fatigue, nausea, lethargy, and hypotension, and in the adjunctive trial
with INTUNIV were somnolence, fatigue, insomnia, dizziness, and abdominal pain.

Please see Full Prescribing Information
[http://pi.shirecontent.com/?product=intuniv&country=USA&language=ENG
], including Patient Information.

About ADHD

Attention-Deficit/Hyperactivity Disorder is a neurobehavioral
disorder that manifests as a persistent pattern of inattention and/or
hyperactivity-impulsivity and is more frequent and severe than is
typically observed in individuals at a comparable level of
development.

ADHD is one of the most common childhood psychiatric disorders.
Although many people tend to think of ADHD as a childhood problem,
60% to 85% of children with ADHD may continue to meet the criteria
for the disorder during their teenage years. Nearly 50% of children
with ADHD may continue to meet the criteria for the disorder in
adulthood, based on parent-report. The disorder is 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,
approximately 10 million adults are estimated to have ADHD. Drug
treatment may not be appropriate for all patients with ADHD.

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 specified in the Diagnostic
and Statistical Manual of MentalDisorders, 4th Edition, Text Revision
(DSM-IV-TR(R)) or International Classification of Diseases, 10th
revision (ICD-10).

Although there is no cure for ADHD, there are accepted treatments
that have been demonstrated to improve symptoms. Standard treatments
include educational approaches, psychological therapies which may
include behavioral modification, and/or medication.

NOTES TO EDITORS

Shire enables people with life-altering conditions to lead better
lives.

Our strategy is to focus on developing and marketing innovative
specialty medicines to meet significant unmet patient needs.

We provide treatments in Neuroscience, Rare Diseases,
Gastrointestinal, Internal Medicine and Regenerative Medicine and we
are developing treatments for symptomatic conditions treated by
specialist physicians in other targeted therapeutic areas.

http://www.shire.com

FORWARD - LOOKING STATEMENTS - "SAFE HARBOR" STATEMENT UNDER THE
PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

Statements included in this announcement that are not historical
facts are forward-looking statements. 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 adversely affected. The risks and
uncertainties include, but are not limited to, that:

- Shire's products may not be a commercial success;
- revenues from ADDERALL XR are subject to generic erosion;
- the failure to obtain and maintain reimbursement, or an adequate level of
reimbursement, by third-party payors in a timely manner for Shire's products may
impact future revenues and earnings;
- Shire relies on a single source for manufacture of certain of its products and
a disruption to the supply chain for those products may result in Shire being unable
to continue marketing or developing a product or may result in Shire being unable to
do so on a commercially viable basis;
- Shire uses third party manufacturers to manufacture many of its products and
is reliant upon third party contractors for certain goods and services, and any
inability of these third party manufacturers to manufacture products, or any failure
of these third party contractors to provide these goods and services, in each case in
accordance with its respective contractual obligations, could adversely affect Shire's
ability to manage its manufacturing processes or to operate its business;
- the development, approval and manufacturing of Shire's products is subject to
extensive oversight by various regulatory agencies and regulatory approvals or
interventions associated with changes to manufacturing sites, ingredients or
manufacturing processes could lead to significant delays, increase in operating costs,
lost product sales, an interruption of research activities or the delay of new product
launches;
- the actions of certain customers could affect Shire 's ability to sell or
market products profitably and fluctuations in buying or distribution patterns by such
customers could adversely impact Shire's revenues, financial conditions or results of
operations;
- investigations or enforcement action by regulatory authorities or law
enforcement agencies relating to Shire's activities in the highly regulated markets in
which it operates may result in the distraction of senior management, significant
legal costs and the payment of substantial compensation or fines;
- adverse outcomes in legal matters and other disputes, including Shire's
ability to obtain, maintain, enforce and defend patents and other intellectual
property rights required for its business, could have a material adverse effect on
Shire's revenues, financial condition or results of operations;

and other risks and uncertainties detailed from time to time in
Shire's filings with the U.S. Securities and Exchange Commission,
including its most recent Annual Report on Form 10-K.

VIU-05006 05/13

Vyvanse(R) and INTUNIV(R) are registered trademarks of Shire LLC.

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, jmann@shire.com, +44-1256-894-280
Gwen Fisher, gfisher@shire.com, +1-484-595-9836

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