Press Release Source: Shire plc on Wednesday February 2, 2011, 5:59 am EST
MONTREAL, Feb. 2 /CNW Telbec/ – Shire plc (LSE: SHP, NASDAQ: SHPGY), theglobal specialty biopharmaceutical company, announces that Health Canada hasapproved VYVANSE® (lisdexamfetamine dimesylate capsules) for the treatment ofattention deficit hyperactivity disorder (ADHD) in adolescents and adults.
“There is a misconception that ADHD is a childhood condition but thereality is that an estimated 1.1 million Canadian adultsi,ii are living withthis neurological condition, the symptoms of which can significantly impactall aspects of daily living,” said ADHD expert, Dr. Isaac Szpindel, MD. “Thistreatment option is significant news for adults with ADHD.”
VYVANSE is the first and only once-daily prodrug stimulant approved totreat ADHD in adolescents and adults.
Current unmet need a recent Angus-Reid survey of 302 Canadian adultsdiagnosed with ADHD showed most adults with ADHD rank symptom control as oneof the most important qualities they look for in an ADHD medication. 96 percent of those surveyed reported symptom control throughout the day as animportant attribute of the ideal ADHD medication. less than one in five (18per cent) say that their ADHD causes no disruption during the course of theday.
“When it comes to adult ADHD we shouldn’t underestimate the potentiallydownward-spiralling effects of uncontrolled ADHD and the benefit of symptomcontrol throughout the day,” said Heidi Bernhardt, National Director of theCentre for ADHD/ADD Advocacy, Canada (CADDAC). “ADHD is a treatable conditionthat can be managed if people with it have access to effective treatment thattheir doctors recommend.”
About the survey a nationwide online survey of Canadian adults age 18 andover who have been diagnosed with ADHD was conducted by Angus Reid PublicOpinion on behalf of Shire Canada Inc. a total of 302 adults from across thecountry were surveyed. The data were collected between October 19, 2010 andNovember 1, 2010. The margin of error for results based on the total sample of302 is ±5.7 percentage points, 19 times out of 20.
About ADHD Attention deficit hyperactivity disorder (ADHD) is aneurobiological disorder that is often hereditary and results in difficultyregulating attention and can include impulsiveness and hyperactivity. ADHDsymptoms impact most aspects of daily living including organizational and timemanagement skills. According to the Centre for ADHD/ADD Advocacy, Canada(CADDAC), the most conservative estimates indicate that ADHD affects over 1million Canadians. Experts estimate that 80 per cent of children diagnosedwith ADHD continue to meet the criteria for diagnosis in adolescence and morethan 60 per cent of report suffering from symptoms of ADHD in adulthood. ADHDhas a significant impact on our social and economic systems, and is estimatedto cost the Canadian economy close to 8 million dollars each year.
About VYVANSE VYVANSE (lisdexamfetamine dimesylate capsules) is atherapeutically inactive prodrug, in which d-amphetamine is covalently bondedto l-lysine. For VYVANSE to release its active ingredient, d-amphetamine, anenzymatic reaction has to take place: after oral ingestion it is rapidlyabsorbed from the gastro-intestinal tract and converted to pharmacologicallyactive d-amphetamine and L-lysine by hydrolysis in the bloodiii,iv.
VYVANSE was approved by Health Canada in February 2009 for the treatmentof ADHD in children aged 6 to 12 years and is now also indicated for thetreatment of ADHD for adolescents aged 13 to 17 years and adults.
The approval of VYVANSE in adolescents and adults was based on theresults of two pivotal clinical studies (one in adolescents aged 13 to 17, andone 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 simulatedworkplace 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 leadingspecialty biopharmaceutical company that focuses on meeting the needs of thespecialist physician. Shire focuses its business on attention deficit andhyperactivity disorder (ADHD), human genetic therapies (HGT) andgastrointestinal (GI) diseases as well as opportunities in other therapeuticareas to the extent they arise through acquisitions. The structure issufficiently flexible to allow Shire to target new therapeutic areas to theextent opportunities arise through acquisitions. Shire’s in-licensing, mergerand acquisition efforts are focused on products in niche markets with strongintellectual property protection and global rights. Shire believes that acarefully selected and balanced portfolio of products with strategicallyaligned and relatively small-scale sales forces will deliver strong results.
For further information about Shire Canada, please visit the Company’swebsite: shirecanada.com
“SAFE HARBOR” STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORMACT OF 1995 Statements included herein that are not historical facts areforward-looking statements. such forward-looking statements involve a numberof risks and uncertainties and are subject to change at any time. In the eventsuch risks or uncertainties materialize, the Company’s results could bematerially adversely affected. The risks and uncertainties include, but arenot limited to, risks associated with: the inherent uncertainty of research,development, approval, reimbursement, manufacturing and commercialization ofthe Company’s Specialty Pharmaceutical and Human Genetic Therapies products,as well as the ability to secure and integrate new products forcommercialization and/or development; government regulation of the Company’sproducts; the Company’s ability to manufacture its products in sufficientquantities to meet demand; the impact of competitive therapies on theCompany’s products; the Company’s ability to register, maintain and enforcepatents and other intellectual property rights relating to its products; theCompany’s ability to obtain and maintain government and other third-partyreimbursement for its products; and other risks and uncertainties detailedfrom time to time in the Company’s filings with the Securities and ExchangeCommission.
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For further informationNatacha Raphaël Manager, Communications & Community Relations ShireCanada Inc 514-787-2364 nraphael-c@shire.com Katie Lofquist Hill and Knowlton