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Shire Announces Publication of Open-Label Study on Coadministration of INTUNIV(TM) (guanfacine) Extended-Release Tablets with Stimulants
Date:11/16/2009

, never, seldom) to 3 (very much true, very often, very frequent). The CPRS-R was completed at 6 AM, 6 PM, and 8 PM during the baseline visit and visit 6.

PDSS is a self-rated assessment of daytime sleepiness that was completed at screening, baseline, and visits 1 through 9. The subjects responded to 8 questions related to sleepiness using a Likert scale rating (never = 0; always = 4). Higher scores on the PDSS indicated greater levels of sleepiness.

PGA is a parent-rated variation of the CGI in which the parent or caregiver evaluates the subject's symptom severity. The PGA was completed between screening and baseline visits and again at visit 6. Responses from the PGA were dichotomized into 2 categories: "improvement" (included the responses "very much improved" and "much improved") and "no improvement" (all other responses).

PSERS is a clinician-rated scale used to assess the severity of AEs such as dullness, tiredness, listlessness, headache, stomach ache, loss of appetite, and trouble sleeping. The PSERS was completed at screening and visits 1 through 9. Severity of AEs was rated as none, mild, moderate, or severe.

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 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
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2. Shire Enhances its Orphan Drug Pipeline With the Acquisition of a New Clinical Candidate for Metachromatic Leukodystrophy
3. Shire to Present Additional Scientific Data on ADHD Treatment Portfolio at American Psychiatric Association Annual Meeting
4. Shires Investigational Nonstimulant ADHD Treatment INTUNIV(TM) (Guanfacine Extended Release) Demonstrated Significant Efficacy in Reducing ADHD Symptoms at All Measured Time Points Up to 24 Hours Postdose
5. Shire Announces Approval of ELAPRASE(R) (idursulfase) in Brazil
6. Shire to add New Orphan Drug to its HGT Portfolio - EU Launch Imminent
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