Shire to Present Scientific Data Across a Range of Psychiatric Disorders at
American Psychiatric Association Annual Meeting
PHILADELPHIA, May 17, 2013
PHILADELPHIA, May 17, 2013 /PRNewswire/ --
Research explores data on treatments for psychiatric disorders; health
economics and outcomes research also to be presented
Shire plc (LSE: SHP, NASDAQ: SHPG), 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 ^®
(lisdexamfetamine dimesylate) Capsules, (CII) and INTUNIV® (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
"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-cont aining products) have a high potential for abuse
and dependence. Assess the risk of abuse prior to prescribing and moni to
r 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
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
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
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
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.
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.
*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
*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
*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 (≥5% 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
*Adolescents aged 13 to 17: decreased appetite, insomnia, and
*Adults: decreased appetite, insomnia, dry mouth, diarrhea, nausea,
anxiety and anorexia.
Please click here for Full Prescribing Information 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.
*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
*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 ≥5% 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
Please see Full Prescribing Information , including Patient Information.
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 Mental
Disorders, 4th Edition, Text Revision (DSM-IV-TR®) or International
Classification of Diseases, 10 ^th 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,
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
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
*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.
Vyvanse ^® and INTUNIV ^® are registered trademarks of Shire LLC.
For further information please contact:
Inves to r Relations
Eric Rojas , email@example.com , +1-781-482-0999Sarah Elton-Farr ,
firstname.lastname@example.org , +44-1256-894157
Jessica Mann, email@example.com , +44-1256-894-280Gwen Fisher, firstname.lastname@example.org
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