Shire to Present Scientific Data at American Psychiatric Association Annual
PHILADELPHIA, May 2, 2014
PHILADELPHIA, May 2, 2014 /PRNewswire/ --
Shire plc (LSE: SHP, NASDAQ: SHPG), the global specialty biopharmaceutical
company, announces that seven posters highlighting scientific data and
clinical research will be presented at the upcoming American Psychiatric
Association (APA) 167^th Annual Meeting in New York City, May 3 to May 7,
2014. These data represent Shire's ongoing commitment to clinical research and
to understanding the unmet needs of patients.
"Improving the diagnosis and care of people living with mental health
disorders is a priority for Shire" said Phil Vickers, Global Head of Research
and Development for Shire. "For example, the research Shire is presenting at
APA exemplifies our commitment to better understanding binge eating disorder
and the needs of the adult patients who suffer from it."
Scientific Poster Presentations:
The titles and dates of the APA scientific presentations are noted below.
Specific information about the data contained in these scientific
presentations is embargoed until the start of the meeting.
o(Poster Number NR3-107; Sunday May 4, 10:30am EDT): Characteristics of
Patients with BED Compared to Patients with EDNOS and Patients Without an
Eating Disorder; Presented by Brandon Bellows, Pharm. D
o(Poster Number NR6-990; Monday May 5, 2:30pm EDT): Lisdexamfetamine
Dimesylate Effects on Cytochrome P450 Substrate Pharmacokinetics in
Healthy Adults in an Open-Label, Randomized, Crossover Study; Presented by
James Ermer, MS
o(Poster Number NR6-97; Monday May 5, 2:30pm EDT): Prevalence and Frequency
of Residual Symptoms of Depression in US Adults; Presented byBryanDirks,
o(Poster Number NR8-44; Tuesday May 6, 2:30pm EDT): Estimating the
Prevalence of Binge Eating Disorder in a Community Sample, Comparing
DSM-IV-TR and DSM-5 Criteria; Presented by Nicole Cossrow, Ph.D, MPH
o(Poster Number NR8-55; Tuesday May 6, 2:30pm EDT): Survey of Binge Eating
Disorder Recognition, Diagnosis, Treatment and Referral in US Physician
Practices; Presented by Dylan Supina, Ph.D
o(Poster Number NR8-53; Tuesday May 6, 2:30pm EDT): Binge Eating Disorder
Patient Characteristics and Barriers to Treatment: A Qualitative Study;
Presented by Barry K. Herman MD, MMM
o(Poster Number NR8-54; Tuesday May 6, 2:30pm EDT): Randomized Controlled
Safety and Efficacy Trials of Lisdexamfetamine Dimesylate for Adults With
Moderate to Severe Binge Eating Disorder; Presented by Susan McElroy, MD
About VYVANSE (lisdexamfetamine dimesylate)
Vyvanse is a prescription medicine currently only approved in the United
States, Canada, Australia, several European countries (trade name:
Elvanse^®/Tyvense^®) and Brazil (trade name: Venvanse™) for ADHD. Vyvanse
should only be used to treat ADHD.
Vyvanse is a prescription medicine for the treatment of ADHD in patients 6
years and above.
IMPORTANT SAFETY INFORMATION
Vyvanse is a federally controlled substance (CII) because it can be abused or
lead to dependence. Keep in a safe place to prevent misuse and abuse. Selling
or sharing Vyvanse may harm others and is illegal.
oDo not take Vyvanse if you or your child:
ois taking or has taken within the past 14 days an anti-depression
medicine called a monoamine oxidase inhibitor or MAOI
ois sensitive to, allergic to, or had a reaction to other stimulant
oSome people have had the following problems when taking stimulant
medicines, such as Vyvanse:
1. Heart-related problems including:
osudden death in people who have heart problems or heart defects
osudden death, stroke and heart attack in adults
oincreased blood pressure and heart rate
Tell your doctor if you or your child has any heart problems, heart defects,
high blood pressure, or a family history of these problems. The doctor should
check your or your child's blood pressure and heart rate regularly during
Call your doctor right away if you or your child has any signs of heart
problems such as chest pain, shortness of breath, or fainting while taking
2. Mental (psychiatric) problems including:
onew or worse behavior and thought problems
onew or worse bipolar illness
In Children and Teenagers
onew psychotic symptoms such as:
oseeing things or hearing voices that are not real
obelieving things that are not true
onew manic symptoms
Tell your doctor about any drug abuse, alcohol abuse or mental problems that
you or your child has had, or about a family history of suicide, bipolar
illness, or depression.
Call your doctor right away if you or your child has any new or worsening
mental symptoms or problems while taking Vyvanse.
3. Circulation problems in fingers and toes [Peripheral
vasculopathy,including Raynaud's phenomenon]:
oFingers or toes may feel numb, cool, painful, sensitive to temperature
and/or change color from pale, to blue, to red
Call your doctor right away if you have or your child has any of these signs
or symptoms or develops unexplained wounds on fingers or toes while taking
oTell the doctor if you or your child is pregnant, breast-feeding, or plans
to become pregnant or breast-feed.
oVyvanse may cause serious side effects, including:
oslowing of growth (height and weight) in children. Your child should
have his or her height and weight checked often while taking Vyvanse.
The doctor may stop treatment if a problem is found during these
oThe most common side effects reported in studies of Vyvanse were:
oloss of appetite
oupper stomach pain
For additional safety information, click here forPrescribing
InformationandMedication Guideand discuss with your doctor.
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 and
Internal Medicine, and we are developing treatments for symptomatic conditions
treated by specialist physicians in other targeted therapeutic areas.
FORWARD-LOOKING STATEMENTS - "SAFEHARBOR" 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
oShire's products may not be a commercial success;
orevenues from ADDERALL XR are subject to generic erosion and revenues from
INTUNIV will become subject to generic competition starting in December
othe 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, financial condition and results of
oShire conducts its own manufacturing operations for certain of its Rare
Diseases products and is reliant on third party contractors to manufacture
other products and to provide goods and services. Some of Shire's products
or ingredients are only available from a single approved source for
manufacture. Any disruption to the supply chain for any of Shire's
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 for some period of time.
othe 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;
othe actions of certain customers could affect Shire's ability to sell or
market products profitably. Fluctuations in buying or distribution
patterns by such customers can adversely impact Shire's revenues,
financial conditions or results of operations;
oinvestigations 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;
oadverse outcomes in legal matters and other disputes, including Shire's
ability to 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;
oShire faces intense competition for highly qualified personnel from other
companies, academic institutions, government entities and other
organizations. Shire is undergoing a corporate reorganization and the
consequent uncertainty could adversely impact Shire's ability to attract
and/or retain the highly skilled personnel needed for Shire to meet its
ofailure to achieve Shire's strategic objectives with respect to the
acquisition of ViroPharma Incorporated may adversely affect Shire's
financial condition and 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^® is a registered trademark of Shire LLC.
For further information please contact:
SOURCE Shire plc
Press spacebar to pause and continue. Press esc to stop.