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New analysis shows DAYTRANA offered ADHD symptom control for 12 months

Washington, D.C. May 7, 2008 Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced findings from a new data analysis that was conducted to examine treatment differences with DAYTRANA (methylphenidate transdermal system) between boys and girls aged 6 to 12 years with Attention Deficit Hyperactivity Disorder (ADHD). The findings from the analysis reaffirmed that DAYTRANA has an established safety profile and effectively controlled ADHD symptoms in both boys and girls for the duration of the study. Results from this analysis were presented today at a national scientific medical meeting in Washington, D.C.

This analysis further demonstrates that DAYTRANA has a recognized safety profile and is an effective treatment for ADHD symptoms in both boys and girls with the disorder, said Robert Findling, M.D., investigator of the analysis and Director of the Division of Adolescent and Child Psychiatry at University Hospitals Case Medical Center and Professor of Psychiatry at Case Western Reserve University. The findings are significant because only a relatively modest amount of work has been done to examine the effects of ADHD treatments by gender. This is an important consideration for parents because not only do they need to recognize that ADHD symptoms present differently in girls than in boys, but also because it is important to understand the role of treatment for both sexes.

According to the U.S. Centers for Disease Control and Prevention (CDC), a national survey conducted in 2003 showed that 11 percent of boys have been diagnosed with ADHD, in contrast to 4.4 percent of girls. Additional studies suggest the prevalence of ADHD in girls is critically underestimated and that many school-aged girls with the disorder are undiagnosed and under treated. This may be due to the fact that girls tend to show less disruptive ADHD symptoms such as inattention (e.g., inability to focus, organize and finish tasks), while boys tend to exhibit disruptive symptoms such as hyperactivity and impulsivity (e.g., restlessness, interrupting, impulsive decisions). In children, ADHD may interfere with paying attention in school, completing homework or making friends. Difficulties experienced by these children may continue into adulthood.

Summary of Analysis Findings

This analysis was conducted using data from an open-label, flexible dose, 12-month extension study in which 326 children received DAYTRANA. Children who enrolled in this study previously participated in other studies in which they received DAYTRANA, osmotic-release oral system (OROS) methylphenidate or placebo as part of the study design. The primary objective of this study was to investigate the long term safety profile of ADHD treatment with DAYTRANA, and the secondary objective examined the efficacy of the medication between genders. This subanalysis was conducted to examine treatment differences between boys and girls receiving DAYTRANA.

Adverse events were reported in a higher percentage of boys than girls in all dose groups; however, they were generally comparable between genders. Further, no clinically significant differences in adverse events were noted between boys and girls. Adverse events were typically mild or moderate and consistent with stimulant treatment. The most common adverse events included decreased appetite, headache, upper respiratory tract infection, cough, fever and decreased weight.

In the study, the efficacy of DAYTRANA was measured using the ADHD Rating Scale (ADHD-RS-IV), the Clinical Global Impressions-Improvement (CGI-I) scale and the Parent Global Assessment (PGA) rating scale and measurement results were found to be statistically significant on all scales. In the analysis, boys had a 41 percent change on the ADHD-RS-IV (as calculated from a mean baseline score of 11.6, with a mean change from baseline to endpoint of -4.8) and girls had a 23 percent change on the scale (as calculated from a mean baseline score of 11.3, with a mean change from baseline to endpoint of -2.6). Lower scores on the ADHD-RS-IV reflect an improvement in symptom control.

On the CGI-I scale, clinicians rated 83 percent of boys and girls improved or very much improved at the end of the study compared to week one. Additionally, the PGA rating scale showed that 78 percent of boys and girls improved or very much improved at the end of the study compared to week one. The results in both the CGI-I and PGA scale were comparable between boys and girls.

Dr. Findling added, These positive findings, along with previously presented research, reinforces that the ADHD patch is an important treatment option for children, especially those who may benefit from an ADHD medication that can accommodate their changing daily needs.

DAYTRANA is the first and only non-oral medication for treating ADHD in children aged 6 to 12 years. Parents can adjust the wear time up to 9 hours under the physicians advice to accommodate for their childs varying weekdays, weekend and vacation schedules. DAYTRANA is available in four dosage strengths 10 mg, 15 mg, 20 mg and 30 mg all designed for once-daily use.

While this study evaluated the safety and effectiveness of DAYTRANA for up to 12 months, DAYTRANA has not been studied versus placebo for longer than 7 weeks. Physicians, who prescribe DAYTRANA for long-term use, should periodically re-evaluate patients to assess the usefulness of DAYTRANA for the individual patient.


Contact: Alana Brier
Porter Novelli

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