Shire Announces Filing Of SPD465 For The Treatment Of Adult ADHD

Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ)
announced today that it has submitted a new drug application (NDA) to the
U.S. Food and Drug Administration (FDA) for SPD465, an investigational
amphetamine compound for the treatment of Attention-Deficit/Hyperactivity
Disorder (ADHD) in the adult population. The application is subject to a
12-month FDA review period. SPD465 has the same active ingredient as
ADDERALL XR(R) (mixed salts of a single-entity amphetamine product), but is
designed to provide ADHD symptom control for up to 16 hours. Upon approval,
this novel product will be the first and only ADHD stimulant product that
controls inattention, hyperactivity and impulsivity for up to 16 hours.


"The FDA filing for SPD465 is another milestone met and underscores
Shire's commitment to be the market leader in ADHD treatments by offering
patients new solutions to manage this chronic disorder," said Matthew
Emmens, Shire Chief Executive Officer. "If approved, the 16-hour
formulation of SPD465 would make it the longest-acting stimulant medication
for adult patients with ADHD, while also providing the efficacy of ADDERALL
XR, the most prescribed brand of ADHD treatment."


ADHD is a neurological brain disorder that manifests as a persistent
pattern of inattention and/or hyperactivity-impulsivity that is more
frequent and severe than typically observed in individuals at a comparable
age and maturity level. Scientists now agree that up to 65 percent of
adolescents with ADHD will continue to have the ADHD diagnosis as adults.
More than 9 million American adults currently exhibit symptoms of ADHD,
based on independent research by the National Institute of Mental Health.
Approximately 36 percent of ADHD prescriptions are currently written for
adult patients.



About SPD465


SPD465, a mixed amphetamine salt formulation designed to provide
sustained release of medication and symptom control for up to 16 hours, is
being studied for the treatment of ADHD in adults. The most common adverse
events reported in SPD465 phase 3 studies were insomnia, decreased appetite
and stomachache.


About ADDERALL XR


ADDERALL XR was generally well tolerated in clinical studies. The most
common side effects in studies included: children - decreased appetite,
difficulty falling asleep, stomachache, and emotional lability; adolescents
- loss of appetite, difficulty falling asleep, stomachache, and weight
loss; adults - dry mouth, loss of appetite, difficulty falling asleep,
headache, and weight loss.















Tell your doctor about any heart conditions, including structural
abnormalities, that you, your child, or a family member, may have. ADDERALL
XR should not be taken by patients who are currently taking or have
recently taken a type of antidepressant called a MAO inhibitor, have a
history of high blood pressure, problems with alcohol or drugs, agitated
states, or glaucoma. Patients should also tell the doctor if they have
seizures, visual disturbances, thyroid problems, abnormal
thoughts/behaviors, bipolar disorder, depression, or other mental illness,
or a known allergy to this type of medication.


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. Aggression, new
abnormal thoughts/behaviors, mania, and growth suppression have been
associated with use of drugs of this type. There is a potential for
worsening of motion or verbal tics and Tourette's syndrome. Report any new
psychological symptoms to the doctor and inform the doctor immediately of
any symptoms that suggest heart problems, such as chest pain or fainting.


Shire plc


Shire's strategic goal is to become the leading specialty
pharmaceutical company that focuses on meeting the needs of the specialist
physician. Shire focuses its business on ADHD, gastrointestinal, renal and
human genetic therapies. The structure is sufficiently flexible to allow
Shire to target new therapeutic areas to the extent opportunities arise
through acquisitions. Shire believes that a carefully selected portfolio of
products with a strategically aligned and relatively small-scale sales
force will deliver strong results.


Shire's focused strategy is to develop and market products for
specialty physicians. 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.


For further information on Shire, please visit the Company's website:
shire.


"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 plc'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, manufacturing and
commercialization; the impact of competitive products, including, but not
limited to, the impact of those on Shire plc's Attention Deficit and
Hyperactivity Disorder ("ADHD") franchise; patents, including but not
limited to, legal challenges relating to Shire plc's ADHD franchise;
government regulation and approval, including but not limited to the
expected product approval dates of SPD503 (ADHD), SPD465 (ADHD), MESAVANCE TM (SPD476) (ulcerative colitis), ELAPRASE TM (I2S) (Hunter syndrome) and NRP104 (ADHD), including its scheduling classification by the Drug Enforcement Administration in the United States; Shire plc's ability to
benefit from the acquisition of Transkaryotic Therapies Inc.; Shire plc'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
and its predecessor registrant Shire Pharmaceuticals Group plc's filings
with the US Securities and Exchange Commission, including Shire plc's
Annual Report on Form 10-K for the year ended December 31, 2005.


Adderall XR(R) is a registered trademark of companies within the Shire
group.


Diagnostic and Statistical Manual of Mental Disorders is a registered
trademark of the American Psychiatric Association.


Shire PLC

shire/shire/


View drug information on Adderall XR; Elaprase.