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		<title>Health Canada Approves VyvanseÂ® for the Treatment of ADHD in Adolescents and Adults</title>
		<link>http://symptomadvice.com/health-canada-approves-vyvansea%c2%ae-for-the-treatment-of-adhd-in-adolescents-and-adults/</link>
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		<pubDate>Tue, 15 Feb 2011 22:34:08 +0000</pubDate>
		<dc:creator>Symptom Advice</dc:creator>
				<category><![CDATA[adhd symptoms]]></category>
		<category><![CDATA[adhd in adolescents]]></category>
		<category><![CDATA[adult adhd]]></category>
		<category><![CDATA[deficit hyperactivity disorder adhd]]></category>
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		<category><![CDATA[misconception]]></category>
		<category><![CDATA[shp]]></category>

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		<description><![CDATA[Press Release Source: Shire plc &#111;&#110; Wednesday February 2, 2011, 5:59 &#097;&#109; EST MONTREAL, Feb. 2 /CNW Telbec/ &#8211; 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. &#8220;There &#105;&#115; &#097; misconception that [...]]]></description>
			<content:encoded><![CDATA[<p></p><p><img src="http://symptomadvice.com/wp-content/uploads/2011/02/1297809248-50.jpg" style="clear:both;clear:both;margin:0 15px 15px 0" /><strong>Press Release</strong> Source: Shire plc &#111;&#110; Wednesday February 2, 2011, 5:59 &#097;&#109; EST
<p>MONTREAL, Feb. 2 /CNW Telbec/ &#8211; 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.</p>
<p>&#8220;There &#105;&#115; &#097; misconception that ADHD &#105;&#115; &#097; childhood condition &#098;&#117;&#116; thereality &#105;&#115; that &#097;&#110; estimated 1.1 million Canadian adultsi,ii are living withthis neurological condition, the symptoms &#111;&#102; which &#099;&#097;&#110; significantly impactall aspects &#111;&#102; daily living,&#8221; said ADHD expert, Dr. Isaac Szpindel, MD. &#8220;Thistreatment option &#105;&#115; significant news for adults with ADHD.&#8221;</p>
<p>VYVANSE &#105;&#115; the &#102;&#105;&#114;&#115;&#116; and &#111;&#110;&#108;&#121; once-daily prodrug stimulant approved totreat ADHD in adolescents and adults.</p>
<p>Current unmet &#110;&#101;&#101;&#100; &#097; recent Angus-Reid survey &#111;&#102; 302 Canadian adultsdiagnosed with ADHD &#115;&#104;&#111;&#119;&#101;&#100; &#109;&#111;&#115;&#116; adults with ADHD rank symptom control &#097;&#115; oneof the &#109;&#111;&#115;&#116; important qualities they &#108;&#111;&#111;&#107; for in &#097;&#110; ADHD medication. 96 percent &#111;&#102; &#116;&#104;&#111;&#115;&#101; surveyed reported symptom control throughout the day &#097;&#115; animportant attribute &#111;&#102; the ideal ADHD medication. &#108;&#101;&#115;&#115; than one in &#102;&#105;&#118;&#101; (18per cent) say that their ADHD &#099;&#097;&#117;&#115;&#101;&#115; no disruption &#100;&#117;&#114;&#105;&#110;&#103; the &#099;&#111;&#117;&#114;&#115;&#101; &#111;&#102; theday.</p>
<p>&#8220;When it comes &#116;&#111; adult ADHD we shouldn&#8217;t underestimate the potentiallydownward-spiralling effects &#111;&#102; uncontrolled ADHD and the benefit &#111;&#102; symptomcontrol throughout the day,&#8221; said Heidi Bernhardt, National Director &#111;&#102; theCentre for ADHD/ADD Advocacy, Canada (CADDAC). &#8220;ADHD &#105;&#115; &#097; treatable conditionthat &#099;&#097;&#110; &#098;&#101; managed &#105;&#102; people with it &#104;&#097;&#118;&#101; access &#116;&#111; effective treatment thattheir doctors recommend.&#8221;</p>
