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Shire plc to Present Scientific Data Across Range of Psychiatric Disorders at American Psychiatric Association Annual Meeting May 5-9


5/4/2012 11:48:27 AM

PHILADELPHIA, May 4, 2012 /PRNewswire/ --

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that it will present scientific data from one oral and 16 poster presentations at the American Psychiatric Association (APA) 165th Annual Meeting to be held May 5-9. The data being presented represent Shire's ongoing commitment to the clinical research of Vyvanse® (lisdexamfetamine dimesylate) Capsules, (CII) and INTUNIV® (guanfacine) Extended-Release Tablets, its approved treatments for ADHD. In addition to ADHD research, data being presented will focus on investigational research in other psychiatric and neurobehavioral disorders, such as major depressive disorder and negative symptoms of schizophrenia. Shire also will present health economic outcomes research, as part of the company's efforts to develop cost-effective treatments for ADHD.

The new research poster entitled, "The Hidden Costs of Attention Deficit/Hyperactivity Disorder (ADHD): A Focus on School and Work in the United States," was selected by the American Psychiatric Association to be highlighted at a special press briefing to be held during the meeting on Sunday, May 6, at 11:30 am in the Pennsylvania Convention Center room 104B.

"As a leader in the field of ADHD, Shire is committed to continuously expanding research in this and other psychiatric disorders, as evidenced by the breadth of data being presented at this important meeting," said Jeffrey Jonas, M.D., Senior Vice President of Research and Development for Shire's Specialty Pharmaceuticals and Regenerative Medicine Businesses. "With these data, we seek to further advance the body of scientific and health economics knowledge across a range of serious conditions that present significant challenges for patients including ADHD, major depressive disorder, and negative symptoms of schizophrenia."

Vyvanse is a prescription medicine currently approved in the United States and Canada, as well as in Brazil under the name Venvanse, for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). Vyvanse should be used to treat only ADHD.

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.

INTUNIV is indicated for the treatment of ADHD as monotherapy and as adjunctive therapy to stimulant medications in children and adolescents ages 6 to 17. The effectiveness of INTUNIV for more than 9 weeks has not been systematically evaluated. The physician electing to use INTUNIV for extended periods should periodically reevaluate its long-term usefulness for the individual patient.

Patients with a history of hypersensitivity to INTUNIV, its inactive ingredients, or other products containing guanfacine (eg, TENEX®) should not take INTUNIV.

Both Vyvanse and INTUNIV are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, and social).

Highlights of the scientific presentations are noted below. Information about scientific presentations mentioned in this release is embargoed until the respective presentation sessions have taken place at the meeting.

ADHD Presentations

Lisdexamfetamine Dimesylate

  • May 5, 2012; 11:00 am to 12:30 pm EDT
    Duration of Action of Lisdexamfetamine Dimesylate in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder
    Scientific and Clinical Report #2 (Oral Presentation) - Location: 109B, Level 1
  • May 6, 2012; 1:00 pm to 3:00 pm EDT
    Effect of Lisdexamfetamine Dimesylate on Symptoms of Hyperactivity/Impulsivity and Inattention in Children and Adolescents with ADHD
    Poster #NR4-16
  • May 6, 2012; 1:00 pm to 3:00 pm EDT
    Lisdexamfetamine Dimesylate Impact on 2 Subjective Quality-of-Life Scales in Adult Attention-Deficit/Hyperactivity Disorder and Executive Dysfunction
    Poster #NR4-17
  • May 6, 2012; 1:00 pm to 3:00 pm EDT
    Efficacy of Lisdexamfetamine Dimesylate on Self- and Informant-Reported Executive Dysfunction in Adults with Attention-Deficit/Hyperactivity Disorder
    Poster #NR4-21

Guanfacine Extended Release

  • May 6, 2012; 1:00 pm to 3:00 pm EDT
    Efficacy of Guanfacine Extended Release Administered in the Morning or Evening as Assessed by the Conners' Parent Rating Scale-Revised: Short Form
    Poster Presentation #NR4-15
  • May 6, 2012; 1:00 pm to 3:00 pm EDT
    ADHD Symptoms During Morning, Afternoon, and Evening with Guanfacine Extended Release Treatment Administered in the AM or PM
    Poster Presentation #NR4-20

Health Economics and Outcomes Research

  • May 6, 2012; 1:00 pm to 3:00 pm EDT
    A Comparison of Rates and Reasons for Urgent Care Utilization Among Children with ADHD Treated with Atypical Antipsychotics vs. Non-Antipsychotics
    Poster Presentation #NR4-12
  • May 6, 2012; 1:00 pm to 3:00 pm EDT
    Urgent Care Utilization for Adolescents Treated with Atypical Antipsychotics vs. Non-Antipsychotics: A Comparison of Rates and Reasons
    Poster Presentation #NR4-18
  • May 6, 2012; 1:00 pm to 3:00 pm EDT
    The Hidden Costs of Attention Deficit/Hyperactivity Disorder (ADHD): A Focus on School and Work in the United States
    Poster Presentation #NR4-19
  • May 8, 2012; 9:00 am to 10:30 am EDT
    Determining an Optimal Cut-Off Score for the WFIRS-P Using ROC Curve Analysis
    Poster Presentation #NR8-15

