Celebrity Designer and ADHD Spokesperson Ty Pennington Partners With Shire to Announce...

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Tue Jul 22, 2008 9:12am EDT

Celebrity Designer and ADHD Spokesperson Ty Pennington Partners With Shire to
Announce the Launch of VYVANSE(TM) (lisdexamfetamine dimesylate) for the
Treatment of ADHD in Adults
Ty Pennington returns home to Atlanta to give back to a local art college and
discuss his experiences with ADHD

ATLANTA, July 22 /PRNewswire-FirstCall/ -- Shire Limited
(LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company,
today announced that it has launched VYVANSE(TM) (lisdexamfetamine dimesylate)
for the treatment of adults with Attention Deficit Hyperactivity Disorder
(ADHD).  This launch follows the recent FDA approval of VYVANSE to treat ADHD
in the adult population.  VYVANSE is now available in U.S. pharmacies
nationwide in six once-daily dosage strengths.  To raise awareness of ADHD in
adults and recognize the launch of VYVANSE for adults, Shire has partnered
with celebrity designer Ty Pennington to shine the spotlight on living as an
adult with ADHD.  Pennington takes VYVANSE as part of his treatment plan to
manage his ADHD symptoms so he can focus and get work done.
    Pennington returns today to his hometown of Atlanta, where he will visit
the Savannah College of Art and Design-Atlanta (SCAD-Atlanta) and announce the
Daily Successes with ADHD Scholarship for an adult with ADHD who is pursuing
an education or career in a creative field at SCAD-Atlanta.  The $10,000
scholarship, sponsored by Shire, the maker of VYVANSE, will benefit an adult
with ADHD who is enrolled in, or applying to, a graduate program at the art
institution.  The objective of the scholarship is to recognize achievements,
and to motivate a student to continue to focus and achieve daily successes.
    "As an adult with ADHD, I know, firsthand, the importance of understanding
and treating ADHD.  I believe if I'd been diagnosed and treated earlier, I
would have struggled less as a child," said Ty Pennington, host of ABC's
Extreme Makeover: Home Edition(TM).  "Today, I have a very demanding schedule
with long production days and constant travel, and I take VYVANSE to help
control my ADHD symptoms so that I can focus and organize."
    ADHD Can Affect Adults' Daily Lives
    In adults with ADHD, symptoms can impact their professional life, social
life, relationships and personal finances.  In a new survey conducted by Shire
of adults who experienced ADHD symptoms in a typical week, 88 percent of 328
adults surveyed reported that they have difficulty organizing tasks and
activities, while 89 percent of 381 of these adults had difficulty finishing
things, such as projects or work at home.  These adults reported that this has
had a negative impact on their daily life and activities.  Additionally, among
the 347 adults surveyed who are currently employed, 66 percent felt that they
would do a better job at work if they were more focused and organized.
    "Although ADHD can affect children and adults, the core symptoms of the
disorder, inattention, hyperactivity, and impulsivity, may present differently
in these two patient groups.  For example, hyperactivity may present in adults
as inner restlessness and inattention may present as a lack of focus and
organization, poor time management, and an inability to finish tasks," said
David W. Goodman, M.D., director of the Adult Attention Deficit Disorder
Center of Maryland and assistant professor of psychiatry and behavioral
sciences at Johns Hopkins University School of Medicine.  VYVANSE is one of
several treatment options that may provide effective treatment control for
adults with ADHD.  In a clinical study, VYVANSE was shown to significantly
improve ADHD symptoms within the first week:  inattention -- such as the
ability to focus and organize -- and hyperactivity and impulsivity -- such as
restlessness, and interrupting."
    Shire received approval in April 2008 from the FDA for VYVANSE for the
treatment of ADHD in adults aged 18 to 55 years.  VYVANSE was introduced in
July 2007 for the treatment of ADHD in children aged 6 to 12 years.  VYVANSE
is available in six dosage strengths of 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and
70 mg.  In its first year of availability, more than 2 million VYVANSE
prescriptions have been filled.
    VYVANSE works with the body's natural metabolism to deliver active
medication.  VYVANSE is a once-a-day capsule that should be taken in the
morning with or without food as prescribed by your doctor.
    Additional information about VYVANSE and Full Prescribing Information are
available at www.vyvanse.com.
    About VYVANSE
    Vyvanse is indicated for the treatment of ADHD.  Efficacy based on two
controlled trials in children aged 6 to 12 and one controlled trial in adults.
    Tell the doctor about any heart conditions, including structural
abnormalities, that you, your child, or a family member, may have.   Inform
the doctor immediately if you or your child develops symptoms that suggest
heart problems, such as chest pain or fainting.
    Vyvanse should not be taken if you or your child has advanced disease of
the blood vessels (arteriosclerosis); symptomatic heart disease; moderate to
severe high blood pressure; overactive thyroid gland (hyperthyroidism); known
allergy or unusual reactions to drugs called sympathomimetic amines (for
example, pseudoephedrine); seizures; glaucoma; a history of problems with
alcohol or drugs; agitated states; taken a monoamine oxidase inhibitor (MAOI)
within the last 14 days.
    Tell the doctor before taking Vyvanse if you or your child is being
treated for or has symptoms of depression (sadness, worthlessness, or
hopelessness) or bipolar disorder; has abnormal thought or visions, hears
abnormal sounds, or has been diagnosed with psychosis; has had seizures or
abnormal EEGs; has or has had high blood pressure; exhibits aggressive
behavior or hostility.  Tell the doctor immediately if you or your child
develops any of these conditions or symptoms while taking Vyvanse.
    Abuse of amphetamines may lead to dependence.  Misuse of amphetamine may
cause sudden death and serious cardiovascular adverse events.  These events
have also been reported rarely with amphetamine use.
    Vyvanse was generally well tolerated in clinical studies.  The most common
side effects reported in studies of Vyvanse were: children -- decreased
appetite, difficulty falling asleep, stomachache, and irritability; adult --
decreased appetite, difficulty falling asleep, and dry mouth.
    Aggression, new abnormal thoughts/behaviors, mania, growth suppression,
worsening of motion or verbal tics, and Tourette's syndrome have been
associated with use of drugs of this type.  Tell the doctor if you or your
child has blurred vision while taking Vyvanse.
    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 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 access a wide range of DSM-IV disorders.
When this percentage is extrapolated to the full U.S. population,
approximately 9.8 million adults are believed to have ADHD.  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.
    SHIRE LIMITED
    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:
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 and
velaglucerase alfa (GA-GCB); manufacturing and JUVISTA(R) (Human TGF b3)
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.
SOURCE  Shire Limited

Mindy Greene, +1-212-601-8330, or +1-917-653-6134 (mobile),
Mindy.Greene@porternovelli.com, or Jacelyn Seng, +1-212-601-8385, or
+1-917-392-0756 (mobile), Jacelyn.Seng@porternovelli.com, both for Shire
Limited
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