<p>About the survey &#097; nationwide online survey &#111;&#102; Canadian adults age 18 andover &#119;&#104;&#111; &#104;&#097;&#118;&#101; &#098;&#101;&#101;&#110; diagnosed with ADHD &#119;&#097;&#115; conducted &#098;&#121; Angus Reid PublicOpinion &#111;&#110; behalf &#111;&#102; Shire Canada Inc. &#097; total &#111;&#102; 302 adults from across thecountry &#119;&#101;&#114;&#101; surveyed. The data &#119;&#101;&#114;&#101; collected between October 19, 2010 andNovember 1, 2010. The margin &#111;&#102; error for results based &#111;&#110; the total sample of302 &#105;&#115; ±5.7 percentage points, 19 times &#111;&#117;&#116; &#111;&#102; 20.</p>
<p>About ADHD Attention deficit hyperactivity disorder (ADHD) &#105;&#115; aneurobiological disorder that &#105;&#115; often hereditary and results in difficultyregulating attention and &#099;&#097;&#110; include impulsiveness and hyperactivity. ADHDsymptoms impact &#109;&#111;&#115;&#116; aspects &#111;&#102; daily living including organizational and timemanagement skills. According &#116;&#111; the Centre for ADHD/ADD Advocacy, Canada(CADDAC), the &#109;&#111;&#115;&#116; conservative estimates &#105;&#110;&#100;&#105;&#099;&#097;&#116;&#101; that ADHD affects &#111;&#118;&#101;&#114; 1million Canadians. Experts estimate that 80 &#112;&#101;&#114; cent &#111;&#102; children diagnosedwith ADHD continue &#116;&#111; meet the criteria for diagnosis in adolescence and morethan 60 &#112;&#101;&#114; cent &#111;&#102; report suffering from symptoms &#111;&#102; ADHD in adulthood. ADHDhas &#097; significant impact &#111;&#110; our social and economic systems, and &#105;&#115; estimatedto cost the Canadian economy close &#116;&#111; 8 million dollars each year.</p>
<p>About VYVANSE VYVANSE (lisdexamfetamine dimesylate capsules) &#105;&#115; atherapeutically inactive prodrug, in which d-amphetamine &#105;&#115; covalently bondedto l-lysine. For VYVANSE &#116;&#111; release its active ingredient, d-amphetamine, anenzymatic reaction &#104;&#097;&#115; &#116;&#111; &#116;&#097;&#107;&#101; &#112;&#108;&#097;&#099;&#101;: &#097;&#102;&#116;&#101;&#114; oral ingestion it &#105;&#115; rapidlyabsorbed from the gastro-intestinal tract and converted &#116;&#111; pharmacologicallyactive d-amphetamine and L-lysine &#098;&#121; hydrolysis in the bloodiii,iv.</p>
<p>VYVANSE &#119;&#097;&#115; approved &#098;&#121; Health Canada in February 2009 for the treatmentof ADHD in children aged 6 &#116;&#111; 12 years and &#105;&#115; now &#097;&#108;&#115;&#111; indicated for thetreatment &#111;&#102; ADHD for adolescents aged 13 &#116;&#111; 17 years and adults.</p>
<p>The approval &#111;&#102; VYVANSE in adolescents and adults &#119;&#097;&#115; based &#111;&#110; theresults &#111;&#102; &#116;&#119;&#111; pivotal clinical studies (one in adolescents aged 13 &#116;&#111; 17, andone in adults). In the phase 3, randomized, double-blind placebo-controlled,four-week studies, the primary efficacy endpoint &#119;&#097;&#115; the ADHD Rating Scale(ADHD-RS-IV) total score change from baseline. In &#097;&#110; additional randomized,double-blind placebo-controlled clinical study in adults in &#097; simulatedworkplace environment, efficacy &#119;&#097;&#115; measured &#117;&#115;&#105;&#110;&#103; the PERMP (math problems)score &#097;&#116; 2, 4, 8, 10, 12 and 14 hours post-dose.</p>
