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 physician's advice to accommodate for their child's 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.
This analysis was supported by Shire Development Inc.
Additional information about DAYTRANA and Full Prescribing Information are available at www.DAYTRANA.com.
Note to Editors:
ADHD-RS-IV assesses 18 individual symptoms of ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR®), a publication of the American Psychiatric Association.
The CGI-I scale is a standard assessment used to rate the severity of a patient's illness and improvement over time.
The PGA is a scale that measures overall improvement as assessed by parents.
DAYTRANA™ is a trademark of Shire Pharmaceuticals Ireland Limited.
Important Safety Information
Tell your doctor about any heart conditions, including structural abnormalities, your child or a family member may have. Inform your doctor immediately if the child develops symptoms that suggest heart problems, such as chest pain or fainting.
DAYTRANA should not be used if the child has: significant anxiety, tension, or agitation; allergies to methylphenidate or other ingredients of DAYTRANA; glaucoma; discontinued in the last 14 days or is taking a monoamine oxidase inhibitor (MAOI); tics, or family history or diagnosis of Tourette's syndrome.
Tell your doctor before using DAYTRANA if the child: is being treated for or has symptoms of depression (e.g. sadness, worthlessness or hopelessness) or bipolar disorder; has family history of tics; has abnormal thoughts or visions, hears abnormal sounds or has been diagnosed with psychosis; has had seizures or abnormal EEGs; has or has had high blood pressure; exhibits aggressive behavior or hostility. Tell your doctor immediately if the child develops any of these conditions/symptoms while using DAYTRANA.
In clinical studies, side effects were generally mild to moderate. The most common side effects reported with DAYTRANA were decreased appetite, sleeplessness, sadness/crying, twitching, weight loss, nausea, vomiting, tics and affect lability (mood swings). Aggression, new abnormal thoughts/behaviors, mania and growth suppression have been associated with use of drugs of this type. Tell your doctor if the child has blurred vision while using DAYTRANA.
Abuse of DAYTRANA can lead to dependence.
DAYTRANA should be applied daily to clean, dry skin, which is free of any cuts or irritation. Skin redness or itching is common with DAYTRANA. Allergic skin rash may occur.
ADHD is one of the most common psychiatric disorders in children and adolescents. Approximately 7.8 percent of all school-aged children, or about 4.4 million U.S. children aged 4 to 17 years, have been diagnosed with ADHD at some point in their lives, according to the U.S. Centers for Disease Control and Prevention (CDC). The disorder is also estimated to affect 4.4 percent of U.S. adults aged 18-44 based on results from the National Comorbidity Survey Replication, a nationally representative household survey, which used a lay-administered diagnostic interview to assess a wide range of DSM-IV disorders. ADHD is a neurobiological disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable level of development. To be properly diagnosed with ADHD, a child needs to demonstrate at least six of nine symptoms of inattention; and/or at least six of nine symptoms of hyperactivity/impulsivity; the onset of which appears before age 7 years; that some impairment from the symptoms is present in two or more settings (e.g., at school and home); that the symptoms continue for at least six months; and that there is clinically significant impairment in social, academic or occupational functioning and the symptoms cannot be better explained by another psychiatric disorder.
Although there is no "cure" for ADHD, there are accepted treatments that specifically target its symptoms. The most common standard treatments include educational approaches, psychological or behavioral modification, and medication.
For further information please contact:
Porter Novelli for Shire
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 and hyperactivity disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. 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. Shire believes that a carefully selected portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.
For further information on Shire, please visit the Company's website: www.shire.com.
"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'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 including, but not limited to the successful development of JUVISTA® (Human TGF?3) and velaglucerase alfa (GA-GCB); manufacturing and commercialization including, but not limited to, the establishment in the market of VYVANSE™ (lisdexamfetamine dimesylate) (Attention Deficit and Hyperactivity Disorder ("ADHD")); the impact of competitive products, including, but not limited to, the impact of those on Shire's ADHD franchise; patents, including but not limited to, legal challenges relating to Shire's ADHD franchise; government regulation and approval, including but not limited to the expected product approval date of INTUNIV™ (guanfacine extended release) (ADHD); Shire'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 filings with the Securities and Exchange Commission, including Shire plc's Annual Report on Form 10-K for the year ended December 31, 2007.