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Shire Re-Launches FOCUS, an Online, Personalized Patient Support Program for Adults with ADHD Taking Vyvanse(R) (lisdexamfetamine dimesylate) Capsules CII
Date:11/11/2009

PHILADELPHIA, Nov. 11 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, today announced the re-launch of FOCUS (http://www.vyvanseFOCUS.com), a free, online patient support program for adults taking once-daily Vyvanse® (lisdexamfetamine dimesylate) Capsules CII for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD), and the only online, branded personalized patient support program providing tips and tools for adults diagnosed with ADHD taking a prescription medication. FOCUS is designed for the individual needs of adults with ADHD who are taking Vyvanse by letting them choose the tips and tools in the areas that most impact their life. These tips suggest organizational strategies designed to help adults during their busy day. Each adult patient taking Vyvanse has the option to enroll in FOCUS at http://www.vyvanseFOCUS.com and receive:

  • Customized practical tips relevant to their needs
  • Reminders to help plan their days, including remembering upcoming appointments and Vyvanse prescriptions
  • A timer to help allocate blocks of time to finish large projects at work
  • A white noise player to help drown out distractions

"In today's fast-paced environment, each day can bring new responsibilities and challenges both in the workplace and at home. For an adult with ADHD, these responsibilities can quickly become overwhelming," said Michael Yasick, Senior Vice President of the Shire ADHD Business Unit. "FOCUS was born out of the understanding that each patient manages his or her day differently. FOCUS provides customized support for patients taking Vyvanse, so that in addition to working with their doctor on a comprehensive treatment plan, patients also have a resource for helpful tips that they can use throughout their day both at work and at home."

Vyvanse is indicated for the treatment of ADHD in children aged 6 to 12 and in adults with ADHD. The most common side effects reported in studies of Vyvanse in adults were decreased appetite, difficulty falling asleep and dry mouth. The symptoms of ADHD in adults, such as inattention, hyperactivity, and impulsivity, may result in having trouble focusing, avoiding tasks that require sustained mental efforts, or frequently losing things.

To learn more about FOCUS, visit http://www.vyvanseFOCUS.com. Additional information about Vyvanse and Full Prescribing Information, including Medication Guide, are available at http://www.vyvanse.com.

About Vyvanse

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 healthcare 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.

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 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/.

THE "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.

SOURCE Shire plc


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