HONOLULU — October 29, 2009 — Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced today that it will present key scientific data on its Attention-Deficit/Hyperactivity Disorder (ADHD) treatments, INTUNIV™ (guanfacine) Extended Release Tablets, Vyvanse® (lisdexamfetamine dimesylate) Capsules CII, and Daytrana® (methylphenidate transdermal system) CII, at a national meeting of psychiatrists to be held October 27 – November 1 in Honolulu.
“Shire is committed to the advancement of ADHD treatment research and is leading the way in developing a diverse range of safe and effective ADHD treatments,” said Michael Yasick, Senior Vice President of the Shire ADHD Business Unit. “We are excited to provide new scientific data on our ADHD portfolio, which includes the newest FDA-approved ADHD treatment INTUNIV; Vyvanse, the first prodrug stimulant for the treatment of ADHD; and Daytrana, the only patch approved for the treatment of ADHD. We are proud to provide important contributions to the growing body of research on our ADHD portfolio to the medical community.”
Following is a summary of the key Shire scientific presentations. Information about these data presentations mentioned in this media alert is embargoed until the respective presentation sessions have taken place at the meeting.
INTUNIV (guanfacine) Extended Release Tablets
October 29, 2009; 6:30 PM to 9:00 PM ET / 12:30 PM to 3:00 PM HT
Effects of Guanfacine Extended Release in Children Aged 6 to 12 With Oppositional Symptoms and a Diagnosis of ADHD
Poster Presentation # 3.8
October 29, 2009; 6:30 PM to 9:00 PM ET / 12:30 PM to 3:00 PM HT
Twenty-Four?Month Effectiveness of Guanfacine Extended Release in Children and Adolescents Aged 6 to 17 Years With ADHD
Poster Presentation # 3.24
Vyvanse (lisdexamfetamine dimesylate) Capsules CII
October 29, 2009; 6:30 PM to 9:00 PM ET / 12:30 PM to 3:00 PM HT
The Effects of Lisdexamfetamine Dimesylate on Emotional Lability in Children 6 to 12 Years of Age With ADHD in a Double-Blind, Placebo-Controlled Trial
Poster Presentation # 3.6
October 29, 2009; 6:30 PM to 9:00 PM ET / 12:30 PM to 3:00 PM HT
Reading Performance as a Function of Treatment With Lisdexamfetamine Dimesylate in Elementary School Children Diagnosed With ADHD
Poster Presentation # 3.19
October 29, 2009; 6:30 PM to 9:00 PM ET / 12:30 PM to 3:00 PM HT
Clinical Response and Symptomatic Remission in Children Treated With Lisdexamfetamine Dimesylate for ADHD
Poster Presentation # 3.20
October 29, 2009; 6:30 PM to 9:00 PM ET / 12:30 PM to 3:00 PM HT
Cardiovascular Outcomes in Children and Adults Treated With Lisdexamfetamine Dimesylate for ADHD
Poster Presentation # 3.23
Daytrana (methylphenidate transdermal system) CII
October 30, 2009; 3:00 PM to 5:30 PM ET / 9:00 AM to 11:30 AM HT
Pharmacokinetics of Methylphenidate Transdermal System and Osmotic-Release Oral System Methylphenidate in Children and Adolescents With ADHD
Poster Presentation # 4.52
October 30, 2009; 3:00 PM to 5:30 PM ET / 9:00 AM to 11:30 AM HT
Pharmacokinetic Predictors of Abuse-Related Liking With Transdermal and Subcutaneous Methylphenidate
Poster Presentation # 4.54
October 30, 2009; 3:00 PM to 5:30 PM ET / 9:00 AM to 11:30 AM HT
Evaluation of the Tolerability and Effectiveness of the Methylphenidate Transdermal System Over 6 Months in Adolescents With ADHD
Poster Presentation # 4.55
Additional information about INTUNIV and Full Prescribing Information are available at http://www.intuniv.com.
Additional information about Vyvanse and Full Prescribing Information, including the Medication Guide, are available at http://www.vyvanse.com.
Additional information about Daytrana and Full Prescribing Information, including the Medication Guide, are available at http://www.daytrana.com.
INTUNIV IMPORTANT SAFETY INFORMATION
INTUNIV is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17. Efficacy was established in two controlled clinical trials (8 and 9 weeks in duration). The physician electing to use INTUNIV for extended periods should periodically reevaluate its long-term usefulness for the individual patient.
INTUNIV should not be used in patients with a history of hypersensitivity to guanfacine or any of its inactive ingredients or by patients taking other products containing guanfacine.
Hypotension, bradycardia, and syncope were observed in clinical trials. Use INTUNIV with caution in treating patients who have experienced hypotension, bradycardia, heart block, or syncope, or who may have a condition that predisposes them to syncope; are treated concomitantly with antihypertensives or other drugs that can reduce blood pressure or heart rate or increase the risk of syncope. Heart rate and blood pressure should be measured prior to initiation of therapy, following dose increases, and periodically while on therapy. Patients should be advised to avoid becoming dehydrated or overheated.
Sedation and somnolence were commonly observed in clinical trials. The potential for additive sedative effects with CNS depressant drugs should be considered. Patients should be cautioned against operating heavy equipment or driving until they know how they respond to INTUNIV. Avoid use with alcohol.
Common adverse reactions in patients taking INTUNIV that may be dose related over the range of 1 to 4 mg/day include somnolence, sedation, abdominal pain, dizziness, hypotension/decreased blood pressure, dry mouth, and constipation.
VYVANSE IMPORTANT SAFETY INFORMATION
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.
Talk to your health care provider if your child experiences slowing of growth (height and weight). Children should have their height and weight checked periodically while taking Vyvanse. Your health care provider may stop Vyvanse treatment if a problem is found during these check-ups.
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.
DAYTRANA IMPORTANT SAFETY INFORMATION
Daytrana is indicated for the treatment of ADHD in children aged 6 to 12 years.
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. Talk to your health care provider if your child experiences slowing of growth (height and weight). Children should have their height and weight checked periodically while taking Daytrana. Your healthcare provider may stop Daytrana treatment if a problem is found during these check-ups. 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.
For further information please contact:
Media
Matthew Cabrey (Shire North America)
+1 484 595 8248
Debra Gemme (Porter Novelli for Shire)
+1 212 601 8342
+1 703 298 4030 (mobile)
Mindy Huber (Porter Novelli for Shire)
+1 212 601 8330
+1 917 653 6134 (mobile)
About ADHD
ADHD is one of the most common psychiatric disorders in children and adolescents. Worldwide prevalence of ADHD is estimated at 5.3 percent (with large variability), according to a comprehensive systematic review of this topic published in 2007 in the American Journal of Psychiatry. In the United States, approximately 7.8 percent of all school-aged children, or about 4.4 million 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 to 44 based on results from the National Comorbidity Survey Replication. When this percentage is extrapolated to the full US population aged 18 and over, almost 10 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. The specific etiology of ADHD is unknown and there is no single diagnostic test for this syndrome. Adequate diagnosis requires the use of medical and special psychological, educational, and social resources, utilizing diagnostic criteria such as Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV®) or International Classification of Diseases 10 (ICD-10).
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/or medication.
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 Company’s Web site: http://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 adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Company’s Specialty Pharmaceutical and Human Genetic Therapies products, as well as the ability to secure and integrate new products for commercialization and/or development; government regulation of the Company’s products; the Company’s ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company’s products; the Company’s ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company’s ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company’s filings with the Securities and Exchange Commission.
