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01 Feb 2010
VYVANSE® — new ADHD treatment option — now available in Canada

Survey reveals insights into ADHD treatment

Montreal, QC – February 1, 2010 – Canadian families managing Attention Deficit Hyperactivity Disorder (ADHD) have a new treatment option.  Today, Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced the Canadian availability of VYVANSE (lisdexamfetamine dimesylate capsule), the first and only prodrug therapy approved for ADHD treatment in Canada.

ADHD National Survey
According to an Angus Reid survey of 301 parents with ADHD-diagnosed children, while symptom control during school hours is the single most important reason for medication, 25 per cent of parents report their child’s medication wears off before school ends at 4:00 p.m.  Half (50%) say their current medication wears off before dinner time (6:00 p.m.) and 73 per cent report their child’s ADHD is a challenge between 6:00 and 9:00 p.m.

Other highlights from the national survey:

  • 60 per cent of families felt their teacher treated their child differently as a result of their ADHD diagnosis
  • 88 per cent of parents felt treating their child’s ADHD had a positive impact on their self-esteem
  • 93 per cent of families were interested in learning about new treatment options for their child’s ADHD
  • 71 per cent of ADHD families in Canada have chosen medication as part of their ADHD treatment plan
  • 84 per cent of ADHD families say their child is easily distracted and experiences difficulty in sustaining attention during activities.

Based on patient survey feedback, consistent symptom control with no highs or lows (83 per cent) and consistent symptom control from one day to the next (81 per cent) are important characteristics when choosing a medication for their child.i

"Consistent ADHD symptom control from one day to the next, with no highs and lows, is an ongoing challenge for our family," said Lisa Doucette, mother of a six year-old diagnosed with ADHD.  "My child needs symptom control all day, every day, in order to reach his full potential and VYVANSE has helped us achieve our goals."

ADHD: A common childhood challenge
According to the Canadian Attention Deficit Hyperactivity Disorder Resource Alliance (CADDRA), ADHD is the most common psychiatric disorder of childhood, affecting five to 12 per cent of school-aged children.ii    At any given time, more than 270,800 Canadian children may experience ADHD.iii   Finding the right medication to treat a child’s core ADHD symptoms – inattention, hyperactivity and impulsivity can be a complex puzzle for parents.  VYVANSE can provide an important missing piece.

VYVANSE: A new option
VYVANSE is the first and only prodrug therapy approved for ADHD treatment in Canada, and is indicated for the treatment of ADHD in children aged six to 12 years.

“Having access to a new ADHD treatment is welcomed news,” said Dr. Margaret Weiss, leading expert in teaching ADHD and prominent Canadian Psychiatrist and Associate Professor of Psychiatry at the University of British Columbia.  “VYVANSE has been available in the US for over two years, where it has been well received.  VYVANSE is interesting as it only becomes an active drug when in the body, because of the prodrug technology.”

Since June of 2007, VYVANSE has been used in the United States.  To date, more than seven million VYVANSE prescriptions have been filled.iv

ADHDandYou.ca: A new resource for families
As a Canadian leader in ADHD research and treatment, Shire is pleased to launch www.ADHDandYou.ca – an online educational resource for families to learn more about ADHD.  According to a study released by Statistics Canada, two-thirds of adult Canadians use the internet and almost 60 per cent of these adults looked for health information on the web.v   This online resource will provide balanced, up-to-date information for Canadian ADHD families.

About the ADHD National Survey
Angus Reid Public Opinion surveyed 301 Canadian families with children between the ages of 6-12 who have been diagnosed with ADHD.  The survey was conducted between November 24 and December 7, 2009 using the Angus Reid Forum on-line panel.  The margin of error for a patient group sample of this size is +/-5.7%, nineteen times out of twenty.

About ADHD
ADHD is a mental health disorder that interferes with a child’s ability to regulate activity level, inhibit behaviour and attend to the task at hand. The three main symptoms of ADHD are inattention, hyperactivity and impulsivity. Boys are four to nine times more likely to be diagnosed with ADHD than girls.vi  The most common age for onset for ADHD is between three and four years, most children with ADHD continue to experience symptoms into adolescence and young adulthood.vii  Although the exact cause of ADHD is unknown, children with ADHD often have structural and functional variations in their brains including asymmetries and differences in blood flow.viii

About VYVANSE
The approval of VYVANSE was based on the results of two pivotal clinical studies.  In the phase III, randomized, double-blind placebo-controlled, four-week study, the primary efficacy endpoint was the ADHD Rating Scale (ADHD-RS-IV) total score change from baseline . In a phase II, randomized, double-blind, placebo and active controlled study conducted in a laboratory classroom setting, efficacy was measured based on the ADHD-RS scale across the 4-week treatment and the average of Swanson, Kotkin, Agler, M.Flynn and Pelham (SKAMP)-Deportment scores across the 8 sessions of a 12-hour treatment day.


About Shire (www.shire.com)
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. Shire Canada Inc. is a subsidiary of Shire plc. Shire Canada Inc.’s operations are headquartered in Montréal, Québec.

 

For further information on Shire, please visit the Company’s website: www.shire.com.

 

For further information or to arrange an interview, please contact:

Rob McEwan

Catherine Rose Cunningham

Argyle Communications

Massy-Forget Public Relations

416-968-7311

514-842-2455, ext. 33

rmcewan@argylecommunications.com

ccunningham@mfrp.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.

 

i Angus Reid Public Opinion poll of 301 Canadian families with children between the ages of 6-12 who have been diagnosed with ADHD.  The survey was conducted between November 24 and December 7, 2009 using the Angus Reid Forum on-line panel.

ii Canadian ADHD Practice Guidelines. Canadian ADHD Resource Alliance (CADDRA). Introduction. 2008.

iii Wadell et al 2007. Developing a research-policy partnership to improve children’s mental health in British Columbia. In LeClair & Foster (Eds.) Contemporary issues in mental health: Concepts, policy, and practice (Vol. 41, pp. 183-198).

iv IMS National prescription Audit (NpA). August 2009.

v Statistics Canada. Canadian Internet Use Survey. The Daily. Tuesday, August 15, 2006. http://www.statcan.gc.ca/daily-quotidien/060815/dq060815b-eng.htm

vi American Psychiatric Association. 2000. Diagnostic and statistical manual of mental disorders: DSM-IV-TR (4th ed.). Washington: American Psychiatric Association.

vii Connor.2002. Preschool attention deficit hyperactivity disorder: a review of prevalence, diagnosis, neurobiology and stimulant treatment. Journal of Developmental and Behavioral Pediatrics; 23: S1-9.

viii Connor.2002. Preschool attention deficit hyperactivity disorder: a review of prevalence, diagnosis, neurobiology and stimulant treatment. Journal of Developmental and Behavioral Pediatrics; 23: S1-9.

01 Feb 2010 VYVANSE® — new ADHD treatment option — now available in Canada (54KB PDF)

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