CHICAGO – October 29, 2008 – Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced results from a 13-hour analog classroom study in school-aged children aged 6 to 12 years with Attention Deficit Hyperactivity Disorder (ADHD). In this study, researchers found that VYVANSE controlled ADHD symptoms from the first time point measured (1.5 hours) through the last time point assessed (13 hours) post-dose. Findings from this analog classroom study were presented today at a national psychiatric meeting in Chicago.
"The study presented today is the first published data demonstrating improvements in attention and behavior with an oral ADHD stimulant treatment for up to 13 hours post-dose," said Ann C. Childress, MD, study investigator, president of the Center for Psychiatry and Behavioral Medicine, Inc. in Las Vegas, and volunteer assistant professor of psychiatry at the University of Nevada School of Medicine in Las Vegas. "In this study, once-daily VYVANSE significantly improved attention and behavior at 1.5 hours after a morning dose of the medication and continued to do so for each time point measured throughout the 13-hour treatment day. These findings are significant because children with ADHD require symptom control that lasts throughout the school day as well as after-school hours."
This study confirms the results of a previous clinical trial in which VYVANSE demonstrated ADHD symptom control throughout a 12-hour treatment day. The adverse events in the 12-hour study for patients taking Vyvanse during the double-blind treatment period that were greater than or equal to 2 percent were insomnia, decreased appetite, and anorexia.
"This is encouraging news for physicians and patients seeking a long-acting ADHD treatment option as this study demonstrated symptom control during a 13-hour treatment day," said Mike Cola, President of Shire's Specialty Pharmaceuticals business. "This VYVANSE study further supports Shire's commitment to research efforts that address the need for ADHD symptom control throughout the day, and into the evening."
About the 13-Hour Analog Classroom Study
This randomized, double-blind, placebo-controlled, analog study assessed the efficacy and safety of VYVANSE in 129 children aged 6 to 12 years with ADHD. Following a four-week, open-label, dose-optimization phase with VYVANSE at 30 mg, 50 mg, and 70 mg doses, patients entered a two-week, double-blind, crossover phase where they were randomized into two groups. One group received their optimal dose of VYVANSE the first week and placebo the second week. The second group received placebo the first week and their optimal dose of VYVANSE the second week.
The primary objective of this study was to assess the time of onset of VYVANSE compared with placebo, as measured by the Swanson, Kotkin, Agler, M-Flynn, and Pelham Deportment (SKAMP-D) rating scale. Secondary objectives were to assess the duration of efficacy of VYVANSE compared with placebo, as measured by the SKAMP-D, SKAMP Attention (SKAMP-A), and Permanent Product Measure of Performance (PERMP) scales.
In the study, VYVANSE demonstrated significant efficacy versus placebo at 1.5 hours, the first time point measured. VYVANSE treatment was associated with significant improvement in behavior and attention as measured by both subjective (SKAMP-D) and objective (PERMP) assessments from the first time point (1.5 hours) through the last time point (13 hours) assessed during the classroom day.
When measured using the PERMP scales, VYVANSE demonstrated significant improvement in math problems attempted and answered correctly with improvement for up to 13 hours post-dose.
Safety was also evaluated during the study and VYVANSE was generally well tolerated. The most frequently reported adverse events for patients taking VYVANSE were decreased appetite, insomnia, headache, irritability, upper abdominal pain, and affect lability.
VYVANSE, which was introduced in July 2007 for the treatment of ADHD in children aged 6 to 12 years, was approved in April 2008 to treat ADHD in adults. VYVANSE is now available in six dosage strengths of 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg. To date, more than 3 million VYVANSE prescriptions have been filled.
VYVANSE is a therapeutically inactive prodrug, in which d-amphetamine is covalently bonded to l-lysine, and after oral ingestion it is converted to pharmacologically active d-amphetamine. The conversion of VYVANSE to d-amphetamine is not affected by gastrointestinal pH and is unlikely to be affected by alterations in GI transit times.
