Quantcast
Last updated on April 17, 2014 at 1:21 EDT

Shire to Present Scientific Data Across Range of Psychiatric Disorders at American Psychiatric Association Annual Meeting May 5-9

May 4, 2012

PHILADELPHIA, May 4, 2012 /PRNewswire/ –

Shire plc [http://www.shire.com/shireplc/en/home ] (LSE: SHP, NASDAQ: SHPGY), the
global specialty biopharmaceutical company, today announced that it will present
scientific data from one oral and 16 poster presentations at the American Psychiatric
Association (APA) 165th Annual Meeting to be held May 5-9. 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 treatments for ADHD. In addition to ADHD research, data being
presented will focus on investigational research in other psychiatric and neurobehavioral
disorders, such as major depressive disorder and negative symptoms of schizophrenia. Shire
also will present health economic outcomes research, as part of the company’s efforts to
develop cost-effective treatments for ADHD.

The new research poster entitled, “The Hidden Costs of Attention Deficit/Hyperactivity
Disorder (ADHD): A Focus on School and Work in the United States,” was selected by the
American Psychiatric Association to be highlighted at a special press briefing to be held
during the meeting on Sunday, May 6, at 11:30 am in the Pennsylvania Convention Center
room 104B.

“As a leader in the field of ADHD, Shire is committed to continuously expanding
research in this and other psychiatric disorders, as evidenced by the breadth of data
being presented at this important meeting,” said Jeffrey Jonas, M.D., Senior Vice
President of Research and Development for Shire’s Specialty Pharmaceuticals and
Regenerative Medicine Businesses. “With these data, we seek to further advance the body of
scientific and health economics knowledge across a range of serious conditions that
present significant challenges for patients including ADHD, major depressive disorder, and
negative symptoms of schizophrenia.”

Vyvanse is a prescription medicine currently approved in the United States and Canada,
as well as in Brazil under the name Venvanse, for the treatment of
Attention-Deficit/Hyperactivity Disorder (ADHD). Vyvanse should be used to treat only
ADHD.

Vyvanse is a Schedule II controlled substance. Stimulants, such as amphetamines and
methylphenidates, are subject to misuse, abuse, addiction, and criminal diversion. Misuse
of amphetamines may cause sudden death and serious cardiovascular adverse events.

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.

Patients with a history of hypersensitivity to INTUNIV, its inactive ingredients, or
other products containing guanfacine (eg, TENEX(R)) should not take INTUNIV.

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

Highlights of the scientific presentations are noted below. Information about
scientific presentations mentioned in this release is embargoed until the respective
presentation sessions have taken place at the meeting.

ADHD Presentations

Lisdexamfetamine Dimesylate

        - May 5, 2012; 11:00 am to 12:30 pm EDT
          Duration of Action of Lisdexamfetamine Dimesylate in Children and Adolescents with
          Attention-Deficit/Hyperactivity Disorder Scientific and Clinical Report #2 (Oral
          Presentation) - Location: 109B, Level 1
        - May 6, 2012; 1:00 pm to 3:00 pm EDT
          Effect of Lisdexamfetamine Dimesylate on Symptoms of Hyperactivity/Impulsivity and
          Inattention in Children and Adolescents with ADHD Poster #NR4-16
        - May 6, 2012; 1:00 pm to 3:00 pm EDT
          Lisdexamfetamine Dimesylate Impact on 2 Subjective Quality-of-Life Scales in Adult
          Attention-Deficit/Hyperactivity Disorder and Executive Dysfunction Poster #NR4-17
        - May 6, 2012; 1:00 pm to 3:00 pm EDT
          Efficacy of Lisdexamfetamine Dimesylate on Self- and Informant-Reported Executive
          Dysfunction in Adults with Attention-Deficit/Hyperactivity Disorder Poster #NR4-21

Guanfacine Extended Release

        - May 6, 2012; 1:00 pm to 3:00 pm EDT
          Efficacy of Guanfacine Extended Release Administered in the Morning or Evening as
          Assessed by the Conners' Parent Rating Scale-Revised: Short Form Poster Presentation
          #NR4-15
        - May 6, 2012; 1:00 pm to 3:00 pm EDT
          ADHD Symptoms During Morning, Afternoon, and Evening with Guanfacine Extended Release
          Treatment Administered in the AM or PM Poster Presentation #NR4-20

