Shire Withdraws European Application for DAYTRANA(TM) (Methylphenidate Transdermal System)

March 16, 2009

DUBLIN, March 16 /PRNewswire-FirstCall/ — Shire plc (LSE: SHP, NASDAQ:
SHPGY), the global specialty biopharmaceutical company, announces that it has
decided to withdraw the European Marketing Authorization Application (MAA)
for DAYTRANA(TM) (methylphenidate transdermal system) for the treatment of
Attention Deficit Hyperactivity Disorder (ADHD). A request from European
regulators to conduct an additional clinical study on DAYTRANA in a European
patient population combined with the recently announced planned acquisition
of the worldwide rights (excluding the US, Canada and Barbados) to EQUASYM(R)
IR and XL (methylphenidate hydrochloride) for the treatment of ADHD are the
basis for this decision.

The decision to withdraw the MAA does not impact Shire’s commitment to
DAYTRANA in the U.S. where the product has been used as a pediatric treatment
for ADHD since 2006.

EQUASYM IR and XL will provide Shire with an entry to the European ADHD
market upon completion of the transaction, which subject to customary
completion conditions, is anticipated in Q2 2009. EQUASYM XL is approved and
currently marketed for the treatment of ADHD in children over 6 years of age,
and is available in 10 countries outside of the US, Canada and Barbados
including Denmark, Finland, Germany, Ireland, Netherlands, Norway, Sweden,
UK, Mexico and South Korea. Shire will be working to progress a number of
additional planned launches for EQUASYM XL in European and ROW markets.

EQUASYM will allow Shire to build on its status as the leader in the
United States
ADHD market with patients and customers in Europe, and
establishes a solid bridge for Shire’s other ADHD treatments, including
VYVANSE(TM) (lisdexamfetamine dimesylate), its flagship ADHD product, in
territories outside of the United States. VYVANSE is approved in the US for
the treatment of ADHD in children aged 6-12 and adults. Shire continues to
enroll patients in two European ADHD trials for VYVANSE.

Shire remains committed to providing a variety of medicines for the
treatment of ADHD to benefit ADHD patients and their families around the

Notes to editors

About ADHD

ADHD is one of the most common psychiatric disorders in children and
adolescents. Worldwide prevalence of ADHD is estimated at 5.3 percent (with
large variability), according to a comprehensive systematic review of this
topic published in 2007 in the American Journal of Psychiatry. In the United
, approximately 7.8 percent of all school-aged children, or about 4.4
million 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 US
adults aged 18-44 (approx 9.8 million) based on results from the National
Comorbidity Survey Replication.

ADHD is a psychiatric behavioral 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. The specific aetiology of ADHD is unknown and there is no single
diagnostic test for this syndrome. Adequate diagnosis requires the use of
medical and special psychological, educational and social resources,
utilizing diagnostic criteria such as Diagnostic and Statistical
Manual(TM)-IV (DSM-IV) or International Classification of Diseases 10

Although there is no “cure” for ADHD, there are accepted treatments that
specifically target its symptoms. Standard treatments include educational
approaches, psychological, or behavioural modification, and medication.


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.


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 (ADHD), human genetic therapies (HGT) and gastrointestinal (GI)
diseases 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:

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 Pharmaceutical and Human Genetic Therapies products,
as well as the ability to secure and integrate 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

    For further information please contact:


    Jessica Mann (Rest of the World)

    Matthew Cabrey (Specialty Pharma)

SOURCE Shire Plc

Source: newswire

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