<p>About Shire plc Shire plc&#8217;s strategic goal &#105;&#115; &#116;&#111; become the leadingspecialty biopharmaceutical company that focuses &#111;&#110; meeting the needs &#111;&#102; thespecialist physician. Shire focuses its business &#111;&#110; attention deficit andhyperactivity disorder (ADHD), human genetic therapies (HGT) andgastrointestinal (GI) diseases &#097;&#115; &#119;&#101;&#108;&#108; &#097;&#115; opportunities in other therapeuticareas &#116;&#111; the extent they arise through acquisitions. The structure issufficiently flexible &#116;&#111; &#097;&#108;&#108;&#111;&#119; Shire &#116;&#111; target new therapeutic areas &#116;&#111; theextent opportunities arise through acquisitions. Shire&#8217;s in-licensing, mergerand acquisition efforts are focused &#111;&#110; products in niche markets with strongintellectual property protection and global rights. Shire believes that acarefully selected and balanced portfolio &#111;&#102; products with strategicallyaligned and &#114;&#101;&#108;&#097;&#116;&#105;&#118;&#101;&#108;&#121; small-scale sales forces will deliver strong results.</p>
<p>For &#102;&#117;&#114;&#116;&#104;&#101;&#114; information &#097;&#098;&#111;&#117;&#116; Shire Canada, &#112;&#108;&#101;&#097;&#115;&#101; visit the Company&#8217;swebsite: shirecanada.com</p>
<p>&#8220;SAFE HARBOR&#8221; STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORMACT OF 1995 Statements included herein that are not historical facts areforward-looking statements. &#115;&#117;&#099;&#104; forward-looking statements involve &#097; numberof risks and uncertainties and are subject &#116;&#111; change &#097;&#116; any time. In the eventsuch risks or uncertainties materialize, the Company&#8217;s results &#099;&#111;&#117;&#108;&#100; bematerially adversely affected. The risks and uncertainties include, &#098;&#117;&#116; arenot limited &#116;&#111;, risks associated with: the inherent uncertainty &#111;&#102; research,development, approval, reimbursement, manufacturing and commercialization ofthe Company&#8217;s Specialty Pharmaceutical and Human Genetic Therapies products,&#097;&#115; &#119;&#101;&#108;&#108; &#097;&#115; the ability &#116;&#111; secure and integrate new products forcommercialization and/or development; government regulation &#111;&#102; the Company&#8217;sproducts; the Company&#8217;s ability &#116;&#111; manufacture its products in sufficientquantities &#116;&#111; meet demand; the impact &#111;&#102; competitive therapies &#111;&#110; theCompany&#8217;s products; the Company&#8217;s ability &#116;&#111; register, maintain and enforcepatents and other intellectual property rights relating &#116;&#111; its products; theCompany&#8217;s ability &#116;&#111; obtain and maintain government and other third-partyreimbursement for its products; and other risks and uncertainties detailedfrom time &#116;&#111; time in the Company&#8217;s filings with the Securities and ExchangeCommission.</p>
<p>Video News Release available &#118;&#105;&#097; satellite</p>
<p>Wednesday February 2, 2011 10:00 &#8211; 10:30 and &#097;&#103;&#097;&#105;&#110; &#097;&#116; 14:00 &#8211; 14:30Eastern Anik F2C/3B Download Freq: 3820MHz V Audio subcarriers 6.8 left, 6.2right For assistance with the feed &#099;&#097;&#108;&#108;: 1-800-565-1471</p>
<p>Video News Release will &#097;&#108;&#115;&#111; available &#118;&#105;&#097; download &#111;&#110; Wednesday February2, 2011</p>
<p>Click &#104;&#101;&#114;&#101; &#116;&#111; access broadcast quality footage:newscanada.com/mpgdownload.asp?id=4117</p>
<p>Please contact cdillon(at)newscanada.&#099;&#111;&#109; &#105;&#102; &#121;&#111;&#117; do not &#104;&#097;&#118;&#101; &#121;&#111;&#117;&#114; login IDand password.</p>
<p>To view this news release in HTML formatting, &#112;&#108;&#101;&#097;&#115;&#101; use the following URL:cnw.ca/en/releases/archive/February2011/02/c7032.html</p>
<p><b>For &#102;&#117;&#114;&#116;&#104;&#101;&#114; information</b>Natacha Raphaël Manager, Communications &amp; Community Relations ShireCanada Inc 514-787-2364 nraphael-c@shire.&#099;&#111;&#109; Katie Lofquist Hill and Knowlton </p></p>
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