Health Economics and Outcomes Research

        - May 6, 2012; 1:00 pm to 3:00 pm EDT
          A Comparison of Rates and Reasons for Urgent Care Utilization Among Children with ADHD
          Treated with Atypical Antipsychotics vs. Non-Antipsychotics Poster Presentation
          #NR4-12
        - May 6, 2012; 1:00 pm to 3:00 pm EDT
          Urgent Care Utilization for Adolescents Treated with Atypical Antipsychotics vs.
          Non-Antipsychotics: A Comparison of Rates and Reasons Poster Presentation #NR4-18
        - May 6, 2012; 1:00 pm to 3:00 pm EDT
          The Hidden Costs of Attention Deficit/Hyperactivity Disorder (ADHD): A Focus on School
          and Work in the United States Poster Presentation #NR4-19
        - May 8, 2012; 9:00 am to 10:30 am EDT
          Determining an Optimal Cut-Off Score for the WFIRS-P Using ROC Curve Analysis
          Poster Presentation #NR8-15

Presentations of Investigational New Uses Data for Lisdexamfetamine Dimesylate (Other
Psychiatric Disorders)

Major Depressive Disorder

        - May 6, 2012, 1:00 pm to 3:00 pm EDT
          Assessment of Executive Dysfunction in Adults With Major Depressive Disorder Receiving
          Lisdexamfetamine Dimesylate Augmentation of Escitalopram Poster Presentation #NR4-43
        - May 6, 2012, 1:00 pm to 3:00 pm EDT
          Efficacy of Lisdexamfetamine Dimesylate Augmentation for Executive Dysfunction in
          Adults With Fully or Partially Remitted Major Depressive Disorder Poster Presentation
          #NR4-46
        - May 8, 2012; 11:00 am to 12:30 pm EDT
          Lisdexamfetamine Dimesylate in the Treatment of Cognitive Dysfunction in Patients With
          Partially or Fully Remitted Major Depressive Disorder Poster Presentation #NR9-30
        - May 8, 2012; 11:00 am to 12:30 pm EDT
          Assessment of Anxiety in Adults With Fully or Partially Remitted Major Depressive
          Disorder Receiving Lisdexamfetamine Dimesylate Augmentation Therapy Poster
          Presentation #NR9-38

Negative Symptoms of Schizophrenia

        - May 5, 2012, 2:00 pm to 3:30 pm EDT
          Adjunctive Lisdexamfetamine Dimesylate With Antipsychotics: Effects on Negative
          Symptoms of Schizophrenia and Self-Reported Executive Function Poster Presentation
          #NR2-55
        - May 7, 2012, 11:00 am to 12:30 pm EDT
          Effect of Adding Lisdexamfetamine Dimesylate to Antipsychotics on Predominant Negative
          Symptoms of Schizophrenia: Analysis of PANSS Factors Poster Presentation #NR6-16
        - May 7, 2012, 11:00 am to 12:30 pm EDT
          Adding Lisdexamfetamine Dimesylate to Antipsychotics: Does Functional Capacity Improve
          in Tandem With Negative Symptoms of Schizophrenia? Poster Presentation #NR6-38

ABOUT VYVANSE (lisdexamfetamine dimesylate)

Vyvanse [http://www.vyvanse.com ], 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, and approved in November 2010 to treat ADHD in adolescents ages 13 to 17.

INDICATION

Vyvanse is indicated for the treatment of ADHD in patients ages 6 and above as part of
a total treatment plan that may include other measures (psychological, educational,
social). Efficacy was established in short-term controlled studies in children aged 6 to
17 and adults. Vyvanse is also approved as a maintenance treatment for adults with ADHD
based on one randomized withdrawal study. Extended use of Vyvanse should be periodically
reevaluated to determine its long-term usefulness for the individual patient.

IMPORTANT SAFETY INFORMATION

WARNING: POTENTIAL FOR MISUSE, ABUSE, ADDICTION, AND DIVERSION

See Full Prescribing Information for complete Boxed WARNING.

        - Vyvanse is a Schedule II controlled substance. Stimulants, such as
          amphetamines and methylphenidates, are subject to misuse, abuse, addiction, and
          criminal diversion.
        - Misuse of amphetamines may cause sudden death and serious cardiovascular
          adverse events.

