/R E P E A T -- New ADHD treatment now available in Canada: INTUNIV XR™ offers alternatives for children not responding well to current treatment/

INTUNIV XR is the first ever and only ADHD treatment approved by Health Canada for use both alone or in addition to stimulants

MONTREAL, Nov. 20, 2013 /CNW Telbec/ - Canadian families now have a new option to help manage their child's Attention Deficit Hyperactivity Disorder (ADHD); INTUNIV XR (guanfacine hydrochloride extended release tablets), a new and different class of ADHD medication, is now available in Canada for the treatment of ADHD in children ages 6 to 12.¹ The new once-daily treatment is approved for use either as a stand-alone treatment for ADHD or in addition to stimulants for children not responding optimally to stimulants.¹

"ADHD is a  neurobiological disorder that can result in significant impairment to learning and other distressing symptoms when not well-controlled, often  causing stress and suffering for the whole family," said Heidi Bernhardt, President and Executive Director, Centre for ADHD Awareness Canada (CADDAC). "The more options we have to treat children with ADHD the better chance we have of finding the best combination of treatments for all children struggling with this disorder."

Between 500,000 to 1.2 million Canadian children have ADHD.^2,3 In a recent survey of 311 parents of children with ADHD, more than half stated that their child is not well controlled on current medication. Almost one in ten (8 per cent) reported their child is not controlled, and a further 44 per cent stated their child is only partially controlled,⁴ suggesting many children may not be receiving the best possible care to manage their ADHD symptoms.

"Stimulants are the go-to treatment option for ADHD as they successfully manage the symptoms of most children, but not all respond as well as hoped." says Dr. Kenny Handelman, psychiatrist at the Oakville Trafalgar Memorial Hospital and expert in ADHD. "INTUNIV XR works differently than all other approved ADHD treatments. What's more, it can be used as a stand-alone treatment, or in combination with stimulant medication - opening the door to new choices for children still struggling with their ADHD."

INTUNIV XR is a selective alpha_2A-adrenergic receptor agonist, providing an alternative treatment for children (6 to 12 years old) in whom response to stimulant therapy has been suboptimal.¹

About INTUNIV XR
INTUNIV XR (guanfacine hydrochloride extended-release tablets) is an oral, once-daily treatment for Attention Deficit Hyperactivity Disorder (ADHD). Its active ingredient, guanfacine, is a selective alpha_2A-adrenergic receptor agonist.

INTUNIV XR received Health Canada approval 1) as monotherapy for the treatment of ADHD in children aged 6 to 12 years, and 2) as adjunctive therapy to psychostimulants for the treatment of ADHD in children, aged 6 to 12 years, with a sub-optimal response to psychostimulants.

The efficacy of INTUNIV XR in the treatment of ADHD was established in two, placebo-controlled monotherapy pivotal trials. A third study further evaluated the safety and efficacy of INTUNIV XR as adjunctive therapy to psychostimulants.

For more information regarding INTUNIV XR, please consult the product monograph available here: http://shirecanada.com/en/shire-canada/PDF%202013/Intuniv_XR_PM%2005-Jul-2013%20(2).pdf.

About ADHD
Attention Deficit Hyperactivity Disorder (ADHD) is a neurobiological disorder that affects approximately 5 to 12 per cent of the population.2 The most common behaviors exhibited by those who have ADHD are inattention, hyperactivity, and impulsivity. People with ADHD often have difficulty focusing, are easily distracted, have trouble staying still, and frequently are unable to control their impulsive behavior. If left unmanaged, ADHD can have serious adverse effects on the lives of those affected. Although there is no cure for ADHD, there are accepted treatments that specifically target its symptoms. Standard treatments include educational approaches, medication as well as psychological or behavioral therapy.

About Shire
Shire enables people with life-altering conditions to lead better lives.

Our strategy is to focus on developing and marketing innovative specialty medicines to meet significant unmet patient needs.

We provide treatments in Neuroscience, Rare Diseases, Gastrointestinal, Internal Medicine and Regenerative Medicine and we are developing treatments for symptomatic conditions treated by specialist physicians in other targeted therapeutic areas.

www.shire.com

About Shire Canada Inc.
Shire Canada Inc. is a subsidiary of Shire with headquarters located in Montréal (Saint-Laurent), Québec. For more information, please visit: www.shirecanada.com.

References:
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¹ INTUNIV XR Product Monograph, Shire Canada Inc., July 5, 2013.
² Canadian ADHD Resource Alliance. What is ADHD? http://caddra.ca/cms4/index.php?option=com_content&view=article&id=22&Itemid=233&lang=en Accessed July 31, 2013.
³ Statistics Canada. Census families by number of children at home, by province and territory http://www.statcan.gc.ca/tables-tableaux/sum-som/l01/cst01/famil50a-eng.htm
⁴ IPSOS ADHD Parent Poll. (Sponsored by Shire). August 2013

SOURCE: Shire