ADHD Skin Patch

Source: Shire Pharmaceuticals Marketing Dept.

Shire Pharmaceuticals Group plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) today announced positive preliminary results from clinical trials of its methylphenidate transdermal system* (MTS) which is being developed in conjunction with Noven Pharmaceuticals Inc. for children with attention deficit and hyperactivity disorder (ADHD).

These trial results will be included as part of an amendment to the New Drug Application for the product currently pending at the FDA. Both Shire and Noven believe that the studies will address the issues raised by the FDA's review in April 2003. The FDA has previously confirmed that the amendment will be reviewed within six months after submission.

The two studies, a phase 2 study involving 79 patients over a seven week period and a phase 3 study involving 268 patients over a seven week period, examined MTS in children between the ages of 6 and 12 previously diagnosed with ADHD. In these studies, use of MTS was well tolerated and the objectives of both studies were achieved.

Shire will release additional details of the trial results following
further analysis and as part of an R&D update** in May 2005.
Matthew Emmens, Chief Executive Officer of Shire said: "These results
demonstrate that MTS has the potential to provide significant benefits for
children with ADHD, especially those that have difficulty taking oral
medications and those that find a once-a-day patch more appropriate for their
lifestyle. As the ADHD market develops, new choices of treatment are
emerging, including specialized delivery systems (such as MTS) to meet the
needs of different patients. Shire aims to have a range of medicines in its
ADHD portfolio, with ADDERALL XR(r) being the most prescribed treatment for
ADHD in the US. If approved, this product will be a strong addition and we
look forward to advancing its development further."
Robert Strauss, Noven's President, CEO & Chairman said: "Today's news is
an important step forward in the development of our methylphenidate patch.
The next step is preparation of an amendment to the pending New Drug
Application, and we expect to be working closely with our partner Shire to
achieve that goal."
Robert Findling, M.D., Professor of Psychiatry at Case Western Reserve
University in Cleveland, Ohio commented: "Methylphenidate has been shown to
be an effective treatment, used orally, for children with ADHD for decades.
Upon approval, MTS holds the promise of being a welcome additional treatment
option for children with ADHD."
Shire acquired the worldwide sales and marketing rights to MTS from Noven
in February 2003.
Notes to editors
*Formerly referred to as METHYPATCH(r)
** Details of the Shire R&D update will be issued in due course
The Methylphenidate Transdermal System
The most common adverse events reported by patients who received the
methylphenidate transdermal system in previous clinical trials were:
application site reactions such as skin redness, insomnia (difficulty
sleeping), anorexia (loss of appetite), headache, abdominal pain, sudden
changes in emotions, viral infection (symptoms of a virus), vomiting, weight
loss, nervousness, twitching, increased cough, inflammation of the nose,
inflammation of the throat, irritability, overall body discomfort, apathy
(lack of interest or emotion), fever, anxiety, impaired body movement, and
accidental injury.
Preliminary evaluation of adverse events seen in the two trials
referenced in this press release included abdominal pain, anorexia (loss of
appetite), application site reactions, headache, insomnia, and nausea.
About Adderall XR
The most common adverse events in pediatric trials included loss of
appetite, insomnia, abdominal pain, and emotional lability. The most common
adverse events in the adult trial included dry mouth, loss of appetite,
insomnia, headache, and weight loss.
The effectiveness of ADDERALL XR for long-term use has not been
systematically evaluated in controlled trials. As with other psychostimulants
indicated for ADHD, there is a potential for exacerbating motor and phonic
tics and Tourette's syndrome. A side effect seen with the amphetamine class
is psychosis. Caution also should be exercised in patients with a history of
psychosis.
Abuse of amphetamines may lead to dependence. Misuse of amphetamine may
cause sudden death and serious cardiovascular adverse events. ADDERALL XR
generally should not be used in children or adults with structural cardiac
abnormalities. ADDERALL XR is contraindicated in patients with symptomatic
cardiovascular disease, moderate to severe hypertension, hyperthyroidism and
glaucoma, known hypersensitivity to this class of compounds, agitated states,
history of drug abuse, or current or recent use of MAO inhibitors. ADDERALL
XR should be prescribed with close physician supervision.
Shire Pharmaceuticals Group plc
Shire is a global specialty pharmaceutical company with a strategic focus
on meeting the needs of the specialist physician and currently focuses on
developing projects and marketing products in the areas of central nervous
system (CNS), gastrointestinal (GI), and renal diseases. Shire has operations
in the world's key pharmaceutical markets (US, Canada, UK, France, Italy,
Spain and Germany) as well as a specialist drug delivery unit in the US.
For further information on Shire, please visit the Company's website:
http://www.shire.com