�Shire Limited (LSE: SHP, NASDAQ: SHPGY), the spherical specialty biopharmaceutical company, has announced that VYVANSE is now available in U.S. pharmacies countrywide in ternary additional dosage strengths, delivery the number 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 individualise treatment for each affected role. VYVANSE, which received FDA approval for the treatment of ADHD in children in 2007, was besides recently sanctioned to treat ADHD in adults.
VYVANSE is the first prodrug stimulant approved to treat ADHD and was shown to provide consistent livery of participating 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 end-to-end the day, even at 6pm, as reported by parents.
VYVANSE Has Nationwide Formulary Coverage
Since the availability of VYVANSE a year ago to process children with ADHD, VYVANSE has achieved a U.S. market share of more than than 8 percent based on weekly branded prescription volume, with an mean second quarter 2008 mart share of 7.4 percent. VYVANSE formulary coverage has been positive; the top 6 managed care plans now cover the product in a preferred formulary position, and as of June 30, 2008, Shire has executed agreements with nine-spot of the top 11 managed care organizations. At a national level, more than than 92 percent of VYVANSE prescriptions are sanctioned without restrictions (which means without requiring any extra steps from the dr. 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 crataegus oxycantha still march symptoms into adulthood. The disorder is estimated to affect 4.4 pct of U.S. adults aged 18-44 based on results from the National Comorbidity Survey Replication, a nationally representative family survey, which used a lay-administered diagnostic interview to assess a wide mountain chain of DSM-IV disorders. When this share is extrapolated to the full U.S. population, roughly 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," aforementioned 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 workweek, to significantly improve ADHD symptoms, inattention, such as the power to stress and get up, 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 born-again 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 http://www.vyvanse.com.
About VYVANSE�
Vyvanse is indicated for the treatment of ADHD. Efficacy based on two controlled trials in children ripened 6 to 12 and one controlled trial in adults.
Tell the medico about whatsoever 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 advise heart problems, such as chest pain sensation or fainting.
Vyvanse should not be taken if you or your child has advance disease of the blood vessels (arterial sclerosis); symptomatic heart disease; contain to spartan 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 baby is existence treated for or has symptoms of depression (sadness, worthlessness, or hopelessness) or bipolar disorderliness; 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 aggression. Tell the doctor immediately if you or your child develops any of these weather condition or symptoms while taking Vyvanse.
Abuse of amphetamines may lead to dependency. Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events. These events have too been reported rarely with amphetamine purpose.
Vyvanse was generally well tolerated in clinical studies. The most common side of meat effects reported in studies of Vyvanse were: children - reduced appetite, difficulty falling numb, stomachache, and irritability; adult - reduced appetite, difficulty falling asleep, and dry mouth.
Aggression, new abnormal thoughts/behaviors, passion, growth suppression, worsening of motion or verbal tics, and Tourette's syndrome experience been associated with usance of drugs of this type. Tell the doctor if you or your child has blurred vision while pickings Vyvanse.
About ADHD
ADHD is one of the most coarse psychiatric disorders in children and adolescents. Approximately 7.8 percent of all school-aged children, or about 4.4 million U.S. children senior 4 to 17 geezerhood, 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 example 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 one thousand thousand adults ar believed to have ADHD. ADHD is a neurobiological disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more than frequent and severe than is typically observed in individuals at a corresponding level of development. To be right diagnosed with ADHD, a child of necessity to demonstrate at least six of nine symptoms of inattention; and/or at least six-spot of baseball club symptoms of hyperactivity/impulsivity; the onset of which appears before age 7 age; that some impairment from the symptoms is present in iI or more settings (e.g., at school and home); that the symptoms continue for at least six months; and that there is clinically substantial impairment in social, academic, or occupational functioning and the symptoms cannot be better explained by another psychiatric upset.
Although there is no "cure" for ADHD, there are recognized treatments that specifically target its symptoms. The almost common standard treatments include educational approaches, psychological, or behavioral modification, and medication.
Shire Limited
Shire's strategic goal is to become the leading specialism biopharmaceutical company that focuses on get together the needs of the specialist doc. 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 remedial areas to the extent they arise through acquisitions. Shire's in-licensing, amalgamation 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 comparatively small-scale gross revenue forces will deliver potent results.
For further information on Shire, please visit the Company's website: hTTP://www.shire.com.
"Safe Harbor" Statement Under The Private Securities Litigation Reform Act Of 1995
Statements included herein that are not historical facts are modern statements. Such forward-looking statements involve a number of risks and uncertainties and are national to change at whatever time. In the result such risks or uncertainties materialize, the Company's results could be materially moved. The risks and uncertainties include, simply are not limited to, risks associated with: the inherent uncertainty of pharmaceutical research, product development, manufacturing and commercialisation including, just not limited to, the establishment in the marketplace of VYVANSE� (lisdexamfetamine dimesylate) (Attention Deficit and Hyperactivity Disorder ("ADHD")); the impact of private-enterprise products, including, but non 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 non limited to the expected product approval date of INTUNIV� (guanfacine extended spill) (ADHD); the Company's power to secure new products for commercialisation and/or development; the Company's proposed pop the question for Jerini AG, including but non limited to, the Company's ability to successfully complete the offer and integrate Jerini AG, as well as realize the hoped-for benefits of the acquisition; and other risks and uncertainties elaborated 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 complete December 31, 2007.
Shire Limited
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