SAN DIEGO, May 14 /PRNewswire-FirstCall/ -- Shire plc , the market leader in treatments for Attention-Deficit/Hyperactivity Disorder (ADHD), announced that it will present key scientific data on its ADHD treatment portfolio at the American Psychiatric Association (APA) annual meeting to be held May 19 to 24 in San Diego.
“The upcoming clinical research to be presented at APA reaffirms Shire’s commitment to understanding the science of ADHD treatment,” said Eliseo Salinas, Chief Scientific Officer and Executive Vice President, Global R&D. “We are looking forward to sharing new scientific data from clinical trials involving our ADHD portfolio of treatments with the medical community.”
Shire’s portfolio of ADHD treatments includes VYVANSE(TM) (lisdexamfetamine dimesylate), the first prodrug stimulant, which is planned to launch 2Q 2007, DAYTRANA(TM) (methylphenidate transdermal system), the first and only ADHD patch, and ADDERALL XR(R) (mixed salts of a single-entity amphetamine product), a long-acting formulated stimulant. Additional ADHD treatments under development by Shire include SPD465 (triple-bead mixed amphetamine salts) and SPD503 (guanfacine HCl extended release).
A summary of the key scientific presentations is provided below. Information about the data presentations mentioned in this release is embargoed until the respective presentation sessions have taken place at the APA annual meeting.
VYVANSE (lisdexamfetamine dimesylate): May 23, 2007; 3:00 p.m. PDT (6:00 p.m. EDT) Long-Term Effectiveness and Safety of Lisdexamfetamine Dimesylate (LDX) in Children Aged 6 to 12 Years With Attention-Deficit/Hyperactivity Disorder APA Poster# NR739 May 23, 2007; 3:00 p.m. PDT (6:00 p.m. EDT) Improved Interpatient Pharmacokinetic Variability of Lisdexamfetamine Dimesylate Compared With Mixed Amphetamine Salts Extended Release (MAS XR) in Children Aged 6 to 12 Years With Attention-Deficit/Hyperactivity Disorder APA Poster# NR750 DAYTRANA (methylphenidate transdermal system): May 23, 2007; 12:00 p.m. PDT (3:00 p.m. EDT) Efficacy and Safety of MTS in Male and Female Pediatric Subjects with ADHD APA Poster# NR665 May 23, 2007; 12:00 p.m. PDT (3:00 p.m. EDT) 12-Month Efficacy and Tolerability of MTS in Children with ADHD APA Poster# NR664 ADDERALL XR (mixed salts of a single-entity amphetamine product): May 23, 2007; 12:00 p.m. PDT (3:00 p.m. EDT) Long-Term Cardiovascular Safety of Mixed Amphetamine Salts Extended Release in Adolescents with ADHD APA Poster# NR652 SPD465 (triple-bead mixed amphetamine salts): May 21, 2007; 11:00 a.m. PDT (2:00 p.m. EDT) Extended Duration of Action of SPD465, a 16-Hour Mixed Amphetamine Salts Formulation, in the Treatment of Adults with ADHD Oral Presentation SPD503 (guanfacine HCl extended release): May 23, 2007; 12:00 p.m. PDT (3:00 p.m. EDT) A Randomized, Double-Blind, Placebo-Controlled Study of Guanfacine Extended Release in Children and Adolescents with Attention- Deficit/Hyperactivity Disorder APA Poster# NR659 May 23, 2007; 12:00 p.m. PDT (3:00 p.m. EDT) Long-Term, Open-Label Study of Guanfacine Extended Release in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder APA Poster# NR658
About VYVANSE and ADDERALL XR
VYVANSE or ADDERALL XR 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 deaths, 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, and visual disturbances 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 monitoring is advised during prolonged treatment.
Amphetamines have a high potential for abuse. Administration of amphetamines for prolonged periods of time may lead to drug dependence. Particular attention should be paid to the possibility of subjects obtaining amphetamines for non-therapeutic uses or distribution to others and the drugs should be prescribed or dispensed sparingly. Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events.
