PHILADELPHIA, May 1 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP,
Nasdaq: SHPGY), the global specialty biopharmaceutical company, announced
today that it will present key scientific data on its Attention Deficit
Hyperactivity Disorder (ADHD) treatments, lisdexamfetamine dimesylate,
methylphenidate transdermal system and the investigational non-stimulant
treatment under FDA review, guanfacine extended release, at the American
Psychiatric Association (APA) annual meeting to be held May 3rd to 8th in
Washington, D.C.
"Shire is committed to the advancement of ADHD research, and we are
pleased to be presenting the efficacy and safety results from several
studies of our ADHD treatments," said Gwendolyn Niebler, Vice President of
Global Medical Affairs at Shire. "We believe the physician community will
find the lisdexamfetamine dimesylate, methylphenidate transdermal system
and guanfacine extended release study findings to be presented at APA a
relevant contribution to the growing body of research on our ADHD treatment
options."
A summary of the key scientific presentations is provided below.
Information about these data presentations mentioned in this release is
embargoed until the respective presentation sessions have taken place at
the meeting.
Lisdexamfetamine Dimesylate:
May 7, 2008; 12:00 p.m. ET
Lisdexamfetamine Dimesylate Treatment in Children Diagnosed with ADHD:
Parental Impressions and Experiences
APA Poster Presentation # NR6-025
May 8, 2008; 11:00 a.m. ET
Efficacy and Safety of Lisdexamfetamine Dimesylate in Adults with ADHD
APA Oral Presentation Session # 28
Methylphenidate Transdermal System:
May 7, 2008; 12:00 p.m. ET
Long-Term Treatment Effects of the Methylphenidate Transdermal System in
Boys and Girls with ADHD
APA Poster Presentation # NR6-018
Guanfacine Extended Release:
May 7, 2008; 12:00 p.m. ET
Guanfacine Extended Release: Duration of Effect in Children and
Adolescents Aged 6 to 17 Years With ADHD
APA Poster Presentation # NR6-008
May 7, 2008; 12:00 p.m. ET
Response to Guanfacine Extended Release in Children and Adolescents Aged 6
to 17 Years With ADHD
APA Poster Presentation # NR6-040
About ADHD
ADHD is one of the most common psychiatric disorders in children and
adolescents. Approximately 7.8 percent of all school-aged children, or
about 4.4 million U.S. children aged 4 to 17 years, have been diagnosed
with ADHD at some point in their lives, according to the U.S. Centers for
Disease Control and Prevention (CDC). The disorder is also estimated to
affect 4.4 percent of U.S. adults aged 18-44 based on results from the
National Comorbidity Survey Replication, a nationally representative
household survey, which used a lay-administered diagnostic interview to
assess a wide range of DSM-IV disorders. ADHD is a neurobiological 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. To
be properly diagnosed with ADHD, a child needs to demonstrate at least six
of nine symptoms of inattention; and/or at least six of nine symptoms of
hyperactivity/impulsivity; the onset of which appears before age 7 years;
that some impairment from the symptoms is present in two or more settings
(e.g., at school and home); that the symptoms continue for at least six
months; and that there is clinically significant impairment in social,
academic or occupational functioning and the symptoms cannot be better
explained by another psychiatric disorder.
Although there is no "cure" for ADHD, there are accepted treatments
that specifically target its symptoms. The most common standard treatments
include educational approaches, psychological or behavioral modification,
and medication.
For further information please contact:
Porter Novelli for Shire:
Lucia Lodato
Lucia.Lodato@porternovelli.com
212.601.8037
917.617.3058 (on site at the meeting)
Lauren Plate
Lauren.Plate@porternovelli.com
212.601.8188
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 and
hyperactivity disorder (ADHD), human genetic therapies (HGT),
gastrointestinal (GI) and renal diseases. The structure is sufficiently
flexible to allow Shire to target new therapeutic areas to the extent
opportunities arise through acquisitions. Shire's in-licensing, merger and
acquisition efforts are focused on products in niche markets with strong
intellectual property protection either in the US or Europe. Shire believes
that a carefully selected 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, Shire's results could be
materially affected. The risks and uncertainties include, but are not
limited to, risks associated with: the inherent uncertainty of
pharmaceutical research, product development including, but not limited to
the successful development of JUVISTA(R) (Human TGF(beta)3) and
veleglucerase alfa (GA-GCB); manufacturing and commercialization including,
but not limited to, the establishment in the market of VYVANSE(TM)
(lisdexamfetamine dimesylate) (Attention Deficit and Hyperactivity Disorder
("ADHD")); the impact of competitive products, including, but not limited
to, the impact of those on Shire's ADHD franchise; patents, including but
not limited to, legal challenges relating to Shire's ADHD franchise;
government regulation and approval, including but not limited to the
expected product approval date of INTUNIV(TM) (guanfacine extended release)
(ADHD); Shire's ability to secure new products for commercialization and/or
development; and other risks and uncertainties detailed from time to time
in Shire plc's filings with the Securities and Exchange Commission,
including Shire plc's Annual Report on Form 10-K for the year ended
December 31, 2007.
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Via: Healthcare
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