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.
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.
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
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
"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:
Manager, Communications & Community Relations
Shire Canada Inc
Hill and Knowlton