Additional information about VYVANSE and Full Prescribing Information are available at www.vyvanse.com.
Notes to Editor:
The Swanson, Kotkin, Agler, M-Flynn, and Pelham Deportment (SKAMP-D) scale is a standardized, validated classroom assessment tool used for evaluating the behavioral symptoms of ADHD and higher SKAMP-D ratings reflecting greater impairment.
The Permanent Product Measure of Performance (PERMP) is an age-adjusted collection of math problems that provides an objective measure of performance based on the number of attempted and completed math problems.
For further information please contact:
Vyvanse is indicated for the treatment of ADHD. Efficacy based on two controlled trials in children aged 6 to 12 and one controlled trial in adults.
Tell the doctor about any heart conditions, including structural abnormalities, that you, your child, or a family member, may have. Inform the doctor immediately if you or your child develops symptoms that suggest heart problems, such as chest pain or fainting.
Vyvanse should not be taken if you or your child has advanced disease of the blood vessels (arteriosclerosis); symptomatic heart disease; moderate to severe high blood pressure; overactive thyroid gland (hyperthyroidism); known allergy or unusual reactions to drugs called sympathomimetic amines (for example, pseudoephedrine); seizures; glaucoma; a history of problems with alcohol or drugs; agitated states; taken a monoamine oxidase inhibitor (MAOI) within the last 14 days.
Tell the doctor before taking Vyvanse if you or your child is being treated for or has symptoms of depression (sadness, worthlessness, or hopelessness) or bipolar disorder; has abnormal thought 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 the doctor immediately if you or your child develops any of these conditions or symptoms while taking Vyvanse.
Abuse of amphetamines may lead to dependence. Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events. These events have also been reported rarely with amphetamine use.
Vyvanse was generally well tolerated in clinical studies. The most common side effects reported in studies of Vyvanse were: children – decreased appetite, difficulty falling asleep, stomachache, and irritability; adult – decreased appetite, difficulty falling asleep, and dry mouth.
Aggression, new abnormal thoughts/behaviors, mania, growth suppression, worsening of motion or verbal tics, and Tourette's syndrome have been associated with use of drugs of this type. Tell the doctor if you or your child has blurred vision while taking Vyvanse.
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 US children aged 4 to 17 years, have been diagnosed with ADHD at some point in their lives, according to the Centers for Disease Control and Prevention (CDC). The disorder is also estimated to affect 4.4 percent of US 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 access a wide range of DSM-IV disorders. When this percentage is extrapolated to the full US population, approximately 9.8 million adults are believed to have ADHD. ADHD is a psychiatric behavioral 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, the person needs to demonstrate at least six of nine symptoms of inattention; and/or at least six of nine symptoms of hyperactivity/impulsivity; these symptoms continue for at least six months; some hyperactive-impulsive or inattentive symptoms that cause impairment were present before age 7 years; that some impairment from the symptoms is present in two or more settings (eg, at work, school, and home); and that there is clear evidence of clinically significant impairment in social, academic, or occupational functioning and 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. Standard treatments include educational approaches, psychological, or behavioral modification, and medication.
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 Company's Web site: 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, the Company'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, manufacturing and commercialization including, but not limited to, the establishment in the market of VYVANSE® (lisdexamfetamine dimesylate) (Attention Deficit Hyperactivity Disorder ("ADHD")); the impact of competitive products, including, but not limited to, the impact of those on the Company's ADHD franchise; patents, including but not limited to, legal challenges relating to the Company's ADHD franchise; government regulation and approval, including but not limited to the expected product approval date of INTUNIV™ (guanfacine extended release) (ADHD); the Company's ability to secure new products for commercialization and/or development; the Company's proposed offer for Jerini AG, including but not limited to, the Company's ability to successfully complete the offer and integrate Jerini AG, as well as realize the anticipated benefits of the acquisition; and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K for the year ended December 31, 2007.