PHILADELPHIA, May 1 Shire plc (LSE: SHP, Nasdaq:SHPGY), the global specialty biopharmaceutical company, announced today thatit will present key scientific data on its Attention Deficit HyperactivityDisorder (ADHD) treatments, lisdexamfetamine dimesylate, methylphenidatetransdermal system and the investigational non-stimulant treatment under FDAreview, guanfacine extended release, at the American Psychiatric Association(APA) annual meeting to be held May 3rd to 8th in Washington, D.C.
"Shire is committed to the advancement of ADHD research, and we arepleased to be presenting the efficacy and safety results from several studiesof our ADHD treatments," said Gwendolyn Niebler, Vice President of GlobalMedical Affairs at Shire. "We believe the physician community will find thelisdexamfetamine dimesylate, methylphenidate transdermal system and guanfacineextended release study findings to be presented at APA a relevant contributionto the growing body of research on our ADHD treatment options."
A summary of the key scientific presentations is provided below.Information about these data presentations mentioned in this release isembargoed until the respective presentation sessions have taken place at themeeting.
ADHD is one of the most common psychiatric disorders in children andadolescents. Approximately 7.8 percent of all school-aged children, or about4.4 million U.S. children aged 4 to 17 years, have been diagnosed with ADHD atsome point in their lives, according to the U.S. Centers for Disease Controland Prevention (CDC). The disorder is also estimated to affect 4.4 percent ofU.S. adults aged 18-44 based on results from the National Comorbidity SurveyReplication, a nationally representative household survey, which used alay-administered diagnostic interview to assess a wide range of DSM-IVdisorders. ADHD is a neurobiological disorder that manifests as a persistentpattern of inattention and/or hyperactivity-impulsivity that is more frequentand severe than is typically observed in individuals at a comparable level ofdevelopment. To be properly diagnosed with ADHD, a child needs to demonstrateat least six of nine symptoms of inattention; and/or at least six of ninesymptoms of hyperactivity/impulsivity; the onset of which appears before age 7years; that some impairment from the symptoms is present in two or moresettings (e.g., at school and home); that the symptoms continue for at leastsix months; and that there is clinically significant impairment in social,academic or occupational functioning and the symptoms cannot be betterexplained by another psychiatric disorder.
Although there is no "cure" for ADHD, there are accepted treatments thatspecifically target its symptoms. The most common standard treatments includeeducational approaches, psychological or behavioral modification, andmedication.
Shire's strategic goal is to become the leading specialtybiopharmaceutical company that focuses on meeting the needs of the specialistphysician. Shire focuses its business on attention deficit and hyperactivitydisorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) andrenal diseases. The structure is sufficiently flexible to allow Shire totarget new therapeutic areas to the extent opportunities arise throughacquisitions. Shire's in-licensing, merger and acquisition efforts are focusedon products in niche markets with strong intellectual property protectioneither in the US or Europe. Shire believes that a carefully selected portfolioof products with strategically aligned and relatively small-scale sales forceswill deliver strong results. For further information on Shire, please visitthe Company's website: www.shire.com.
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