The most common adverse events reported in clinical studies of VYVANSE included: pediatric -- loss of appetite, insomnia, abdominal pain, and irritability. The most common adverse events reported in clinical studies of ADDERALL XR included: pediatric -- loss of appetite, insomnia, abdominal pain, and emotional lability; adolescent -- loss of appetite, insomnia, abdominal pain, and weight loss; adult -- dry mouth, loss of appetite, insomnia, headache, and weight loss.
About DAYTRANA
DAYTRANA should not be used in patients with allergy to methylphenidate or patch components; marked anxiety, tension and agitation; glaucoma; tics, diagnosis or a family history of Tourette’s syndrome; seizures; 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 deaths, 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, and visual disturbances have been associated with the use of stimulants. Use with caution in patients with a history of: psychosis; EEG abnormalities; bipolar disorder; depression. Growth and hematologic monitoring is advised during prolonged treatment. Patients should avoid applying external heat to the DAYTRANA patch. Skin irritation or contact sensitization may occur.
DAYTRANA should be given cautiously to patients with a history of drug dependence and alcoholism. Chronic abuse can lead to marked tolerance and psychological dependence. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use, since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder.
Common adverse events reported by patients who received DAYTRANA in clinical trials were decreased appetite, insomnia, nausea, vomiting, decreased weight, tics, affect lability, and anorexia, consistent with adverse events commonly associated with the use of methylphenidate.
About SPD465 (triple-bead mixed amphetamine salts):
SPD465 is currently under review with the U.S. Food and Drug Administration (FDA) for the treatment of ADHD in adults. SPD465, a single entity, mixed amphetamine salt formulation was studied to determine if it provides symptom control for up to 16 hours in adults with ADHD. The most commonly reported treatment-emergent adverse events were decreased appetite, insomnia, dry mouth, headache, upper abdominal pain and anorexia.
About SPD503 (guanfacine HCl extended release):
SPD503 is currently under review with FDA for the treatment of ADHD in children aged 6 to 17 years. SPD503 is a once-daily formulation of the selective alpha-2A-adrenoceptor agonist guanfacine and was studied to determine if it provided control of ADHD symptoms throughout the day in children aged 6 to 17 years. The most commonly reported treatment-emergent adverse events were headache, somnolence, fatigue, upper abdominal pain and sedation.
About ADHD
Approximately 7.8 percent of all school-age 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 CDC. ADHD is one of the most common psychiatric disorders in children and adolescents. The disorder is also estimated to affect approximately 9.8 million adults across the U.S. based on a retrospective survey of adults aged 18 to 34, projected to the full U.S. adult population. ADHD is a neurobiological psychiatric 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.
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 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 believes that a carefully selected portfolio of products with a strategically aligned and relatively small-scale sales force will deliver strong results.
Shire’s focused strategy is to develop and market products for specialty physicians. Shire’s in-licensing, merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the U.S. or Europe.
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, manufacturing and commercialization; the impact of competitive products, including, but not limited to the impact of those on Shire’s Attention Deficit and Hyperactivity Disorder (“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 dates of SPD503 (guanfacine extended release) (ADHD) and SPD465 (extended release triple-bead mixed amphetamine salts) (ADHD); Shire’s ability to secure new products for commercialization and/or development; Shire’s ability to benefit from its acquisition of New River Pharmaceuticals Inc.; and other risks and uncertainties detailed from time to time in Shire plc’s filings with the Securities and Exchange Commission, particularly Shire plc’s Annual Report on Form 10-K for the year ended December 31, 2006.
Shire plc
CONTACT: Marion E. Glick , +1-212-601-8273, or +1-917-301-4206 (on site atAPA), or Jacelyn Seng, +1-212-601-8385, or +1-917-392-0756 (on site atAPA), both of Porter Novelli for Shire
Web site: http://www.shire.com/
