Health Canada Approves Vyvanse® for the Treatment of ADHD in Adolescents and Adults

MONTREAL, Feb. 2 /CNW Telbec/ - Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that Health Canada has approved VYVANSE® (lisdexamfetamine dimesylate capsules) for the treatment of attention deficit hyperactivity disorder (ADHD) in adolescents and adults.

"There is a misconception that ADHD is a childhood condition but the reality is that an estimated 1.1 million Canadian adultsi,ii are living with this neurological condition, the symptoms of which can significantly impact all aspects of daily living," said ADHD expert, Dr. Isaac Szpindel, MD.  "This treatment option is significant news for adults with ADHD."

VYVANSE is the first and only once-daily prodrug stimulant approved to treat ADHD in adolescents and adults.

Current unmet need
A recent Angus-Reid survey of 302 Canadian adults diagnosed with ADHD showed most adults with ADHD rank symptom control as one of the most important qualities they look for in an ADHD medication. 96 per cent of those surveyed reported symptom control throughout the day as an important attribute of the ideal ADHD medication. Less than one in five (18 per cent) say that their ADHD causes no disruption during the course of the day.

"When it comes to adult ADHD we shouldn't underestimate the potentially downward-spiralling effects of uncontrolled ADHD and the benefit of symptom control throughout the day," said Heidi Bernhardt, National Director of the Centre for ADHD/ADD Advocacy, Canada (CADDAC). "ADHD is a treatable condition that can be managed if people with it have access to effective treatment that their doctors recommend."

About the survey
A nationwide online survey of Canadian adults age 18 and over who have been diagnosed with ADHD was conducted by Angus Reid Public Opinion on behalf of Shire Canada Inc.  A total of 302 adults from across the country were surveyed. The data were collected between October 19, 2010 and November 1, 2010. The margin of error for results based on the total sample of 302 is ±5.7 percentage points, 19 times out of 20.

About ADHD
Attention deficit hyperactivity disorder (ADHD) is a neurobiological disorder that is often hereditary and results in difficulty regulating attention and can include impulsiveness and hyperactivity. ADHD symptoms impact most aspects of daily living including organizational and time management skills. According to the Centre for ADHD/ADD Advocacy, Canada (CADDAC), the most conservative estimates indicate that ADHD affects over 1 million Canadians. Experts estimate that 80 per cent of children diagnosed with ADHD continue to meet the criteria for diagnosis in adolescence and more than 60 per cent of report suffering from symptoms of ADHD in adulthood. ADHD has a significant impact on our social and economic systems, and is estimated to cost the Canadian economy close to 8 million dollars each year.

About VYVANSE
VYVANSE (lisdexamfetamine dimesylate capsules) is a therapeutically inactive prodrug, in which d-amphetamine is covalently bonded to l-lysine. For VYVANSE to release its active ingredient, d-amphetamine, an enzymatic reaction has to take place: after oral ingestion it is rapidly absorbed from the gastro-intestinal tract and converted to pharmacologically active d-amphetamine and L-lysine by hydrolysis in the bloodiii,iv.

VYVANSE was approved by Health Canada in February 2009 for the treatment of ADHD in children aged 6 to 12 years and is now also indicated for the treatment of ADHD for adolescents aged 13 to 17 years and adults.

The approval of VYVANSE in adolescents and adults was based on the results of two pivotal clinical studies (one in adolescents aged 13 to 17, and one in adults). In the phase 3, randomized, double-blind placebo-controlled, four-week studies, the primary efficacy endpoint was the ADHD Rating Scale (ADHD-RS-IV) total score change from baseline. In an additional randomized, double-blind placebo-controlled clinical study in adults in a simulated workplace environment, efficacy was measured using the PERMP (math problems) score at 2, 4, 8, 10, 12 and 14 hours post-dose.

About Shire plc
Shire plc'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. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire's in-licensing, merger and acquisition efforts are focused on products in niche 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 about Shire Canada, please visit the Company's website: www.shirecanada.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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i Kessler RC et al. The prevalence and correlates of adult ADHD in the United States: results from the National Comorbidity Survey Replication. Abstract available at: http://www.ncbi.nlm.nih.gov/pubmed/16585449 Accessed on January 24, 2011.
ii Statistics Canada. 2010 Canada: Population by sex and age group. Available at: http://www40.statcan.gc.ca/l01/cst01/demo10a-eng.htm Accessed on January 24, 2011
iii Biederman J, Hodgkins P, Krishnan S, Findling RL. Efficacy and tolerability of lisdexamfetamine (NRP104) in children with attention-deficit/hyperactivity disorder (ADHD):  A phase 3, randomized, multi-center, randomized, double-blind, forced-dose, parallel group study. Clinical Therapeutics.  2007; 29:450-463.
iv VYVANSE Product Monograph. Shire Canada Inc., November 25, 2010.

SOURCE Shire plc

For further information:

Natacha Raphaël
Manager, Communications & Community Relations
Shire Canada Inc
514-787-2364
nraphael-c@shire.com

Katie Lofquist
Hill and Knowlton
416-413-4756
katie.lofquist@hillandknowlton.ca

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