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01 Jul 2009
Study Showed VYVANSE® (lisdexamfetamine dimesylate) CII Provided Significant Efficacy at 14 Hours After Administration in Adults with ADHD in an Adult Simulated Workplace Environment

01 Jul 2009 - Hollywood – Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced results from a Phase 3b study that found VYVANSE® (lisdexamfetamine dimesylate) CII demonstrated significant efficacy at 14 hours after administration during a simulated workplace environment study in adults with Attention Deficit Hyperactivity Disorder (ADHD). VYVANSE is the first approved stimulant for adults with ADHD to be evaluated in this setting, and these data were presented today at the 49th annual New Clinical Drug Evaluation Unit meeting in Hollywood, FL. VYVANSE is currently approved by the US Food and Drug Administration (FDA) for the treatment of ADHD in children age 6 to 12 years and in adults with ADHD.

“Long-acting medication may be important for adults with ADHD because ADHD symptoms, such as inattention, hyperactivity, and impulsivity, may impact them at work, as well as in at least one other area of their life,” said Matthew Brams, MD, study author and psychiatrist in private practice with Bayou City Research, Ltd in Houston. “In this study, adults taking VYVANSE demonstrated significant efficacy as measured by the Permanent Product Measure of Performance (PERMP), from two hours, the first time point measured, up to 14 hours following administration. Additionally, adults taking VYVANSE demonstrated significant ADHD symptom improvement, as measured by the ADHD Rating Scale (ADHD-RS) with adult prompts. These findings may be important for adults who require ADHD symptom management at work, at home, and in social settings.”

In this study, investigators evaluated adults with ADHD in an adult simulated workplace environment setting. In this setting, adults engaged in tests and activities that require a level of attention needed in many workplace settings. The efficacy of VYVANSE was measured by PERMP, a validated, time sensitive, skill adjusted math test designed to evaluate an adult’s ability to attend, initiate, and complete written seatwork. The PERMP was administered at intervals during the course of the simulated workplace environment day.

"This study provides important information for physicians about the effect of treatment with VYVANSE throughout the day in adults," said Michael Yasick, Senior Vice President of the ADHD Business Unit at Shire. “Shire is committed to providing effective treatments for adults with ADHD who need significant symptom improvement through the day and into the evening. We are proud to have evaluated VYVANSE in adults in this workplace-like environment.”

The adult simulated workplace environment study supports the results of a previous phase 3 clinical trial in adults in which once-daily VYVANSE significantly improved ADHD symptoms of inattention, such as the ability to focus and organize, as well as hyperactivity and impulsivity. In this previous study, the most common adverse events (greater than or equal to 5 percent and twice placebo) were decreased appetite, dry mouth, insomnia, nausea, diarrhea, anxiety, and anorexia.

About the Adult Simulated Workplace Environment Study
This randomized, double-blind placebo-controlled, crossover study evaluated the efficacy and safety of three doses of VYVANSE, 30 mg, 50 mg, and 70 mg, compared to placebo in 142 adults with ADHD using the adult simulated workplace environment setting. A four-week, open-label phase to identify the optimal dose preceded the two-week double-blind phase in which efficacy was evaluated.

The primary efficacy measure of the study was the average of postdose PERMP total scores in adults taking VYVANSE compared to placebo. The key secondary efficacy measure was to assess the duration of efficacy of VYVANSE compared to placebo using PERMP; the PERMP total score is the sum of the number of math problems attempted (PERMP-A) plus the number of math problems answered correctly (PERMP-C) in a 10-minute session. Patients took the PERMP test one half hour before their first dosing and then at 2, 4, 8, 10, 12, and 14 hours after dosing at two visits (visits 5 and 6) during the double-blind crossover phase.

VYVANSE demonstrated significant improvement in the average total PERMP scores, 312.9 for the VYVANSE group compared to 289.5 for the placebo group; P<.0001. Also, at each postdose assessment from two hours to 14 hours, the VYVANSE group had significantly better average PERMP total scores than the placebo group, (P<.01 for all). At the first time point measured, two hours postdose, the average change from predose measurement in total PERMP scores for the VYVANSE group was 41.5 versus 22.5 for the placebo group; P<.001.

In addition to PERMP, the investigators measured the efficacy of VYVANSE using the ADHD-RS with adult prompts, which is a standardized test for assessing symptoms of ADHD and for assessing response to treatment. This scale, which contains 18 items, is based on the ADHD diagnostic criteria as defined in the APA’s Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision®, a publication of the American Psychiatric Association. In this study, VYVANSE demonstrated a reduction (approximately 52 percent) from baseline in average ADHD-RS total scores in adults, from 37.2 at baseline to 18.1 at visits 5 and 6. Adult patients taking placebo also demonstrated a reduction (approximately 21 percent) in average ADHD-RS total scores, from 37.2 at baseline to 29.6 at visits 5 and 6.

The study also assessed the safety of VYVANSE, finding that the most frequently reported adverse events (greater than or equal to 5 percent) for patients during the dose-optimization phase were decreased appetite, dry mouth, headache, insomnia, upper respiratory tract infection, irritability, nausea, anxiety, and feeling jittery.

VYVANSE, which was introduced in the United States in July 2007 for the treatment of ADHD in children age 6 to 12 years and approved in April 2008 to treat ADHD in adults, is currently available in six dosage strengths of 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg. To date, more than 6 million VYVANSE prescriptions have been filled, bringing the current US market share to over 12 percent based on weekly branded prescription volume. Additionally, Shire has executed agreements with 10 of Shire’s top 11 managed care organizations (MCOs) to cover VYVANSE in a preferred formulary position. Approximately 95 percent of prescriptions are approved by health plans at the national average copay of $34.00. These figures are comparable with other ADHD treatment options.

VYVANSE is a therapeutically inactive prodrug, in which d-amphetamine is covalently bonded to l-lysine, and after oral ingestion it is converted to pharmacologically active
d-amphetamine. The conversion of VYVANSE to d-amphetamine is not affected by gastrointestinal pH and is unlikely to be affected by alterations in GI transit times.

Additional information about VYVANSE and Full Prescribing Information, including the Medication Guide, are available at www.vyvanse.com.

For further information please contact:

Investor Relations
Cléa Rosenfeld (Shire Rest of the World) +44 1256 894 160
Eric Rojas (Shire North America) +1 617 551 9715

Media
Matthew Cabrey (Shire North America) +1 484 595 8248
Mindy Huber (Porter Novelli for Shire) +1 212 601 8330

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 health care 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, approximately 9.8 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 and 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: 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.

 

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