        - Contraindications: Known hypersensitivity to amphetamines or other
          ingredients in Vyvanse. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema,
          and urticaria have been observed in postmarketing reports. Using Vyvanse with
          monoamine oxidase inhibitors (MAOIs) can result in hypertensive crisis. Stop MAOIs at
          least 14 days prior to Vyvanse use.
        - Sudden death, stroke and myocardial infarction have been reported with
          stimulants at usual doses for the treatment of ADHD. Stimulants generally should not
          be used in patients with known structural cardiac abnormalities or other serious heart
          problems. Adults have a greater likelihood than children of having such cardiac
          disease. Patients being considered for stimulant treatment should have a careful
          history (including family history of sudden death or ventricular arrhythmia) and
          physical exam to assess for the presence of cardiac disease. Further evaluation should
          be conducted if needed (eg, electrocardiogram and echocardiogram). Patients who
          develop symptoms suggestive of cardiac disease (eg, exertional chest pain, unexplained
          syncope) during stimulant treatment should undergo a prompt evaluation.
        - Use with caution in patients whose underlying medical condition might be
          compromised by increases in blood pressure or heart rate. Stimulants cause modest
          increases in average blood pressure (about 2-4 mmHg) and average heart rate (about 3-6
          bpm) and patients may have larger increases. Monitor all patients for larger changes.
        - Use of stimulants may cause psychotic or manic symptoms in patients with no
          prior history, or exacerbation of symptoms in patients with pre-existing psychosis.
          Clinical evaluation for bipolar disorder is recommended prior to stimulant use.
          Monitor for aggressive behavior.
        - Monitor growth in children during treatment with Vyvanse. Children who are not
          growing (gaining height or weight) as expected may need to have their treatment
          interrupted.
        - Stimulants may lower the convulsive threshold. Discontinue if seizures
          develop.
        - Visual disturbances and exacerbation of tics and Tourette's syndrome have been
          reported with stimulant treatment.
        - 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, decreased weight, vomiting, nausea, dizziness and dry mouth;
        - Adolescents aged 13 to 17: decreased appetite, insomnia, and decreased weight;
        - Adults: decreased appetite, insomnia, dry mouth, nausea, diarrhea, anxiety and
          anorexia.

Please see Full Prescribing Information
[http://pi.shirecontent.com/PI/PDFs/Vyvanse_USA_ENG.pdf ] for Vyvanse (lisdexamfetamine
dimesylate), including Boxed WARNING regarding Potential for Misuse, Abuse, Addiction, and
Diversion.

ABOUT INTUNIV (guanfacine) EXTENDED RELEASE TABLETS

INDICATION

INTUNIV (guanfacine) is indicated for the treatment of Attention Deficit Hyperactivity
Disorder (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).

IMPORTANT SAFETY INFORMATION

Patients with a history of hypersensitivity to INTUNIV, its inactive ingredients, or
other products containing guanfacine (eg, TENEX(R)) should not take INTUNIV.

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 reported adverse reactions in clinical studies
(38% for INTUNIV vs. 12% for placebo in monotherapy studies and 18% for INTUNIV vs. 7% for
placebo in the adjunctive study). 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.

Guanfacine, the active ingredient in INTUNIV, is also approved as an antihypertensive.
Do not use INTUNIV in patients concomitantly taking other guanfacine-containing products
(eg, TENEX).

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/PI/PDFs/Intuniv_USA_ENG.pdf ] for INTUNIV (guanfacine).

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.

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 Mental Disorders, Fourth Edition, Text Revision
(DSM-IV-TR(R)) or International Classification of Diseases, Tenth 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 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, human genetic therapies, gastrointestinal
diseases and regenerative medicine 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.

Vyvanse(R) is a registered trademark of Shire LLC.

Venvanse(TM) is a trademark of Shire Pharmaceuticals Ireland Ltd.

INTUNIV(R) is a registered trademark of Shire LLC.

“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 Pharmaceuticals, Human Genetic Therapies and
Regenerative Medicine products, as well as the ability to secure 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.

        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 (Corporate)
        jmann@shire.com
        +44-1256-894-280

        Gwen Fisher (Specialty Pharma)
        gfisher@shire.com
        +1-484-595-9836

SOURCE Shire plc


Source: PR Newswire