Shire Announces FDA Acceptance of Filing for Review of the Vyvanse® (lisdexamfetamine dimesylate) Capsules, (CII) sNDA for Maintenance Treatment in Children and Adolescents with ADHD

PHILADELPHIA, Sept. 12, 2012 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that the US Food and Drug Administration (FDA) has accepted the filing for review of a supplemental New Drug Application (sNDA) for Vyvanse^® (lisdexamfetamine dimesylate) Capsules, (CII). Shire is seeking approval of Vyvanse as a maintenance treatment in children and adolescents ages 6 to 17 years with Attention-Deficit/Hyperactivity Disorder (ADHD). There are currently no stimulants approved for maintenance treatment in children and adolescents ages 6 to 17 years with ADHD. The FDA has issued a Prescription Drug User Fee Act (PDUFA) action date of April 29, 2013.

"Shire is committed to furthering knowledge about ADHD and the ways in which this disorder can be treated," said Jeffrey Jonas, M.D., Senior Vice President of Research and Development for Shire's Specialty Pharmaceuticals and Regenerative Medicine Businesses. "This filing is important because only minimal data exist in children and adolescents assessing the maintenance of efficacy with a stimulant medication versus a placebo."

Shire is seeking approval for maintenance treatment in children and adolescents ages 6 to 17 with ADHD based on the results of a clinical study (SPD489-326), a phase 3b, randomized withdrawal, multicenter, extension study to evaluate the long-term maintenance of efficacy and safety of Vyvanse. This study was also included in the European Marketing Authorization Application (MAA) submission package for approval of lisdexamfetamine dimesylate in Europe.

Vyvanse is a prescription medication currently approved in the United States for the treatment of ADHD in patients ages 6 to 17 and adults as part of a total treatment plan. Vyvanse is also approved in the United States as a maintenance treatment for adults with ADHD. Extended use of Vyvanse should be periodically reevaluated to determine its long-term usefulness for the individual patient.

Vyvanse is a Schedule II controlled substance. Stimulants, such as amphetamines and methylphenidates, are subject to misuse, abuse, addiction, and criminal diversion. Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events.

Vyvanse is also approved in Canada (in patients 6 years and above), as well as in Brazil (patients 6 to 12 years) under the name Venvanse, for the treatment of ADHD.

ABOUT VYVANSE (lisdexamfetamine dimesylate)

Vyvanse, was introduced in the United States in July 2007 for the treatment of ADHD in children ages 6 to 12 years, approved in April 2008 to treat ADHD in adults, approved in November 2010 to treat ADHD in adolescents ages 13 to 17, and approved in January 2012 for maintenance therapy in adults.

INDICATION

Vyvanse (lisdexamfetamine dimesylate) is indicated for the treatment of ADHD in patients ages 6 and above as part of a total treatment plan that may include other measures (psychological, educational, social). Efficacy was established in short-term controlled studies in children aged 6 to 17 and adults. Vyvanse is also approved as a maintenance treatment for adults with ADHD based on one randomized withdrawal study. Extended use of Vyvanse should be periodically reevaluated to determine its long-term usefulness for the individual patient.

IMPORTANT SAFETY INFORMATION

WARNING: POTENTIAL FOR MISUSE, ABUSE, ADDICTION, AND DIVERSION

• Vyvanse is a Schedule II controlled substance. Stimulants, such as amphetamines and methylphenidates, are subject to misuse, abuse, addiction, and criminal diversion.
• Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events.

• Contraindications: Known hypersensitivity to amphetamines or other ingredients in Vyvanse. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have been observed in postmarketing reports. Using Vyvanse with monoamine oxidase inhibitors (MAOIs) can result in hypertensive crisis. Stop MAOIs at least 14 days prior to Vyvanse use.
• Sudden death, stroke and myocardial infarction have been reported with stimulants at usual doses for the treatment of ADHD. Stimulants generally should not be used in patients with known structural cardiac abnormalities or other serious heart problems. Adults have a greater likelihood than children of having such cardiac disease.  Patients being considered for stimulant treatment should have a careful history (including family history of sudden death or ventricular arrhythmia) and physical exam to assess for the presence of cardiac disease. Further evaluation should be conducted if needed (eg, electrocardiogram and echocardiogram). Patients who develop symptoms suggestive of cardiac disease (eg, exertional chest pain, unexplained syncope) during stimulant treatment should undergo a prompt evaluation.
• Use with caution in patients whose underlying medical condition might be compromised by increases in blood pressure or heart rate. Stimulants cause modest increases in average blood pressure (about 2-4 mmHg) and average heart rate (about 3-6 bpm) and patients may have larger increases. Monitor all patients for larger changes.
• Use of stimulants may cause psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with pre-existing psychosis. Clinical evaluation for bipolar disorder is recommended prior to stimulant use. Monitor for aggressive behavior.
• Monitor growth in children during treatment with Vyvanse. Children who are not growing (gaining height or weight) as expected may need to have their treatment interrupted.
• Stimulants may lower the convulsive threshold. Discontinue if seizures develop.
• Visual disturbances and exacerbation of tics and Tourette's syndrome have been reported with stimulant treatment.
• The most common adverse reactions (≥5% and at least twice the rate of placebo) reported in clinical trials were:
  • Children aged 6 to 12: decreased appetite, insomnia, upper abdominal pain, irritability, decreased weight, vomiting, nausea, dizziness and dry mouth;
  • Adolescents aged 13 to 17: decreased appetite, insomnia, and decreased weight;
  • Adults: decreased appetite, insomnia, dry mouth, nausea, diarrhea, anxiety and anorexia.

Please see Full Prescribing Information for Vyvanse (lisdexamfetamine dimesylate), including Boxed WARNING regarding Potential for Misuse, Abuse, Addiction, and Diversion.

ABOUT ADHD

Attention-Deficit/Hyperactivity Disorder is a neurobehavioral disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity and is more frequent and severe than is typically observed in individuals at a comparable level of development.

ADHD is one of the most common childhood psychiatric disorders. In the United States, the estimated prevalence of parent-reported ADHD (ever) is approximately 9.5 percent or 5.4 million of all school-aged children diagnosed with ADHD at some point in their lives, according to the Centers for Disease Control and Prevention (CDC). Although many people tend to think of ADHD as a childhood problem, 60% to 85% of children with ADHD may continue to meet the criteria for the disorder during their teenage years. Nearly 50% of children with ADHD may continue to meet the criteria for the disorder in adulthood, based on parent-report. The disorder is 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, approximately 10 million adults are estimated to have ADHD.

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 specified in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR^®) or International Classification of Diseases, Tenth Revision (ICD-10).

Although there is no cure for ADHD, there are accepted treatments that have been demonstrated to improve symptoms. Standard treatments include educational approaches, psychological therapies which may include behavioral modification, and/or medication.

For further information please contact:

Notes to editors

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, human genetic therapies, gastrointestinal diseases and regenerative medicine 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: www.shire.com.

Vyvanse^® is a registered trademark of Shire LLC.
Venvanse™  is a trademark of Shire Pharmaceuticals Ireland Ltd.

"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 Pharmaceuticals, Human Genetic Therapies and Regenerative Medicine products, as well as the ability to secure 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.

SOURCE Shire plc

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