PHILADELPHIA, May 19 Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, will present scientific data on its Attention Deficit Hyperactivity Disorder (ADHD) treatments Vyvanse® (lisdexamfetamine dimesylate) Capsules CII and INTUNIV(TM) (guanfacine) Extended Release Tablets at two national scientific meetings for psychiatrists May 20-26, 2010 in New Orleans, LA.
"We believe that the Vyvanse and INTUNIV study findings will be an important contribution to the current collection of ADHD research. These studies reflect Shire's commitment to advancing ADHD treatment research," said Jeffrey Jonas, MD, Senior Vice President of Research & Development of Shire Pharmaceuticals Inc.
Key scientific presentations at these conferences are summarized below. Information about data presentations mentioned in this release is embargoed until the respective presentation sessions have taken place at the meeting.
Vyvanse, which was introduced in the United States in July 2007 for the treatment of ADHD in children aged 6 to 12 years and approved in April 2008 to treat ADHD in adults, is currently available in six once-daily dosage strengths of 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg.
Vyvanse is a therapeutically inactive prodrug stimulant, in which d-amphetamine is covalently bonded to l-lysine, and after oral ingestion it is converted to pharmacologically active d-amphetamine.
Additional information about Vyvanse and Full Prescribing Information, including the Medication Guide, are available at http://www.vyvanse.com.
INDICATION AND IMPORTANT SAFETY INFORMATION FOR VYVANSE
Vyvanse is indicated for the treatment of ADHD. Efficacy based on two controlled trials in children aged 6 to 12 and two controlled trials in adults. Vyvanse is indicated as an integral part of a comprehensive treatment program that may include other measures (psychological, educational, social).
Amphetamines have a high potential for abuse; prolonged administration may lead to dependence. Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events. See Full Prescribing Information for complete Boxed WARNING.
Vyvanse should not be taken by patients who have advanced arteriosclerosis; symptomatic cardiovascular disease; moderate to severe hypertension; hyperthyroidism; known hypersensitivity or idiosyncrasy to sympathomimetic amines; agitated states; glaucoma; a history of drug abuse; or during or within 14 days after treatment with monoamine oxidase inhibitors (MAOIs).
Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Sudden death, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses in ADHD. Physicians should take a careful patient history, including family history, and physical exam, to assess the presence of cardiac disease. Patients who report symptoms of cardiac disease such as exertional chest pain and unexplained syncope should be promptly evaluated. Use with caution in patients whose underlying medical condition might be affected by increases in blood pressure or heart rate.
New psychosis, mania, aggression, growth suppression, visual disturbances and exacerbation of tics and Tourette's syndrome have been associated with the use of stimulants. Use with caution in patients with a history of psychosis, seizures or EEG abnormalities, bipolar disorder, or depression. Growth should be monitored in children during treatment with stimulants, and patients who are not growing (gaining height or weight) as expected may need to have their treatment interrupted.
The most common adverse reactions (greater than or equal to 5 percent and at least twice the rate of placebo) reported in the pivotal clinical trials were pediatric - decreased appetite, insomnia, upper abdominal pain, irritability, decreased weight, vomiting, nausea, dizziness and dry mouth; adult - decreased appetite, insomnia, dry mouth, nausea, diarrhea, anxiety and anorexia.
For Full Prescribing Information, including the Medication Guide about Vyvanse, please visit http://www.vyvanse.com.
Once-daily INTUNIV is the first nonscheduled selective alpha-2A agonist for the treatment of ADHD in children and adolescents aged 6 to 17. INTUNIV was approved in the United States in September 2009 and is available in US pharmacies in four dosage strengths of 1 mg, 2 mg, 3 mg, and 4 mg. INTUNIV is not a controlled substance and has no known potential for abuse or dependence.
Although it is not known exactly how INTUNIV works, guanfacine, the active ingredient in INTUNIV, has been shown to interact with certain receptors in the part of the brain called the prefrontal cortex (PFC). Research has shown that behaviors related to ADHD, such as inattention and impulsiveness, may be controlled in this part of the brain.