Presentations of Investigational New Uses Data for Lisdexamfetamine Dimesylate (Other Psychiatric Disorders)

Major Depressive Disorder

  • May 6, 2012, 1:00 pm to 3:00 pm EDT
    Assessment of Executive Dysfunction in Adults With Major Depressive Disorder Receiving Lisdexamfetamine Dimesylate Augmentation of Escitalopram
    Poster Presentation #NR4-43
  • May 6, 2012, 1:00 pm to 3:00 pm EDT
    Efficacy of Lisdexamfetamine Dimesylate Augmentation for Executive Dysfunction in Adults With Fully or Partially Remitted Major Depressive Disorder
    Poster Presentation #NR4-46
  • May 8, 2012; 11:00 am to 12:30 pm EDT
    Lisdexamfetamine Dimesylate in the Treatment of Cognitive Dysfunction in Patients With Partially or Fully Remitted Major Depressive Disorder
    Poster Presentation #NR9-30
  • May 8, 2012; 11:00 am to 12:30 pm EDT
    Assessment of Anxiety in Adults With Fully or Partially Remitted Major Depressive Disorder Receiving Lisdexamfetamine Dimesylate Augmentation Therapy
    Poster Presentation #NR9-38

Negative Symptoms of Schizophrenia

  • May 5, 2012, 2:00 pm to 3:30 pm EDT
    Adjunctive Lisdexamfetamine Dimesylate With Antipsychotics: Effects on Negative Symptoms of Schizophrenia and Self-Reported Executive Function
    Poster Presentation #NR2-55
  • May 7, 2012, 11:00 am to 12:30 pm EDT
    Effect of Adding Lisdexamfetamine Dimesylate to Antipsychotics on Predominant Negative Symptoms of Schizophrenia: Analysis of PANSS Factors
    Poster Presentation #NR6-16
  • May 7, 2012, 11:00 am to 12:30 pm EDT
    Adding Lisdexamfetamine Dimesylate to Antipsychotics: Does Functional Capacity Improve in Tandem With Negative Symptoms of Schizophrenia?
    Poster Presentation #NR6-38

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, and approved in November 2010 to treat ADHD in adolescents ages 13 to 17.

INDICATION

Vyvanse 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

See Full Prescribing Information for complete Boxed WARNING.

  • 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 INTUNIV (guanfacine) EXTENDED RELEASE TABLETS

INDICATION

INTUNIV (guanfacine) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications in children and adolescents ages 6 to 17. The effectiveness of INTUNIV for more than 9 weeks has not been systematically evaluated. 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).

IMPORTANT SAFETY INFORMATION

Patients with a history of hypersensitivity to INTUNIV, its inactive ingredients, or other products containing guanfacine (eg, TENEX®) should not take INTUNIV.

Hypotension, bradycardia, and syncope were observed in clinical trials. Use INTUNIV with caution in treating patients who have experienced hypotension, heart block, bradycardia, 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.

Somnolence and sedation were commonly reported adverse reactions in clinical studies (38% for INTUNIV vs. 12% for placebo in monotherapy studies and 18% for INTUNIV vs. 7% for placebo in the adjunctive study). 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.

Guanfacine, the active ingredient in INTUNIV, is also approved as an antihypertensive. Do not use INTUNIV in patients concomitantly taking other guanfacine-containing products (eg, TENEX).

The most common adverse reactions (incidence 5% and at least twice the rate for placebo) in the monotherapy trials with INTUNIV were somnolence, fatigue, nausea, lethargy, and hypotension, and in the adjunctive trial with INTUNIV were somnolence, fatigue, insomnia, dizziness, and abdominal pain.

Please see Full Prescribing Information for INTUNIV (guanfacine).

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. 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.

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: http://www.shire.com.

Vyvanse® is a registered trademark of Shire LLC.

Venvanse is a trademark of Shire Pharmaceuticals Ireland Ltd.

INTUNIV® is a registered trademark of Shire LLC.

"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.

For further information please contact:


Investor Relations

Eric Rojas
erojas@shire.com
+1-781-482-0999

Sarah Elton-Farr
seltonfarr@shire.com
+44-1256-894157


Media

Jessica Mann (Corporate)
jmann@shire.com
+44-1256-894-280

Gwen Fisher (Specialty Pharma)
gfisher@shire.com
+1-484-595-9836

SOURCE Shire plc


Read at BioSpace.com

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