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FDA Approves INTUNIV(R) (guanfacine) Extended-Release Tablets for Use as Adjunctive Therapy to Stimulants for the Treatment of ADHD in Children and Adolescents

February 28, 2011

PHILADELPHIA, February 28, 2011 /PRNewswire-FirstCall/ — Shire plc,
(http://www.shire.com/shireplc/en/home ) (LSE: SHP, NASDAQ: SHPGY), the
global specialty biopharmaceutical company, today announced that the US Food
and Drug Administration (FDA) approved the use of once-daily INTUNIV(R)
(guanfacine) Extended-Release Tablets (http://www.intuniv.com/) as adjunctive
therapy to stimulants for the treatment of attention deficit hyperactivity
disorder (ADHD) in children and adolescents ages 6 to 17 as part of a total
treatment program. The approval is based on results from a 9-week
placebo-controlled study of INTUNIV when given in combination with a
stimulant, in children and adolescents with ADHD.(1)

“This approval of INTUNIV for treating ADHD as adjunctive therapy to a
stimulant offers physicians a new treatment option for children and
adolescents with ADHD who are having a suboptimal response to their current
stimulant therapy,” said Robert Findling, MD, Director of Child & Adolescent
Psychiatry at University Hospitals Case Medical Center and Professor of
Psychiatry & Pediatrics at Case Western Reserve University School of
Medicine, a lead investigator for the study. “In this study, the once-daily
dosing of INTUNIV was effective when taken in the morning or the evening,
giving physicians flexibility when it comes to treating their patients with
ADHD.”

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 9 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. INTUNIV is indicated as an integral part of a total
treatment program for ADHD that may include other measures (psychological,
educational, and social).(1)

INTUNIV is the only once-daily ADHD medication approved for
administration as adjunctive therapy to stimulants. INTUNIV, a nonstimulant,
is a selective alpha-2A agonist.(1)

During the 9-week, multicenter, double-blind, randomized,
placebo-controlled study, patients (N=455) experiencing a suboptimal response
to stimulant treatment for ADHD received a morning or evening dose of INTUNIV
(1 mg, 2 mg, 3 mg, or 4 mg) or placebo in combination with their prescribed
dose of a stimulant.(2) Clinicians using the ADHD-RS-IV, which includes both
hyperactive/impulsive and inattentive subscales, reported significant
reductions in total scores from baseline at end point for patients receiving
INTUNIV and stimulant when INTUNIV was dosed either in the morning or
evening, compared with placebo and stimulant.(2)

Suboptimal response was defined as treatment with a stable dose of
stimulant for at least four weeks with improvement, yet persistence of mild
to moderate ADHD symptoms in the opinion of the investigator (defined as an
ADHD-RS-IV total score of at least 24, Clinical Global Impressions-Severity
of Illness scale score of at least three). Patients with no response to
stimulants prior to study enrollment were excluded from participating in this
study.(2)

The most commonly observed adverse reactions (incidence greater than or
equal to 5 percent and at least twice the rate for placebo) in this
adjunctive trial were: somnolence, fatigue, insomnia, dizziness, and
abdominal pain.(1) The majority of events were mild or moderate in severity
and no unique events were observed with INTUNIV given with a stimulant
compared with those reported historically for either treatment alone.(2)
Three percent of patients receiving INTUNIV plus stimulant discontinued from
the study due to adverse events, compared to 1 percent in the placebo plus
stimulant group.(1)

Four serious adverse events (SAEs) were reported in the study and
included syncope, mixed disturbance of emotions (similar to behaviors prior
to study start), poison ivy, and a nonintentional overdose in a sibling of a
study participant. All SAEs were considered by the investigator to be
unrelated to INTUNIV.(2)

“This approval marks a significant development in our ADHD portfolio-one
that may help to address symptoms (
http://www.intuniv.com/attention-deficit-hyperactivity-disorder/symptoms-of-a
dhd.aspx) that many children with ADHD may experience while on stimulant
treatment,” said Michael Yasick, Senior Vice President of Shire’s ADHD
Business Unit. “We understand that every child is unique, and it is our goal
to offer treatment options for ADHD in a variety of situations, whether a
child could benefit from treatment with a stimulant, nonstimulant, or both.”

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About INTUNIV

INTUNIV is available in four doses(
http://www.intuniv.com/adhd-medication/intuniv-dosing.aspx) -1 mg, 2 mg, 3
mg, and 4 mg.(1) INTUNIV should be taken once a day.(1) The active ingredient
in INTUNIV is guanfacine. INTUNIV is not a central nervous system (CNS)
stimulant or a controlled substance.(1) It is not likely to cause dependence
or be abused.(1)

IMPORTANT SAFETY INFORMATION

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 (eg, TENEX(R)).

Hypotension, bradycardia, and syncope were observed in clinical trials.
Use INTUNIV with caution in treating patients who have experienced
hypotension, heart block, bradycardia, 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. Advise patients to avoid becoming dehydrated
or overheated.

Somnolence and sedation 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. Advise patients to avoid
use with alcohol.

The most common adverse reactions (incidence greater than or equal to 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://www.intuniv.com/adhd-medication/intuniv-dosing.aspx)

Additional information about INTUNIV is available at intuniv.com.

About ADHD

Attention deficit hyperactivity disorder (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.(3)

ADHD is one of the most common childhood psychiatric disorders.(4) In the
United States
, the prevalence of ADHD is approximately three to seven percent
in school-aged children according to the Centers for Disease Control and
Prevention (CDC).(5)

The specific etiology of ADHD is unknown, and there is no single
diagnostic test for this disorder.(4) 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 Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR(R)) or
International Classification of Diseases, 10th revision (ICD-10).(3,4)

Although there is no cure for ADHD, there are accepted treatments that
have been demonstrated to improve symptoms.(4) Standard treatments include
educational approaches, psychological therapies that may include behavioral
modification, and/or medication.(4)

Notes to editors

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 website:
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.

References:

1) INTUNIV [package insert], Wayne, PA: Shire US Inc.; 02/2011.

2) Wilens T, Bukstein OG, Cutler AJ, Findling RL, Youcha S, White C,
Rubin J. A multicenter placebo controlled study of extended-release
guanfacine coadministered with stimulants in the treatment of ADHD: Effects
on overall, morning, and evening ADHD assessments. Paper presented at:
American Academy of Child and Adolescent Psychiatry Annual Meeting; October
28, 2010
; New York, NY.

3) American Psychiatric Association. Diagnostic and Statistical Manual of
Mental Disorders. 4th ed., Text Revision (DSM-IV-TR (R)). Washington, DC:
American Psychiatric Association; 2000:85-93.

4) Pliszka S and the AACAP Work Group on Quality Issues. Practice
parameter for the assessment and treatment of children and adolescents with
attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry.
2007;46(7):894-921.

5) Centers for Disease Control and Prevention. Increasing prevalence of
parent reported attention deficit/hyperactivity disorder among
children-United States, 2004 and 2007. Morb Mortal Weekly Rep (MMWR).
2010;59(44):1439-1443.

    For further information please contact:

    Media

    Matthew Cabrey
    (mcabrey@shire.com)
    +1-484-595-8248

    Jennifer Sohn
    (Jennifer.sohn@toniclc.com)
    (Tonic Life Communications for Shire)
    +1-215-928-2183

SOURCE Shire plc


Source: newswire



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