BASINGSTOKE, U.K., and PHILADELPHIA, Aug. 26 /PRNewswire-FirstCall/ -- Shire Limited , the global specialty biopharmaceutical company, has announced that VYVANSE is now available in U.S. pharmacies nationwide in three additional dosage strengths, bringing the total number to six: 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg. The expanded VYVANSE dosing options will allow physicians to individualize treatment for each patient. VYVANSE, which received FDA approval for the treatment of ADHD in children in 2007, was also recently approved to treat ADHD in adults.
VYVANSE is the first prodrug stimulant approved to treat ADHD and was shown to provide consistent delivery of active medication from patient to patient. In clinical studies of VYVANSE in children and adults, VYVANSE showed significant improvement in the core ADHD symptoms of inattention, hyperactivity, impulsivity. In children, VYVANSE demonstrated significant efficacy throughout the day, even at 6pm, as reported by parents.
VYVANSE Has Nationwide Formulary Coverage
Since the availability of VYVANSE a year ago to treat children with ADHD, VYVANSE has achieved a U.S. market share of more than 8 percent based on weekly branded prescription volume, with an average second quarter 2008 market share of 7.4 percent. VYVANSE formulary coverage has been positive; the top six managed care plans now cover the product in a preferred formulary position, and as of June 30, 2008, Shire has executed agreements with nine of the top 11 managed care organizations. At a national level, more than 92 percent of VYVANSE prescriptions are approved without restrictions (which means without requiring any additional steps from the doctor or patient), and VYVANSE has a competitive copay among covered formulary plans.
ADHD May Affect Adults in All Aspects of Daily Life
Although many people tend to think of ADHD as a childhood problem, up to 65 percent of children with ADHD may still exhibit symptoms into adulthood. The disorder is estimated to affect 4.4 percent of U.S. adults aged 18-44 based on results from the National Comorbidity Survey Replication, a nationally representative household survey, which used a lay-administered diagnostic interview to assess a wide range of DSM-IV disorders. When this percentage is extrapolated to the full U.S. population, approximately 9.8 million adults are believed to have ADHD.
“The prevalence of ADHD is concerning to the medical community. ADHD may affect adults in their professional life, social life, and relationships,” said Greg Mattingly, M.D., associate clinical professor at the department of psychiatry at Washington University School of Medicine in St. Louis, Mo. “VYVANSE is a recently approved ADHD treatment option for the adult population. In a clinical study with adults, VYVANSE was shown, within the first week, to significantly improve ADHD symptoms, inattention, such as the ability to focus and organize, and hyperactivity and impulsivity, such as restlessness, and interrupting.”
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 normal GI transit times.
Additional information about VYVANSE and Full Prescribing Information are available at www.vyvanse.com.
About Vyvanse(R)
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.
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. Approximately 7.8 percent of all school-aged 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 Centers for Disease Control and Prevention (CDC). The disorder is also estimated to affect 4.4 percent of U.S. adults aged 18-44 based on results from the National Comorbidity Survey Replication, a nationally representative household survey, which used a lay-administered diagnostic interview to access a wide range of DSM-IV disorders. When this percentage is extrapolated to the full U.S. population, approximately 9.8 million adults are believed to have ADHD. ADHD is a neurobiological 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 LIMITED
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 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, the Company’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 including, but not limited to, the establishment in the market of VYVANSE(R) (lisdexamfetamine dimesylate) (Attention Deficit and Hyperactivity Disorder (“ADHD”)); the impact of competitive products, including, but not limited to, the impact of those on the Company’s ADHD franchise; patents, including but not limited to, legal challenges relating to the Company’s ADHD franchise; government regulation and approval, including but not limited to the expected product approval date of INTUNIV(TM) (guanfacine extended release) (ADHD); the Company’s ability to secure new products for commercialization and/or development; the Company’s proposed offer for Jerini AG, including but not limited to, the Company’s ability to successfully complete the offer and integrate Jerini AG, as well as realize the anticipated benefits of the acquisition; and other risks and uncertainties detailed from time to time in the Company’s filings with the Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2007.
CONTACT: Mindy Greene, +1-212-601-8330, +1-917-653-6134 (mobile),
Mindy.Greene@porternovelli.com, or Jacelyn Seng, +1-212-601-8385,
+1-917-392-0756 (mobile), Jacelyn.Seng@porternovelli.com both of Porter
Novelli for Shire Limited
Web site: http://www.shire.com/