Additional information about INTUNIV and Full Prescribing Information are available at http://www.intuniv.com/.
INDICATION AND IMPORTANT SAFETY INFORMATION FOR INTUNIV
INTUNIV is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents ages 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 is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, and social).
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. Advise patients 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. Advise patients to 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.
Please see accompanying Full Prescribing Information at http://www.intuniv.com/documents/INTUNIV_Full_Prescribing_Information.pdf
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 disorder. 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'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 website: 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.
NOTE TO EDITORS: All times above are central daylight time (CDT)
Vyvanse Presentations Tuesday, May 25, 2010, 1:30 PM - 3:00 PM Podium Presentation: Room 235 Double-Blind, Placebo-Controlled Efficacy and Safety Study of Lisdexamfetamine Dimesylate in Adolescents with Attention-Deficit/ Hyperactivity Disorder Tuesday, May 25, 2010, 3:00 PM - 5:00 PM Poster Presentation: NR5-3 Safety Profile of Lisdexamfetamine Dimesylate in Clinical Trials in Children, Adolescents, and Adults With Attention-Deficit/ Hyperactivity Disorder Tuesday, May 25, 2010, 3:00 PM - 5:00 PM Poster Presentation: NR5-4 Comparative Effects of Lisdexamfetamine Dimesylate and Mixed Amphetamine Salts Extended Release in Adults With Attention- Deficit/Hyperactivity Disorder Tuesday, May 25, 2010, 3:00 PM - 5:00 PM Poster Presentation: NR5-14 Efficacy of Lisdexamfetamine Dimesylate in Children With Attention- Deficit/Hyperactivity Disorder and Suboptimal Response to Methylphenidate Tuesday, May 25, 2010, 3:00 PM - 5:00 PM Poster Presentation: NR5-15 Examination of Effects of Lisdexamfetamine Dimesylate on Sleep Quality in Studies of Adults With Attention-Deficit/Hyperactivity Disorder Tuesday, May 25, 2010, 3:00 PM - 5:00 PM Poster Presentation: NR5-21 Clinical Utility of ADHD Symptom Thresholds to Assess Normalization of Executive Function With Lisdexamfetamine Dimesylate Treatment Wednesday, May 26, 2010, 3:00 PM - 5:00 PM Poster Presentation: NR7-43 Non-Medical Use Surveillance And Signal Identification Of Lisdexamfetamine Dimesylate, A Pro-Drug Stimulant For The Treatment Of ADHD INTUNIV Presentations Thursday, May 20, 2010, 5:00 PM - 6:30 PM Poster Presentation: Grand Ballroom DE A Multisite Placebo Controlled Trial of Morning or Evening Dosed Extended-Release Guanfacine in Combination with Psychostimulants in Children and Adolescents with ADHD Monday, May 24, 2010, 3:00 PM - 5:00 PM Poster Presentation: NR3-47 Response and Symptomatic Remission With Open-Label Coadministration of Guanfacine Extended Release and Stimulants for ADHD Tuesday, May 25, 2010, 3:00 PM - 5:00 PM Poster Presentation: NR5-25 Changes in Parental Stress With Guanfacine Extended Release in Children With Attention-Deficit/Hyperactivity Disorder and Oppositional Symptoms Tuesday, May 25, 2010, 3:00 PM - 5:00 PM Poster Presentation: NR5-24 Effects of Long-Term Open-Label Coadministration of Guanfacine Extended Release and Stimulants on Core Symptoms of ADHD Tuesday, May 25, 2010, 3:00 PM - 5:00 PM Poster Presentation: NR5-33 Long-Term Safety and Effectiveness of Open-Label Coadministration of Guanfacine Extended Release and Stimulants for ADHD in Children and Adolescents Other Shire Presentations Tuesday, May 25, 2010, 3:00 PM - 5:00 PM Poster Presentation: NR5-10 Differences in the Diagnosis and Treatment of Childhood Attention- Deficit/Hyperactivity Disorder With or Without Oppositional Symptoms
SOURCE Shire plc