7th Apr 2006 09:36
Shire's DAYTRANATM transdermal patch approved by FDA for treatment of ADHD Philadelphia, PA, US and Basingstoke, UK - April XX, 2006 -- Shire plc (LSE:SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that the U.S. Food and DrugAdministration (FDA) approved DAYTRANA (methylphenidate transdermal system),the first and only non-oral medication for the treatment of attention deficithyperactivity disorder (ADHD). DAYTRANA, a once daily transdermal patchformulation of methylphenidate, will be available in 10 mg, 15 mg, 20 mg and 30mg dosage strengths."The approval of DAYTRANA is important news for ADHD patients, their familiesand healthcare providers. In addition to being the only patch treatment forADHD, it offers a convenient option to deliver medicine for those diagnosedwith ADHD," said Shire Chief Executive Officer Matthew Emmens. "The addition ofDAYTRANA to Shire's portfolio reaffirms our position as the market leader inADHD."Shire and Noven Pharmaceuticals, Inc. submitted an amended New Drug Application(NDA) for DAYTRANA to the FDA in June of last year. DAYTRANA is licensedglobally to Shire by Noven and will be available in pharmacies in the U.S. inmid 2006.The efficacy of DAYTRANA was established in two controlled clinical trials inchildren aged 6 to 12 years old with ADHD. DAYTRANA combines methylphenidate, amedication with a 50-year history of use, with Noven's patented DOT Matrix¢â€ž¢transdermal technology. This transdermal delivery system delivers medicationdirectly through the skin into the bloodstream, and is designed to provideconsistent, smooth drug release throughout the day. The patch is designed tostay on during the normal daily activities of a child, including swimming,exercising, and bathing. Because DAYTRANA is a patch, physicians can manage theduration of its effect and potential side effects by having the patient wearthe patch for a shorter time period than the recommended 9 hour wear time on agiven day. In clinical trials, wearing a DAYTRANA patch for 9 hours provided aduration of effect of 12 hours."The FDA's approval of DAYTRANA offers an important new option in the treatmentof ADHD in children," said Robert Findling, MD, lead investigator and Professorof Psychiatry; Director, Division of Adolescent and Child Psychiatry, CaseWestern University. "DAYTRANA has been shown to be effective and generally welltolerated in clinical studies, and offers ADHD treatment in the convenient formof a patch."As part of the agreement between Shire and Noven for DAYTRANA, Shire completedan upfront payment to Noven of $25 million in 2003, and may make separatemilestone payments up to $125 million; $50 million will be paid dictated bythis FDA approval and $75 million conditioned upon the achievement of certainsales targets.DAYTRANA Significantly Controls ADHD SymptomsData from phase II and phase III clinical trials demonstrated statisticallysignificant improvements in the primary and secondary endpoints analyzed forchildren treated with DAYTRANA compared to children treated with placebo.The phase II analog classroom study included 79 children with ADHD. The patchwas worn for nine hours, and efficacy was assessed throughout the day for 12hours. DAYTRANA demonstrated statistically significant improvement over placeboon the measures tested. Behavior, which was measured using the Swanson, Kotkin,Agler, M-Flynn, and Pelham-Deportment (SKAMP-D) scale, was improved withDAYTRANA overall (mean score 3.2 for DAYTRANA versus 8.0 for placebo) and atall time points assessed up to and including 12 hours post-application (P <.01). The mean number of math problems attempted by children taking DAYTRANA onthe Permanent Product Measure of Performance (PERMP) scale was significantlymore than those taking placebo (P SHIRE PLCRelated Shares:
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